Evaluation under REACH : progress report 2017 : 10 years of experience.
Date: 2018-03-20
Institutions: European Chemicals Agency
Subjects: chemical industry, chemical product, environmental risk prevention, industrial research, report, research and development, testing

Evaluation under REACH: 
Progress Report 2017 

10 years of experience 

 
 
 
 
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Disclaimer 

Evaluation under REACH: Progress Report 2017 

This publication is solely intended for information purposes and does not necessarily represent 
the official opinion of the European Chemicals Agency. The European Chemicals Agency is not 
responsible for the use that may be made of the information contained in this document. 

Version 

Changes 

Title: Evaluation under REACH: Progress Report 2017 
10 years of experience 

Reference: ECHA-18-R-05-EN  
ISBN: 978-92-9020-425-1 
Cat. Number: ED-AD-18-001-EN-N  
ISSN: 1831-6506 
DOI: 10.2823/76886 
Publ.date: February 2018 
Language: EN 

© European Chemicals Agency, 2018 
Cover page © European Chemicals Agency 

If you have questions or comments in relation to this document please send them (quote the 
reference and issue date) using the information request form. The information request form 
can be accessed via the Contact ECHA page at: 
http://echa.europa.eu/contact  

European Chemicals Agency 

Mailing address: P.O. Box 400, FI-00121 Helsinki, Finland 
Visiting address: Annankatu 18, Helsinki, Finland 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Evaluation under REACH: Progress Report 2017 

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Table of contents 

FOREWORD ................................................................................................................. 5 

EXECUTIVE SUMMARY ................................................................................................ 6 

KEY RECOMMENDATIONS TO REGISTRANTS ............................................................... 9 

1. THE EVOLUTION OF EVALUATION AND ECHA - 10 YEARS OF EXPERIENCE ........... 11 

1.1 Objectives of the legislation .................................................................................... 11 
1.2 Registrations ......................................................................................................... 11 
1.3 Compliance of information and the safe use of chemicals ............................................ 12 

1.3.1 Compliance checks .......................................................................................................... 12 
1.3.2 Testing proposal examinations .......................................................................................... 15 
1.3.3 Follow-up to dossier evaluation ......................................................................................... 17 
1.3.4 Substance evaluation ....................................................................................................... 18 

1.4 The future of REACH evaluation ............................................................................... 20 

2. EVALUATION PROGESS IN 2017 ........................................................................... 22 

2.1 Summary of evaluation progress in 2017 in numbers ................................................. 22 
2.2 Dossier selection and pre-processing ....................................................................... 24 
2.3 Compliance checks ................................................................................................ 26 

2.3.1 Compliance check overall ................................................................................................. 26 
2.3.2 Scientific and legal assessment ......................................................................................... 27 
2.3.3 Decision making .............................................................................................................. 28 
2.3.4 Information requested in ECHA adopted compliance check decisions ...................................... 29 

2.4 Testing proposals .................................................................................................. 31 

2.4.1 Alternatives to animal testing ........................................................................................... 32 
2.4.2 Testing proposal examination............................................................................................ 32 
2.4.3 Decision making .............................................................................................................. 33 
2.4.4 Information requested ..................................................................................................... 35 

2.5 Follow-up to dossier evaluation ............................................................................... 35 
2.6 Substance evaluation ............................................................................................. 37 

2.6.1 Selection and prioritisation of substances for evaluation ....................................................... 40 
2.6.2 Evaluation by Member State competent authorities ............................................................. 41 
2.6.3 Decision making .............................................................................................................. 42 
2.6.4 Information requested ..................................................................................................... 43 
2.6.5 Follow-up evaluation of substance evaluation decisions ........................................................ 44 
2.6.6 Concluding substance evaluation ....................................................................................... 44 

3. OTHER MEASURES TO ENHANCE DOSSIER QUALITY ............................................. 47 

3.1 Enhanced completeness check ................................................................................ 47 
3.2 Promoting dossier updates ...................................................................................... 49 
3.3 Substance identification.......................................................................................... 50 
3.4 The collaborative approach pilots ............................................................................. 51 
3.5 Working with sectors .............................................................................................. 53 
3.6 Letter campaign on shortlisted substances ................................................................ 53 
3.7 Intermediate status verification ............................................................................... 54 
3.8 Transparency regarding content and target of ECHA decisions ..................................... 55 

 
 
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Evaluation under REACH: Progress Report 2017 

4. EVALUATION RELATED ACTIVITIES ...................................................................... 56 

4.1 Non-animal approaches .......................................................................................... 56 
4.2 Expert working groups ........................................................................................... 58 
4.3 Good laboratory practice ........................................................................................ 58 
4.4 Test guideline developments ................................................................................... 59 
4.5 Extended one-generation reproductive toxicity study ................................................. 59 
4.6 Litigation and European Ombudsman cases .............................................................. 60 

5. RECOMMENDATIONS TO REGISTRANTS ................................................................ 64 

5.1 Report the identity of your substance and representative test material correctly ............ 64 
5.2 Provide information on GLP compliance of the whole study ......................................... 65 
5.3 Make sure your registration dossier is complete......................................................... 65 
5.4 Use the support available for REACH 2018 registrants ................................................ 65 
5.5 Avoid unnecessary testing on animals ...................................................................... 67 
5.6 Your chemical safety report should reflect the actual uses and risks ............................. 68 
5.7 Familiarise yourself with new guidance on PBT/vPvB assessment ................................. 71 
5.8 Identify and address information of the degradation products ..................................... 71 
5.9 Classify multi-constituent and UVCB substances correctly ........................................... 71 
5.10 Familiarise yourself with new documents on nanomaterials ....................................... 72 
5.11 Respond to ECHA’s evaluation decisions ................................................................. 72 
5.12 Recommendations related to substance evaluation................................................... 73 
5.13 Take note of ECHA’s Guidance updates ................................................................... 75 
5.14 Consider the impact of the United Kingdom’s withdrawal from the EU on your 

registration ........................................................................................................ 76 

LIST OF ABBREVIATIONS AND ACRONYMS ............................................................... 77 

 
 
 
Evaluation under REACH: Progress Report 2017 

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FOREWORD 

Dear reader, 

This is ECHA’s tenth report on progress in evaluation under REACH – and 
for me the first one as ECHA’s Executive Director. I am thrilled to 
continue the important work assigned to our Agency under this very 
challenging legislation. This includes the core tasks on evaluating 
dossiers and substances under REACH, the area where ECHA has been 
given significant powers – and the high responsibility coming with such 
powers.  

Three months from the publication of this report, the 11-year-long 
transitional period comes to its end: after 31 May 2018, all so-called 
phase-in substances that are manufactured or imported in the EU in 
amounts of more than 1 tonne per year must have been registered. This last registration 
deadline will complete the database on existing substances, and it will also bring a whole new 
challenge for evaluation. In addition to examining the testing proposals in the last phase-in 
dossiers, ECHA will have to select at least 5 % of the dossiers for compliance check also from 
the newly submitted low-tonnage registrations, which may mean over 3000 dossiers. At the 
same time, the frequent non-compliances found when evaluating higher tonnage (>100 
tn/year) dossiers mean that we need to continue to address the inadequate adaptations and 
waiving statements in those dossiers and to request the missing data. This work forms an 
essential part of ECHA’s Integrated Regulatory Strategy and is key to meeting our ambitious 
global goal on chemicals management. 

The forthcoming Commission communication on the review of REACH will take stock of the 
overall effectiveness and efficiency of the legislation and its implementation. Dossier and 
substance evaluation are such a core part of the regulation that we can expect 
recommendations also regarding their further improvement. I firmly believe that together with 
the Member States we can indeed further speed up and increase the impact of our joint 
evaluation work and ensure that the necessary information on substances is being generated, 
allowing authorities to conclude on whether further regulatory measures are needed. 

For the key audience of this report, the REACH registrants, we again bring a set of 
recommendations. After the phase-in period is over, the focus of registrants needs to turn to 
ensuring that their dossiers are kept up to date, in terms of tonnages, uses, exposure and 
hazard information. As this report also briefly describes, a large part of dossiers have not been 
updated since they were first submitted, which raises questions on the incentives (or lack of 
them) for complying with obligations regarding updates. ECHA is screening all dossiers and, 
together with Member States, prioritises those where we have reasons to suspect exposure 
and hazards not being properly addressed. Take care that your dossier is ready to be 
scrutinised and is not prioritised because of inaccurate or missing information! 

This tenth annual progress report on evaluation is also the last one in its current format. From 
next year onwards we will merge this report with the annual report on implementing the SVHC 
Roadmap. This illustrates the learnings of the past 10 years: effective and efficient 
implementation of REACH needs to continue forcefully and the various processes and actors 
need to come together to step up the efforts for meeting the ambitious objectives set by the 
legislator!  

Bjorn Hansen  

Executive Director 

 
 
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Evaluation under REACH: Progress Report 2017 

EXECUTIVE SUMMARY 

This is ECHA’s tenth progress report on evaluation under the REACH Regulation. It summarises 
10 years of experience from the evaluation activities carried out so far, and gives a more 
detailed account of ECHA’s evaluation activities in 2017. It also provides recommendations to 
new and existing registrants deriving from this experience. 

Trends in ECHA’s evaluation activities since 2008 
During the first years of evaluation, from 2008 to 2010, the ECHA Secretariat picked dossiers 
for compliance check based on random selection, IT screening and manual prioritisation. 
During these years, 105 dossiers were checked and 12 decisions were adopted. Altogether 
these decisions addressed compliance deficiencies on 23 information requirements, mainly on 
physico-chemical properties, screening for reproductive/developmental toxicity and the quality 
of the chemical safety report. At the same time ECHA, its Member State Committee and the 
Member States gained important experience on all aspects of the dossier evaluation process 
and built the capacity and skills necessary for addressing a higher volume of cases. 

Over the three years following the first registration deadline of 2010, ECHA focused compliance 
checks increasingly on dossiers picked up by systematic IT screening. Selected information 
requirements were addressed in a standardised manner. This led to total of 1 464 targeted 1  
and overall checks and 329 adopted decisions, each often containing one or two information 
requests. The first 5 % target2 on 2010 dossiers was thereby also met at the end of 2013. 

In 2014, ECHA moved to addressing also dossiers from the second phase-in deadline. With the 
help of improved screening tools, the Agency started selecting dossiers of substances of 
potential concern, i.e. those substances for which (i) the hazard profile for higher-tier 
(eco)toxicity information requirements3,4 indicates a potential concern (or the hazard profile is 
unclear and needs to be further examined) and (ii) there is significant exposure potential. The 
focus was put on the key information requirements that could help to clarify if the substance is 
likely to be carcinogenic, mutagenic and reprotoxic (CMR) and/or (very) persistent, 
bioaccumulative and toxic (PBT/vPvB). Those information requirements are key in enabling the 
identification of a substance as being of very high concern. Since 2015, this approach has 
formed a core part of ECHA’s Integrated Regulatory Strategy5. Compared to the previous 
approach, the number of compliance checks and decisions is lower, but the number of 
information requests has increased to an average of five requests per decision taken in 2017. 

Overall, during the 10 years of evaluation, ECHA checked, to various degrees, the compliance 
of 1 350 (7.33 %) dossiers in the >1000 tn/a tonnage band and 430 (3.79 %) of the dossiers 
in the 100-1000 tn/a tonnage band. Due to the selection based on screening of suspected data 
gaps, in the vast majority of the cases (69 % and 77 % respectively), the compliance checks 
have confirmed one or more non-compliances and resulted in ECHA (draft) decisions. 

By the end of 2017, altogether 2 586 information requests were made in the compliance check 
decisions. Of these requests, 420 (16 %) have targeted substance identification, 178 (7 %) 
physico-chemical properties, 955 (37 %) human health hazards, 662 (26 %) ecotoxicity and 

1  For  same  registration  more  than  one  compliance  check  could  have  been  opened  to  address  different 
targeted concern scenarios or incompliances. 
2 The 5% target is calculated by using number of unique registration dossiers checked for compliance (see 
Table 1.) 
3 Genotoxicity, repeated-dose toxicity, pre-natal developmental toxicity, reproduction toxicity, 
carcinogenicity, long-term aquatic toxicity, biodegradation and bioaccumulation. 
4 https://echa.europa.eu/documents/10162/17208/echa_cch_strategy_en.pdf/607b157b-a35d-4d1c-
8e62-ce8668324b1a 
5 https://echa.europa.eu/documents/10162/22837330/mb_44_2016_regulatory_strategy_en.pdf/  

 
 
 
 
 
 
                                           
 
 
Evaluation under REACH: Progress Report 2017 

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fate, and 367 (14 %) the quality of the chemical safety reporting. The most common non-
compliances related to human health have been found in pre-natal developmental toxicity (first 
and second species), sub-chronic toxicity (90-day study), in vitro studies for gene mutation 
and/or cytogenicity in mammalian cells and in the in vitro gene mutation study in bacteria. For 
the environmental information requirements, the most commonly found non-compliances have 
been in the long-term toxicity in fish, identification of degradation products, growth inhibition 
in the aquatic plants, bioaccumulation and effects in terrestrial organisms. In relation to 
physico-chemical properties, the partition coefficient, water solubility, vapour pressure and the 
dissociation constant were the most often requested information requirements in the decisions. 

In parallel to the work on compliance checks, ECHA successfully met the two deadlines set in 
REACH, 2012 and 2016, for the examination of the phase-in substances’ testing proposals and 
issued 806 decisions. The total number of requests made in the testing proposal decisions over 
the years is 1 588 – 964 (61 %) regarding toxicological testing, 494 (31 %) testing on  
ecotoxicology and environmental fate, and 130 (8 %) regarding physico-chemical testing. 
Registrants proposed testing mostly for pre-natal developmental toxicity, the 90-day sub-
chronic toxicity study and the long-term toxicity testing on invertebrates. 

The first cases in follow-up to dossier evaluation were processed in 2012, and a structured 
approach was fully established in 2013. Currently, the number of follow-up evaluations carried 
out annually is between 300 and 350, with approximately 55 % originating from compliance 
check decisions and 45 % from testing proposal decisions. Since 2013, ECHA has notified the 
Member States competent authorities and the Commission of 73 cases where substances are 
possible candidates for harmonised classification and labelling, and flagged 11 cases for 
substance evaluation. After setting the Integrated Regulatory Strategy to focus on substances 
of potential concern, ECHA has also considered more systematically whether further regulatory 
risk management processes are needed based on the follow-up evaluation. 

The other main evaluation process, substance evaluation, started effectively with the 
publication of the Community rolling action plan (CoRAP) in February 2012. ECHA coordinates 
the work and collaborates with the evaluating Member States throughout the substance 
evaluation process, aiming to achieve consistent and scientifically robust decisions and to 
ensure that the necessary information is requested using the most viable route to clarify the 
concerns and inform regulatory risk management. 

Between 2012 and 2017, a total of 221 substances were evaluated by Member States, who 
considered that 159 (72 %) of these required further information to clarify the suspected 
concerns; the remaining 62 substances could be concluded on without the need for further 
information. Of the 159 substances requiring further information to clarify the concern, 147 are 
currently at the process stage of either further information being requested (decision-making) 
or newly submitted information being evaluated (follow-up). The remaining 12 substances 
were concluded on following the submission and evaluation of requested information. 
Consequently, a total of 74 substances have been concluded on, and in 43 % of these cases 
the evaluating Member States considered that further regulatory risk management may be 
needed. 

ECHA’s evaluation activities in 2017 
In line with the Integrated Regulatory Strategy set in 2015, ECHA continued to check the 
compliance of dossiers for registering substances in amounts of more than 100 tonnes per 
annum, addressing relevant higher-tier hazard endpoints for substances of potential concern. 
In addition, ECHA started a pilot focusing on selected groups of priority substances on which 
registrants are using read-across or grouping approaches for the key endpoints, and initiated 
informal interaction to more effectively ensure that such a grouping approach is in compliance 
with the information requirements. In addition, ECHA continued to use other measures –  
including letter campaigns and sector-specific approaches – to work together with industry to 
help to increase the overall compliance of the registration dossiers and improve the quality of 
chemical safety reports. 

 
 
 
 
 
 
 
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Evaluation under REACH: Progress Report 2017 

Outcome of compliance checks 
In 2017, 185 (83 %) out of the 222 compliance checks concluded were done on substances of 
potential concern. ECHA issued 151 new draft decisions addressing non-compliances; the most 
common information requests were in relation to pre-natal developmental toxicity, 
mutagenicity/genotoxicity, reproduction toxicity, and long-term aquatic toxicity. In addition, 
ECHA adopted 139 compliance check decisions. Altogether, 679 standard information requests 
were made in ECHA decisions, with an average of five information requests per decision. The 
most common non-compliances addressed in the compliance check decisions were: pre-natal 
developmental toxicity, mutagenicity/genotoxicity, simulation testing (water, soil and 
sediment), long-term aquatic toxicity, reproduction toxicity, and repeated dose toxicity. These 
information requirements enable the identification of a substances of very high concern. 

Testing proposal examination 
Overall, 58 testing proposal decisions were adopted in 2017, comprising 127 requests for 
testing. The most common human health-related testing proposals were for pre-natal 
developmental toxicity and the sub-chronic 90-day toxicity study. On the environmental side, 
the most frequent information gaps identified by the registrants were on short- and long-term 
effects on terrestrial organisms and long-term aquatic toxicity. The results of these tests will 
inform the identification of substances of very high concern, but will also complete the 
information on the hazards of a substance to enable its safe use. 

Follow-up evaluation of compliance check and testing proposal decisions 
In 2017, 327 dossier follow-up evaluations were concluded. The outcome of the follow-up 
evaluations shows that of the endpoints originally identified as being non-compliant with the 
information requirements or where a testing proposal was submitted, 639 (85 %) are now 
compliant as a consequence of dossier evaluation. For the remaining 117 (15 %) endpoints, 
the ECHA Secretariat sent a statement of non-compliance (SONC) for 109 endpoints and 
launched a new decision-making process according to Article 42(1) for 8 endpoints. 

Of the concluded follow-up evaluations, 67 cases were flagged as candidates for further 
regulatory processes, i.e. classification and labelling, substance evaluation or a new 
compliance check. As the first decisions based on ECHA’s Integrated Regulatory Strategy’s 
focus on selected key endpoints were made only in 2015, the first of such cases reached the 
follow-up stage at the end of 2017. 

Progress in substance evaluation 
The 2017-2019 CoRAP update, adopted on 21 March 2017, consists of 115 substances, of 
which 22 were scheduled for evaluation in 2017. Following the common screening round in 
2017, ECHA proposed to include 107 substances in the draft CoRAP for 2018-2020 to be 
evaluated by the Member States. 

From the previous round of substance evaluations, the evaluating Member States prepared 
draft decisions for 27 substances to request further information to clarify suspected concerns. 
For the remaining 12 substances, the evaluating Member States considered the available 
information sufficient to conclude on the identified concerns.  

The substance evaluation process is shifting more towards follow-up assessment, and the 
timing depends on the deadlines set in the decisions for the registrants to submit the data. In 
2017, 26 substances were at the stage where new information should have been submitted 
following an initial request for further information. The responsible evaluating Member State 
competent authorities are currently reviewing the newly submitted information to conclude on 
its suitability.  

ECHA adopted 31 substance evaluation decisions and published 25 substance evaluation 
conclusions: for 13 substances it was concluded that the risks are sufficiently controlled with 
existing measures, and for 12 substances it was concluded that EU-wide risk management 
measures are necessary. 

 
 
 
 
 
 
 
 
Evaluation under REACH: Progress Report 2017 

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KEY RECOMMENDATIONS TO REGISTRANTS 

The following are ECHA’s key recommendations to registrants based on the evaluations carried 
out in 2017. All recommendations and advice are available in chapter 5 of this report and on 
ECHA’s web pages on evaluation6. 

UPDATE YOUR REGISTRATION DOSSIER WITHOUT UNDUE DELAY WHEN 
RELEVANT NEW INFORMATION IS AVAILABLE 

•  According to Article 22 of the REACH Regulation, you are responsible for 

updating your registration with relevant new information on your own initiative 
and without undue delay and submitting it to ECHA, for example in the 
following cases:  

o 
o 
o 

there are changes in your status as registrant;  
there are changes in the composition of your registered substance;  
there are changes in the annual or total quantities manufactured or 
imported, resulting in a change of tonnage band;  

o  you have identified new uses or new uses advised against;  
o  you have new knowledge of the risks of substance to human health 

and/or the environment; 
there are changes in the classification and labelling of the substance;  
o 
o  you have updated or amended the chemical safety report or guidance 

on safe use; 

o  you have identifed the need to perform a new test listed in Annex IX or 

o 

Annex X to the REACH Regulation;  
there is a change in the access granted to information in your 
registration.  

•  The new information may have an impact on the protection of human health 

and the environment. 

JUSTIFY AND DOCUMENT YOUR WEIGHT OF EVIDENCE APPROACH  

• 

If you propose an adaptation based on weight of evidence, the individual lines 
of evidence and the justification should provide a sufficient confidence level 
when compared to information expected with the default test. Documentation 
of the weight-of-evidence adaptation should be transparent and conclusions 
justified.  

•  You need to document the quality and relevance of the pieces of evidence, as 

well as their consistency and completeness, in relation to the standard 
information requirements. 

•  You should also address the associated uncertainties and their impact in a way 
that allows ECHA to assess and verify all the pieces of evidence provided in the 
technical dossier. 

6 https://echa.europa.eu/regulations/reach/evaluation  

 
 
 
 
 
 
                                           
 
 
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Evaluation under REACH: Progress Report 2017 

PROVIDE ROBUST GROUPING AND READ-ACROSS ARGUMENTS  

•  Use ECHA’s Read-Across Assessment Framework (RAAF7) to check the 

• 

• 

robustness of your read-across adaptation. The RAAF describes the aspects of 
grouping and read-across justifications that ECHA considers to be crucial for 
both human health and environmental endpoints. 
In March 2017, a technical document8 was published on ECHA’s website on 
assessing the complexity of grouping and read-across for multi-constituent and 
UVCB substances. It describes the additional key issues proposed to be 
considered when predictions based on grouping and read-across cases 
involving multi-constituent substances and/or UVCBs are used to adapt 
standard information requirements. 
Justify the grouping and read-across approach by showing how structural 
similarity and dissimilarity are connected to the prediction and create a data 
matrix, allowing side-by-side comparison of properties of the source(s) and 
target substance(s). 

