COMMISSION STAFF WORKING DOCUMENT Review of certain provisions of Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restrictions of Chemicals (REACH), as laid down in its Article 138 Accompanying the document COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Chemicals Strategy for Sustainability Towards a Toxic-Free Environment
Date: 2020-10-14
Institutions: Directorate-General for Environment, European Commission
Subjects: EU strategy, chemical product, chemicals legislation, dangerous substance, environmental protection, marketing standard, product safety, public health, research

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 14.10.2020  SWD(2020) 247 final  COMMISSION STAFF WORKING DOCUMENT Review of certain provisions of Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restrictions of Chemicals (REACH), as laid down in its Article 138 Accompanying the document COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Chemicals Strategy for Sustainability   Towards a Toxic-Free Environment {COM(2020) 667 final} - {SWD(2020) 225 final} - {SWD(2020) 248 final} - {SWD(2020) 249 final} - {SWD(2020) 250 final} - {SWD(2020) 251 final}  
 
 
1.  Background 

Regulation  (EC)  No  1907/2006  (hereinafter,  REACH)1  provides  in  its  Article  138  for  a  number  of 
reviews  to  be  carried  out  by  the  European  Commission.  The  objective  of  this  Staff  Working 
Document is to summarise these reviews, notably: 

1. 

to  assess  whether  or  not  to  extend  the  application  of  the  obligation  to  perform  a  chemical 
safety assessment (CSA) and to document it in a chemical safety report (CSR) for substances 
meeting  the  criteria  for  classification  in  the  hazard  classes  carcinogenicity,  germ  cell 
mutagenicity,  or  reproductive  toxicity2,  not  covered  by  this  obligation  because  they  are  not 
subject to registration or subject to registration but manufactured or imported in quantities of 
less than 10 tonnes per year" (Article 138 (1)); 

2. 

to  assess  whether  or  not  to  extend  the  scope  of  Article  33  to  cover  other  dangerous 
substances, taking into account the practical experience in implementing that Article (Article 
138 (8));  

3.  and  to  review,  in  accordance  with  the  objective  of  promoting  non-animal  testing  and  the 
replacement,  reduction  or  refinement  of  animal  testing  required  under  this  Regulation,  the 
testing requirements of Section 8.7 of Annex VIII (i.e. reproductive toxicity data requirements 
for substances that are manufactured or imported in quantities of 10 tonnes or more), Article 
138(9).  

These  reviews  are  independent  from  each  other.  The  following  chapters  are  therefore  also 
independent, with their own conclusions. 

2.  Review according to Article 138 (1) 

2.1.  Introduction 

2.1.1.  The Review  

The  main  objectives  of  the  REACH  Regulation3  are  to  ensure  a  high  level  of  protection  of  human 
health and the environment, including the promotion of alternative methods for the assessment of the 
hazards  of  substances,  as  well  as  the  free  circulation  of  substances  on  the  internal  market  while 
enhancing  competitiveness  and  innovation.  The  Regulation  obliges  manufacturers  and  importers  to 
register  their  substances  manufactured  or  imported  in  the  EU  above  certain  tonnage  levels,  and  to 
provide a technical dossier for those registered substances. This dossier should include information on 
the physicochemical, toxicological and ecotoxicological properties of the substance, according to the 
standard information requirements of Annexes VII to X or the adaptation rules set out in Annex XI. 
For non-intermediate hazardous substances marketed above 10 tonnes per year, the manufacturer or 
importer needs to perform a chemical safety assessment (CSA) and document it in a chemical safety 
report (CSR).  

1  Regulation  (EC)  No  1907/2006  concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals 
(REACH) OJ L 396, 30.12.2006, p. 1. Corrected version in OJ L 136, 29.5.2007, p. 3. 
2 The review of this provision for all substances not covered by this obligation because they are not subject to registration or 
subject  to  registration  but  manufactured  or  imported  in  quantities  of  less  than  10  tonnes  per  year  will  be  carried  out  and 
published at a later stage. 
3 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a 
European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 
793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and 
Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L396, 30.12.2006, p. 1). 

1 

 
 
                                                            
Article  138  of  REACH  specifies  a  number  of  review  obligations  for  the  European  Commission. 
Article 138(1) requires that: 

“By 1 June 2019, the Commission shall carry out a review to assess whether or not to extend 
the application of the obligation to perform a chemical safety assessment and to document it 
in a chemical safety report to substances not covered by this obligation because they are not 
subject to registration or subject to registration but manufactured or imported in quantities of 
less than 10 tonnes per year. However, for substances meeting the criteria for  classification 
in  the  hazard  classes  carcinogenicity,  germ  cell  mutagenicity  or  reproductive  toxicity, 
category  1A or  1B, in accordance  with  Regulation  (EC)  No  1272/2008,  the  review  shall  be 
carried  out  by  1  June  2014.  When  carrying  out  the  review  the  Commission  shall  take  into 
account all relevant factors, including:  

(a)  the  costs  for  manufacturers  and  importers  of  drawing  up  the  chemical  safety 
reports;  

(b) the distribution of costs between actors in the supply chain and the downstream 
user;  

(c) the benefits for human health and the environment.  

On  the  basis  of  these  reviews,  the  Commission  may,  if  appropriate,  present  legislative 
proposals to extend this obligation.” 

In this report SWD, the Commission addresses the obligation to perform a CSA and to document it in 
a  CSR  for  substances  marketed  at  less  than  10  tonnes  per  year  and  meeting  the  criteria  for 
classification  in  the  hazard  classes  carcinogenicity,  germ  cell  mutagenicity  or  reproductive  toxicity, 
category  1A  or  1B  (CMR  substances4).  A  review  of  this  obligation  for  substances  marketed  at  less 
than  10  tonnes  per  year  but  not  meeting  these  CMR-criteria  will  be  undertaken  separately, together 
with  the  review  obligation  in  Article  138(3)  of  REACH.  For  substances  not  subject  to  registration, 
such obligation is not considered useful, as there are no mandatory data to be reported in a CSA.  

2.1.2.  The objective of the action 

According to the 2018 REACH Review5, the main drivers of the REACH Registration process include 
improving    the  knowledge  on  the  uses  of  substances  and  level  of  exposure,  which  in  turn  allows 
companies to decide on the most appropriate risk management measures to be put in place on site and 
to communicate these across the supply chain. The Chemical Safety Assessment and Chemical Safety 
Report (CSA/CSR) is a key instrument in communicating appropriate risk management measures in 
the  supply  chain.  The  REACH  Regulation  has  not  mandated  the  CSA/CSR  for  1-  10  tonnes 
substances when it went into force, but it asked the Commission to review the benefits of extending 
this requirement to the low tonnage substances.  

The objective of the action of requesting  companies  to provide a CSR also for 1  – 10 tonnes CMR 
substances  would  thus  be,  by  increasing  the  level  of  information  on  substances,  on  their  associated 
uses and their exposures, and by making this information available to all downstream users, to allow 
for the full achievement of the overall objectives of the REACH registration process. 

4 Where this report refers to CMR substances or CMRs, substances meeting criteria for CMR 1A/1B are meant. 
5 https://ec.europa.eu/docsroom/documents/28201 

2 

 
 
 
                                                            
2.2.  Reports  collecting  information  on  1  –  10  tonnes  CMR  substances  and 

consequences of requiring a CSA/CSR for those substances 

The  Commission  put  in  place  a  study  in  2014  (“Final  Report  on  the  extension  of  the  obligation  to 
perform a chemical safety assessment and to document a chemical safety report to CMR substances 
manufactured  or  imported  between  1  and  10  tonnes  per  year”)6  to  assess  the  benefits  and  costs  of 
extending the requirement for a CSA/CSR to 1 – 10 tonnes CMR substances. A subsequent study in 
20177 further elaborated that question in combination with increased information requirements for 1 – 
10 tonnes substances. The outcome of those studies was reported in the second REACH review8 that 
concluded that there was a need to assess affordability of additional registration requirements for the 
companies involved, especially given the number of SMEs who might be affected. That assessment 
should take advantage of the experience gained from the last registration deadline in 20189.  

The  two  reports  referred  above  pre-dated  the  June  2018  registration  deadline  for  1-10  tonnes 
substances  and,  since  the  registration  information  for  low  tonnage  substances  was  then  not  yet 
available,  it  was  necessary  to  apply  a  Monte  Carlo  simulation  methodology10  to  develop  virtual 
substance  registration  data  and  to  estimate  the  associated  costs.  After  the  expiry  of  the  2018 
registration  deadline,  the  Commission  contracted  a  third  study11  on  the  1-10  tonnes  substances 
requirements, which is using data on actual registrations submitted until 2018 and currently available 
from  the  REACH  Registration  database.  Therefore,  no  simulation  methodology  is  used  in  this  last 
contract and the conclusions based on actual registration data is believed to be more robust. The 2020 
study  will be published in Q3 2020 but results on the 1-10 tonnes CMR substances could already be 
extracted for this report.   

ECHA  supplied  detailed  information  on  all  1-10  tonnes  substances  registered  under  REACH  at  the 
end  of  2019.  Some  of  these  substances  are  only  registered  at  the  1-10  tonnes  level,  others  are 
registered  at  1-10  tonnes  and  higher  tonnages.  For  each  registered  substance  (identified  via  EC 
number), ECHA’s dataset provides information including the types of registration, the tonnage bands, 
the date of registration (anonymised), and information describing the type and role of each registrant. 
Alongside  these  data,  for  each  substance,  ECHA  provided  a  separate  dataset  with  the  hazard 
classifications  and  labelling  identified  in  the  substance  registration  dossiers.  These  datasets  allowed 
identifying: 

  which substances would be required to undertake what level of assessment as part of a CSA 

and  

  which (anonymised) registrants would incur the costs of providing this information.  

6 https://ec.europa.eu/environment/chemicals/reach/pdf/1-10t%20P2%201-10t.pdf   
7https://ec.europa.eu/environment/chemicals/reach/pdf/phase-3-1-10t-main-report-final.pdf  
8 COM (2018)116 and SWD(2018)58 
9  The  Commission  has  contracted  out  a  study  on  the  impacts  of  the  2018  REACH  registration  deadline,  expected  to  be 
published early 2021.  
10 Monte Carlo methods, or Monte Carlo experiments, are a broad class of computational algorithms that rely on repeated 
random sampling to obtain numerical results. The underlying concept is to use randomness to solve problems that might be 
deterministic in principle. They are often used in physical, mathematical or economical problems and are most useful when 
it is difficult or impossible to use other approaches. 
11  No  07.0203/2019/8  M999/ENV.B.2,"Gather  further  information  to  be  used  in  support  of  an  Impact  Assessment  of 
potential  options,  in  particular  possible  amendments  of  REACH  Annexes,  to  modify  requirements  for  registration  of  low 
tonnage  substances  (l-10  tonnes/year)  and  the  CSA/CSR  requirement  for  low  tonnage  substances  with  or  without  CMR 
properties in the framework of REACH", Phase 4, to be published in Q3 2020. 

3 

 
 
 
                                                            
Information  from  ECHA’s  database  of  registered  substances  reveals  that  9  520  substances  are  
registered at 1-10 tonnes. Of these, 256 substances are registered only with physico-chemical data and 
9 264 with full Annex VII data. Among these last ones, 3 520 are also registered above 10 tonnes and 
209 of those are CMR-substances. 5 744 substances are fully registered at 1-10 tonnes only (i.e. not 
also  at  higher  tonnages)  and  85  of  those  are  CMR-substances.  Therefore,  the  total  number  of  1-10 
tonnes CMR-substances in ECHA’s database is 294.  