7 ECHA Read-Across Assessment Framework (RAAF): 
https://echa.europa.eu/documents/10162/13628/raaf_en.pdf. 
8 Read-Across Assessment Framework (RAAF) - Considerations on multi-constituent substances and 
UVCBs: https://echa.europa.eu/documents/10162/13630/raaf_uvcb_report_en.pdf/3f79684d-07a5-
e439-16c3-d2c8da96a316. 

 
 
 
 
                                           
 
 
Evaluation under REACH: Progress Report 2017 

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1. THE EVOLUTION OF EVALUATION AND ECHA - 10 YEARS 
OF EXPERIENCE 

This chapter summarises the evolution, progress and achievements of evaluation activities 
during this 10-year reporting period, including information on the number of registration 
dossiers submitted to ECHA and their rate of update by industry.  

1.1 Objectives of the legislation 

The European Chemicals Agency (ECHA) was established in 2007 and the REACH Regulation 
(hereinafter REACH) entered into force on 1 June 2007. The purpose of REACH is to ensure a 
high level of protection of human health and the environment, including the promotion of 
alternative methods for assessment of hazards of substances, as well as the free circulation of 
substances on the European internal market while enhancing competitiveness and innovation. 

REACH is based on the principle that manufacturers, importers and downstream users should 
ensure that they manufacture, place on the market or use substances that do not adversely 
affect human health or the environment. Its provisions are underpinned by the precautionary 
principle. 

ECHA and the Member States of the European Union evaluate the information submitted by 
registrants in their registration dossiers. Dossier and substance evaluation processes are 
fundamental in REACH to instil confidence registrants meet their legal obligations, to ensure 
that unnecessary testing on animals is avoided, and to make sure that sufficient information is 
provided to assess and manage risks related to chemicals. After evaluation, if ECHA or a 
Member State competent authority considers that further information is needed, a decision 
requesting the missing information is issued. When the deadline set in an ECHA evaluation 
decision has passed, a follow-up to dossier or  substance evaluation takes place, and if the 
dossier is found to be non-compliant, national enforcement action is initiated. 

1.2 Registrations 

Under REACH, there have been two registration deadlines so far, in 2010 and 2013. By the 
third and last registration deadline on 31 May 2018, substances produced or imported in the 
European Union in relatively low volumes (1 to 100 tonnes per year), such as speciality 
chemicals, will also have been registered.  

By the end of 2017, 12 242 companies had registered their chemicals and the ECHA 
registration database contained a total of 67 005 registrations9 covering 17 143 unique 
substances. Of these, 2 495 were manufactured in or imported to the EU in quantities of over 
1 000 tonnes per year. After the 2018 registration deadline, the REACH database will contain 
information on all chemical substances that are manufactured and/or imported in the European 
Union in amounts above one tonne per year. Figure 1 presents the number of initial 
registrations submitted to ECHA between 2008 and 2017 by tonnage band. 

9 Comprising registrations for phase-in and non phase-in substances as well as notifications made under 
the previous European chemicals legislation (NONS). 

 
 
 
 
 
 
 
 
 
                                           
 
 
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Evaluation under REACH: Progress Report 2017 

20000

18000

16000

14000

12000

10000

8000

6000

4000

2000

0
<2008

2008

2009

2010

2011

2012

2013

2014

2015

2016

2017

over 1000 tpa

between 100 to 1000 tpa

between 10 to 100 tpa

between 1 to 10 tpa

Figure 1: Initial registration dossiers submitted to ECHA in 2008-2017 grouped by 
tonnage band (excluding information on intermediates and NONS). The total number 
of initial full registrations in the ECHA database by the end of the 2017 was 56 364. 

1.3  Compliance of information and the safe use of chemicals 

ECHA’s evaluation activities, and compliance checks in particular, are not only a legal duty but 
also an integral part of ECHA’s strategy to improve the availability and quality of the 
information provided by registrants in their REACH dossiers and to ensure the safe use of 
chemicals in the European Union. In addition to evaluation activities, ECHA uses a range of 
tools to try to improve the compliance and quality of data in REACH registrations and to 
coordinate the development of regulatory measures to manage the risks posed by the 
registered substances. 

1.3.1 Compliance checks 

During the first years of REACH implementation, ECHA focused on establishing and building 
capacity in relation to the main REACH processes. The selection of dossiers for compliance 
checks was based on IT-screening, manual prioritisation and random selection. From 2011 to 
2014, the majority of checks targeted specific parts of dossiers, so-called “areas of concern”, 
such as substance identity, physico-chemical properties or missing environmental and human 
health information. The focus was on targeting easily identifiable data gaps and addressing 
them in a standardised manner. 

By the end of 2013, ECHA reached the first regulatory milestone by meeting the 5 % target for 
compliance checks for the dossiers submitted for the 2010 deadline10 (i.e. dossiers for 
substances that are manufactured or imported in quantities of 1000 tonnes or more per year). 
The experience gained from this work gave ECHA better insight into the overall quality of the 
information in the registration database and influenced the design and implementation of the 

10 https://echa.europa.eu/-/target-met-for-5-percent-compliance-checks-of-the-2010-registration-dossiers  

 
 
 
 
 
 
                                           
 
 
Evaluation under REACH: Progress Report 2017 

13 

Integrated Regulatory Strategy in 2015, which was developed to meet the United Nations 
chemicals management goals set by the World Summit on Sustainable Developments (WSSD).  

The Integrated Regulatory Strategy brings all the REACH and CLP processes coherently 
together to achieve the aims of these two regulations. Together with Members States, ECHA 
has developed a common screening process, which aims to identify the substances that have 
the greatest potential for negative impact on human health and the environment. The common 
screening helps reach conclusions on which substances need to have further information 
submitted about them and may need to go through the compliance check, as well as on cases 
where there is enough information available to conclude on a concern and the substances can, 
where necessary, be directly earmarked for substance evaluation or for EU risk management 
measures. Furthermore, in 2016-2017 the focus on screening has shifted towards addressing 
groups of substances.  

Dossier evaluation is the main tool to require further generation of hazard data when the 
dossier is not complying with information requirements. Under compliance check, priority is 
given to substances of potential concern, i.e. those substances where (i) the hazard profile for 
higher tier (eco)toxicity information requirements 11,12 indicates a potential concern (or the 
hazard profile is unclear and needs to be further examined) and (ii) where there is significant 
exposure potential for workers, consumers or the environment. The focus is on the key 
information requirements that could help to clarify if the substance is likely to be carcinogenic, 
mutagenic and reprotoxic (CMR) and/or (very) persistent, bioaccumulative and toxic 
(PBT/vPvB). 

The change in strategy and moving from targeted, area-of-concern-based compliance checks 
towards evaluating the selected substances of potential concern is reflected in the number of 
concluded cases, adopted ECHA decisions and the information requests made within them. The 
targeted compliance checks resulted in more decisions, the typical decision containing one or 
two information requirements. Under the current concern-based approach, the complexity of 
the evaluation has increased, and also the number of information requests made in one 
decision has increased to five or more requests per decision in 2017 (see Figure 2). More 
importantly, the majority of the information requests are now more targeted for higher-tier 
tests, like pre-natal developmental toxicity, mutagenicity or genotoxicity, reproduction toxicity 
and long-term aquatic toxicity. As a consequence, the time given to registrants to comply with 
a decision has increased. It now takes on average two or three years from the date of issue of 
ECHA decision for registrants to update their dossier with the results of the requested studies. 
This means that the bulk of the information requested under the new integrated strategy can 
only be assessed by ECHA from 2019 onwards. 

11 Genotoxicity, repeated-dose toxicity, pre-natal developmental toxicity, reproduction toxicity, carcinogenicity, long-term 
aquatic toxicity, biodegradation and bioaccumulation. 
12 https://echa.europa.eu/documents/10162/17208/echa_cch_strategy_en.pdf/607b157b-a35d-4d1c-8e62-
ce8668324b1a  

 
 
 
 
 
                                           
 
 
Evaluation under REACH: Progress Report 2017 

14 

800

700

600

500

400

300

200

100

0

2009

2010

2011

2012

2013

2014

2015

2016

2017

Number of adopted decisions

Number of information requests

Figure 2: Concluded compliance check decisions by ECHA in 2009-2017 and the 
number of information requests that they contained.  

Figure 3 shows the number of requests made over the years on different groups of information 
requirements. As explained above, under the current strategy and from 2015 onwards, the 
number of requests made for human heath and environment-related higher-tier tests have 
increased, in absolute terms and relative to other requests (e.g. in relation to substance 
identity), as ECHA started actively selecting and addressing dossiers with substances of 
potential concern. The total number of requests made in ECHA compliance check decisions by 
the end of 2017 was 2 582. 

Non-compliance in the human health-related information requirements was most common for 
pre-natal developmental toxicity (first and second species), sub-chronic toxicity (90-day 
study), in vitro studies for gene mutation and/or cytogenicity in mammalian cells, and the in 
vitro gene mutation study in bacteria. For environmental information requirements, data gaps 
were commonly found in long-term toxicity in fish, identification in degradation products, 
growth inhibition in aquatic plants, bioaccumulation, and the effects in terrestrial organisms. 
For physico-chemical properties, the partition coefficient, water solubility, vapour pressure and 
the dissociation constant were the most often addressed information requirements in the ECHA 
decisions. 

 
 
 
 
 
Evaluation under REACH: Progress Report 2017 

15 

1200

1000

800

600

400

200

0

2009

2010

2011

2012

2013

2014

2015

2016

2017

SID

Phys-chem

Human health

Env + fate

CSR

C&L

Figure 3: Cumulative number of standard information requests in the adopted 
compliance check decisions in 2009-2017. 

Overall, ECHA has checked, to various degrees, the compliance of 1 350 (7.33 %) dossiers in 
the >1 000 tn/a tonnage band and 430 (3.79 %) of the dossiers in the 100-1 000 tn/a 
tonnage band (see Table 1 below). Due to the selection based on screening of suspected data 
gaps, in the vast majority of the cases (69 % and 77 % respectively), the compliance checks 
confirmed one or more data gaps and resulted in a ECHA (draft) decision. 

Table 1: Number of compliance checks performed by tonnage band. 

Tonnage band 

Concluded 
with DD 

Performed unique compliance checks  
Concluded 
without DD 

Registration 
dossiers* 

Total 

Percentage of 
registrations 
checked for 
compliance (%) 
7.33  

3.79  

1.24  

1.46  

4.60  

≥1 000 t/a 

100 to 1 000 t/a 

10 to 100 t/a 

1 to 10 t/a 

934 

332 

45 

31 

416 

1 350 

98 

26 

70 

430 

71 

101 

18 408 

11 342 

5 714 

6 929 

Total 

1 342 

610 

1 952 

42 393 

* Number of unique registration dossiers; registrations of intermediates and NONSs excluded from the 
count. 

1.3.2 Testing proposal examinations 

A testing proposal needs to be included in the registration dossier if the registrant or 
downstream user identifies a need to perform a test that belongs to the standard information 
requirements for substances manufactured or imported in annual quantities of 100 tonnes or 
more. ECHA examines all testing proposals received. Furthermore, ECHA publishes information 
on its web pages on all the testing proposals that involve tests on vertebrate animals, and 
invites third parties to submit scientifically valid information and studies that address the 
relevant substance and the hazard endpoint that is subject to the testing proposal. ECHA takes 

 
 
 
 
 
 
16 

Evaluation under REACH: Progress Report 2017 

into account all information submitted and based on the information available will accept, 
reject, modify or ask for additional testing as necessary. 

So far, ECHA has successfully met the two deadlines set in REACH (in 2012 and 2016) 
regarding the examination of phase-in substances’ testing proposals. In the case of non-
phase-in substances, ECHA examines and prepares a draft decision within 180 days of 
receiving a registration or downstream user report containing a testing proposal.  

Since 2009, ECHA has examined 1 348 testing proposals and has issued 806 decisions (Figure 
4). As part of the testing proposal examination, ECHA has launched 1 087 third party 
consultations and has received 826 pieces of information regarding the testing proposals under 
consultation.  

400

350

300

250

200

150

100

50

0

2009

2010

2011

2012

2013

2014

2015

2016

2017

Number of adopted decisions

Number of tests requested in decisions

Figure 4: ECHA adopted decisions on testing proposal examinations in 2009-2017. 

So far, the most common human health-related testing proposals have been for pre-natal 
developmental toxicity and the 90-day sub-chronic toxicity study. The most commonly 
proposed ecotoxicity test has been long-term toxicity testing on invertebrates. Between 2009 
and 2017, the most testing proposals were submitted to ECHA to clarify the potential hazards 
to human health (see Figure 5 below). A total of 1 588 requests were made in the testing 
proposal decisions, of which 964 (61 %) were toxicological testing requests, 494 (31 %) 
ecotoxicological and fate testing requests, and 130 (8 %) physico-chemical testing requests. 

 
 
 
 
 
 
 
Evaluation under REACH: Progress Report 2017 

17 

1200

1000

800

600

400

200

0

2009

2010

2011

2012

2013

2014

2015

2016

2017

total Phys-chem

total Human health

total Env + fate

Figure 5: Cumulative number of requests made in adopted testing proposal decisions 
in 2009-2017 by type of test request.  

1.3.3 Follow-up to dossier evaluation 

Once the deadline given in the dossier evaluation decision has passed, ECHA will assess the 
information submitted to ECHA and verify if it complies with the decision. If it does, ECHA 
notifies the Commission and the Member States competent authorities of the case and the 
conclusions made on the received information. In the case of non-compliance, national 
enforcement action will be initiated. 

ECHA has been adopting evaluation decisions since 2009 and the first deadlines for registrants 
to update their dossiers with the requested information expired in 2011. The number of 
decisions issued increased steadily in the first years and required a systematic approach to 
follow-up evaluation to be set up, which was fully established in 2013. Since then, the follow-
up evaluation process has been developed further, streamlined and adapted to new and 
refined policies as well as newly introduced IT tools. In cases where registrants have not 
fulfilled the obligations set in a decision by the given deadline, ECHA has collaborated 
successfully with the Member States enforcement authorities to execute the decision. The 
annual average for such cases is around 40, including both compliance checks and testing 
proposal decisions. Currently, the number of follow-up evaluations carried out annually is 300 
to 350 annually, with approximately 55 % originating from compliance checks and 45 % of 
testing proposal decisions.  

In December 2016, ECHA concluded its 1000th follow-up evaluation. Since 2016 and after the 
Integrated Regulatory Strategy focused on substances of potential concern, ECHA has also 
considered more systematically if further regulatory risk management processes are needed 
based on the follow-up evaluation. This approach has led to notifying the Commission and the 
Member States competent authorities of possible candidates for harmonised classification and 
labelling, as well as flagging some cases for substance evaluation (see Table 2 below). 

 
 
 
 
 
 
 
18 

Evaluation under REACH: Progress Report 2017 

Table 2: Outcomes of the follow-up to dossier evaluation, including the flagging for 
further assessment and the need for regulatory risk management identified. (CCH = 
compliance check, TP = testing proposal.) 

Outcome of the follow-up 
evaluation 

Article 42(2) notification* 

Statement of non-compliance** 

Non-compliant cases still open 
(recorded by the year the non-
compliance was notified to the 
Member State authorities)*** 
Flags for future regulatory 
actions 

Proposal for harmonised 
classification and labelling  

Candidate for substance 
evaluation 

TP 

CCH 

TP 

CCH 

TP 

CCH 

TP 

CCH 

TP 

CCH 

2012  2013  2014  2015  2016  2017  Total 

0 

2 

2 

8 

0 

1 

72 

77 

10 

22 

0 

2 

99 

136 

111 

148 

118 

201 

143 

129 

27 

17 

2 

2 

16 

26 

2 

7 

17 

16 

10 

8 

21 

25 

17 

18 

543 
692 
93 
114 
31 

38 

2012   2013   2014   2015   2016   2017   Total 
51 

10 

17 

19 

0 

1 

4 

0 

0 

0 

0 

0 

0 

4 

4 

2 

1 

3 

0 

1 

0 

0 

16 

22 

1 

1 

8 

3 

* Information requirements were complied with by the deadline. 
** No information provided or an unacceptable adaptation was provided. 
*** No (or no adequate) information was provided by the deadline. ECHA invited MS authorities to consider 
enforcement actions towards the registrant. The requested information still has not been provided. 

1.3.4 Substance evaluation 

Substance evaluation aims to verify whether a substance constitutes a risk to human health or 
the environment from an EU-wide perspective. It contributes to the identification of chemicals 
of concern requiring further risk management. 

In preparation for the start of the substance evaluation process, ECHA organised workshops 
with, the Member State Committee (MSC) and the Commission to discuss the prioritisation 
criteria for inclusion of substances in the Community rolling action plan (CoRAP) as well as 
procedural matters. The first CoRAP was published on 29 February 2012 and contained 36 
substances to be evaluated in 2012.  

During 2015, a common screening process was developed in collaboration with the Member 
States to identify substances with the greatest potential for negative impact on human health 
and the environment. Furthermore, ECHA launched a review of the substance evaluation 
process to further reduce process time and increase time available for higher-value tasks such 
as expert input to cases. In addition, the first decisions by the Board of Appeal provided 
important feedback on the process and the substance evaluation decisions.  

To provide further support in considering the best approaches to clarify the concern and any 
risk management measures, ECHA implemented a more structured approach for interaction 
with the evaluating Member State competent authorities in 2016. 

Between 2012 and 2017, 221 substances were evaluated by Members State competent 
authorities (MSCAs). The evaluating MSCAs considered that 159 (72 %) of these required 
further information to clarify the suspected concerns.  

 
  
  
 
 
 
 
 
 
 
Evaluation under REACH: Progress Report 2017 

19 

180

160

140

120

100

80

60

40

20

0

2013

2014

2015

2016

2017

Number of adopted decisions

Number of information requests

Figure 6: ECHA adopted decisions on substance evaluation in 2013-2017. 

For the remaining 62 (28 %) substances, the evaluating MSCAs considered the available 
information was sufficient to conclude on the concerns and submitted their conclusion 
documents to ECHA. It is worth noting that the reported number of substance evaluations 
resulting in a request for further information does not take into account situations where the 
draft decision was subsequently terminated during the decision-making stages. 

An evaluation may conclude that risks are sufficiently under control with the measures already 
in place (i.e. no further EU-wide regulatory action is proposed). Otherwise, it may lead to the 
proposal of EU-wide risk management measures, such as restrictions, identification of 
substances of very high concern, harmonised classification, or other actions outside the scope 
of REACH. 

Figure 7 below summarises the number of substance evaluation conclusions published between 
2013 and 2017. These numbers include conclusions made after the evaluation of additional 
information requested via the decision-making process.  

30

25

20

15

10

5

0

2013

2014

2015

2016

2017

Concluded with no further EU-wide regulatory action proposed

Concluded with further EU-wide regulatory action proposed

Figure 7: Substance evaluation conclusions published in 2013-2017. 

 
 
 
 
 
 
 
 
 
 
20 

Evaluation under REACH: Progress Report 2017 

Figure 8 below summarises the number and type of regulatory actions at EU level proposed 
within all substance evaluation conclusions published between 2013 and 2017. It is worth 
noting that a conclusion may propose more than one type of regulatory action at EU level. 

Harmonised C&L

SVHC (Authorisation)

Restriction

Other EU-wide measures

Further action to be decided

7

5

6

1

22

Figure 8: Regulatory actions at EU level proposed within substance evaluation 
conclusions published in 2013-2017. 

1.4 The future of REACH evaluation  

ECHA’s current two main strategic objectives aim at maximising the availability of high quality 
information to enable safe manufacture and use of chemicals and at mobilising authorities to 
use information intelligently to identify and address chemicals of concern. ECHA is working 
towards these objectives by following its Integrated Regulatory Strategy, in close co-operation 
with the Member States, using common screening for selecting the dossiers and substances for 
evaluation and prioritising the substances of potential concern.  

During the first ten years of REACH, dossier and substance evaluation have been established 
as the key processes for generating further information on the substances. The work 
continues, focusing on substances that have been registered at 100 tonnes or more and on 
meeting the WSSD goals. A lot of work remains to be done to maximise the availability of 
high-quality data and ensuring the safe use of chemicals. The focus of the screening and 
evaluation of dossiers and substances has moved from single substances to groups of 
substances and in the future ECHA will continue to strengthen this approach. ECHA will 
continue to improve the efficiency and effectiveness of the processes and to adapt its 
approaches and practices based on experience, new scientific and technical developments, 
including alternative methods to animal testing, learnings from litigation cases, and other 
feedback from its partners and stakeholders. 

After the 2018 registration deadline, the new, sometimes complex and previously unknown 
lower-tonnage substances will bring an interesting and challenging task to ECHA and 
evaluation: how to identify candidates for risk reduction among the lower-volume substances 
with limited data available? For the 2018 registration dossiers, a new approach and plan needs  
to be developed. Grouping of substances is likely to play an even bigger role and due to limited 
standard information requirements, substance evaluation will most likely be required to 
request more often for data that is necessary to conclude on the key CMR and PBT properties 
of substances. 

 
 
 
 
 
 
 
Evaluation under REACH: Progress Report 2017 

21 

With this and other new challenges ahead, ECHA will continue to seek opportunities to work 
more closely in collaboration with Member States competent authorities and to rely on their 
continued investment in risk management and enforcement activities. 

 
 
 
 
22 

Evaluation under REACH: Progress Report 2017 

2. EVALUATION PROGESS IN 2017 

This chapter presents the progress made in dossier and substance evaluation during 2017. 

2.1 Summary of evaluation progress in 2017 in numbers 

The following is a summary of evaluation progress based on the main outputs in 2017.  

Dossier selection 

The selection of candidates for compliance check continued to focus on substances of potential 
concern, in line with ECHA’s Integrated Regulatory Strategy. In 2017, 315 dossiers were 
scrutinised as candidates for compliance check and 218 of them were selected for further 
processing. The other cases were for the time being not selected for compliance check due to, 
for example, low priority for further regulatory work or other ongoing processes. Furthermore, 
compliance check was opened for 25 dossiers which are planned to be subject to new 
substance evaluations.  

New testing proposals were submitted in 104 registration dossiers. In addition, testing 
proposals for extended one-generation reproductive toxicity studies (EOGRTS) were submitted 
in 16 dossiers based on the Commission decision on the related previous testing proposal 
examinations or compliance checks. 

Dossier evaluation 

222 new compliance checks concluded, resulting in 151 draft decisions. 185 (83 %) of the 
compliance checks were performed on dossiers of high-priority substances. Of the 151 draft 
decisions, 138 were on high-priority substances, i.e. on substances of potential concern. 