For  the  1-10  tonnes  only  substances,  no  CSA  is  required  at  present  and  only  general  advice  is 
provided  to  downstream  users  in  the  Safety  Data  Sheet  (SDS).  To  comply  with  the  risk  assessment 
and  risk  management  obligations  under  the  parallel  legislation12  triggered  by  the  classification  as  a 
CMR,  manufacturers/importers  (MIs)  and  downstream  users  (DUs)  must  rely  on  the  general 
information presented in the SDS to complete their own in-house assessments of exposure and risk for 
their own operations.  

Extending  the  CSA/CSR  obligation  to  1-10  tonnes  CMRs  would  require  MIs  of  such  substances  to 
complete the process established under Article 14 of REACH and the detailed requirements set out in 
Annex I of REACH. The elements to be documented in the CSR are listed in Annex I to this report. 
For DUs, the information in the CSA/CSR would greatly facilitate their own assessments of exposure 
and risk for their own operations and their compliance with other parallel legislation. This is because 
the  exposure  scenarios  that  would  have  to  be  included  in  the  CSR  and  which  describe  operational 
conditions  and  risk  management  measures  would  facilitate  compliance  with  the  many  regulatory 
instruments  that  are  triggered  by  classification  in  accordance  with  Regulation  (EC)  No  1272/2008. 
This facilitation would result in a cost saving for the DUs. Those obligations in parallel legislation are 
summarised in section 2.3. The requirement for a CSR would also lead to the development of a more 
detailed extended Safety Data Sheet (eSDS). The importance of a good quality eSDS has also been 
identified in the REACH review actions 3 and 1213, to ensure that the safe use information delivered 
via the SDS can be directly used by employers and site managers in terms of OSH and environment 
legislation.  Improving  the  eSDS  forms  part  of  development  work  currently  done  by  ECHA  and  the 
Commission.  

Hence, the requirement for a CSA/CSR effectively moves some  workload from each DU to  the MI 
and  is  likely  to  benefit  multiple  DUs  of  each  substance,  thus  reducing/eliminating  duplication  of 
efforts and leading to harmonisation of information.  

The  requirement  for  a  CSR  would  also  necessitate  a  PBT  (persistent,  bioaccumulative  and  toxic)  -
assessment.  The  purpose  of  the  PBT/vPvB  (very  persistent,  very  bioaccumulative)  assessment  is  to 
determine  if  the  substance  fulfils  the  criteria  for  PBT/vPvB  given  in  Annex  XIII  and,  if  so,  to 
characterise the potential emissions of the substance. For substances registered only at 1-10 tonnes, no 
PBT/vPvB assessment will have yet been performed because it forms part of a CSA/CSR that is not 
currently required by Annex VII of REACH. 

For the 1-10 tonnes substances also registered at higher tonnages, a CSA/CSR already exists and will 
cover most uses, including the manufacturer’s own use. For some substances, however, some of the 
uses registered only at 1-10 tonnes may not be covered by the existing CSA and additional exposure 
assessment and risk characterisation would be required. This would represent a cost of the CSA/CSR 
option for the substances.   

12 Worker health and safety regulation, general product safety requirements and waste legislation were considered. 
13 COM, General Report on the operation of REACH, SWD(2018) 58 final. Action 3 Improving the quality & workability of 
the extended SDS, and Action 12 REACH-OSH interface . 

4 

 
 
                                                            
The assumptions concerning the numbers of 1-10 tonnes substances uses and the cost of the exposure 
assessments and risk characterisation are described further down. 

2.3.  Requirements under parallel regulation (from 2017 RPA study) 

2.3.1  Overview 

In the event that a substance is identified as meeting the criteria for classification as C, M, or R 1A/1B  
in accordance with Regulation (EC) No 1272/2008, the change in classification triggers actions on the 
part  of  manufacturers,  importers  and  downstream  users  to  comply  with  other  pieces  of  community 
legislation covering areas including worker health and safety, product safety, and waste. Each area of 
regulation requires action to assess exposure and risks and to implement risk management measures.  

For the purpose of this report, it is useful to recall what the obligations under parallel legislation are, 
as well as the associated costs. This will enable drawing a comparison with the costs from providing a 
CSR. 

The key requirements are summarised below. 

2.3.2  Worker Health and Safety Legislation 

Key  legislation  and  associated  requirements  in  relation  to  worker  health  and  safety  include: 

  Directive 98/24/EC on the protection of the health and safety of workers from the risks 

related to chemical agents at work (CAD)14– which requires employers (i.e. manufacturers 
and downstream users) to determine whether any hazardous chemical agents are present at the 
workplace and assess any risk to the safety and health of workers arising from the presence of 
those chemical agents; 

  Carcinogens  and  Mutagens  Directive  2004/37/EC  (CMD)15  –  which  requires  that,  as  a 
priority,  workers'  exposure  must  be  prevented  through  substitution.  If  not  possible,  the 
employer shall use  a closed  technological system. Where a closed system is not  technically 
possible,  the  employer  shall  reduce  exposure  to  a  minimum  through  a  number  of  risk 
management measures specified in the Directive; 

  Pregnant  and  Breastfeeding  Workers  Directive  92/85/EEC16  –  which  requires  that  the 
employer  shall  assess  the  nature,  degree  and  duration  of  exposure,  assess  any  risks  to  the 
safety  or  health  and  any  possible  effects  on  the  pregnancy  or  breastfeeding  of  workers  and 
then decide what measures should be taken; and 

  Directive 94/33/EC on Young Workers17 – under which employers are obliged to assess the 
hazards to young people, generate new site-specific data on the nature, degree and duration of 

14 Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to 
chemical agents at work, (OJ L 131, 5.5.1998, p. 11–23) 
15  DIRECTIVE  2004/37/EC  OF  THE  EUROPEAN  PARLIAMENT  AND  OF  THE  COUNCIL  of  29  April  2004  on  the 
protection of workers from the risks related to exposure to carcinogens or mutagens at work  (OJ L 158, 30.4.2004, p. 50) 
16  Council  Directive  92/85/EEC  of  19  October  1992  on  the  introduction  of  measures  to  encourage  improvements  in  the 
safety and health at work of pregnant workers and workers who have recently given birth or are breastfeeding, (OJ L 348 , 
28/11/1992,  p. 0001 – 0008) 
17 Council Directive 94/33/EC of 22 June 1994 on the protection of young people at work, (OJ L 216, 20.8.1994, p. 12–20) 

5 

 
 
 
 
 
 
 
                                                            
exposure to chemical agents and adopt the measures necessary to protect the safety and health 
of young people. 

At present, for substances for which there is no obligation to conduct a CSA under REACH, there is 
no obligation to provide exposure scenarios detailing the technical means to achieve risk management 
for  identified  uses  in  an  extended  SDS  in  relation  to  human  exposures  in  the  workplace.  As  such, 
under  this  parallel  legislation,  manufacturers  and  each  downstream  user  must  conduct  their  own 
bespoke assessments of exposure, risk and identification of risk management measures based on the 
general information provided in the SDS. 

2.3.3  Product Safety Requirements 

In  addition  to  worker  health  and  safety  requirements,  classification  as  C,  M  or  R  1A/1B  has 
implications in terms of safety of products. Annex XVII of REACH (entries 28 to 30) prohibits the 
placing on the market and the use of CMRs 1A/1B as substances or as constituents of other substances 
or mixtures for supply to the general public when the individual concentration in the substance or the 
mixture  is  equal  to  or  greater  to  the  generic/specific  concentration  limit  of  Regulation  (EC)  No 
1272/2008. Consumer articles are not in the scope of the entries 28 to 30, but some specific legislation 
applies to some of these articles and all products in general. This includes: 

  Directive  2001/95/EC  on  General  Product  Safety18  -  under  Article  3  of  the  GPSD 
producers  are  obliged  to  place  only  safe  products  on  the  market.  Assessment  of  the  risk  to 
consumers from the presence of a CMR substance in a product would be required where this 
would include consideration of human exposure to the substance due to the use of the product 
under reasonably foreseeable conditions; 

  Regulation No 305/2011 for the Marketing of Construction Products19 - all manufacturers 
of  construction  products  containing  substances  identified  with  C,  M  or  R  properties  must 
consider the implications of this in terms of risk and safety of their products; and 

  Toy  Safety  Directive  2009/48/EC20  -  Article  18  of  the  Toy  Safety  Directive  requires 
manufacturers, before placing a toy on the market, to carry out an analysis of the chemical, 
physical, mechanical, electrical, flammability, hygiene and radioactivity hazards that the toy 
may present, as well as an assessment of the potential exposure to such hazards. 21 To comply 
with  their  obligations,  manufacturers  of  products  containing  1-10  tonnes  ‘CMRs  1A/1B’ 
substances would have to rely on the general information presented in the SDS to complete 
their  assessments  where  this  will  not  include  detailed  information  on  the  technical 
considerations in relation to exposure, risk and safety (as no CSA is required). 

18 Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety, (OJ 
L 11, 15.1.2002, p. 4–17) 
19 Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised 
conditions for the marketing of construction products and repealing Council Directive 89/106/EEC, (OJ L 88, 4.4.2011, p. 5–
43) 
20 DIRECTIVE 2009/48/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 June 2009 on the safety 
of toys, (OJ L 170, 30.6.2009, p. 1-37) 
21  
The  Toys Directive,  in its Annex  II,  part  III,  also  sets  out  particular  safety  requirements regarding  the  chemical 
properties of toys. In point 3, it refers to substances that are classified as carcinogenic, mutagenic or toxic for reproduction 
(CMR) of category 1A, 1B or 2 under Regulation (EC) No 1272/2008, which shall not be used in toys, subject to certain 
exceptions. 

6 

 
 
 
 
 
 
 
 
                                                            
2.3.4  Waste Legislation 

The Waste Framework Directive 2008/98/EC22 defines hazardous waste as waste that fulfils 
certain properties, including carcinogenic, toxic for reproduction or mutagenic properties. This would 
apply to waste containing 1-10 tonne substances classified as C, M or R 1A/1B. This would require 
the determination of safe and environmentally preferred waste management options. 

In relation to the 1-10 tonnes substances, the information provided in the SDS for waste management 
will be of a general nature with no specific quantitative analysis of risk and exposure in 
relation to the recommended risk management measures in relation to waste and the technical means 
to achieve this (as no CSA is required). 

2.3.5  Costs  of  compliance  with  requirements  under  all  parallel 

legislation described above 

On  the  basis  of  the  above,  RPA  have  made  an  estimation23  of  the  cost  of  compliance  with  parallel 
legislation  in  the  absence  of  a  CSA/CSR  for  1-10  tonnes  CMRs.  The  table  below  reflects  those 
estimates  for  low,  medium  and  high  cost  scenarios.  These  assume  that  assessments  for  compliance 
with parallel legislation (using the general information currently required to be provided in the SDS 
for 
and 
 € 3 500 for substances with ‘CMR 1A/1B’ properties.  

substance)  would 

downstream 

between 

each 

user 

cost 

500 

€ 

1 

a 

Table 2.1 DU’s costs to comply with parallel legislation (per use per substance) 

Number of uses per substance 
Number of DUs per use 
Cost  for  a  DU  to  conduct  assessments  to 
comply with parallel regulation 

Low scenario  Medium scenario  High scenario 
1 
20 
€ 1 500 

2 
30 
€ 2 500 

5 
40 
€ 3 500 

2.4.  Costs  of  extending  the  CSA/CSR  obligation  to  1  –  10  tonnes  CMR 

substances  

2.4.1  Overview 

The  2020  study  by  RPA24  assesses  options  for  possible  amendments  of  REACH,  modifying 
information requirements for 1-10 tonnes substances as well as the option of requiring a CSA/CSR for 
the 1-10 tonnes substances. The following REACH compliance costs have been identified as relevant 
and potentially significant for Manufacturers/Importers in relation to this: 