Overall, in all the draft decisions ECHA addressed 787 standard information requests, of which 
564 were on higher-tier human health and environment endpoints. The 13 non-priority 
compliance check draft decisions were either targeted to substance identity or on substances 
not specifically shortlisted for high priority. 

72 testing proposal examinations concluded. ECHA examined 72 testing proposals of 
which 14 were concluded with no action and 58 with a draft decision. In these drafts, 118 tests 
were proposed to be requested, of which 71 were tests on human health hazards, 40 on 
environmental hazards and fate, and 7 on physico-chemical properties. 

197 dossier evaluation decisions adopted. ECHA adopted 139 compliance check decisions 
and 58 decisions on testing proposals, which contained 806 standard information requests in 
total. 

327 dossier evaluation follow-up evaluations were concluded. In these follow-up 
evaluations, ECHA examined whether the information provided by registrants, in response to 
decisions adopted by ECHA, complied with REACH requirements. In 272 cases ECHA received 
the information requested in a compliance check or a testing proposal decision. 

Substance evaluation 

Community rolling action plan (CoRAP) update 2017-2019. The 2017-2019 CoRAP 
update was adopted on 21 March 2017, consisting of 115 substances, of which 22 were 
scheduled for evaluation in 2017. 

For CoRAP 2018-2020, ECHA proposed to include 107 substances to be evaluated by Member 
States. Of these, 26 substances are expected to be evaluated in 2018, 37 in 2019, and 44 in 
2020. 

 
 
 
 
 
 
 
 
 
 
 
 
 
Evaluation under REACH: Progress Report 2017 

23 

39 substance evaluations conducted in 2017. The evaluating Member State competent 
authorities prepared draft decisions for 27 substances to request further information to clarify 
suspected concerns. For the other 12 substances, the evaluating MSCAs considered the 
available information to be sufficient to conclude on the concerns. 

31 substance evaluation decisions adopted. ECHA adopted 31 decisions originating from 
substance evaluation, requesting further information from registrants to verify the suspected 
concerns. 

25 substance evaluation conclusions published, completing the substance evaluation. 13 
of these concluded that the risks are sufficiently controlled with existing measures, and 12 
concluded that EU-wide risk management measures are necessary. 

 
 
 
 
 
 
24 

Evaluation under REACH: Progress Report 2017 

2.2 Dossier selection and pre-processing 

In line with ECHA’s Integrated Regulatory Strategy, compliance checks continued to be opened 
for standard registration dossiers in tonnage bands over 100 tonnes per year which indicate 
high potential for exposure and have potential non-compliance in one of the eight so-called 
super endpoints. Moreover, in 2017 the interplay between dossier evaluation and the other 
REACH and CLP processes was further strengthened by focusing the compliance check 
selection to substances that have uncertain priority for regulatory risk management due to 
lacking hazard information as it was then not possible to confirm or refute that the substance 
is of concern. 

Another enhancement was that candidates for compliance check were selected increasingly in 
groups or pairs of similar substances based on structural similarities and read-across, or in 
categories applied by the registrants or regulatory bodies. Such grouping was applied both in 
ECHA’s own selection and in the common screening13. Groups of substances having uncertain 
priority for regulatory risk management were processed by ECHA as candidates for compliance 
check and groups having suspected concerns were directed to common screening. However, 
later the manual screening also concluded on some of the groups that a compliance check may 
be needed to be able to confirm or refute a suspected concern. In 2017, the majority of 
compliance check candidates originated from ECHA’s own IT based selection and manual 
screening of substances having uncertain priority for regulatory risk management (83 %) (see 
Figure 10 for the breakdown of sources for compliance check candidates).  

7%

10%

Figure 10: Breakdown of sources for 315 compliance check candidates in 2017.  

Before opening a compliance check, ECHA pre-checks the dossier to ensure that the case is 
relevant and matches the priority criteria laid down in the Integrated Regulatory Strategy. In 
2017, 315 dossiers were scrutinised as candidates for compliance check and 212 were selected 
for further processing. In addition, the dossiers which were planned to be subject to substance 
evaluation were directly taken for compliance check. 

13 Further information on common screening: https://echa.europa.eu/screening. 

 
 
 
 
 
 
 
                                           
 
 
Evaluation under REACH: Progress Report 2017 

25 

After pre-check, 50 candidate dossiers were considered to be of low priority for further 
regulatory work – three of them based on low potential for exposure only and 47 due to low 
toxicity or other low priority. An overview of the reasons for early termination of 96 compliance 
check candidates in 2017 are given in Figure 11. No compliance check will be currently opened 
for these dossiers, but the need for compliance check may be reconsidered in the future based 
on new information on, for example, uses and exposure. 

Figure 11: Reasons for early termination of 96 compliance check candidates in 2017. 
Other reasons include e.g. cease of manufacture, and the substance being a member of a large 
category to be evaluated later. Note that in a few instances several reasons may apply for the 
same case – for example, a reason based on human health-related endpoints may be different 
to one based on environment-related endpoints. 

 
 
 
 
 
26 

Evaluation under REACH: Progress Report 2017 

2.3 Compliance checks 

2.3.1 Compliance check overall 

Figure 9 below presents the overall compliance check process in 2017. 

278 dossiers opened in 2017 

13  dossiers under evaluat ion 
carried over from 2016 

69  dossiers under evaluation 

 71 evaluat ions concluded with 
no action 

 151 evaluat ions concluded with 
a draf t decision 

185 evaluat ions concluded with 
a draf t decision carried over 
from 2016 

159  draf t decisions in decision-
making stage 

38  draf t decisions not 
continued 

139  ECHA decisions taken 

D
E
C
I
S
I
O
N
M
A
K
I
N
G

A Scientific and legal evaluation stage. 
B No formal action towards the registrant is deemed necessary. 
C Formal action to request further information from the registrant is deemed necessary. 
D  Stages  of  processing  the  draft  decision,  including  notification  of  the  draft  decision  to  the  registrants, 
notification  to  the  MSCAs,  referral  to  the  MSC  (when  MSCAs  submitted  proposals  for  amendment),  and 
referral to the Commission (when unanimous agreement was not reached in the MSC). 
E  Scientifically-relevant  data  or  important  administrative  changes  lead  to  termination  of  the  ongoing 
decision-making procedure. 
F  ECHA  evaluation  decision  taken  either  following  a  unanimous  agreement  of  the  MSC,  or  where  no 
proposals for amendment of the draft decision were submitted by the MSCAs. 

Figure 9: Number and outcome of compliance checks in 2017.  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Evaluation under REACH: Progress Report 2017 

27 

2.3.2 Scientific and legal assessment 

In total, ECHA checked 222 dossiers for compliance during 2017. In 151 (68 %) of these, 
ECHA concluded that the non-compliances found were severe enough to require further action 
and generation of new information. Consequently, ECHA prepared draft decisions requesting 
registrants to submit the missing information. 

Clarity of the substance identity (SID) information is a prerequisite for ensuring that the 
dossier complies with the information requirements. If the provided SID information allows 
ECHA to interpret the scope of the registration, the assessment turns to the REACH 
information requirements on physico-chemical and hazard data in the technical dossier. 

However, if the substance identity information is not clear enough to meaningfully assess the 
rest of the dossier, ECHA will issue a substance identity-targeted compliance check (draft) 
decision. In the context of the evaluation process in 2017, substance identity issues were 
addressed in 36 draft decisions containing also other types of information requirements. In 22 
cases, substance identification issues were clarified due to informal calls made to the registrant 
that resulted in dossier updates where such issues were clarified and solved. 

In 71 (32%) of the compliance checks14, ECHA concluded that the generation of new 
information was not needed or that requesting it was not proportionate, and therefore no 
further action was required. Table 3 below summarises the overall compliance check 
conclusions, grouped by registration tonnage band, made during 2017. This result reflects only 
indirectly the effectiveness of the screening and selection of dossiers and cannot directly be 
used to assess the overall rate of compliance of all registration dossiers. 

Table 3: Compliance checks concluded in 2017 with a draft decision or without 
action, by tonnage band.  

Performed CCHs 

Concluded 
with DD 

Concluded without 
action 

Tonnage band 

≥1 000 t/a 

100 to 1 000 t/a 

10 to 100 t/a 

1 to 10 t/a 

54 

86 

9 

2 

Total 

151 

34 

29 

7 

1 

71 

Total 

88 

115 

16 

3 

222 

Focusing on the substances of potential concern 
The Integrated Regulatory Strategy is effectively addressing the dossiers and substances of 
potential concern. Since 2015, compliance checks have been focused on eight key standard 
information requirements of Annexes IX and X to REACH. These are mutagenicity/genotoxicity, 
repeated-dose toxicity, pre-natal developmental toxicity, reproduction toxicity, carcinogenicity, 
long-term aquatic toxicity, biodegradation and bioaccumulation.  

These key higher-tier human health and environment endpoints will allow a conclusion to be 
made on whether the criteria for substances of very high concern are likely to be fulfilled. 

Out of the 222 compliance checks concluded in 2017, 185 (83 %) were performed on priority 
substances, and 138 of these resulted in draft decisions.  

14 B within Figure 9 

 
 
 
 
 
 
 
 
 
 
 
                                           
 
 
28 

Evaluation under REACH: Progress Report 2017 

Overall, in these 138 priority draft decisions ECHA addressed 735 information requests, of 
which 537 were focused on the eight key standard information requirements of concern (see 
Table 4). The most common suspected concerns were addressed in the ECHA draft decisions 
with the following information requests: pre-natal developmental toxicity, 
mutagenicity/genotoxicity, reproduction toxicity, and long-term aquatic toxicity. These results 
confirm that the dossiers selected for compliance check in the common screening contain 
important data. In 2017, ECHA also issued 13 non-priority draft decisions with 62 information 
requirements, of which 27 were on the key information requirements. On average, in 2017 a 
draft decision contained over five information requests, of which three to four were for higher-
tier tests. 

Table 4: Information requests made in the compliance check draft decisions in 2017. 

Endpoint 

Repeated-dose toxicity 

Mutagenicity/genotoxicity 

Pre-natal developmental toxicity 

Reproduction toxicity* 

Carcinogenicity 

Long-term aquatic toxicity 

Biodegradation 

Bioaccumulation 

Other endpoints 

Total  

Priority CCH  

Number of 
requests in the 
138 draft 
decisions 

Non-priority 
CCH 
Number of 
requests in 
the 13 draft 
decisions 

Total requests 

Number of 
requests in all the 
151 draft decisions 

65 

97 

121 

83 

0 

84 

66 

21 

198 

735 

6 

5 

7 

7 

0 

2 

0 

0 

35 

62 

71 

102 

128 

90 

0 

86 

66 

21 

233 

797 

* 35 of these were requests for Annex VIII, 8.7.1 screening studies. 

Evaluating groups of substances 
In 2017, ECHA started pilots with selected groups of priority substances for which registrants 
had proposed a read-across and grouping approach for the key endpoints and initiated 
informal interaction on how to most effectively address such groups of substances and dossiers 
and to ensure their compliance with information requirements. One such pilot addressed a 
category of 14 substances. The novelty of the approach was to involve registrants in discussion 
on shortcomings and data gaps and agree on the testing strategy before formal compliance 
check was initiated. The draft decision itself is also different from a standard case as it 
addresses all the substances of the category in one single document. As the decision making of 
this pilot is still ongoing, it is too early to report on its results. However, ECHA expects that 
this type of approach could help bring groups of dossiers to compliance faster, potentially 
using fewer resources and involving fewer vertebrate tests. 

2.3.3 Decision making  

The decision-making part of dossier evaluation starts when ECHA sends the compliance check 
draft decisions to registrants for comments. As part of the current process, registrants who 
received an ECHA compliance check draft decision are also offered the opportunity to 
informally discuss the scientific rationale behind the draft decision with ECHA during their 30-
day commenting period. The opportunity is well received and the registrants frequently use it 
to discuss with ECHA the reasons behind decisions taken. In addition, during 2017, 65 % of 
registrants used their right to comment on ECHA draft decisions. 

 
 
 
 
 
 
 
Evaluation under REACH: Progress Report 2017 

29 

After the registrants’ commenting period and after addressing the comments, ECHA refers the 
draft decision to the Member State competent authorities and they can submit their proposals 
for amendments (PfAs) to the ECHA decision. When PfAs are submitted, the Member State 
Committee seeks a unanimous agreement through a written procedure or in plenary meetings. 
For the latter, registrants can attend the open sessions. In addition, the registrant concerned is 
always invited to comment on the PfAs within 30 days and the Member State Committee takes 
those comments into account in the decision making. 

If the Member State Committee does not reach a unanimous agreement on the draft decision, 
ECHA refers the case to the Commission for decision making. 

During 2017, ECHA adopted 139 decisions15 under compliance checks and closed 38 cases 16 
after a draft decision. Two draft decisions were referred to the Commission for decision 
making, both related to the design of the extended one-generation reproductive toxicity study 
design.  

2.3.4 Information requested in ECHA adopted compliance check decisions 

Figure 12 below summarises the types of information requested in ECHA’s 139 adopted 
compliance check decisions in 2017. Altogether, ECHA adopted decisions contained 679 
standard information reguests, on average 4.9 information requests per decision. The most 
common incompliances addressed in the 2017 decisions were pre-natal developmental toxicity, 
mutagenicity/genotoxicity, simulation testing (water, soil and sediment), long-term aquatic 
toxicity, reproduction toxicity, and repeated-dose toxicity.  

15 F within Figure 9. 
16 E within Figure 9. 

 
 
 
 
 
 
                                           
 
 
30 

Evaluation under REACH: Progress Report 2017 

0

20

40

60

80

100

120

103

94

83

73

69

58

51

44

Prenatal developmental toxicity

Mutagenicity/Genotoxicity

Simulation testing (water, soil and sediment)

Long term aquatic toxicity

Reproduction toxicity

Repeated dose toxicity

Other aquatic toxicity

Substance identification and composition

Bioaccumulation

CSR (Includes DNELs, PNECs, PBT assessment)

Physicochemical properties

Robust study summaries

Ready biodegradation and hydrolysis

Effects on terrestrial organisms

Other toxicological information

C&L according to CLP

Carcinogenicity

Long-term toxicity to sediment organisms

Other environmental toxicity

4

3

1

1

1

24

22

14

13

11

10

Figure 12: Information requested in the 139 adopted ECHA compliance check 
decisions in 2017. Altogether, the decisions contained 679 standard information 
reguests. 

 
 
 
Evaluation under REACH: Progress Report 2017 

31 

2.4 Testing proposals 

ECHA examines each testing proposal to make sure that they address the actual information 
needed and avoid unnecessary testing, particularly when testing involves the use of vertebrate 
animals.  

ECHA prepares a draft decision on each valid testing proposal. The legal text sets a deadline 
for ECHA to prepare a draft decision for certain types of testing proposals. 

Figure 13 below highlights the number and outcome of testing proposal examinations (TPEs) 
processed during 2016.  

101 TPEs opened in 
2017 

64 TPEs carried over 
from 2016 

93  TPEs under 
evaluat ion 

14  TPEs concluded 
with no act ion 

58  TPEs concluded 
with a draf t decision 

206 TPEs concluded with a 
draf t decision carried over 
from 2016 

115  draft decisions 
in the decision-

91  draft decisions 
not continued 

58  ECHA decisions 
taken 

D
E
C
I
S
I
O
N
M
A
K
I
N
G

A Scientific and legal evaluation stage. 
B Testing proposal is deemed inadmissible by ECHA or is withdrawn by the registrant. 
C A draft decision on the proposed testing is deemed necessary. 
D  Stages  of  processing  the  draft  decision  including  notification  of  the  draft  decision  to  the  registrants, 
notification  to  the  MSCAs,  referral  to  the  MSC  (when  MSCAs  submitted  proposals  for  amendment),  and 
referral to the Commission (when unanimous agreement was not reached in the MSC). 
E Scientifically-relevant data or important administrative changes led to termination of the decision-making 
procedure. Of the 91 cases 73 were formally closing the cases that the Commission had adopted decisions 
on.  
F  ECHA  testing  proposal  decision  taken  either  following  unanimous  agreement  of  the  MSC,  or  where  no 
proposals for amendment of the draft decision were submitted by the MSCAs. 

Figure 13: Number and outcome of testing proposal examinations processed in 2017.  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
32 

Evaluation under REACH: Progress Report 2017 

2.4.1 Alternatives to animal testing 

Testing on vertebrate animals is the last resort for obtaining missing information on a 
substance to meet the information requirements of REACH.  

ECHA examines each testing proposal to make sure that reliable and adequate data will be 
produced, and to prevent unnecessary animal testing. Since September 2015, registrants must 
submit their considerations on alternatives to their testing proposals involving vertebrate 
animals. 

ECHA publishes17 every testing proposal that involves vertebrate animals. Furthermore, ECHA 
invites third parties to submit scientifically-valid information or studies addressing the 
substance and hazard endpoints in question. All valid information is taken into account when 
ECHA evaluates and prepares its decision on the testing proposal.  

The registrants’ considerations on alternatives to their proposed vertebrate testing is published 
as part of the third party consultation or, if the dossiers were submitted after June 2016, in the 
testing proposal information inside the disseminated dossier. 

During 2017, third party consultations were launched for 67 substances. As a response to 
these consultations, ECHA received eight sets of information.  

2.4.2 Testing proposal examination 

ECHA concluded a total of 72 testing proposal examinations18 during 2017. For 58 (81 %) of 
these 19, ECHA sent draft decisions to the registrants, while in 14 cases (19 %) 20, no further 
action was necessary because either the registrant withdrew the proposal after ECHA started 
to examine it, or the testing proposal was not admissible.  

Table 5 below lists the type of tests included in the testing proposal draft decisions sent for 
registrants’ comments. Altogether, 118 requests were included in the 58 testing proposal draft 
decisions that were sent to registrants in 2017. The most common testing proposals, 
accounting for over half (53 %) of all testing proposals examined, were for: pre-natal 
developmental toxicity, sub-chronic toxicity study (90-day), pre-natal developmental toxicity 
study, and extended one-generation reproductive toxicity study. 

17 http://echa.europa.eu/information-on-chemicals/testing-proposals 
18 B+C within Figure 13. 
19 C within Figure 13. 
20 B within Figure 13. 

 
 
 
 
 
 
 
 
 
 
 
                                           
 
 
Evaluation under REACH: Progress Report 2017 

33 

Table 5: List of requests made in the ECHA testing proposal draft decisions during 
2017. Altogether 58 testing proposal draft decisions were sent to registrants.  

Endpoint 

Pre-natal developmental toxicity (Annex IX, 8.7.2) 

Sub-chronic toxicity study 90-day (Annex IX, 8.6.2) 

Pre-natal developmental toxicity study (Annex X, 8.7.2) 

Extended one-generation reproductive toxicity study (Annex X, 8.7.3) 

Long-term toxicity to aquatic invertebrates (Annex IX, 9.1.5) 

Effects on soil micro-organisms (Annex IX, 9.4.2) 

Long-term toxicity to fish (Annex IX, 9.1.6) 

Short-term toxicity to plants (Annex IX, 9.4.3) 

Dissociation constant (Annex IX, 7.16) 

Simulation testing on ultimate degradation in surface water (Annex IX, 9.2.1.2) 

Short-term toxicity to invertebrates (Annex IX, 9.4.1) 

Mutagenicity, in vivo (Annex IX, 8.4) 

In vitro gene mutation study in mammalian cells (Annex VIII, 8.4.3) 

Long-term toxicity to invertebrates (Annex X, 9.4.4) 

Long-term toxicity to plants (Annex X, 9.4.6) 

Viscosity (Annex IX, 7.17) 

In vitro gene mutation study in bacteria (Annex VII, 8.4.1) 

In vivo mammalian alkaline comet assay (Annex VIII, 8.4) 

Mutagenicity (Annex X, 8.4) 

Bioaccumulation in aquatic species (Annex IX, 9.3.2) 

Long-term toxicity to terrestrial invertebrates (Annex IX, 9.4.4) 

Long-term toxicity to sediment organisms (Annex X, 9.5.1) 

Total 

29 

20 

7 

7 

7 

7 

6 

5 

5 

4 

4 

3 

2 

2 

2 

2 

1 

1 

1 

1 

1 

1 

Total number of requests 

118 

2.4.3 Decision making 

As with the compliance check process, registrants who receive an ECHA draft decision on 
testing proposals are given the opportunity to not only comment on the draft decision but also 
to informally discuss the scientific rationale behind the draft decision with ECHA during their 
30-day commenting period. During 2017, 45 % of registrants commented on the ECHA draft 
decision. 

After the draft decision is notified to them, the Member State competent authorities can submit 
their PfAs on the ECHA decision. In 2017, ECHA notified 46 testing proposal draft decisions to 
Member State competent authorities and received PfAs on 15 (33 %) of them. Eight decisions 
which received PfAs were agreed during Member State Committee written procedure, another 
five decisions (33 %) were unanimously agreed and adopted in the Member State Committee 
meeting, while the deadline to agree on the last two decisions (14 % of the cases with PfAs) 
falls in early 2018. The other 31 (67 %) testing proposal draft decisions that were notified to 
Member State competent authorities in 2017 did not receive any PfAs and were adopted 
without amendment. 

 
 
 
 
34 

Evaluation under REACH: Progress Report 2017 

In 2017, ECHA adopted 58 decisions21 under testing proposal examination and closed 91 
cases22 after draft decisions. For the closed cases, 73 draft decisions were ones that had been 
referred to the Commission for decision making in 2012-2014, and the evaluation process was 
now closed due to a decision taken by the Commission. Other reasons for closing an 
examination were dossier updates where the registrants removed their testing proposals (15 
cases), manufacture of the substance having been ceased (2 cases), or a wrong submission 
number having been used (one case). 

In the decision, ECHA can accept, modify, request additional testing or reject the testing 
proposal. Additional testing is requested if there is non-compliance of the testing proposal with 
Annexes IX, X and XI to REACH and it can relate to either acceptance, modification or rejection 
of the original testing proposal. Table 6 below summarises the types of testing requested and 
the TPE decisions adopted during 2017. It is important to note that a decision may contain 
more than one request. 

Table 6: Summary of ECHA testing proposal decisions adopted in 2017. 