22 Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain 
Directives, (OJ L 312, 22.11.2008, p. 3–30) 
23 Estimations based on previous work in RPA (2017): Study to gather further information to be used in support of an Impact 
Assessment  of  potential  options,  in  particular  possible  Amendments  of  REACH  Annexes,  to  modify  requirements  for 
registration of low tonnage substances (1-10t/year) and the CSA/CSR Requirement for CMR substances in the framework of 
REACH,  report  prepared  for  DG  Environment    https://ec.europa.eu/environment/chemicals/reach/pdf/phase-3-1-10t-main-
report-final.pdf  and  CSES  (2015)  Monitoring  Impacts  of  REACH  on  Innovation,  Competitiveness  and  SMEs,  report 
prepared for DG Growth  http://ec.europa.eu/DocsRoom/documents/14581/attachments/1/translations/en/renditions/native  
24  Phase  4  study  of  RPA  on  the  1-10  tonne  substances  and  whether  to  increase  information  requirements  and  whether  to 
expand the CSA/CSR requirement to them, to be published in Q4 2020.  

7 

 
 
 
 
  
 
                                                            
  Cost  of  completing  information  on  the  substance,  quantities  and  uses,  classification  and 

environmental fate; 

  Cost of producing Robust Study Summaries; 

  Cost  of  completing 

the  physicochemical,  human  health  and  environmental  hazard 

assessments; 

  Cost of completing the human exposure assessment and risk characterisation where required 

by the outcome of the human health hazard assessment; 

  Cost  of  completing  the  environmental  exposure  assessment  and  risk  characterisation  where 

required by the outcome of the environmental hazard assessment; and 

  Cost of  producing an extended Safety Data Sheet (eSDS). 

The  extension  of  the  CSA/CSR  obligations  would  also  impact  the  downstream  users’  (DUs) 
compliance costs to comply with their duty under REACH to pass information up the supply chain (to 
the manufacturer/importer).  Thus, for all of the 1-10 tonnes substances for which either or both the 
human  and  environmental  exposure  assessment  are  required,  DUs  would  need  to  provide  relevant 
information up the supply chain.  

As  with  costs  of  information  and  dossier  submission,  in  relation  to  each  of  these  cost  components 
there  are  differences  in  the  type  and  nature  of  costs  for  substances  registered  only  at  1-10  tonnes 
versus those also registered at higher tonnages. For 1-10 tonnes only substances, no CSA/CSR exists 
at present and, thus, they need to be developed. For 1-10 tonnes substances also registered at higher 
tonnage  bands,  CSAs/CSRs  have  already  been  produced  by  the  registrants  at  above  10  tonnes  and 
cover the manufacturing uses and those of the downstream users of those registrants. These CSRs are 
not available for any registrant in the range 1-10 tonnes only and they might not cover uses of their 
DUs. 

For  1-10t  substances  also  registered  at  above  10  tonnes,  some  components  of  the  CSA  are  already 
complete  and  some  of  this  can  be  used  to  complete  tasks  within  the  CSA  for  the  1-10  tonnes  only 
registrants. These components include:  

  Hazard assessment and classification – This will have already been completed for the initial 
registration at 1-10 tonnes. It will also have been completed by higher tonnage registrants as 
part of their CSA and published in the Chemical Safety Report (CSR). Further, 63% (130) of 
the  1-10  tonnes  CMR  substances  also  registered  at  above  10  tones  have  a  harmonised 
classification.  Regarding  DNELs,  the  vast  majority  of  the  CMR  substances  will  be  non-
threshold  substances  (for  which  no  DNEL  exists).  For  those  that  have  a  threshold,  DNEL 
information can be extracted from the published CSR, as well as from other publicly available 
sources (without having to buy full access to the study/ies that the DNEL is based on). In the 
event that such data are not available to the 1-10 tonnes registrant, the CSA can ‘default’ to 
that for a non-threshold substance, as there is no requirement in Annex I to provide additional 
information for CSA over and above that required in the relevant Annex (Annex VII). With 

8 

 
 
 
all of these factors combined, the cost of completing hazard assessment and classification is 
zero or near zero for the 1-10 tonnes registrants.  

  PBT/vPvB assessment – This section will have been completed by higher tonnage registrants 
and  the  outcomes  been  published  in  the  CSR,  as  well  as  other  publicly  available  sources.  
Thus,  costs  for  entering  the  information  for  1-10  tonnes  registrants’  CSA  are  zero  or  near 
zero.  

  Exposure  assessment  and  risk  characterisation  –  for  some,  potentially  all,  of  the 
downstream  uses  registered  by  1-10  tonnes  only  registrants,  a  CSA  will  already  have  been 
completed.  It  is  not  known  which  of  these  uses  will  or  will  not  have  been  covered  in  any 
existing  CSA.  The  worst-case  assumption  that  registrants  would  have  to  complete  full 
assessments for their own registered uses has been applied. The number of uses to be assessed 
is calculated with reference to a percentage of all of the existing known uses. This percentage 
is given by the ratio of the number of 1-10 tonnes only registrants versus the number of all 
registrants. Thus,  for  example,  for  a  substance  with  a  total  of  100  registrants  and  10  1-10 
tonnes  only  registrants,  the  percentage  of  uses  that  the  1-10  tonnes  only  registrants  would 
have  to  assess  is  equivalent  to  10%  of  all  known  uses.  In  reality,  some  of  these  uses  will 
already have been covered in the existing CSA and, where this is the case, the cost for access 
to  this  is  likely  to  be  less  than  the  costs  for  full  assessment  that  have  been  assumed  in  the 
figures presented further down.    