TPE adopted decisions 

Endpoint 

Pre-natal developmental 
toxicity 

Sub-chronic 90-day toxicity 

Effects on terrestrial 
organisms 
Long-term aquatic toxicity 
Extended one-generation 
study  

Mutagenicity/genotoxicity 

Other aquatic toxicity 

Simulation tests (water, soil, 
sediment) 
Viscosity 

Short-term 28-day toxicity 

Bioaccumulation in aquatic 
species 

Dissociation constant 

Accepted 
under 
Article 
40(3)(a) 

Modified 
under 
Article 
40(3)(b) 

Rejected 
under 
Article 
40(3)(d) 

Additional 
testing 
requested 
under 
Article 
40(3)(c) 

Total 
number 
of 
requests 
evaluated 

Original test 
rejected 
under Article 
40(3)(d) and 
additional 
testing 
requested 
under Article 
40(3)c*  

27 

15 

12 

7 

1 

6 

3 

2 

1 

1 

1 

2 

3 

3 

3 

4 

9 

1 

2 

1 

8 

6 

1 

3 

3 

2 

38 

23 

16 

15 

9 

9 

9 

3 

2 

1 

1 

1 

Total 

76 

5 

19 

4 

23 

127 

*The combination of rejection and requesting additional testing may be used for example with testing 
proposals with an analogue test material or when a test different to the one originally proposed is 
requested.  

21 F within Figure 13. 
22 E within Figure 13. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                           
 
 
Evaluation under REACH: Progress Report 2017 

35 

2.4.4 Information requested 

In the 58 testing proposal decisions that were adopted in 2017, a total of 127 requests were 
made (see Table 6). The most common human health-related testing proposals were pre-natal 
developmental toxicity and sub-chronic repeated-dose toxicity (90-day). On the environmental 
side, the effects on terrestrial organisms and the long-term aquatic toxicity were the most 
frequent data gaps identified by the registrants. 

2.5 Follow-up to dossier evaluation 

Under Article 42 of REACH, ECHA examines the information provided by registrants in response 
to evaluation decisions in their dossier updates and considers whether the information 
complies with REACH requirements. This follow-up evaluation takes place after the deadline 
specified in the decision has passed. Further information on the follow-up process can be found 
in the follow-up factsheet23. 

As in previous years, ECHA continued to inform the Member States enforcement authorities 
with statements of non-compliance (SONCs) following a dossier evaluation decision and to 
invite them to consider enforcement actions towards the registrants when some or all of the 
requests in a decision were not complied with. In some cases, a new consultation as per 
Articles 50 and 51 of REACH was initiated where a registrant submitted – in response to a 
decision – information which is substantial and new but still not sufficient to meet the initial 
request. 

In general, the collaboration between ECHA and the Member State competent authorities and 
national enforcement authorities has worked well and the majority of cases has been resolved 
within a reasonable time frame.  

In 2017, ECHA concluded the evaluation process after follow-up evaluation in 272 cases, which 
are summarised in Table 7. In 31 of these cases, ECHA was able to close the SONC with an 
Article 42(2) notification following a dossier update by the registrants after the national 
enforcement authorities had been involved in the case. In addition, ECHA issued 46 new 
SONCs, of which 35 were not resolved by the end of the year. At the end of 2017, there were 
76 unresolved SONCs that had been notified to the Member States authorities since 2012. 

23 https://echa.europa.eu/publications/fact-sheets  

 
 
 
 
 
 
 
 
 
                                           
 
 
36 

Evaluation under REACH: Progress Report 2017 

Table 7: Number and outcome of follow-up evaluations conducted in 2017. 

Decision type 

Outcome 

Information 
requirements were 
complied with by 
the deadline 

Information 
requirements were 
complied with after 
involving national 
enforcement 
authorities* 

Information 
requirements 
were not 
complied with** 

Information 
requirements were 
not complied with 
and a new 
decision was 
needed*** 

TPE decisions 

CCH decisions  

131 

110 

12 

19 

17 

18 

5 

3 

Total 

8 
* No (or no adequate) information was provided by the deadline. ECHA invited MSCAs to consider enforcement actions 
towards the registrant. This lead to a dossier update with sufficient information. 
**No (or no adequate) information was provided by the deadline. ECHA invited MSCAs to consider enforcement 
actions towards the registrant. The requested information still has not been provided. 
***New substantial information has been provided but the information requirement was not met. 

241 

31 

35 

Table 8 provides a summary of the outcome of the follow-up evaluations performed in 2017, 
by endpoint or group of endpoints. It is important to note that a follow-up evaluation outcome 
may contain both compliant and non-compliant endpoints. 

Table 8: Number and outcome of the follow-up evaluations conducted in 2017, by 
endpoint. 

Endpoint 

Substance identity 
Physical/chemical properties 
Biodegradation 
Bioaccumulation 
Other environmental 
fate/behaviour 
Long-term aquatic toxicity 
Other ecotoxicological hazard 
Mutagenicity/genotoxicity 
Carcinogenicity 
Repeated-dose toxicity 
Pre-natal developmental toxicity 
Reproduction toxicity 
Other human health hazard 
CSR 

Total 

Outcome 

Compliant 
endpoints after 
follow-up 
evaluation* 

Compliant endpoints 
with adaptations (e.g. 
read-across, weight of 
evidence)** 

Non-compliant 
endpoints after 
follow-up 
evaluation*** 

121 
16 
4 
6 

3 

34 
72 
33 
1 
94 
129 
1 
9 
62 
585 

1 
2 
0 
1 

1 

10 
7 
1 
0 
11 
13 
1 
6 
0 
54 

18 
3 
3 
3 

4 

15 
18 
9 
1 
15 
22 
0 
2 
4 
117 

* Including "full correspondence" and "acceptable with deviations". 
** The registrant did not provide the requested data, but an acceptable adaptation instead (regardless of any ECHA's 
pre-approval in evaluation). 
*** No information provided or an unacceptable adaptation was provided. ECHA sent SONC or launched a new decision 
making to invite the Member States to consider enforcement actions. 

The outcome of the 2017 follow-up evaluations shows that 639 (85 %) of the endpoints 
originally identified (by compliance checks or submission of a testing proposal) as non-
compliant with REACH information requirements are now deemed compliant as a consequence 
of dossier evaluation. For the remaining 117 (15 %) endpoints that were deemed non-
compliant, ECHA sent a SONC for 109 endpoints and launched a new decision-making process 
according to Article 42(1) for 8 endpoints. 

 
 
 
 
 
 
Evaluation under REACH: Progress Report 2017 

37 

Table 9: Conclusions made in 2017 based on the received information leading to 
possible further regulatory actions. 

Endpoint 

TPE decisions 
CCH decisions  

Proposed cases 
as possible 
candidates for 
harmonised 
classification and 
labelling 

19 
16 
35 

Total 

Outcome 

Proposed cases as 
possible candidates for 
substance evaluation 

Proposed cases for 
opening a new 
compliance check 
after follow-up 
evaluation* 

1 
1 
2 

20 
10 
30 

* Information requirements were fulfilled for the requested endpoints, but new data indicated concerns for other 
endpoints. 

The information received through the dossier evaluation processes is screened to identify any 
cases where further regulatory actions may be needed. The number of such substances is 
expected to increase in the future due to the adopted regulatory strategy to address 
substances and dossiers with a potential concern. In 2017, 67 cases were flagged as 
candidates for further regulatory processes, i.e. classification and labelling, substance 
evaluation, or a new compliance check. However, as the regulatory strategy to focus on 
selected key endpoints was adopted only in 2015, the first of such cases reached the follow-up 
stage only towards the end of 2017. 

2.6 Substance evaluation 

Substance evaluation aims to verify whether a substance constitutes a risk to human health or 
the environment from an EU-wide perspective. It contributes to the identification of chemicals 
of concern requiring further risk management. 

The evaluation may conclude that the risks are sufficiently under control with the measures 
already in place. Otherwise, it may lead to the proposal of EU-wide risk management 
measures, such as restrictions, identification of substances of very high concern, harmonised 
classification, or other actions outside the scope of REACH. 

From the date of publication of the Community rolling action plan (CoRAP) list, the evaluating 
MSCA has, for those substances to be evaluated in the first year24, 12 months to conclude 
whether further information must be requested from the registrants to clarify the concerns. 
The information requested usually goes beyond the standard information requirements of 
REACH and may relate to the intrinsic properties of the substance or its exposure. 

The view that further information is needed is shared with all the other Member States and 
ECHA to achieve a general agreement. ECHA takes the decision to request further information, 
whenever necessary. 

Further information on substance evaluation is provided on ECHA’s website25. 

To  further  improve  the  effectiveness  and  efficiency  of  the  substance  evaluation  process,  a 
workshop  on  Substance  Evaluation  within  the  Integrated  Regulatory  Strategy  was  hosted  by 
ECHA during October 2017. The aim of the workshop was to: 

24 The CoRAP covers 3 years, and its rolling nature means that the list of prioritised substances included 
for  evaluation  during  the  second  and  the  third  year  may  change  when  the  updated  CoRAP  is  annually 
published. In the update of the previous CoRAP, the second year’s list becomes the list of the first year and 
a new list of substances for the third year is added. 
25 https://echa.europa.eu/regulations/reach/evaluation/substance-evaluation 

 
 
 
 
 
 
 
 
 
                                           
 
 
38 

Evaluation under REACH: Progress Report 2017 

- 

review the substance evaluation process and its contribution to the  Integrated Regulatory 
Strategy; 

-  consider ways of amplifying the outcomes and impact of substance evaluation;  
- 

reinforce  the  collaboration  between  ECHA,  Member  State  competent  authorities  and 
registrants throughout the process; 

-  ensure efficient interplay with dossier evaluation and other regulatory processes; 
-  strengthen  the  follow-up  evaluation  and  conclusion  phases  as  well  as  the  interface  with 

regulatory risk management measures; 

-  discuss legal issues and learnings from appeals on substance evaluation decisions. 

Figure 14 on next page provides an overview of the current status of the 243 substances 
published within the CoRAP for evaluation between 2012-2017. 

 
 
 
 
Evaluation under REACH: Progress Report 2017 

39 

243 substances assigned 
for evaluation 

221 substances 
evaluated 

SEv Follow-Up 

44 substances with a 
published conclusion not 
requiring further action 

30 substances with a 
published conclusion 
requiring further action 

A Substance is currently being evaluated by the Member State competent authority (MSCA). 
B Evaluating MSCA can conclude on the suspected risk based on the available information. 
C A draft decision requesting further information to clarify the concern(s) is deemed necessary. 
D Substance evaluation is suspended (i.e. no draft decision prepared) pending the outcome of a 

compliance check that must be performed first.  

E Stages of processing the draft decision.  
F ECHA evaluation decision taken. 
G Decisions appealed before the Board of Appeal of ECHA. 
H Registrants to submit the requested information, within the timelines specified in the decision. 
I The evaluating MSCA will examine all new information in the updated registration. 
J Conclusion documents are drafted and being prepared for publication. 
K Conclusion documents are published on ECHA’s web pages. 

Figure 14: Status of all substance evaluations started in 2012-2017 at the end of 2017. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
40 

Evaluation under REACH: Progress Report 2017 

2.6.1 Selection and prioritisation of substances for evaluation 

Article 44(1) of REACH provides general criteria for selecting substances for substance 
evaluation. In cooperation with the Member States, ECHA has refined the risk-based criteria26, 
before applying them to identify substances with potential concerns. The selection of 
substances originates from the common screening that lies at the core of the Integrated 
Regulatory Strategy. Such substances are screened to see whether they should already be 
subject to regulatory measures; if not, whether substance evaluation would be effective to 
clarify the concerns. 

Subsequently, ECHA and the Member States identify substances that could be included in the 
CoRAP. Member States express their interest to evaluate a certain substance so that ECHA can 
create a draft CoRAP with the substance names and the tentative assessment years. The 
CoRAP is adopted after consultation among the Member States and the opinion of ECHA's 
Member State Committee. 

The adopted CoRAP update is published on ECHA’s website27. Its content is also included in the 
dynamic overview table of all substances28. 

The justification document prepared by the evaluating MSCA describes the scientific grounds of 
the initial concerns which require further clarification under substance evaluation, and it also 
informs on possible follow-up actions considered by the evaluating MSCA. 

The CoRAP 2017–2019 update29 was adopted on 21 March 2017 and contained 115 
substances. The list contained 22 newly-selected substances and 93 substances carried over 
from the existing CoRAP. The lower number of selected substances is mainly due to the need 
to wait for important standard information gaps to be closed under a preceding compliance 
check. This standard information is considered necessary in deciding what further information 
should be requested under substance evaluation and, in some cases, it may even be sufficient 
to draw conclusions on the concern. 

ECHA forwarded the draft of the subsequent CoRAP update 2018-2020 to the Member State 
Committee for opinion seeking on 13 October 2017, and published the draft on 24 October 
201730. The draft list contained 107 substances, with 26 substances planned to be evaluated in 
2018. The list contained 16 newly-selected substances and 91 substances carried over from 
the existing CoRAP. Depending on the opinion of the Committee, the number and order of 
substances may change before the list is adopted. ECHA anticipates the adoption of the CoRAP 
2018–2020 update in March 2018. Further information on the CoRAP is provided on ECHA’s 
web pages31. 

To further enhance the effectiveness and efficiency of substance evaluation, ECHA normally 
performs a compliance check before a substance is evaluated under substance evaluation. 
These compliance checks support substance evaluation by ensuring that key information 
requirements for human health and the environment are adequately fulfilled. The interplay 

26 http://echa.europa.eu/documents/10162/13628/background_doc_criteria_ed_32_2011_en.pdf 
27 https://echa.europa.eu/information-on-chemicals/evaluation/community-rolling-action-plan/corap-list-
of-substances 
28 https://echa.europa.eu/information-on-chemicals/evaluation/community-rolling-action-plan/corap-
table 
29 https://echa.europa.eu/documents/10162/13628/corap_update_2017-2019_en.pdf/6a394595-a4e5-
0e10-ec66-eabdc55ce7f6 
30 https://echa.europa.eu/documents/10162/13628/corap_list_2018-2020_en.pdf/3be44b84-5d72-01fe-
f8d7-3a5a9c27951e  
31 https://echa.europa.eu/regulations/reach/evaluation/substance-evaluation/community-rolling-action-
plan 

 
 
 
 
 
 
 
 
                                           
 
 
Evaluation under REACH: Progress Report 2017 

41 

between compliance checks and substance evaluation is defined case-by-case, to prevent the 
substance evaluation process being postponed and consequent delays in identifying regulatory 
risk management. ECHA and Member State competent authorities maintain close collaboration 
and communication to ensure that the most appropriate route is taken to address the 
concerns. 

2.6.2 Evaluation by Member State competent authorities 

The substance evaluation process assesses all registration dossiers from all registrants specific 
to the same substance, although other available sources of information may also be 
considered. The initial reason for selecting a substance for the CoRAP is not limiting the scope 
of the evaluation. 

During the evaluation, the Member State may identify other concerns that need clarification to 
conclude whether a substance is of concern or not. However, the Member State can focus the 
evaluation more on specific concerns raised about the substance. 

ECHA  maintains  regular  interaction  with  evaluating  MSCAs  throughout  the  intial  12-month 
evaluation period. This early interaction between ECHA and the evaluating MSCA was introduced 
to increase efficiency and transparency by: 

-  providing early support to evaluating MSCAs in considering the best approaches to clarify 

the concern and any risk management measures; 

- 

following  the  progress  of  the  evaluating  MSCA’s  evaluation,  identifying  and  resolving 
potential delays at an early stage; 

-  providing  advice  and  support  to  ensure  each  evaluation  is  consistent  and  scientifically 

robust. 

During 2017, early interaction occurred between ECHA and the evaluating MSCAs for the 
majority of the substances being evaluated. 

Additionally, ECHA has developed example text for evaluating MSCAs to use when drafting 
their requests for further information. This example text provides additional support to the 
evaluating MSCAs and contributes to ensuring that requests for further information are 
consistent and transparent. Currently, example text is available for information requests 
related to mutagenicity, reproductive toxicity, endocrine disruption, and PBT/vPvB.  

Prior to the completion of the 12-month evaluation period, the evaluating MSCAs may submit 
their  draft  decision  for  a  consistency  screening  by  ECHA.  During  2017,  ECHA  performed 
consistency screenings on 19 draft decisions for substances allocated for evaluation during 2016. 
The aim of the consistency screening is to: 

-  ensure all requests for further information are well reasoned and appropriate for clarification 

of the concern; 

-  clarify the link between compliance check and substance evaluation, and identify the most 
viable route for requesting information that is necessary to clarify the concern(s) and achieve 
regulatory risk management. 

Of the 39 substances allocated for evaluation during 2016, the evaluating MSCAs considered 
that 27 (69 %) of these required further information to clarify the suspected concerns. For 12 
of the substances evaluated during 2016, the evaluating MSCAs considered the available 
information sufficient to conclude on the concerns and submitted their conclusion documents 
to ECHA. 

For the rest of substances evaluated in 2016, it was considered that a compliance check of the 
relevant tonnage bands was required before the substance evaluation could proceed. Thus, the 
substance evaluation process, for making a request for possible further information to clarify 

 
 
 
 
 
 
 
 
 
42 

Evaluation under REACH: Progress Report 2017 

the suspected concern(s, was suspended pending the outcome of ongoing compliance checks.  

As soon as information on the standard requirements is available in the dossier updates, the 
evaluating MSCA will consider it under their continued substance evaluation, and consider 
whether some other additional information would still be necessary to clarify the remaining 
concerns regarding those substances. 

Furthermore, the evaluating MSCAs started their evaluations of the 22 substances allocated for 
evaluation in 2017. Finalisation of all draft decisions generated as a result of this evaluation 
work will be performed in early 2018. 

2.6.3 Decision making 

In 2017, ECHA sent draft decisions for commenting to 163 registrants of the 27 substances 
evaluated during 2016 where the evaluating MSCAs considered further information was needed 
to clarify the suspected concerns.  

To further improve the quality of the decisions and ensure a smooth decision-making phase, 
ECHA offers enhanced support to evaluating MSCAs during decision making. After 
consideration of the registrants’ comments, the evaluating MSCAs may submit their (revised) 
draft decisions to ECHA for review. In 2017, less than half of the cases were reviewed by ECHA 
before referral. 

This review is as a continuation of the early interaction between ECHA and the evaluating 
MSCAs that occurs during the initial evaluation stage. The review ensures more efficient and 
effective handling of substance evaluation draft decisions and provides the evaluating MSCAs 
with additional support for formulating information requests within the draft decision. 

To date, nearly all consulted draft decisions under substance evaluation have received 
proposals for amendment. When Member State competent authorities or ECHA submit 
proposals for amendment, the Member State Committee seeks a unanimous agreement 
through a written procedure or in plenary meetings. For the latter, the registrants can attend 
the open sessions. The number of decisions agreed through written procedure is increasing. 
During 2017, the Committee agreed on 24 draft decisions for 24 substances, of which 11 (46 
%) were agreed in written procedure. 

If the Member State Committee does not reach a unanimous agreement, the case is referred 
to the Commission. To date, only two decisions under substance evaluation have been referred 
to the Commission following no unanimous agreement being reached at the Committee. The 
first decision was referred to the Commission in 2014, which subsequently adopted the 
decision32 in 2015. The second was referred to the Commission in 2017 and has not yet been 
adopted. 

Following a consultation of the Member States in November 2017, it was agreed that 
registrants of certain intermediates would also receive substance evaluation decisions. 
Consequently, from January 2018, ECHA will send substance evaluation draft decisions also to 
registrants of transported isolated intermediates, but not registrants of on-site isolated 
intermediates. 

The change in practice gives all registrants an equal possibility to comment substance 
evaluation decisions. The registrants of transported isolated intermediates may in the 
comments seek to demonstrate that the concern identified in the draft decision is not relevant 
to their specific strictly controlled conditions of use, as further substantiated. The evaluating 

32 https://echa.europa.eu/documents/10162/e23a2e0e-d456-48f0-9d24-2fb4bbf49dca  

 
 
 
 
 
 
 
 
 
 
 
                                           
 
 
Evaluation under REACH: Progress Report 2017 

43 

MSCA will take the comments into account. 

2.6.4 Information requested 

During 2017, ECHA took decisions on 31 of the substances evaluated. Non-confidential 
versions of 26 of these decisions have been published on ECHA’s website and links to them 
have been included in the dynamic CoRAP list33. Non-confidential versions of the remaining 
four decisions will be published in due course. Table 10 summarises the information requested 
within the decisions taken during 2017 to clarify hazard-based concerns. A decision may 
contain more than one request. 

Table  10:  Information  requests  to  clarify  hazard-based  concerns  within  decisions 
taken during 2017. 

Suspected 
Concern   

Types of information requested to clarify the concern 

Simulation biodegradation test 

Daphnia magna reproduction test 

Physico-chemical tests 

Aqueous exposure bioaccumulation fish test 

Ready biodegradability test 

PBT/vPvB 

Fish, early-life stage (FELS) toxicity test 

Sediment-water Chironomid toxicity test 

Toxicity of sediment-associated contaminants with freshwater 
invertebrates 

Aquatic toxicity test with bivalves 

Freshwater algae and cyanobacteria, growth inhibition test 

Sediment-water Lumbriculus toxicity test  

Extended one-generation reproductive toxicity study 

Combined repeated dose toxicity study with 
reproduction/developmental toxicity screening test 

In vivo mammalian alkaline comet assay 

Reproductive toxicity 

Mutagenicity 

Combined mammalian erythrocyte micronucleus test and 
mammalian alkaline comet assay 

Transgenic rodent somatic and germ cell gene mutation assay 

In vitro mammalian cell micronucleus test 

Fish sexual development test 

Endocrine disruption 

Larval amphibian growth and development assay  

Sensitisation 

Skin sensitisation local lymph node assay 

H295R steroidogenesis assay 

Total   
requests† 

16 

6 

5 

5 

4 

3 

2 

1 

1 

1 

1 

3 

1 

3 

3 

3 

2 

3 

1 

1 

2 

33https://echa.europa.eu/information-on-chemicals/evaluation/community-rolling-action-plan/corap-table 

 
 
 
 
 
 
 
                                           
 
 
44 

Suspected 
Concern   

Other hazard-based 
concerns 

Evaluation under REACH: Progress Report 2017 

Types of information requested to clarify the concern 

Information on composition 

Sediment-water Lumbriculus toxicity test  

Daphnia magna reproduction test 

Sediment-water Chironomid toxicity test 

Sub-chronic 90-day toxicity study 

Total   
requests† 

7 

1 

1 

1 

1 

† For many decisions, an integrated testing strategy (ITS) may be used. 

Total 

79 

Additionally, in 14 of 31 decisions taken by ECHA in 2017, the evaluating MSCA considered that 
further information on exposure and/or risk assessment was necessary to clarify the concerns. 
Some examples of the exposure-based information requests included within the decisions taken 
during 2017 are: 

- 
- 
- 

clarification and detailed justification for environmental exposure scenarios; 
further information and justification on input parameters used for exposure assessment; 
improved characterisation of the tasks and processes covered in exposure scenarios. 

2.6.5 Follow-up evaluation of substance evaluation decisions 

Upon receipt of a dossier update containing all information requested in the decision, the 
evaluating MSCA has 12 months to complete the assessment of the substance.  

Once this assessment is complete, the evaluating MSCA uses the available information to 
decide either to request further information to clarify the concerns, or conclude whether 
further regulatory actions on the substance are necessary. 

In 2017, 26 substances were at the stage where new information should have been submitted 
following an initial request for further information. The responsible evaluating MSCAs are 
currently reviewing the newly submitted information to conclude on its suitability. In 2017, for 
15 substances the evaluating MSCAs concluded that the newly submitted information was 
suitable, and the 12-month assessment of the submitted information is ongoing. For 11 
substances, a conclusion has been published after follow-up evaluation. 

To  facilitate  the  follow-up  work,  ECHA  provides  Member  State  competent  authorities  with  a 
monthly report on submitted dossier updates for cases where the substance evaluation decision 
has  been  issued.  Furthermore,  in  2017,  ECHA  implemented  a  new  webform  that  evaluating 
MSCAs  can  use  to  inform  ECHA  on  whether  all  requested  information  was  provided  by  the 
registrants in their dossier updates. 

2.6.6 Concluding substance evaluation 

Following a review of the available data and new data (where relevant), if the evaluating MSCA 
concludes that the use of the substance poses a risk, it may then proceed with follow-up 
actions to substance evaluation. The following options may address the concern: 

-  a proposal for harmonised classification; 
-  a proposal to identify the substance as a substance of very high concern (SVHC); 
-  a proposal to restrict the substance; 
-  actions outside the scope of REACH and CLP, e.g. a proposal for EU-wide occupational 

exposure limits, national measures or voluntary industry actions. 

During 2017, 25 conclusion documents originating from substance evaluations performed in 

 
 
 
 
 
 
 
 
 
 
 
 
 
Evaluation under REACH: Progress Report 2017 

45 

2012–2016 were published within the dynamic CoRAP list34 on ECHA’s website. In 12 of the 25 
concluded cases published, the evaluating MSCA concluded that further EU-wide regulatory 
action is needed.  

Table 11 summarises the hazard-based concerns concluded on in 2017 and their outcomes. 
More than one concern may be indicated for a substance. Regulatory follow-up actions are not 
needed if the hazard concern is removed or no risk is anticipated due to changes of 
circumstances, like new risk management measures being in place or cease of certain uses or 
import/manufacture. 

More information on the conclusions on concerns in relation to PBT/vPvB, potential endocrine 
disruption, carcinogenicity, mutagenicity, and reproductive toxicity under substance evaluation 
is available within the annual reports for SVHC identification and implementation of REACH risk 
management measures35. 

Table 11: Hazard-based concerns concluded on in 2017 and their outcomes. 

Suspected 
concern 

Concluded regulatory follow-up action 
at EU level 

Total 
conclusions 

Carcinogenicity 

No regulatory follow-up action needed 

Mutagenicity 

Reprotoxicity 

Harmonised classification and labelling 
Concern not clarified* 

No regulatory follow-up action needed 

Harmonised classification and labelling 

Concern not clarified* 

No regulatory follow-up action needed 

Harmonised classification and labelling 

Concern not clarified* 

No regulatory follow-up action needed 

PBT/vPvB 

Concern not clarified* 

7 

1 
1 

4 

2 

1 

6 

3 

1 

3 

2 

Concluded 
substances by 
EC/List number 
205-483-3 
203-631-1 
203-777-6 
271-231-4 
200-817-4 
203-726-8 
204-617-8 
204-820-1 
212-783-8 
203-777-6 
271-231-4 
204-617-8 
204-820-1 
203-631-1 
200-817-4 
212-783-8 
448-020-2 
205-743-6 
203-631-1 
210-871-0 
203-777-6 
203-629-0 
204-327-1 
200-817-4 
272-486-4 
212-783-8 

203-624-3 
604-250-7** 
800-353-8 

448-020-2 
272-486-4 

34 https://echa.europa.eu/information-on-chemicals/evaluation/community-rolling-action-plan/corap-
table 
35 https://echa.europa.eu/addressing-chemicals-of-concern/substances-of-potential-concern/svhc-
roadmap-to-2020-implementation 

 
 
 
 
                                           
 
 
46 

Evaluation under REACH: Progress Report 2017 

3 

Sensitisation 

Endocrine 
disruption 

Suspected 
concern 

Total 
conclusions 

No regulatory follow-up action needed 

No regulatory follow-up action needed 

Identification as a SVHC (Authorisation) 
Further regulatory action to be decided 

Concluded regulatory follow-up action 
at EU level 

Concluded 
substances by 
EC/List number 
204-327-1 
200-817-4 
201-248-4 
201-245-8 
203-585-2 
205-483-3 
200-752-1 
219-470-5 
210-871-0 
204-820-1 
200-752-1 
203-956-9 
210-871-0 
203-777-6 
405-040-6 
204-617-8 
204-820-1 
* Substance evaluation was terminated due to change of the registration to only intermediate under 
strictly controlled conditions or inactivation of registration. Consequently, the evaluating MSCAs 
concluded that the concerns could not be presently clarified and a new assessment should be undertaken 
in the event of new registrations of the substance in the future. 
** Conclusion covers two EC/List numbers (604-250-7 and 415-490-5). 

Harmonised classification and labelling 

Harmonised classification and labelling 

Other hazard-
based concern 

1 
1 

1 

4 

7 

 
 
 
Evaluation under REACH: Progress Report 2017 

47 

3. Other measures to enhance dossier quality 

ECHA also uses measures other than formal decisions to improve dossier quality. Some of 
them are directly related to REACH processes, such as tools used within the registration 
process, others are non-regulatory measures aiming to trigger and help registrants to update 
and to improve their registration dossiers. These measures range from simple phone calls to 
registrants to collaboration with industry to develop sector-specific guidelines related to, for 
example, substance identification, to further assist the registrants to comply with REACH 
requirements.  

3.1 Enhanced completeness check 

ECHA checks the completeness of the registration dossiers systematically at the submission 
phase. In accordance with the decision taken by the Management Board 36, ECHA implemented 
the enhanced completeness check on 21 June 2016 to ensure that submissions contain all the 
information foreseen by REACH. It applies equally to new registrations and to updates of 
registrations previously submitted. The updated completeness check also includes additional 
manual verifications by ECHA staff to ensure that when registrants waive or deviate from the 
information requirements, they provide justifications foreseen by REACH, and that testing 
proposals on vertebrate animals are accompanied by justification for why none of the 
adaptation possibilities under REACH could be used. The manual checks aim to establish a 
level playing field between registrants who follow the standard information requirements set 
out in REACH and those who waive or deviate from these requirements, by ensuring that the 
latter provide justifications with a regulatory relevance. 

During 2017, 4 752 registration dossiers (ca. 30 % of all incoming registration dossiers) were 
stopped for manual verification by ECHA staff of which 1 306 initial dossiers and 3 446 update 
dossiers (Figure 15). In 25 % of the manually verified dossiers (8 % of the submitted 
dossiers), registrants were requested to improve the submitted information. In 95 % of these 
cases, registrants were able to amend the dossiers as requested, and the submissions passed 
the completeness check at the second attempt. This means that 0.5 % of all submitted 
dossiers (15 558 dossiers) were rejected at completeness check, consisting of a total of 74 
dossiers, of which 22 were for initial submissions. 

36 36th MB meeting, 16-17 December 2014, Rome - AP 11: Substance identification in registration 
dossiers – a strategy for improvement (including completeness check) (MB/53/2014), 
https://echa.europa.eu/documents/10162/13608/mb_m_04_2014_minutes_mb_36_en.pdf/9e7bff2a-
ba57-4af4-86ef-783dd685d80e; 38th MB meeting, 17-18 June 2015, Helsinki - AP 11: Improved 
substance identity check as part of the technical completeness check process (MB/26/2015), 
https://echa.europa.eu/documents/10162/21844190/mb_m_02_2015_minutes_mb_38_en.pdf/af58238e
-c948-4de9-aba1-c8c644888e0c. 

 
 
 
 
                                           
 
 
48 

Evaluation under REACH: Progress Report 2017 

Manually verified dossiers
passing

Manually verified dossiers
failing

Automatically checked
dossiers

22%

8%

70%

Figure 15: Breakdown between dossiers manually verified and dossiers where 
registrants were requested to improve the information. In 2017, 15 558 dossiers were 
submitted – 4 752 dossiers (30 %) were manually verified, out of which 3 541 (22 %) passed 
and 1 211 dossiers (8 %) failed the manual verification.  

Figure 16 below shows the areas of the dossiers that were manual verified in 2017. A total of 
4 752 dossiers were manually verified of which 2 182 (46 %) dossiers were checked for 
substance identity, 2 690 (57 %) dossiers were checked for data waiving, 523 (11 %) dossiers 
were checked for testing proposals and 48 (1 %) dossiers were checked for chemical safety 
reports (CSR). Dossiers include both initial and updated submissions with manual verification 
completed between 1 January 2017 and 31 December 2017.  

CSR
1%

TP
10%

SID
40%

DW
49%

Figure 16: Distribution of verification areas in manually verified dossiers. One 
dossier may be checked in more than one area and for more than one item. A total of 
4 752 dossiers were manually verified. Abbreviations: substance identity (SID); data waiving 
(DW); testing proposals (TP) and chemical safety report (CSR). Dossiers include both initial 
and updated submissions with manual verification completed between 1 January 2017 and 31 
December 2017. 

 
 
 
 
 
 
 
Evaluation under REACH: Progress Report 2017 

49 

Impact of the enhanced completeness check 
An impact analysis of the enhanced completeness check was undertaken in 2017, taking into 
account the first year of the enhanced completeness check. A sample of dossiers was further 
analysed to check the quality improvement of dossiers subject to manual verification. In the 
majority of the cases, the manual verification process had brought about significant 
improvements to the level of the information in registration dossiers, having a positive impact 
on the efficiency of subsequent regulatory processes and, indirectly, on the dossiers 
compliance. For example, in relation to substance identity, ECHA staff working on this topic 
were able to identify the substance in a clearer way (through the improvement of the 
manufacturing process description or UVCB composition breakdown). Similar improvements on 
data could be seen in the case of waiving of standard information requirements, where invalid 
justifications for not submitting a study were replaced by experimental data or QSARs. 

3.2 Promoting dossier updates 

In 2017, ECHA commissioned an external study to gain insight on the drivers, barriers, costs 
and benefits for updating REACH registration and CLP notification dossiers37. The study found 
that companies lack incentives to update their REACH registrations. Furthermore, the study 
results suggest that more clarity is needed on how the registration process works and what 
needs to be updated and by whom, in order for more companies to submit new information on 
the safe use of their chemicals. 

According to Article 22 of REACH, registrants are responsible for updating their registrations 
with relevant new information on their own initiative and without undue delay and submitting 
them to ECHA, for example when: there are any changes in a registrant’s status; there is any 
change in the composition of the registered substance; there are changes in the annual or 
total quantities manufactured or imported; new uses and new uses advised against are 
identified; there is new knowledge of the risks of substance to human health and/or the 
environment; there is any change in the classification and labelling of the substance; there is 
an update or amendment of the CSR or guidance on safe use; the registrant identifies the 
need to perform new test listed in Annex IX or Annex X to REACH; and if there is any change 
in the access granted to information in the registration. By the end of 2017, ECHA had 
received a total of 67 005 registrations. Of these, 68.8 % have never been updated by 
industry and 33.2 % have been updated at least once. With joint lead dossiers, the update rate 
is slightly higher than overall: over half (53.8 %) have been updated at least once. 

Updates triggered by regulatory activity 
Not all the updates are based on the registrants’ own initiative to update their dossier. For 
example, the adopted ECHA dossier and substance evaluation decisions, ECHA’s requests to 
clarify the intermediate status for priority substances, or a decision on harmonised 
classification and labelling trigger the need for registrant to update their dossier by a given 
deadline. 

To enhance data quantity and quality, in addition to dossier and substance evaluation, ECHA 
uses also other means to try to trigger dossier updates. Such measures include letter 
campaigns and the publication of pre-alert lists of substances planned to be addressed under 
compliance checks, thereby encouraging timely dossier updates or the use of the multiplier 
effect (e.g. targeting all registrants of the same substance under dossier evaluation). 
Furthermore, ECHA has also increased transparency by improving the dissemination of 
information on the registrations on ECHA’s website in the form of infocards and brief substance 
profiles. 

37 
https://echa.europa.eu/documents/10162/22931011/study_drivers_and_obstacles_reach_clp_updates_e
n.pdf/  

 
 
 
 
 
 
                                           
 
 
50 

Evaluation under REACH: Progress Report 2017 

In  order to assess the impact of the other measures to trigger dossier updates, a substance-
level analysis was conducted on their effectiveness between 2015 and 2017. The analysis showed 
that the average update rate was 13.4 % of the substances receiving at least one update each 
year. However, when a substance was added on a compliance check pre-warning list or included 
in a letter campaign from manual screening, the update rate increased. Based on the analysis, 
adding a substance on the pre-warning list on ECHA website made an update approximately 2.5 
times  more  likely  to  happen,  and  sending  a  targeted  letter  under  manual  screening  made  an 
update 3 times more likely compared with the baseline. This analysis shows that the measures 
taken  have  an  impact  and  can  help  to increase  the  update  activity.  However,  in  this  analysis 
only the update activity was studied and therefore it is not known if these updates actually had 
an impact on the data quality in the registeration dossiers. 

3.3 Substance identification 

Informal discussions with registrants 
ECHA continued to organise informal discussions with the registrants of dossiers where critical 
issues concerning the substance identity have been observed. ECHA has received very positive 
feedback from the registrants for handling problematic dossiers this way. In fact, during the 
informal discussions, not only are such issues highlighted, but ECHA may provide support for 
improving dossier quality from the substance identity point of view. The outcome of these 
informal discussions is usually the update of the dossier, with substance identity issues solved 
and with no need to send a substance identity-targeted draft decision. 

ECHA also continued organising informal discussions with registrants in anticipation of the 
common screening work conducted in cooperation with Member State competent authorities on 
substances of potential concern 38. This approach was initiated in 2016 and resulted at that 
time in informal discussions with registrants for 17 substances. For 2017, nine substances 
were selected. These substances are temporarily removed from the shortlist of substances for 
manual screening until the substance identity information is clarified.  

Substance identity profile  
In order to facilitate the clarification of the identity and composition of the substance that is 
intended to be covered in a joint registration, information on the substance identity profile 
(SIP) is part of the lead registration dossier. Advice on how to define the SIP is available in 
Appendix III of the Guidance on substance identification and naming under REACH and CLP39. 
Also a set of Questions and Answers on the SIP have been published on ECHA’s website40. In 
addition, a new format is now available in IUCLID 6 for structuring the reporting of specific 
information on the composition of test materials. The availability of such information will 
provide an important contribution to activities done in the evaluation process. 

38 Further information on screening is available at: https://echa.europa.eu/addressing-chemicals-of-
concern/substances-of-potential-concern/screening. Different outcomes may follow the manual screening 
work carried out by MSCAs, one of them being the need to request for further information under the 
evaluation provisions. 
39 Guidance for identification and naming of substances under REACH and CLP: 
https://echa.europa.eu/documents/10162/23036412/substance_id_en.pdf/ee696bad-49f6-4fec-b8b7-
2c3706113c7d. 
40 https://echa.europa.eu/support/qas-support/browse/-
/qa/70Qx/view/scope/REACH/Substance+identity+profile?_journalqadisplay_WAR_journalqaportlet_INST
ANCE_70Qx_backURL=https%3A%2F%2Fecha.europa.eu%2Fsupport%2Fqas-
support%2Fbrowse%3Fp_p_id%3Djournalqadisplay_WAR_journalqaportlet_INSTANCE_70Qx%26p_p_life
cycle%3D0%26p_p_state%3Dnormal%26p_p_mode%3Dview%26p_p_col_id%3Dcolumn-
1%26p_p_col_pos%3D2%26p_p_col_count%3D3 

 
 
 
 
 
 
 
 
                                           
 
 
Evaluation under REACH: Progress Report 2017 

51 

Substance identity adaptation 
An essential element in the context of the evaluation process is the use of the correct 
numerical identifiers. In 2017, the service provided by ECHA to facilitate the change of the 
numerical identifiers remains a well-used solution to correct substance identification mistakes 
observed during the dossier evaluation process. Many of these requests were initiated due to a 
compliance check and after the informal discussions with the registrants. ECHA has 
implemented a new customer-friendly webform and template to facilitate submissions of 
requests. 

In addition, ECHA provides a technical solution for maintaining the correlation with other 
identifiers relevant for the substance (such as those used for other regulatory purposes, or 
previously used to identify the substance). Such related identifiers can be added to the field 
“Other identifier” in section 1.1 of the IUCLID 6 dossier. 

Substance identification in the sectoral approach 
ECHA has collaborated with specific industrial sectors to develop sector-specific guidelines on 
substance identification to further assist registrants in complying with the REACH substance 
identification requirements. In particular, ECHA collaborated with the relevant industry 
associations – Eurocolour, a sector group of the European Chemical Industry Council (Cefic), 
and the Inorganic Pigments Consortium – in developing the Guidance for characterising 
complex inorganic coloured pigments. The Guidance is now published on Eurocolour’s website 
and linked to ECHA’s website.41 

Substance identity defined for joint registration and the test material composition 
The first set of lead registrant dossiers updated or submitted after the release of IUCLID 6 in 
April 2016 are now available in the ECHA registration database. For substance identity, there 
are two new key records available: the boundary composition record and the test material 
record. The boundary composition record reports the joint constituent concentration profile. 
The name and other identifiers defined for the jointly registered substance – under the ‘one 
substance, one registration’ principle – are derived from this information. The test material 
record reports the constituent identities and concentration values of the test material used to 
generate the jointly reported REACH Annex VII-XI data. 

Full use of the reporting options by the registrants will bring transparency to the link between 
the jointly defined substance identity and the test material used to generate the data to meet 
the REACH Annex VII-XI standard information requirements in the registration. ECHA is 
providing support for reporting in the Q&A section of ECHA website.42 Transparent reporting in 
these fields will facilitate in particular testing proposal examination and substance evaluation. 
ECHA encourages all registrants to make full use of the reporting fields available so it is clear 
what is being registered and how the reported test data has been generated. 

3.4 The collaborative approach pilots 

The consideration of regulatory actions based on groups of similar substances rather than 
single substances was endorsed as part of ECHA’s Integrated Regulatory Strategy 43 at the 
CARACAL meeting in March 2017. The assessment of groups of substances requires adaptation 
of the approach applied to individual substances and is an opportunity for testing new forms of 
collaboration between ECHA, Member State competent authorities and relevant registrants or 
industry groups. The expectation is that the assessment work, the generation of further 

41 https://echa.europa.eu/support/substance-identification/sector-specific-support-for-substance-
identification/complex-inorganic-pigments 
42 Q&As section: https://echa.europa.eu/support/qas-support/browse; browse by topic “Substance identity 
profile”. 
43 https://echa.europa.eu/documents/10162/22837330/mb_44_2016_regulatory_strategy_en.pdf/  

 
 
 
 
 
 
 
                                           
 
 
52 

Evaluation under REACH: Progress Report 2017 

information and the conclusion on risk management actions for groups of related substances 
can enhance consistency and efficiency in all REACH and CLP processes and have an amplified 
impact on a wider number of substances.  

As indicated in section 2.2.1 above, manual screening in 2017 involved many groups of related 
substances. Three of the groups for manual screening and two other groups with already 
ongoing regulatory actions were selected to test an enhanced collaborative approach 
(“COLLA”). The so-called COLLA pilot projects differ from the regular manual screening by 
offering registrants an early opportunity to contribute to the clarification of identified concerns 
and further testing needs. The registrants are able to contribute with additional information 
and provide proposals on necessary actions to generate missing information and address 
identified concerns. At the end of the pilot projects, ECHA and the authorities will decide on the 
necessary further actions on the related substances, or eventually conclude that no further 
action by authorities is required for the time being for certain substances. 

Table 12: The five COLLA groups, initial concern, and the Member States involved in 
assessment with ECHA. 

COLLA group 

Initial concern  

Lead MS 

Contributing MS 

EDTA derivatives 

Human health, reproduction toxicity  UK 

Sweden 

Antimony compounds  Human health 

Germany 

Lithuania 

Polyol acrylates 

PBT 

Germany 

Ireland 

Substituted 
diphenylamines 

Subset of organotin 
compounds 

PBT, mutagenicity 

France 

Slovenia 

Reproduction toxicity 

The Netherlands 

Bulgaria and 
Sweden 

The Member State competent authorities involved did a manual screening of all the group 
members. All related registrants (leads and individuals) as well as industry groups and other 
accredited stakeholder organisations were contacted. ECHA organised a webinar for the 
relevant registrants and stakeholders in May 2017, to further explain the COLLA approach. 
Kick-off meetings of the five pilots were held between mid-June and September with the 
participation of assessing Member State competent authorities, ECHA and registrants. Within 
each COLLA group, registrants appreciated this initiative and agreed to provide better 
information to address issues raised in the manual screening by Member State competent 
authorities, and to provide a draft testing strategy to clarify concerns found. These testing 
strategies will be finalised by the end of the five projects in March 2018. 

A comprehensive review of the pilot projects and the collaborative approach will be performed 
in spring 2018. The experience gained so far with screening of groups of related substances 
shows that moving from screening of single substances to screening of groups takes time, as 
most actors do not have previous experience. Some re-organisation of the work is also 
needed. The development of integrated strategies that take into account ongoing and already-
planned regulatory actions on similar substances with different timelines is complex but there 
are already indications of benefits. In all COLLA groups, authorities and registrants have now a 
better picture of all the ongoing or envisaged regulatory actions. These pilot projects show how 
actions on individual substances can be magnified to cover the whole group, including future 
registrations, while ensuring better consistency. Finally, the COLLA projects have also brought 
together registrants that were otherwise not collaborating. 

 
 
 
 
 
 
 
Evaluation under REACH: Progress Report 2017 

53 

3.5 Working with sectors 

Another way to foster the improvement of dossier data quality and to identify and address 
substances of concern is to work with industry sectors. As examples of such work, in 2017 
ECHA carried out activities with the sectors related to petroleum and coal stream substances 
(PetCo; see annual report of the SVHC Roadmap for more details on PetCo work), metals, and 
plastic additives. 