Regarding the issue of payments for access to information more generally, any payments made by 1-
10 tonnes only registrants to other registrants at higher tonnages would represent so called ‘transfer 
payments’.  Such  ‘transfer  payments’  do  not  constitute  an  ‘economic  cost’  when  assessing  the  costs 
and  the  benefits  of  options  for  changed  Annex  VII  requirements  and,  strictly,  should  not  be 
considered. And even if one would want to consider it, it would not be practically possible, since the 
price of a Letter of Access is not regulated and that, consequently, companies can freely set it at their 
discretion. One can only assume that smaller companies will have more difficulties to afford it than 
larger ones. A more detailed assessment of affordability is presented further below. However, for the 
exposure  assessment  and  risk  characterisation  elements,  it  is  difficult  to  disassociate  any  such 
payments  from  the  cost  of  full  assessment  and  so  the  latter  cost  is  assumed  in  the  analysis  (even 
though the cost of access to the relevant parts may be significantly less and some of these costs may 
actually represent transfer payments and not costs in the formal sense).  

The  sub-sections  below  discuss  estimation  of  costs  for  each  of  the  components  and  how  they  have 
been calculated for each of the two groups of substances. 

2.4.2 

Information on the substance, its uses, classification and environmental 
fate 

Sections 1 to 4 of the CSR are to provide general information on the substance, its manufacture and 
uses,  classification  and  labelling  and  environmental  fate  properties.  The  table  below  describes  the 
sources of the required information in respect of the 1-10 tonnes substances. As can be seen, much of 
it is already provided according to the requirements of Annexes VI and VII of REACH. As such, in 
the analysis it is assumed that: 

  The costs of completing CSR Sections 1-4 ranges between € 100 and € 250 per substance – an 

average of € 175 per substance. 

9 

 
 
  This  cost  applies  both  for substances  registered  at  only 1-10  tonnes  and  also for  substances 

registered at above 10 tonnes. 

Table 2.2:  CSR Reporting on the Substance, its Uses, Classification and Environmental Fate 

CSR Section 
1.  IDENTITY  OF  THE  SUBSTANCE 
AND  PHYSICAL  AND  CHEMICAL 
PROPERTIES 
2. MANUFACTURE AND USES 
2.1. Manufacture 
2.2. Identified uses 
2.3. Uses advised against 
3. 
LABELLING 
4. 
PROPERTIES 
4.1. Degradation 

ENVIRONMENTAL 

CLASSIFICATION 

FATE 

AND 

4.2. Environmental distribution 

4.3. Bioaccumulation 

4.4. Secondary poisoning 

Availability of information 
Annex VI and VII information and summarised in Section 1 of 
the  SDS:  Identification  of  the  substance/mixture  and  of  the 
company/undertaking 
Annex  VI  information  summarised  in  Section  1  of  the  SDS: 
Identification  of 
the 
company/undertaking/entity 

substance/mixture 

and  of 

the 

Annex VI and application of Annexes VII to XI. Summarised 
in Section 2 of the SDS: Hazards identification  

Results from tests on ready biodegradation in accordance with 
Section 9.2.1.1 of Annex VII and summarised in Section 12.2 
of the SDS: Persistence and degradability  
Characterisation  of  possible  degradation,  transformation,  or 
reaction  processes  and  an  estimation  of  environmental 
distribution and fate based on available data 
Results  from  tests  on  Octanol-water  partitioning  coefficient 
experimentally  determined  in  accordance  with  Section  7.8  of 
Annex  VII  and  summarised  in  Section  12.3  of  the  SDS: 
Bioaccumulative potential 
Based on analysis of composite and available information 

2.4.3  Cost of upgrading to Robust Study Summaries 

i. 

Substances registered at 1-10 tonnes only 

In  relation  to  substances  registered  only  at  1-10  tonnes,  study  summaries  produced  for  the  current 
Annex VII endpoints provided as part of the registration would need to be upgraded to Robust Study 
Summaries. The table below provides the cost of study summaries for the Annex VII endpoints, the 
costs of upgrading these studies and the resulting total costs of Robust Study summaries estimated for 
each endpoint. Costs are based on estimated time for a toxicologist (whether in-house or consultant) at 
€1 000 per day and rounded appropriately. 

10 

 
 
 
 
Table 2.3:  Cost of Robust Study Summaries 

Section 

Test 

Study summary 
cost 

Cost to 
upgrade to a 
robust study 
summary 

8.2 Eye irritation 

8.1 Skin irritation 

8.3 Skin Sensitisation 

An in vitro study 
An in vivo study 
An in vitro study 
An in vivo study 
Annex VII 
Ames test (VII) 
MNT/CAB Vitro 
Cytvivo 
Study on algae (Annex 
VII) 
Ready biodegradability 
(Annex VII) 
Source: Phase 3 study and  CSES study monitoring the impacts of REACH 

Section 9.1 Aquatic 
Toxicity 

€ 100 
€ 100 
€ 100 
€ 100 
€ 100 
€ 250 
€ 250 
€ 500 

8.4 Mutagenicity 

 9.2 Degradation 

€ 100 

€ 100 

€ 50 
€ 50 
€ 50 
€ 50 
€ 50 
€ 50 
€ 50 
€ 100 

€ 50 

€ 50 

Cost of 
producing a 
Robust 
Study 
Summary 
€ 150 
€ 150 
€ 150 
€ 150 
€ 150 
 € 300 
€ 300 
€ 600 

€ 150 

€ 150 

ii. 

1-10 tonnes substances also registered at higher tonnages 

For the 1-10 tonnes CMR substances also registered at higher tonnages, robust study summaries will 
already be part of the existing CSA/CSR produced by higher tonnage registrants and there will be no 
need  for  upgrading,  implying  zero  cost.  However,  the  cost  of  access  and  administration  of  that  is 
taken as being equal to the equivalent costs of upgrading. Thus, the costs set out in the previous table 
are also applied to registrants of 1-10 tonnes substances also registered at higher tonnages. 