Metals sector approach 
Eurometaux, with input from ECHA, has started a sector approach that aims to improve the 
overall chemicals management of metals and metal compounds by creating an overview of the 
reported hazard, use, exposure and risk management information, starting action to fill data 
gaps and, based on that, assess where either company or regulatory action might be needed. 
Meanwhile, also some cross-cutting technical issues and assessment methodologies that have 
a direct impact on hazard and risk assessment are being further developed (such as read-
across and grouping, environmental classification and addressing inorganic UVCBs).  

The approach is a voluntary scheme that aims to include as many metals and inorganic 
industry organisations or consortia as possible. In 2017, a reporting scheme was developed 
and tested that gives a snapshot of the data available for groups of metals that will allow 
consortia to set priorities for generating further data and keep track of the progress. 

The sector approach will be of help in resolving the main outstanding issues regarding dossier 
quality  and  focus  on  how  the  chemicals  management  in  the  metals  sector  can  be  specifically 
improved in a transparent and more effective way. The metals sector approach is not a substitute 
for  compliance  with legal  obligations  and  for  regulatory  action.  ECHA  and  Member  States  will 
continue regulatory actions as necessary.  

Plastic additives 
A sector approach for plastic additives was started in November 2016 in cooperation with 
manufacturers of plastic additives (Cefic sector groups, Eurocolour, Eurometaux, BSEF), and 
compounders and converters of plastics (EuPC and PlasticsEurope). The project aims to foster 
registration dossiers updates by generating a better understanding on the uses and exposure 
potential of substances used as plastic additives, to improve the quality and compliance of 
hazard information and the way chemical safety aspects are covered in registration dossiers, 
and to facilitate priority setting for regulatory action.  

In 2017, ECHA, together with industry, established an overview of substances used as plastic 
additives. This illustrated how more appropriate use descriptions could be provided in 
registrations, in particular for article service life. The work so far has also demonstrated that 
an approach to determine high and low release potential of additives in plastic matrices would 
be needed, both for industry to develop better exposure estimates as part of their registration 
dossiers and for authorities to identify substances for regulatory priority setting purposes. 

3.6 Letter campaign on shortlisted substances 

ECHA uses informal letters to communicate to registrants that their substances are shortlisted 
for manual screening by Member State competent authorities to confirm or dismiss suspected 
hazard and exposure concerns. The third letter campaign in 2017 (the previous campaigns 
were held in 2015 and 2016) addressed 72 substances, considerably fewer than previously. 

The lower number of substances addressed by the 2017 campaign is due to the pilot approach 
of manual screening of groups of related substances. In fact, as also explained in the screening 

 
 
 
 
 
 
 
 
 
54 

Evaluation under REACH: Progress Report 2017 

webinar of 14 February 201744, from round four of common screening, some of the shortlisted 
substances were associated with other registered substances because of structural similarity 
and presence of read-across or category information. ECHA believed that, by considering 
related substances, authorities can ensure consistency in their actions and act in a similar way 
when dealing with substances that pose similar risks. As ECHA and Member State competent 
authorities were piloting the manual screening of such groups, in 2017 it was decided to 
address the letters only to the so-called ‘group seeds’, i.e. the substances identified by the 
screening algorithms and around which these groups were formed. Hence, members of such 
groups were not addressed by these informative letters. It was in fact not known how many of 
these additional substances the Member State competent authorities would have screened. 
Based on the outcome of this pilot, in 2018 ECHA intends to extend the letter sending to all 
group members. 

Therefore, only registrants of the shortlisted substances identified by the screening algorithms 
were addressees of this campaign and invited to review their dossiers with regard to the 
identified potential hazards and their uses and tonnage information. The aim of the campaign 
was to inform these registrants of the screening process and to trigger updates of dossiers 
where potential concerns with hazard and exposure information were identified. The response 
to this campaign was quite positive. Approximately 40 % of shortlisted substances received 
dossier updates within four months of the letters having been sent. The main reason for 
updating, as in the previous campaigns, was to include new or updated information on uses 
and tonnage per use. However, in certain cases, the registrants also updated hazard 
information with a revision of the human health and environmental endpoint summaries, 
improved information on the substance identification, and strengthened the justification for 
certain adaptations from the standard information requirements. 

3.7 Intermediate status verification 

The activity of verifying the intermediate status of registrations for on-site and transported 
isolated intermediates continued in 2017. The scope of this activity, initially set to support 
relevant REACH risk management processes, such as prioritisation of substances of very high 
concern (SVHCs) for inclusion in the Authorisation List, has been further expanded to support 
users of substances included in Annex XIV of REACH, in order to assess whether authorisation 
applies to their processes and to support Member State authorities to assess intermediate 
uses.  

In 2017, ECHA continued to request registrants to provide documentary evidence of the use of 
their substance as intermediates in their registration dossiers. ECHA also continued working 
with industry associations in the metals sector to gain common understanding on intermediate 
uses in complex processes and subsequent authorisation implications, and with Member States 
(through the Forum for Exchange of Information on Enforcement and National Enforcement 
Authorities) to clarify how to assess uses as intermediate and strictly controlled conditions. 
During 2017, ECHA assessed intermediate registration dossiers for five substances. No Article 
36 requests were sent in 2017 as information in registration dossiers was sufficient to conclude 
about intermediate use in the majority of cases. In four cases the companies were contacted 
directly by ECHA and the registration dossiers were updated.  

44  Link  to  2017  webinar  on  screening:  https://echa.europa.eu/-/how-are-substances-screened-and-
shortliste-1  

 
 
 
 
 
 
 
                                           
 
 
Evaluation under REACH: Progress Report 2017 

55 

3.8 Transparency regarding content and target of ECHA decisions 

The information published by ECHA, before or after an evaluation is completed, allow 
stakeholders to contribute to the evaluation of chemical substances undertaken by ECHA. 

Before evaluation starts 
Prior to the initiation of the evaluation processes, ECHA publishes the following lists of 
substances which will be subject to its assessment:  
- 

the list of substances potentially subject to compliance checks is updated several times per 
year. Although it is only indicative, registrants are advised to check this list regularly45; 
the substances listed on the Community rolling action plan (CoRAP)46;  
the list of testing proposal consultations47: in relation to testing proposals, and to ensure 
that information on existing vertebrate tests is best used, ECHA consults third parties on 
all proposals for tests involving vertebrate animals, as specified in Annexes IX and X under 
REACH; Subsequently, third parties have 45 days to submit scientifically valid information 
and studies that address the relevant substance and hazard endpoints. 

- 
- 

After evaluation is completed 
ECHA publishes the dossier evaluation decisions to ensure transparency and to offer 
registrants and third parties an opportunity to increase their understanding of the evaluation 
processes48. Similarly ECHA publishes the outcome of the evaluation of a substance by a 
Member State, including the adopted decision. This allows any third party to understand the 
reasoning leading to the request for information 49 to verify the suspected concern. 

45 https://echa.europa.eu/regulations/reach/evaluation/compliance-checks 
46https://echa.europa.eu/information-on-chemicals/evaluation/community-rolling-action-plan/corap-table 
47 https://echa.europa.eu/information-on-chemicals/testing-proposals/current 
48 https://echa.europa.eu/information-on-chemicals/dossier-evaluation-decisions  
49 https://echa.europa.eu/information-on-chemicals/evaluation/community-rolling-action-plan/corap-
table 

 
 
 
 
 
 
                                           
 
 
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Evaluation under REACH: Progress Report 2017 

4. EVALUATION RELATED ACTIVITIES 

This chapter covers the ongoing evaluation-related activities and projects that support or are 
direcly linked to the implementation of REACH. 

4.1 Non-animal approaches 

In 2017, ECHA for the third time reported to the European Commission on how companies use 
non-animal approaches under REACH 50. The results of the report showed that most registrants 
consider and use alternatives to animal testing. One effective way is data sharing: 98 % of the 
substances are registered jointly. Registrants also make extensive use of existing information 
and alternative methods before conducting new studies. 

The analysis is based on joint and individual registration dossiers submitted to ECHA between 
2008 and 2016 for 6 290 substances. Out of these substances, 89 % have at least one data 
endpoint where an alternative was used instead of a study on animals. The most common 
alternative method was using information on similar substances, read-across and grouping 
adaptations, used in 63 % of the analysed substances, followed by combining information from 
different sources (weight of evidence, 43 %) and computer modelling (QSAR prediction, 34 
%). 

In November 2017, ECHA published a report, “Non-animal approaches - Current status of 
regulatory applicability under the REACH, CLP and Biocidal Product regulations”51, which in 
addition to the current status explored the near future developments of the non-animal 
approaches. The aim of the report is to further improve the understanding on how the non-
animal approaches can be used to meet the legal requirements. The report does not replace 
ECHA Guidance, which is always the main source of information for the registrants. The main 
findings of the report show that: 

-  many of the so-called lower-tier information requirements can now be fulfilled by applying 

- 

non-animal approaches; 
for higher-tier endpoints, specific non-animal approaches that could directly replace 
vertebrate animal tests are not yet available and not foreseen within the near or even 
medium-term future; 

-  adaptations using grouping and read-across and/or weight of evidence are currently the 

- 

main approaches to reduce the need for new animal testing; 
information from non-animal approaches may be used as supporting data for grouping and 
read-across adaptation or as elements in a weight-of-evidence adaptation. 

ECHA keeps on its website updated guidance52 on how to avoid unnessesary testing on animals 
and use alternatives to animal testing to fulfil REACH registration requirements.  

Integrated approaches to testing and assessment 
The use of integrated approaches to testing and assessment (IATA) falls in most cases under 
weight-of-evidence adaptation, unless the components of the IATA strictly correspond to the 
information requirement. An IATA can nevertheless to be used to structure a weight-of-

50 https://echa.europa.eu/documents/10162/13639/alternatives_test_animals_2017_en.pdf/075c690d-
054c-693a-c921-f8cd8acbe9c3  
51 https://echa.europa.eu/documents/10162/22931011/non_animal_approcches_en.pdf/ 
52 https://echa.europa.eu/support/registration/how-to-avoid-unnecessary-testing-on-animals 

 
 
 
 
 
 
                                           
 
 
Evaluation under REACH: Progress Report 2017 

57 

evidence adaptation53. 

In a defined approach to testing and assessment, data generated by non-animal and animal 
methods are evaluated by means of a fixed data interpretation procedure. The data 
interpretation procedure is rule-based in the sense that it is based, for example, on a formula 
or an algorithm (e.g. decision criteria, rule or set of rules) that do not involve weight-of-
evidence determination using expert judgment. The OECD guidance54 on the reporting of 
defined approaches to testing and assessment provides templates to enable a structured 
approach of documentation.  

Several examples of IATAs or defined approaches have been published in 2017 or are under 
discussion by the OECD for skin corrosion or irritation, serious eye damage or eye irritation 
and skin sensitisation, and other IATAs are being developed for non-genotoxic carcinogenicity. 
A specific strategy for skin sensitisation assessment under REACH has been developed based 
on the above OECD guidance documents (see section R.7.3 of ECHA Guidance on Information 
requirements and chemical safety assessment – Chapter R.7a)55. 

While no defined approaches has been formally approved yet, in April 2017 the OECD 
approved a project which analyses the predictivity of several preliminary defined approaches 
for skin sensitisation. If found acceptable, these defined approaches can be used under REACH.  

Other scientific work on the non-animal approaches 
ECHA is collaborating internationally to develop screening approaches for (de)prioritisation of 
substances and exploring how non-animal approaches could support regulatory assessments.  

Together, in vitro, in chemico, in silico, -omics and other techniques and non-animal 
approaches are also called new approach methodologies (NAMs). Data may be collected also 
using high-throughput screening (HTS) methods or high-content methods. These methods are 
analytical techniques that enhance toxicity tests in vivo or in vitro by adding e.g. new 
endpoints or parameters, pattern recognition or high-throughput. These methods may be used 
in screening and (de)prioritisation, suggesting a mode of action (MoA), in identifying endpoints 
that can be used in developing adverse outcome pathway approaches, as supportive 
information for grouping and read-across, in integrated approaches such as IATAs, and as 
elements within weight-of-evidence adaptations. 

In 2017, ECHA followed up the international work on NAMs and hosted the second workshop in 
October 2017 after the workshops on 2016 (in ECHA) 56 and a previous one organised by the 
United States Environmental Protection Agency (EPA). ECHA’s NAM project started a process 
between the chemical regulatory agencies worldwide to reinforce the principles of cooperation 
between the OECD member countries, and enhance the use of non-animal approaches for 
screening and (de)prioritisation, chemical hazard and risk assessment, and for harmonised 
classification and labelling. 

At OECD level, there are currently ongoing discussions on how to integrate the fish embryo 
acute toxicity (FET) test into the OECD Guidance Document 126 on the threshold approach for 

53 http://www.oecd.org/chemicalsafety/risk-assessment/iata-integrated-approaches-to-testing-and-
assessment.htm#guidancedocument 
54ENV/JM/MONO(2016)28: https://www.bior.lv/sites/default/files/inline-files/env-jm-
mono%282016%2928%5B1%5D.pdf. 
55 https://echa.europa.eu/documents/10162/13632/information_requirements_r7a_en.pdf/e4a2a18f-
a2bd-4a04-ac6d-0ea425b2567f  
56 https://echa.europa.eu/view-article/-/journal_content/title/topical-scientific-workshop-new-approach-
methodologies-in-regulatory-science  

 
                                           
 
 
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Evaluation under REACH: Progress Report 2017 

acute fish toxicity. The regulatory use of the FET test has been discussed in ECHA, hosted at 
the expert workshop co-organised by ECHA and German Environment Agency (May 2017, 
Helsinki), where research needs and areas for further developments to improve usability of 
FET for regulatory purposes were identified. Nevertheless, based on current knowledge, ECHA 
considers that the OECD Test Guideline 236 has a potential for use as part of a weight-of-
evidence adaptation, in combination with other information, for the registrant to make a 
scientific justification to predict acute fish toxicity. Registrants are invited to include available 
FET data in the weight-of-evidence adaptations in their registrations to gain experience and to 
build the case studies that might be used as best practice examples. The report from the FET 
Workshop is available on ECHA’s website57. 

4.2 Expert working groups 

The expert group on (very) persistent, (very) bioaccumulative and toxic substances 
The PBT Expert Group provides informal scientific advice on questions related to the 
identification of PBT and very persistent, very bioaccumulative (vPvB) properties of chemicals.  

During the year, the expert group supported evaluation by providing informal scientific advice 
for the majority of substances placed on the CoRAP for 2017 due to PBT/vPvB concerns. The 
discussions within the group focused mainly on the interpretation of the existing data and the 
most appropriate testing strategy to conclude on the concern. In addition, the group reviewed 
the data provided in response to substance evaluation decisions for seven substances listed on 
the CoRAP for 2012-2014.  

The expert group on endocrine disruptors 
During 2017, the Endocrine Disruptor Expert Group provided advice regarding eight substance 
cases, all of them on CoRAP. This year was the first time that substance evaluation cases that 
are in the follow-up evaluation stage were discussed in the expert group. Five out of the six 
substances in the CoRAP 2017 with endocrine disruption as an initial concern were discussed 
by the group. The discussions in the expert group have focused mostly on the interpretation of 
available data, the identification of further information requirements and the most appropriate 
information generation and testing strategy to conclude on the concern. 

The expert group on nanomaterials 
The Nanomaterials Expert Group 58 supports the implementation of ECHA’s Workplan for 
Nanomaterials 2016-2018, and provides informal advice on scientific and technical issues 
regarding the implementation of the REACH, CLP and Biocidal Products regulations in relation 
to nanomaterials. 

In 2017, the group discussed several topics. Some of discussions focused on technical aspects 
involved in the development and adaptation of OECD test guidelines and guidance documents; 
these discussions are now framed by the so-called Malta project, an initiative of several EU 
Member States started in Q3/2017 to intensify the effort to develop or update OECD test 
guidelines and guidance documents. 

4.3 Good laboratory practice 

According to Article 13(4) of REACH, ecotoxicological and toxicological tests and analyses must 
be carried out in compliance with the principles of good laboratory practice (GLP). 

ECHA randomly verifies whether a test facility conducting such tests belongs to an OECD GLP 

57 https://echa.europa.eu/documents/10162/13630/fet_workshop_proceedings_en.pdf/a987ccab-5d4a-a226-
2a73-994be484ca8d 
58 https://echa.europa.eu/regulations/nanomaterials/nanomaterials-expert-group/  

 
 
 
 
 
 
 
 
 
                                           
 
 
Evaluation under REACH: Progress Report 2017 

59 

monitoring programme and whether the test facility is GLP-certified for the area of expertise 
relevant for the particular test. In 2017, ECHA continued random verifications of the GLP 
compliance of ecotoxicological and toxicological tests for which results were provided in the 
registration dossiers. In particular, ECHA requested 10 random study audits of different types 
of studies conducted in test facilities of EU member states. Additionally, ECHA requested one 
targeted study audit based on the identified concern. So far, three studies were found to be in 
compliance with the principles of GLP by the GLP monitoring authorities. The remaining study 
audit reports are pending. ECHA will inform the Member State competent authorities upon 
receiving the audit reports if necessary. 

4.4 Test guideline developments 

In vitro methods 
ECHA’s web pages on testing methods and alternatives were updated to reflect new test 
methods and testing strategies59. The updates concern skin and eye irritation/corrosion, skin 
sensitisation and genotoxicity.  

A new method to cover eye irritation endpoint has been approved by OECD, and included in to 
the OECD test No. 492. An Integrated Approach on Testing and Assessment (IATA)60 for the 
eye effects was approved by OECD. IATA provides advice how to combine in vitro and other 
data in a weight-of-evidence approach. 

Also during the year, the OECD approved the new in vitro methods for skin sensitisation U-
SENS and IL-8 Luc Assay, which are included in OECD test No. 442E. These methods can be 
used to meet the information requirement on the third key event according to REACH Annex 
VII, 8.3.1. In addition, OECD has started a project on how to combine specific in vitro methods 
and other data to conclude on skin sensitisation hazard and potency classification. Use of these 
defined approaches is anticipated to lead in many cases to full replacement of in vivo tests.  

On 9 October 2017, the OECD released three test guidelines specifically updated to enable the 
testing of nanomaterials. The OECD test No. 318, Dispersion stability of nanomaterials in 
simulated environmental media, describes test procedure to gain information on dispersion 
stability of manufactured nanomaterials in simulated environmental media. The main purpose 
of this test guideline is to assess the ability of a nanomaterial to attain a colloidal dispersion 
and to conserve this dispersion under environmentally relevant conditions. The other two tests 
were revised to study the health effects of nanomaterials. The OECD test No. 412, on subacute 
inhalation toxicity (28-day study), has been designed to fully characterise test article toxicity 
by the inhalation route following repeated 28-day exposure time, and to provide data for 
quantitative inhalation risk assessments. Correspondingly, the OECD test No. 413, on sub-
chronic inhalation toxicity (90-day study), characterises the test article toxicity by the 
inhalation route following repeated 90-day exposure time. 

4.5 Extended one-generation reproductive toxicity study 

Commission decisions on dossier evaluation cases 
During 2017, the Commission processed the 216 draft evaluation decisions referred to it for 
decision making in years 2011-2014 regarding two-generation reproductive toxicity 
(information requirements 8.7.3 of REACH Annexes IX and X) on which ECHA’s Member State 

59 https://echa.europa.eu/support/oecd-eu-test-guidelines  
60 Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Serious Eye 
Damage and Eye Irritation Series on Testing & Assessment No. 263: 
http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=ENV/JM/MONO(2017)15&doclan
guage=en. 

 
 
 
 
 
 
 
 
                                           
 
 
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Evaluation under REACH: Progress Report 2017 

Committee could not reach unanimous agreement61. In most cases, the Commission decisions 
requested the registrants to update their registration dossiers with a testing proposal for 
extended one-generation reproductive toxicity study (EOGRTS) or a valid adaptation within a 
deadline of 90 days. Registrants who had already submitted a valid testing proposal were not 
asked to update their dossier again.  

The response rate to the Commission decisions was high. For the 98 individual substances, 
approximately 50 % of registration dossiers were updated with testing proposals for EOGRTS, 
approximately 40 % with an adaptation, and less than 10 % of the registration dossiers were 
not updated within the deadline. All read-across categories (a total of 115 registration dossiers 
bundled in 5 categories) were updated with testing proposals to reflect the new EOGRTS 
information requirement. ECHA has started to process these cases. 

Extension to the assessment of second filial generation (F2) and testing of 
developmental neuro- and immunotoxicity (DNT and DIT) 
For the cases processed under dossier evaluation in 2017, the DNT Cohorts 2A and 2B have 
been mainly requested based on effects seen in thyroid, central nervous system (brain and 
spinal cord) and functional observational batteries. Investigations on DIT were triggered by 
effects seen on thymus and cell counts (eosinophils, leucocytes, lymphocytes), for example. 
The extension of Cohort 1B to produce the F2 generation for substances with significant 
consumer and/or professional exposure was mainly requested based on endocrine disrupting 
mode(s) of action and potential for bioaccumulation. 

In 59 % of adopted dossier evaluation decisions the request was for a basic study design, i.e. 
without any additional cohorts. The second generation was included in 22 % of requests. 
Furthermore, DNT and/or DIT cohorts were triggered in 25 % of cases. Under substance 
evaluation, two out of three study requests included all cohorts, whereas in one request only 
the DIT cohort was triggered. 

4.6 Litigation and European Ombudsman cases 

Under Article 94 of REACH, an action may be brought before the European Court of Justice 
against a decision taken by the Board of Appeal or in cases where no appeal lies before the 
Board. 

On 31 December 2017, three evaluation cases were pending before the General Court, one on 
dossier evaluation, challenging a statement of non-compliance, and two on substance 
evaluation, addressing various issues, including proportionality and the scope of review by the 
Board of Appeal.  

The Board of Appeal 
The Board of Appeal is responsible for deciding on appeals lodged against certain decisions of 
the Agency taken under REACH and the Biocidal Products Regulation. 

During 2017, ten new appeals against ECHA evaluation decisions were announced by the 
Board of Appeal on its website. Of these cases, six concerned dossier evaluation decisions and 
four concerned substance evaluation decisions (two of which challenge the same substance 
evaluation decision).  

In 2017, the Board of Appeal closed 11 appeal cases on evaluation. Of these, five concerned 

61 http://ec.europa.eu/environment/chemicals/reach/implementation_en.htm 

 
 
 
 
 
 
 
                                           
 
 
Evaluation under REACH: Progress Report 2017 

61 

dossier evaluation decisions and six concerned substance evaluation decisions62.  