2.4.4  Cost  of  completing 

the  physicochemical,  human  health  and 

environmental hazard assessments 

i. 

Substances registered at 1-10 tonnes only 

For substances registered at 1-10 tonnes only, the following hazard assessments would be required as 
part of developing the new CSA/CSR: 

  Human  health  hazard  assessment:  to  determine  the  classification  of  a  substance  and  to 

derive DNELs where possible using the available data; 

  Human  health  hazard  assessment  of  physicochemical  properties:  to  determine  the 
classification  of  a  substance  in  relation  to,  as  a  minimum,  explosivity,  flammability  and 
oxidising potential; and 

  Environmental  hazard  assessment:  to  determine  the  classification  of  a  substance  and  to 

identify the PNEC where possible using the available data. 

It  is  noteworthy  that  there  is  no  requirement  in  Annex  I  to  provide  additional  information  for  CSA 
over and above that required in the relevant Annex (in this case Annex VII). If there is insufficient 
information to demonstrate ‘non threshold’ properties (and derive a DNEL) then, as noted above, risk 
management  to  eliminate  exposure  is  the  objective  (as  opposed  to  risk  management  to  reduce 

11 

 
 
 
exposure to a certain threshold concentration). Additional information would not have to be generated 
or otherwise accessed25. 

In earlier studies, a ‘first time’ analysis for the hazard assessments was assumed to take between 1.5 
and 3 days for an in-house or consultant toxicologist at € 1 000 / day.  As such, costs were estimated 
at  between  €  1  500  and  €  3  000,  on  average  €  2  250  per  substance. However,  determination  of 
classification  of  the  substance  will  have  already  been  completed  as  part  of  the  original  registration 
process.  As  such,  costs  for  phase-in  substances  registered  at  1-10t  only  likely  to  be  minimal.  For 
completeness, an estimated cost of € 225 per substance has been included based on 10% of the ‘first 
time’ assessment and determination of the classifications at € 2 250). 

ii. 

1-10 tonnes substances also registered at higher tonnages 

For 1-10 tonnes substances also registered at higher tonnages, hazard assessments and determination 
of  classification  of  the  substance  will  also  have  already  been  completed  as  part  of  the  original 
registration  process  but  also  will  already  have  been  developed  as  part  of  the  existing  CSA  and 
communicated via an eSDS. In this study it was assumed that the cost paid by 1-10t registrants for this 
information to higher tonnage registrants is considered as kind of reimbursement of the cost already 
spent  on  the  generation  of  this  information.  Therefore,  the  costs  associated  with  the  generation  of 
information  for  the  purpose  of  completing  the  physicochemical,  human  health  and  environmental 
hazard assessments are assumed to be zero.     

2.4.5  Cost of undertaking PBT/vPvB screening and assessment 

i. 

Substances registered at 1-10t only 

The  purpose  of  the  PBT/vPvB  assessment  is  to  determine  if  the  substance  fulfils  the  criteria  for 
PBT/vPvB  given  in  Annex  XIII  and,  if  so,  to  characterise  the  potential  emissions  of  the  substance.  
The assessment is divided into a screening stage and an assessment stage. 

PBT/vPvB screening 
The  procedures  for  PBT/vPvB  assessment  are  set  out  in  Annex  XIII,  Section  2.1,  which  identifies 
that, for substances with information from Annexes VII and VIII only  “the registrant shall consider 
information  relevant  for  screening  for  P,  B,  or  T  properties  in  accordance  with  Section  3.1  of  this 
Annex”. There is no requirement to generate information for screening. 

The screening applies to all substances and is assumed to cost € 750 per substance (0.75 days for an 
in-house or consultant toxicologist at € 1 000 per day). 

PBT/vPvB Assessment 
Continuing the requirements set out in Annex XIII, Section 2.1 :”If the result from the screening tests 
or  other  information  indicate  that  the  substance  may  have  PBT  or  vPvB  properties,  the  registrant 
shall  generate  relevant  additional  information  as  set  out  in  Section  3.2  of  this  Annex.[….].No 
additional information needs to be generated for the assessment of PBT/vPvB properties if there is no 
indication of P or B properties following the result from the screening test or other information”. 

25  Note  that,  in  the  case  of  the  206  CMR  1A/1B  substances  also  registered  at  higher  tonnages,  113  of  these  (55%)  were 
originally  registered  in  2010  and,  under  the  12-year  rule,  any  tox/ecotox  information  in  those  registrations  would  be  free 
after 2022. 

12 

 
 
 
                                                            
Following its Annex III screening exercise in 2016, ECHA suggested that Phase 3 should assume that 
2.7% of all substances would be identified as potential PBTs/vPvBs by screening. Registrants of these 
substances would need to do one of the following: 

  generate  any  selected  information  from  Section  3.2  of  Annex  XIII  sufficient  to  allow 

assessment; 

  demonstrate  that  the  process  and  use  conditions  of  the  substance  meet  the  conditions  as 
specified in Section 3.2(b) or (c) of Annex XI, and subsequently the substance is considered 
as if it is a PBT or vPvB in the registration dossier; or 

  withdraw the substance from the market. 