Some of these cases concerned the conditions under which ECHA can request further 
information on nanomaterials under both dossier and substance evaluation, the question 
whether downstream users can appeal evaluation decisions, and the competence of ECHA to 
request further information to examine the persistency of a substance under substance 
evaluation.  

At the end of 2017, five dossier evaluation appeals and six substance evaluation appeals were 
pending.  

Further information on the current status of appeal cases and the Board of Appeal’s decisions 
can be obtained from the Board of Appeal’s web section63. 

Recent learnings from the decisions of the Board of Appeal are summarised in the following 
sections. 

Nanomaterials 

Titanium dioxide case64 (dossier evaluation) 

The Board of Appeal found that ECHA did not have the competence to ask nanomaterial-
specific information for the substance identification under Section 2 of Annex VI to REACH. It 
thus annulled the contested decision in so far as it requested this information. 

The Board ruled that when defining a substance broadly, registrants must provide toxicological 
and ecotoxicological information covering both the bulk form and the nanoforms of the 
substance. It thus considered that rather than requesting more information under Section 2 of 
Annex VI, ECHA could have performed a compliance check to verify whether the dossier 
included toxicological and ecotoxicological information addressing all possible forms of the 
substance as defined by the registrants. Alternatively, the substance evaluation process could 
have been used in case of a need to clarify a potential concern. 

The Board held that neither ECHA nor it are in a position to interpret REACH in such a way as 
to amend or extend it. If the legislature sees a need for further information on the nanoforms, 
it would need to amend the REACH Annexes accordingly. 

Silicon dioxide/synthetic amorphous silica (SAS)65 (substance evaluation) 

The Board of Appeal considered that being a nanomaterial is on its own insufficient to establish 
a concern under substance evaluation.  

As a follow-up of the Board decisions regarding nanomaterials, ECHA reviewed its strategy66 
for addressing nanomaterials under evaluation processes awaiting for an update of the REACH 
Annexes which could eventually strengthen the regulatory tools. 

62 There were, in fact, two appeal cases relating to the same substance evaluation decision, i.e. Cases A-
014-2015  and  A-015-2015  concerning  the  substance  evaluation  of  silicon  dioxide,  also  referred  to  as 
synthetic amorphous silica (SAS). 
63 http://echa.europa.eu/about-us/who-we-are/board-of-appeal 
64 Decision of 2 March 2017 in Case A-011-2014, Hunstman P&A Ltd and others. 
65 Decisions of 30 June 2017 in Case A-014-2015, Grace GmbH & Co. KG and Advanced Refining Technologies GmbH, 
and in Case A-015-2015, Evonik Degussa GmbH and others. 
66 https://echa.europa.eu/documents/10162/2792271/mb_57_2017_echa_strategy_nanoforms_en.pdf/ 

 
                                           
 
 
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Evaluation under REACH: Progress Report 2017 

Persistency concern 

BENPAT case67 (substance evaluation) 

The Board of Appeal upheld the contested decision in so far as the existing data did not 
demonstrate that the substance would not be persistent in the environment. In that respect, 
ECHA was also objectively justified in treating substances 7PPD and 77PD differently from the 
substance in question. However, the Board found that the OECD 309 study would not be 
suitable to identify the metabolites of the substance and it therefore annulled this aspect of the 
study request. Such annulment rendered the next study request, namely the OECD 308 
sediment simulation study as regards the identity and properties of NER68, not justified since 
the two studies together were to assess the possible persistency of the metabolites. 

On a procedural aspect, the Board found that the Agency was not required to reach a firm 
conclusion on the bioaccumulative properties of the substance in order to request further 
information on persistence. Therefore, it requested that the statement related to 
bioaccumulative properties to be removed from the contested decision. This case is currently 
under appeal. 

Interface between dossier and substance evaluation 

TPBP case69 (substance evaluation) 

The Board of Appeal upheld ECHA’s decision regarding both requests for a comet assay and for 
a pre-natal developmental toxicity study in a second species (second species PNDT). Regarding 
the second species PNDT, the Appellant claimed that ECHA should have requested the test under 
dossier evaluation. The Board considered that ECHA was entitled to use the substance evaluation 
procedure to ask for the study since it had demonstrated a potential risk (developmental toxicity) 
and all the registrants of the substance were at the same tonnage band and therefore treated 
equally. 

On a procedural aspect, the Board confirmed that ECHA is competent to submit proposals for 
amendment on substance evaluation draft decisions. 

Duty to state reasons 

In December 2017, the Board of Appeal held that ECHA’s dossier evaluation decision requiring 
vertebrate  testing  for  the  substance  used  exclusively  in  cosmetics  should  have  explained  the 
Agency’s  interpretation  of  the  relationship  between  the  REACH  Regulation  and  the  Cosmetics 
Regulation.  ECHA  should  have  in  the  decision  referred  to  the  joint  ECHA/Commission  public 
statement  on  this  issue  and  explained  how  the  interpretation  set  out  therein  applied  to  the 
present case,  in order to justify why the requested vertebrate test was warranted70. 

Procedural aspects: 

i. 

locus standi of downstream users 

DCBS case71 (substance evaluation) 

67 Decision of 8 September 2017 in Case A-026-2015, Envigo Consulting and DJChem Chemicals. 
68 Non extractable residues 
69 Decision of 13 December 2017 in Case A-023-2015, S.A. Akzo Nobel Chemicals NV and others. 
70 Decision of 12 December 2017 in Case A-013-2016, BASF Personal Care and Nutrition GmbH. 
71 Decision of 30 May 2017 in Case A-022-2015, Manufacture Française des Pneumatiques Michelin. 

 
 
 
 
 
                                           
 
 
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This appeal was lodged by a downstream user against an evaluation decision on a substance 
that it incorporates in tyres. The Board of Appeal considered the appeal as inadmissible 
because the Contested Decision did not impose any direct obligation on downstream users that 
did not prepare a CSR nor submit a downstream user report to ECHA, nor to a substance 
information exchange forum’s (SIEF) member, member of a SIEF agreement, new consortium 
member or again to a registrant registering after the adoption of the substance evaluation 
decision. The Board used this opportunity to clarify the involvement of downstream users 
under substance evaluation. At the same time, the Board observed that substance evaluation 
does not extend to downstream users in general, but a request for information (under 
substance evaluation) may do so in certain cases, for example, confirmed in the case where a 
downstream user submitted a downstream user report related to a use targeted by the 
substance evaluation. This suggests that a downstream user might have a standing for 
challenging a substance evaluation decisions in these limited cases, meaning that a substance 
evaluation may be targeted towards him. 

ii.  Admissibility of expert review during appeal proceedings 

Silicon dioxide/synthetic amorphous silica (SAS) case72 (substance evaluation) 

An expert review, not submitted during the decision-making but at the stage of the appeal 
proceedings, was found to constitute admissible evidence. The Board of Appeal noted that the 
Appellants had already announced at the Member States Committee meeting that they were 
preparing this study, that it was reasonable for the Appellants to commission this study and 
that the delay in producing this study was justified. 

iii. 

Competence of the Board of Appeal on Community Rolling Action Plan 

Silicon dioxide/synthetic amorphous silica (SAS)73 (substance evaluation) 

The Board of Appeal confirmed that it has no competence to decide on an appeal against 
inclusion into the CoRAP.  

The European Ombudsman 
On 21 July 2017 the European Ombudsman issued her decision74 in response to a complaint 
filed by an animal welfare non-governmental organisation concerning a joint statement by the 
European Commission and ECHA clarifying their understanding of the relationship between the 
Cosmetics Regulation, which bans animal testing, and REACH, which allows animal testing of 
chemicals in certain limited circumstances to assess risks to human health and to the 
environment.  

In her decision, the Ombudsman concluded that there was no maladministration by the 
Commission and ECHA in issuing the joint statement and that the Commission and ECHA were 
entitled to explain how animal testing data should be used to fulfil the requirements under 
REACH.  

72 Decision of 30 June 2017 in Case A-015-2015, Evonik Degussa GmbH and others. 
73 Decision of 30 June 2017 in Case A-015-2015, Evonik Degussa GmbH and others. 
74 Decision of 21 July 2017 in Case 1130/2016. 

 
 
 
 
 
                                           
 
 
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Evaluation under REACH: Progress Report 2017 

5. RECOMMENDATIONS TO REGISTRANTS 

This chapter contains advice to all existing and future registrants under REACH. 

The recommendations are based on the most frequent shortcomings observed during dossier 
and substance evaluation, or their follow-up, and includes also information on the guidance 
and tools made available to the registrants during the year. 

5.1 Report the identity of your substance and representative test 
material correctly 

Report clearly what you have registered 
Check that your reported legal entity composition information is within the boundaries of the 
substance identity profile compositional information as reported in the boundary composition 
record in the lead registrant dossier. More information can be found in “Guidance for 
identification and naming of substances under REACH and CLP” 75. 

Make full use of the available IUCLID reporting fields  
Proactively update the lead registrant dossier to make use of the new reporting functionalities 
for the joint compositional profile and the test material records. 

ECHA encourages you to take action to correct substance identification mistakes not only 
during dossier evaluation but also on your own initiative. More information on how to prepare a 
registration can be found in the manual “How to prepare registration and PPORD dossiers” 76. 

Ensure that you can demonstrate you are in the correct joint registration 
Check that your compositional information is within the boundaries agreed by your co-
registrants and that the jointly reported REACH Annex VII-XI information is relevant for your 
composition. 

A broadly defined substance identity means broad Annex VII-XI reporting 
If you and your co-registrants have defined your substance identity broadly, ensure that you 
also clearly report in your registration file how you have fulfilled your REACH Annex VII-XI 
information requirements for all that is registered and covered by the registration. 

Ensure you can demonstrate the relevance of your test materials  
Report the constituent identities and concentration values of each test material and study used 
to generate your reported REACH Annex VII-XI data in the fields available in the Test Material 
Record. 

Registering nanomaterials? Consult ECHA’s Guidance 
Consult the available ECHA Guidance on how to address the specific properties of the 
nanomaterials you register when generating or collecting REACH Annex VII-XI information for 
your registration file. Make use of the IUCLID 6 reporting fields available in the composition 
records to document what you have registered and what your REACH Annex VII-XI data refers 
to77. 

75 https://echa.europa.eu/documents/10162/23036412/substance_id_en.pdf/ee696bad-49f6-4fec-b8b7-
2c3706113c7d 
76 https://echa.europa.eu/manuals 
77  https://echa.europa.eu/documents/10162/13643/appendix_r14_05-2012_en.pdf/7b2ee1ff-3dc7-4eab-
bdc8-6afd8ddf5c8d 

 
 
 
                                           
 
 
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65 

5.2 Provide information on GLP compliance of the whole study 

When you report results of a toxicocological or ecotoxicological study, identify unambiguously 
the test facility in which the study was conducted by providing the complete name and address 
of the facility so that a good laboratory practise (GLP) compliance claim can be verifified. 
If parts of a GLP study were not conducted in line with GLP principles, indicate which parts of 
the study were affected in the remarks field of the GLP compliance section in the IUCLID. 

5.3 Make sure your registration dossier is complete 

The experience gained so far with the manual verifications on incoming dossiers has enabled 
ECHA to identify several recommendations for registrants to successfully prepare and submit a 
registration dossier. ECHA has published an information document on the manual verification 
that describes the different areas of the manual verification checks and provides useful 
instructions on how to prepare a complete registration dossier78. You should take into account 
the information document and the following recommendations when preparing a registration 
dossier. 

•  Before you submit the dossier to ECHA, use the IUCLID Validation assistant tool. 
• 
If the Validation assistant does not indicate any failures, it is not an automatic 
confirmation of that the dossier is complete, since the manual verifications are not 
displayed in the Validation assistant report. Ensure that you have included all the 
required data for the areas that are described in the information document on manual 
verification. 

•  When preparing your dossier, consider that the registration dossier should not only be 
prepared to pass the completeness check – it should contain all the information on the 
substance as specified by REACH and should aim to demonstrate that the substance is 
used in a safe manner. 

•  Each registrant is responsible for ensuring that they register the substance as part of 

the correct joint submission, and that they provide the correct substance identification 
information in their registration dossier. Registrants should not rely on company-
specific substance identification information provided by the lead registrant (such as 
analytical or compositional information). 

•  Use the available templates that exist to support registrants with the reporting of 

certain information requirements. For example, IUCLID has integrated templates for the 
manufacturing process description that is required for UVCB substances and for the 
considerations of alternative methods that need to be reported with testing proposals 
on vertebrate animals. 

•  When certain information is requested in a specific IUCLID field, this information must 

be included in the appropriate field. Reference to other parts of the IUCLID dossier is 
not considered complete. 

5.4 Use the support available for REACH 2018 registrants 

Follow the Directors’ Contact Group 
The Directors’ Contact Group79 restarted their activity in 2017. Their objectives are to monitor 
the overall preparedness of companies and to identify and resolve the priority issues of 
concern in meeting obligations relevant to the registration of chemical substances. They have 
decided to reopen four solutions designed already for the 2010 and 2013 deadlines for 

78 The document is published on ECHA’s website: 
https://echa.europa.eu/documents/10162/13652/manual_completeness_check_en.pdf 
79 https://echa.europa.eu/about-us/partners-and-networks/directors-contact-group  

 
 
 
 
 
 
 
                                           
 
 
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companies in exceptional circumstances (solutions 10, 15, 20 and 21)80 from 31 January 2018. 

Consult the REACH 2018 web pages 
The REACH 2018 website81 remains the main information point for the registrants falling under 
the 31 May 2018 registration deadline. “Practical guide for SME managers and REACH 
coordinators” 82, published already in 2016, includes many tips on how to fulfil information 
requirements at tonnages 1-10 and 10-100 tonnes per year, as does ECHA’s web page “What 
information you need”.83 

Check our practical examples 
A new support web page bringing together practical examples84 was published on 31 May 
2017. Among others, one example relevant for information requirements was published, 
namely “Steps to gather information for low tonnage substances” 85. In early 2018, more 
practical examples related to hazard and risk assessment were published: 

•  How to gather information to register an inorganic mono-constituent substance (including 

the chemical safety assessment); 

•  How to gather information to register a multi-constituent or a UVCB substance - 

toxicological information; 

•  How to decide whether a substance is a polymer or not and how to proceed with the 

relevant registration. 

In addition, links to the existing examples related to assessing hazards and risks of substances 
were gathered on the practical examples web page. Note that the examples with the OECD 
QSAR Toolbox were developed with an older version of the Toolbox, but the reasoning 
described in the document is still valid.  

If you are a SME, consider using ECHA Cloud Services 
ECHA Cloud Services is a secure online platform used to distribute ECHA’s IT applications in a 
cloud environment. By using the services, you can work together in a more transparent and 
interactive way. The service allows SMEs and their consultants to work online with the latest 
version of IUCLID without having to install IUCLID on computers or company servers. It has a 
simple interface focusing on the REACH 2018 registration deadline tasks, and also offers a 
guided approach to help inexperienced SME registrants through the process of entering their 
IUCLID data. The service provides the user with up to 1 GB of data storage, fully managed 
backups and dedicated helpdesk support. More information on IUCLID Cloud is available on-
line 86,87,88.  

80 https://echa.europa.eu/documents/10162/23556156/171219_dcg_four_solutions_en.pdf/9451fa44-
266c-74d5-40d9-8beebd0e5c8b  
81 https://echa.europa.eu/reach-2018 
82 https://echa.europa.eu/practical-guides 
83 https://echa.europa.eu/support/registration/what-information-you-need  
84https://echa.europa.eu/support/registration/practical-examples 
85 https://echa.europa.eu/documents/10162/23221373/example_low_info_reqs_en.pdf/3db4c47b-4ebf-
1768-6350-e87b530a8f7e 
86 https://echa.europa.eu/support/dossier-submission-tools/echa-cloud-services 
87 https://www.linkedin.com/groups/12043483 
88 https://www.youtube.com/playlist?list=PLOPGDACSd6qyDkdXwPua1Fjb5bJksY75k 

 
 
 
 
 
 
 
 
                                           
 
 
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5.5 Avoid unnecessary testing on animals 

Share data and use non-animal approaches where possible 
Potential registrants of the same substance must collaborate to share the requested 
information and agree on the data to be submitted jointly. 

If new data for skin corrosion/irritation, serious eye damage/eye irritation and/or for skin 
sensitisation needs to be generated, you will have to perform the in vitro studies first, 
irrespective of the annual tonnage of the substance. Unjustified in vivo testing when non-
animal alternatives are available may lead to compliance check or direct enforcement action. 

For substances expected to not be acutely toxic based on non-animal approaches (e.g. in vitro 
and QSAR data), consider conducting a sub-acute repeated-dose toxicity study (28-day study) 
first. The results from that study may be used within a weight-of-evidence approach to 
conclude on oral acute toxicity without conducting an acute oral toxicity study.  

Information from non-animal approaches may also be used as supporting data for grouping 
and read-across adaptation. Results from several individual non-animal approaches (e.g. in 
silico, in vitro) may allow to adapt information requirements and avoid an animal test under 
weight-of-evidence adaptation. 

Provide your considerations on non-animal approaches with your testing proposals 
When you have concluded that generation of new information is necessary, verify whether the 
endpoint requires a testing proposal and prior authorisation of the testing by ECHA. Apart from 
information requirements listed in Annexes IX and X, some testing proposals may need to be 
submitted already at Annex VII or at Annex VIII level 89. For example, the Annex VIII, Column 
2 requires the registrant to consider appropriate mutagenicity in vivo studies in cases where 
positive results in in vitro genotoxicity studies have been obtained. It should be noted that 
where this involves tests mentioned in Annexes IX or X, such as in vivo somatic cell 
genotoxicity studies, testing proposals must be submitted by the registrant and accepted by 
ECHA in a formal decision before testing can be initiated. 

When your testing proposal involves testing on vertebrate animals, you have to include your 
considerations on non-animal approaches for that information requirement in the dossier 
documentation. 

Justify and document your weight-of-evidence approach 
If you propose an adaptation based on weight of evidence, the individual lines of evidence and 
the justification should provide a sufficient confidence level when compared to information 
expected with the default test. Documentation of the weight-of-evidence adaptation should be 
transparent and conclusions justified.  

You need to document the quality and relevance of the pieces of evidence, as well as their 
consistency and completeness, in relation to the standard information requirements. You 
should also address the associated uncertainties and their impact in a way that allows ECHA to 
assess and verify all the pieces of evidence provided in the technical dossier. 

Provide robust grouping and read-across arguments 
Use ECHA’s Read-Across Assessment Framework (RAAF 90) to check the robustness of your 

89 https://echa.europa.eu/documents/10162/13632/information_requirements_r7a_en.pdf/e4a2a18f-
a2bd-4a04-ac6d-0ea425b2567f 
90 ECHA Read-Across Assessment Framework (RAAF): 
https://echa.europa.eu/documents/10162/13628/raaf_en.pdf. 

 
 
                                           
 
 
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read-across adaptation. The RAAF describes the aspects of grouping and read-across 
justifications that ECHA considers to be crucial for both human health and environmental 
endpoints. A technical document91 on the key issues for assessing the complexity of grouping 
and read-across for multi-constituent and UVCB substances was published on ECHA’s website 
in March 2017. This document describes the additional key issues proposed to be considered 
when predictions based on grouping and read-across cases involving multi-constituent 
substances and/or UVCBs are used to adapt standard information requirements. 

Justify the grouping and read-across by showing how structural similarity and dissimilarity are 
connected to the prediction and create a data matrix, allowing side-by-side comparison of 
properties of the sources and target substances.  

5.6 Your chemical safety report should reflect the actual uses and risks 

Derive DNELs according to ECHA’s Guidance 
Derivation of DNEL (derived no-effect level) is a key element for the risk characterisation of a 
chemical substance. The DNEL is set by REACH as the threshold above which humans should 
not be exposed. Therefore, it is important that your DNEL is derived appropriately to make 
sure that your substance is manufactured and used in such a way that they do not adversely 
affect human health. A DNEL has to be derived based on the dose descriptor giving rise to the 
highest concern per route of exposure and type of effect. Usually it is the study with the lowest 
NOAEL/LOAEL (no/lowest observed adverse effect level). 

A set of assessment factors should be applied to convert the dose descriptor into a DNEL. For 
an explanation on the background to these assessment factors, consult REACH Guidance on 
information requirements and chemical safety assessment, Chapter R.8: Characterisation of 
dose [concentration]-response for human health (version 2.1, November 2012) 92. 

You need to justify and document any deviation from these default assessment factors with 
scientific arguments that are specific to your registered substance.  

If it is not possible to derive a DNEL for a particular hazard, for example skin/eye 
irritation/corrosion, skin sensitisation, mutagenicity, you should carry out and report a 
qualitative assessment. 

Use the DNEL and PNEC calculators in IUCLID 6 
DNEL and PNEC calculators93 are new features in IUCLID 6 (versions 1.2.0. and 1.3.0.). 

The DNEL calculator was developed in collaboration with the State Secretariat for Economic 
Affairs (SECO) from the Swiss Confederation in order to support the derivation of worker and 
general population derived no-effect levels (DNELs) for long-term systemic effects for oral, 
dermal and inhalation routes based on ECHA’s Guidance. 

The PNEC calculator was developed to support the derivation of predicted no-effect 
concentrations (PNECs) for the aquatic, sediment and terrestrial environmental protection 
targets based on ECHA’s Guidance. 

91 Read-Across Assessment Framework (RAAF) - Considerations on multi-constituent substances and 
UVCBs: https://echa.europa.eu/documents/10162/13630/raaf_uvcb_report_en.pdf/3f79684d-07a5-
e439-16c3-d2c8da96a316. 
92 REACH Guidance on information requirements and chemical safety assessment, Chapter R.8: 
Characterisation of dose [concentration]-response for human health: 
https://echa.europa.eu/documents/10162/13632/information_requirements_r8_en.pdf/. 
93 https://iuclid6.echa.europa.eu/documents/21812392/22308501/iuclid_functionalities_en.pdf 

 
 
 
 
 
 
 
 
 
 
 
                                           
 
 
Evaluation under REACH: Progress Report 2017 

69 

Both DNEL and PNEC calculators use the information already provided in the endpoint study 
summaries of the IUCLID dossier and populate automatically the summary records in sections 
6 (Ecotoxicological information) and 7 (Toxicological information) of IUCLID. 

Your exposure assessment needs to cover all identified hazards 
According to Section 5.0 of Annex I to REACH, when the exposure assessment is triggered, i.e. 
criteria given in Article 14(4) are met, it “shall consider all stages of the life-cycle of the 
substance” and “cover any exposures that may relate to the hazards identified”. ECHA’s 
Guidance on information requirements and chemical safety assessment, Part B: Hazard 
Assessment (version 2.1, December 2011) clarifies that there are three types of identified 
hazards requiring exposure assessment: 

1.  hazards leading to classification; 
2.  classifiable hazards where the severity of the effects is lower than the criteria for 

classification and so the substance is not classified; 

3.  hazards for which currently no classification criteria exist.  

The three points above entail that exposure assessment is not limited to the classifiable 
hazards or adverse effects observed at doses or concentrations where classification is 
triggered, but should cover all hazards identified. It should be noted that hazard is considered 
as identified when adverse effects have been observed in studies at the highest recommended 
concentration or doses tested. The DNEL or PNEC can be derived and hence exposure 
assessment for that route of exposure, type of effect, or protection target would be needed. 
For instance, when adverse effects have been observed in studies conducted at the highest 
practicable and biologically relevant concentration on environmental aquatic toxicity according 
to OECD and EU test guidelines (e.g. 100 mg/l as a limit test for acute aquatic toxicity in the 
OECD guideline), taking into account the properties of the substance determining the 
environmental fate, it would indicate that quantitative exposure assessment, i.e. derivation of 
predicted environmental concentrations (PECs), is mandatory for the water, sediment and soil 
environmental compartments.  

Use correct exposure scenarios and exposure estimations 
The reliability of the exposure assessment highly depends on the reliability of the exposure 
scenarios and input parameters used in the exposure estimation. One of the main parameters 
affecting the outcome of the environmental exposure assessment are the release factors to the 
environment. ECHA’s Guidance on information requirements and chemical safety assessment, 
Chapter R.16: Environmental Exposure Estimation 94 suggests generic worst-case release 
factors for each environmental release category (ERC) that registrants can use without further 
justification. If non-default ERC release factors (site-specific or sector-proposed specific 
environmental release categories (SpERCs)) are available and used for exposure estimation, 
this should always be justified. This justification should be detailed enough, the source 
referenced (and retrievable) and linked to the related operational conditions or risk 
management measures, so ECHA can understand whether it covers the relevant scenarios for 
possible releases from substance processing according to the relevant exposure scenario. For 
example, SpERC developers and users should ensure that the description provided in the 
SpERC factsheet is detailed in a clear and accurate manner with sufficient justification, and 
covers all relevant activities or processes, operational conditions, and risk management 
measures claimed. In general, SpERCs include a definition of scope (applicability domain), 
information on conditions of use leading to a certain expected release factor, expected release 
factors, and an explanation of how the release factors were derived. If the SpERC factsheet 
does not contain sufficient background information on the release factor proposed, the 
registrant’s CSR may not be convincing in demonstrating the control of risk.  

94  https://echa.europa.eu/documents/10162/13632/information_requirements_r16_en.pdf/b9f0f406-ff5f-
4315-908e-e5f83115d6af 

 
 
 
 
 
                                           
 
 
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The exposure assessment requires the estimation of the level of the substance to which 
humans and the environment may be exposed. It is another key element in assessing whether 
the risks are adequately controlled throughout the lifecycle of a substance. It consists of two 
clear steps: identifying exposure scenarios (as discussed above) and estimating the exposure 
in each scenario. 

The exposure estimates give the level of exposure that is expected when manufacturing and 
using a chemical substance and they are compared with the derived DNELs to ensure that 
human health is not adversely affected. For estimating the level of exposure, an adequate or 
representative set of measured data can be used. In the absence of workplace exposure data, 
the exposures should be carefully estimated by using the exposure models that are 
appropriate for the physico-chemical properties of the substance and the route of exposure. 
When using a model to obtain exposure estimates, you should understand how it works and its 
limitations, so that it is fit for purpose and you can enter the parameters correctly. In other 
words, you should use the model within its domain of applicability, and you should not deviate 
from the underlying assumptions in the model. For exposure tools integrated into Chesar, 
users receive warnings when using the tool in a way that may conflict with the applicability 
domain. 

Justify your exposure based adaptions 
When you use Annex XI, section 3, substance-tailored exposure-driven testing by claiming 
implementation of strictly controlled conditions throughout the life-cycle of the substance, for 
confirmation of applied conditions during the whole lifecycle of the substance, you should also 
provide a description of the specific activities performed at each lifecycle stage and on each 
relevant site concerning the handling and use of the substance in the registration dossier. For 
each specific activity it should contain a brief description of the system and/or equipment that 
demonstrates how the substance is rigorously contained by technical means during its whole 
lifecycle and how other requirements of Article 18(4)(a) to (f) of REACH are implemented.  

More information on what information and documentation is relevant and necessary to be 
submitted in the registration dossier to support a claim of strictly controlled conditions is given 
in ECHA’s Practical Guide 16, “How to assess whether a substance is used as an intermediate 
under strictly controlled conditions and how to report the information for the intermediate 
registration in IUCLID”95, and ECHA’s Guidance on intermediates96. 

Improve use descriptions 
The basis for prioritising substances for evaluation and regulatory risk management are their 
hazard properties and exposure potential. In order to assess the exposure potential of a 
substance, there needs to be sufficient information on how it is used. For example, the work 
on the plastic additives has demonstrated that insufficient information on uses has been 
provided in REACH registrations to allow (de)prioritisation of substances used as additives in 
plastics based on their exposure potential. The lack of such information means adequate safety 
assessments for substances in plastic articles cannot be performed. In order to be able to 
prioritise and deprioritise plastic additives, registrations should be updated so that they 
provide a clear picture on the use patterns of these substances and conditions of safe use. 

Use maps are a tool which aim to improve the quality of information on use and conditions of 

95 https://echa.europa.eu/documents/10162/23036412/pg16_intermediate_registration_en.pdf/291b6e50-
5598-42d3-8a2b-d63d50a68104  
96 https://echa.europa.eu/documents/10162/23036412/intermediates_en.pdf/0386199a-bdc5-4bbc-9548-
0d27ac222641  

 
 
 
 
 
                                           
 
 
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71 

use communicated up the supply chain and the efficiency of this communication process. Use 
maps are now available on ECHA’s website for plastic compounding and conversion, which we 
recommend the registrants use. These use maps will be extended to cover article service life. 

5.7 Familiarise yourself with new guidance on PBT/vPvB assessment 

Take note that Chapter R.11 of the Guidance on Information Requirements and Chemical 
Safety Assessment97 which covers PBT/vPvB assessment was updated in 2017. The integrated 
testing strategies for persistence and bioaccumulation were updated and there is further 
explanation on applying a weight-of-evidence approach, as required by REACH Annex XIII.  

5.8 Identify and address information of the degradation products 

The identification of the degradation products is a standard information requirement of Annex 
IX, Section 9.2.3. of REACH. Information on degradation products should be provided if you do 
not have valid evidence showing that your substance is readily biodegradable. 

It is necessary for the PBT/vPvB assessment, as Annex XIII to REACH specifies that “the 
identification [of PBT and vPvB substances] shall also take account of the PBT/vPvB-properties 
of relevant constituents of a substance and relevant transformation and/or degradation 
products”. Information on degradation products should also be taken into account for the 
exposure assessment (Annex I 5.2.4. of REACH), when applicable, and for the hazard 
assessment (e.g. Column 2 of Annex X 9.4 and Annex X 9.5.1 to REACH). Finally, this 
information is required for the preparation of section 12 of the safety data sheet (Annex II to 
REACH), when applicable. 

Information on degradation products is generally obtained from simulation tests. For further 
information see ECHA’s Guidance on Information Requirements and Chemical Safety 
Assessment, Chapter R.7.9. 

5.9 Classify multi-constituent and UVCB substances correctly 

The classification of a substance containing impurities, additives or multiple constituents 
(multi-constituent, UVCB) should, similar to mixtures, primarily be based on available relevant 
information (including test data) on the substance. However, when classifying for CMR 
properties or when evaluating the bioaccumulation and degradation properties within the 
hazardous to the aquatic environment hazard class, it is strongly recommended that the 
classification of the substance, similar to mixtures, should be based on information of the 
known individual constituent(s), as there is no toxicological difference between a mixture and a 
substance containing other constituent substances.  

In exceptional cases, data on the substance itself might show more severe effects for 
classification for CMR or relevant effects on the bioaccumulation or degradation properties, 
which have not been identified from the information on the constituent substances. These data 
should then be used, if available. For non-CMR hazard classes, data on the constituents should 
be used for classification in accordance with the mixture rules where data on the substance is 
not available. The testing of a complex substance for classification purposes is strongly 
discouraged if there are data on the constituents. 

97 https://echa.europa.eu/documents/10162/13632/information_requirements_r11_en.pdf/a8cce23f-a65a-
46d2-ac68-92fee1f9e54f  

 
 
 
 
 
 
 
 
 
 
                                           
 
 
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5.10 Familiarise yourself with new documents on nanomaterials 

ECHA invites you to familiarise yourself with the following five documents that provide advice 
to registrants preparing registration dossiers that cover nanoforms in 2017.  

ECHA has published two completely new publications: the nano-specific Appendix R.6-1 to 
Chapter R.6: QSARs and grouping of chemicals of the Guidance on information requirements 
and chemical safety assessesment 98, and a document proposing best practices for registration 
of nanomaterials, “How to prepare registration dossiers that cover nanoforms: best 
practices” 99.  

The best practices document provides recommendations for distinguishing between different 
nanoforms of a substance. Following the recommendations provided in the document will 
ensure consistent reporting of information on nanoforms in registration dossiers and facilitate 
registrants in clearly demonstrating that they fulfil their registration obligations for 
nanomaterials. Furthermore, Appendix R.6-1 provides an approach on how to justify the use of 
hazard data between nanoforms (and the non-nanoforms) and within groups of nanoforms of 
the same substance.  

In addition, ECHA published updates to three of its existing guidance documents on 
nanomaterials: the Appendices100 for nanomaterials to Chapters R.7a, R.7b and R.7c of the 
Guidance on information requirements and chemical safety assessesment (endpoint-specific 
guidances). These Appendices provide nano-specific guidance on how to meet the information 
requirements set out in Annexes VI-X to REACH. 

5.11 Respond to ECHA’s evaluation decisions 

Respect the deadlines set in the decision 
You are reminded to respect the deadline to update the registration dossier. Even in cases 
where the information may be late, it is in your own interest to communicate to ECHA in a 
dossier update with justifications and to provide all the requested information according to the 
expected timeline. 

Report the new information correctly 
You are requested to pay attention to detail when reporting the requested information in the 
technical dossier. ECHA must be able to assess the studies independently and form its opinion 
about the study validity and the significance of the results.  

Information about the test material composition is crucial for ECHA to be able to conclude on 
the relevance of the study results to the registered substance. 

You must also take all the new hazard information into account in the chemical safety 
assessment and reflect this in the CSR. 

When updating your dossier, if you decide to adapt the information requirement (i.e. you do 
not perform the requested experimental test), any such adaptations must meet the conditions 
described in Column 2 of the respective REACH Annex, or you should follow the rules set out in 

98 Appendix R.6-1 for nanomaterials applicable to the Guidance on QSARs and Grouping of Chemicals: 
https://echa.europa.eu/documents/10162/23036412/appendix_r6_nanomaterials_en.pdf/. 
99 How to prepare registration dossiers that cover nanomaterials: best practices: 
https://echa.europa.eu/documents/10162/13655/how_to_register_nano_en.pdf/.   
100 https://echa.europa.eu/documents/10162/13632/appendix_r7a_nanomaterials_en.pdf/, 
https://echa.europa.eu/documents/10162/13632/appendix_r7b_nanomaterials_en.pdf/ and 
https://echa.europa.eu/documents/10162/13632/appendix_r7c_nanomaterials_en.pdf/. 

 
 
 
 
 
 
 
 
                                           
 
 
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Annex XI to REACH. Such adaptations must be fully justified and documented in order to allow 
ECHA to properly assess and verify the adaptation used. 

5.12 Recommendations related to substance evaluation 

When your registered substance is included in the CoRAP, review and update your 
dossier as early as possible 
Perform a thorough check of your registration dossier and submit a dossier update, if needed, 
to facilitate the future evaluation process. 

It is crucial to: 
-  Update your dossier in a timely manner before the start of the evaluation process; 
-  Ensure that the identitification of your registered substance is clear and appropriately 

documented; 

-  Make sure that your use and exposure scenarios are accurate and up-to-date, and that 

your  exposure estimations are correct. 

Ensure a good communication up and down the supply chain to gather the necessary 
information on the intended uses of your registered substance. 

-  Contact your downstream users as early as possible to have all the relevant information in 
place and also consider being in contact with specific downstream user organisations. 
-  Downstream users of a substance included in the CoRAP who own or have access to useful 
information should consider informing the lead registrant101 or the evaluating MSCA102. 

Whenever possible, avoid submitting dossier updates once the substance evaluation has 
started, unless in agreement with the evaluating MSCA. 

Use the opportunity to interact with the evaluating Member State competent 
authority 
ECHA has published recommendations on best practice for informal interactions, as Member 
State competent authorities have agreed on a common approach on interaction with 
registrants during substance evaluation103.  

Discuss with your co-registrants and decide who could be nominated as a representative for 
interacting with the evaluating MSCA.  

The evaluating MSCA may approach you in writing to request further clarifications before 
preparing a draft decision. Ensure your responses are timely and discuss with the evaluating 
MSCA on the need or timing of any update of the registration dossier. 

Interact with ECHA where necessary 
While the evaluating MSCA performs the evaluation, ECHA coordinates the overall substance 
evaluation process. You can contact ECHA for clarification on issues of more administrative 
nature using the ECHA contact form 104. 

-  Ensure that your REACH-IT contact information is kept up to date. 

101 ECHA publishes the name of the lead registrants if permitted by the companies. For more information, 
check  the  “Lead  registrant  list”  at:  https://echa.europa.eu/regulations/reach/registration/registration-
statistics. 
102 In the CoRAP list, ECHA publishes the Member State and contact details of the respective competent 
authority responsible for the evaluation of each substance. 
103 https://echa.europa.eu/documents/10162/13628/interaction_ms_reg_sev_en.pdf 
104 https://www.echa.europa.eu/contact/helpdesk-contact-form 

 
 
 
 
 
 
 
 
 
 
 
 
                                           
 
 
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When you receive a substance evaluation draft decision, review it and provide your 
coordinated comments 
Upon receipt of the draft decision from ECHA via the REACH-IT tool, review its content to 
understand the requests (including the test methods and/or the testing strategy).  

Whenever possible, coordinate responses and submit a single set of consolidated comments 
within 30 days. The deadline for comments as well as the link to the webform are specified in 
the notification letter. 

-  All relevant registration numbers are listed in an appendix to the draft decision. 
-  Alternatively, you can consult the Co-registrants page in REACH-IT, which displays the 

contact details and roles of the existing registrants of the substance. 

Similarly to the comments on the draft decision, coordinate responses to the proposals for 
amendment (PfAs) and submit a single set of consolidated comments within 30 days.  

-  Only comments on the PfAs are accepted, whereas comments on the (amended) draft 

decision per se are not taken into consideration at this stage of the process. 

-  Also, at this stage it is not possible to extend the deadline to submit comments, due to the 

strict timelines of the decision-making process imposed by REACH. 

Start discussing with testing laboratories to explore their capacity for new testing, so as to 
prepare a smooth start of activities once the final decision is received. 

-  This information can also be used to inform the evaluating MSCA on realistic deadlines to 

be included in the decision. 

-  No testing may be conducted until the decision-making process is completed, as there may 

be changes to the requests. 

When you receive a substance evaluation decision, agree with your co-registrants 
who performs the study 
After the agreement by Member State competent authorities or the Member State Committee 
members, ECHA adopts the decision and communicates it to the concerned registrants using 
REACH-IT. 

Within 90 days of receipt of the decision, you need to inform ECHA of the agreed legal entity 
which is to perform the requested tests on behalf of the other registrants who are addressees 
of the decision and/or impacted by it. 

- 

If ECHA is not informed of such agreement within 90 days, it has the obligation to 
designate one of the addressees of the decision to perform the tests on behalf of all 
concerned registrants. 

Any issues regarding data and cost sharing among the registrants need to be solved within the 
SIEF or consortia. The substance evaluation decision is not setting rules on how to share data 
and costs among the registrants of the same substance. The data and cost sharing should 
happen in accordance with the data-sharing obligation set out in REACH and in the 
Commission Implementing Regulation 2016/9. 

 
 
 
 
 
 
 
 
 
 
 
 
 
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Inform ECHA and the evaluating MSCA once all information requested in the decision 
has been submitted 
Once all the requested information has been provided by an updated registration dossier, 
inform ECHA about this using the webform indicated in the notification letter105. 

Inform the evaluating MSCA by e-mail. 

-  The evaluating MSCAs’ contact information is provided in the CoRAP list published on 

ECHA’s website106. 

If all requested information cannot be submitted according to the deadlines specified in the 
decision, complete the ECHA webform and include any relevant explanations and supporting 
evidence concerning the status of any pending information requirements. 

-  At the same time, inform the evaluating MSCA about the dossier update situation. This 

interaction should enable the evaluating MSCA to have a fully informed view for deciding 
whether to propose specific actions. 

5.13 Take note of ECHA’s Guidance updates 

ECHA has continued to develop and update REACH Guidance in 2017. The following updated 
Guidance documents were published on ECHA’s website during the year. 

•  Corrigendum to the Guidance on data sharing (version 3.1), published 13 January 2017. 
•  New and updated appendices on nanomaterials to Chapters R.6, R.7a, R.7b and R.7c of the 
Guidance on Information Requirements and Chemical Safety Assessment, published 24 May 
2017. 

•  How to prepare registration dossiers that cover nanoforms: best practices (version 1.0), 

published 24 May 2017. 

•  Corrigendum to the Guidance for identification and naming of substances under REACH and 

CLP (version 2.1), published 1 June 2017 in all EU languages. 

•  Update to the Guidance on requirements for substances in articles (version 4.0), published 

28 June 2017. 

•  Update to the Guidance on Information Requirements and Chemical Safety Assessment – 
Chapter R.11, Part C and specific sections of Chapters R.7b and R.7c (related to PBT/vPvB 
assessment) (versions 3.0/4.0), published 28 June 2017. 

•  Update to the Guidance in a nutshell on registration (version 3.0), published 5 July 2017. 
•  Update to the Guidance on Information Requirements and Chemical Safety Assessment – 
Chapter R.7a, Sections R.7.5 on Repeated dose toxicity (version 6.0), published 19 July 
2017. 

•  Update to the Guidance on labelling and packaging in accordance with Regulation (EC) No 

1272/2008 (version 3.0), published 4 July 2017.  

•  Update to the Guidance on the application of the CLP criteria (version 5.0), published 4 July 

2017. 

ECHA invites you to take note of these new or updated resources 107 and to update the relevant 
parts of your dossiers, where appropriate. ECHA will consider the new approaches described in 
the Guidance in ongoing and future dossier evaluations. 

105 https://comments.echa.europa.eu/comments_cms/SEDraftDecisionComments.aspx 
106 https://echa.europa.eu/information-on-chemicals/evaluation/community-rolling-action-plan/corap-
table  
107 ECHA’s Guidance web pages https://echa.europa.eu/support/guidance  

 
 
 
 
 
 
 
 
 
 
                                           
 
 
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Evaluation under REACH: Progress Report 2017 

5.14 Consider the impact of the United Kingdom’s withdrawal from the 
EU on your registration 

As of September 2017, ECHA has been providing companies with advice to help them prepare 
for the expected impact of the UK’s withdrawal from the EU. This is published in the Q&A 
section of ECHA’s web pages on the matter 108. ECHA is continually updating the information it 
provides on these pages as the withdrawal process develops. 

ECHA recommends that you consult this information and its updates over the coming months 
and beyond, until the UK’s withdrawal takes effect. The ongoing negotiation process underlines 
the importance of the recommendation to keep yourself up to date on ECHA’s evolving advice 
on the probable impact of the United Kingdom’s withdrawal from the EU. 

108 https://echa.europa.eu/uk-withdrawal-from-the-eu 

 
 
 
 
                                           
 
 
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77 

LIST OF ABBREVIATIONS AND ACRONYMS 

AFT 

CCH 

Acute fish toxicity 

Compliance check 

Chesar 

Chemical safety assessment and reporting tool 

CLP 

Regulation (EC) No 1272/2008 on classification, labelling and packaging of 
substances and mixtures 

CoRAP 

Community rolling action plan 

CSA 

CSR 

DNEL 

ECHA 

ED 

Chemical safety assessment 

Chemical safety report 

Derived no-effect level 

European Chemicals Agency 

Endocrine disruptor 

EOGRTS 

Extended one-generation reproductive toxicity study 

FET 

GLP 

IATA 

Fish embryo acute toxicity 

Good laboratory practice 

Integrated approaches on testing and assessment 

IUCLID 

International Uniform Chemical Information Database 

MSC 

Member State Committee 

MSCA 

Member State competent authority 

NAM 

New approach methodologies 

NEA 

NER 

PBT 

PfA 

PEC 

PNEC 

OECD 

QSAR 

RAAF 

REACH 

National enforcement authority 

Non extractable residues 

Persistent, bioaccumulative and toxic 

Proposal for amendment 

Predicted environmental concentration 

Predicted no-effect concentration 

Organisation for Economic Co-operation and Development 

Quantitative structure-activity relationship 

Read-Across Assessment Framework 

Regulation (EC) No 1907/2006 concerning the registration, evaluation, 
authorisation and restriction of chemicals 

REACH-IT  A central IT application that supports industry, Member State competent 
authorities and ECHA to securely submit, process and manage data and 
dossiersSEV  Substance evaluation 

SID 

SIP 

SIEF 

SONC 

SVHC 

Substance identity 

Substance identity profile 

Substance information exchange forum 

Statement of non-compliance following a dossier evaluation decision 

Substance of very high concern 

 
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TPE 

t/a 

UVCB 

vPvB 

WoE 

Evaluation under REACH: Progress Report 2017 

Testing proposal examination 

Tonnes per annum (year) 

A substance of unknown or variable composition, complex reaction product or 
biological material 

Very persistent and very bioaccumulative 

Weight of evidence 

 
 
EUROPEAN CHEMICALS AGENCY 
ANNANKATU 18, P.O. BOX 400, 
FI-00121 HELSINKI, FINLAND 
ECHA.EUROPA.EU