Regarding  the  first  of  these,  the  generation  of  additional  information,  Section  3.2  of  Annex  XIII 
identifies  that  the  following  information  shall  be  considered  for  the  PBT/vPvB  assessment  using  a 
weight-of-evidence approach: 

  For assessment of P or vP properties:  

o  Results from simulation testing on degradation in surface water (OECD 309  = € 20 

759)26, soil (OECD 307 = € 60 804) and sediment (OECD 308 = € 55 217); 

o  Other  information,  such  as  suitable  and  reliable  information  from  field  studies  or 

monitoring studies 
  For assessment of B or vB properties:   

o  Results from a bioconcentration or bioaccumulation study in aquatic species (OECD 

305= € 62 150); 

o  Other  suitable  and  reliable  information  on  the  bioaccumulation  potential  including 
results  from  a  chronic  toxicity  study  on  animals  (fish  OECD  204  -  €  59  754)  or 
assessment of the toxicokinetic behaviour of the substance (€ 1 652);  
Information  on  the  ability  of  the  substance  to  biomagnify  in  the  food  chain  such  as 
biomagnification or trophic magnification factors. 

o 

  For assessment of T properties: 

o  Results from growth inhibition study on aquatic plants (Section 9.1.2 of Annex VII); 
o  Classification for C or M 1A/1B, R 1A/1B/2 STOT RE 1 or 2; 
o  Results  from  long-term  toxicity  testing  on  invertebrates  and/or  fish  (Sections 
9.1.5/9.1.6 of Annex IX (Daphnia OECD 211 = € 21 218 / fish (above) OECD 204 - € 
59 754); 

o  Results  from  long-term  or  reproductive  toxicity  testing  with  birds  (Section  9.6.1  of 

Annex X OECD 205 = € 41 248); and 

o  Other demonstrably suitably and reliable information. 

It is not necessary to generate all of this information (which would cost in the region of € 261 000).  
ECHA Guidance27 provides an Integrated Testing Strategy (ITS) that suggests a progressive route for 
the assessment of P, B and T properties. The outcome of the assessments is linked – a substance that 
can be established as not meeting criteria for P cannot be a PBT/vPvB and likewise for a substance 
where it is established that it is not B. 

26 All costs for OECD TG studies have been taken from a database of the consultant of the Phase 3 and 2020 study on the 
costs drawn from various studies, including from an authoritative industry association and have been updated to reflect 2020 
prices.   
27  ECHA Guidance on Information Requirements and Chemical Safety Assessment - Chapter R.11: PBT/vPvB assessment, 
https://echa.europa.eu/documents/10162/13632/information_requirements_r11_en.pdf  

13 

 
 
                                                            
ECB  (2002)28  estimated  that  around  20%  of  the  substances  with  potential  PBT  characteristics  are 
actual PBT substances. As such, for around 20%  of the 2.7% of substances for which the screening 
identifies potential PBT/vPvB properties, ECHA’s ITS might lead to some (but not all) of the studies 
listed  in  Section  3.2  of  Annex  XIII  being  required  to  establish  certainty  on  PBT/vPvB  status.  
Assuming: 

  For P/vP - one of the simulation tests on degradation in surface water (OECD 309 = € 20 759) 
or  soil  (OECD  307  =  €  60  804)  or  sediment  (OECD  308  =  €  55  217)  is  carried  out.    The 
average of €45 593 is taken as the cost of this; 

  For B –a chronic toxicity study on animals  (fish OECD 204 - € 59 754) is carried out; and 
  For T – the results of the chronic study on fish for B also provides the information for T. 
This provides a total cost of € 105 347 for this 20% (of 2.7%) of substances. For the remaining 80% 
of  substances  that  will  be  eliminated,  it  is  assumed  that  the  assessment  costs  €  10  000  on  average. 
Thus,  20%  at  €  105  347  and  80%  at  €  10  000  suggests  a  cost  of  around  €  29  000  when  averaged 
across the 2.7% of substances identified as potential PBTs/vPvBs by screening and then required to 
undertake PBT/vPvB assessment. 

ii. 

1-10 tonnes substances also registered at higher tonnages 

As  with  other  parts  of  the  CSA/CSR,  for  1-10  tonnes  substances  also  registered  at  higher  tonnages 
PBT/vPvB assessment will already have been carried out by the higher tonnage registrants but the 1-
10 tonnes registrants will not have contributed to the costs of that undertaking.  

2.4.6  Cost of completing the environmental and human exposure assessment 

and risk characterisation 

i. 

Overview 

Application  of  Annex  XIII  of  REACH  requires  that  where  human  health  and  or  environmental 
hazards have been identified in the hazard assessments, manufacturers and importers have to consider 
downstream  uses  of  the  substance  in  the  CSA  and  conduct  an  exposure  assessment  and  risk 
characterisation  for  each,  and  develop  recommendations  on  risk  management  measures  and  the 
technical means to achieve them.  

The  hazard  classifications  of  each  substance  registered  at  1-10  tonnes  are  provided  by  the  ECHA 
registration  data  post  the  2018  registration  deadline.  For  each  substance,  where  the  classifications 
identify  human  health  and/or  environmental  hazards,  human  health  and/or  environmental  exposure 
assessment and risk characterisation is required as part of CSA.   

Such assessment  is required  for each  use of a substance. The Phase 3 and CSES impact  monitoring 
studies  assumed  that,  in  addition  to  the  manufacturer’s  use,  there  are  between  1  and  5  downstream 
uses  for  each  substance  registered  at  1-10  tonnes  (an  average  of  4  uses  per  substance  including  the 
manufacturer’s own use).  However, in the last study by RPA (Phase 4 study), these assumptions are 
substituted with actual data on the number of uses drawn from ECHA’s registration database.   

ii. 

Substances registered at 1-10 tonnes only 

Paragraph  0.8 of REACH Annex  I indicates that “exposure scenarios may describe the appropriate 
risk  management  measures  for  several  individual  processes  or  uses  of  a  substance”.  As  such,  one 

28 ECB (2002):  Identification of Potential PBTs or vPvBs Among the IUCLID High Production Volume Chemicals (ECB 
4/14/02 (PBT strategy – report)). 

14 

 
 
                                                            
exposure  scenario  may  be  sufficient  to  cover  multiple  uses  and  processes  and  so,  depending  on  the 
uses, multiple assessments covering each use may not be required.   

However, the extent of overlap between the different uses of substances is difficult to estimate and so 
the analysis assumes that  a separate assessment  is required  for each and every use. This very much 
represents a ‘worst case/highest cost’ assumption. 

The  estimated  costs  of  undertaking  exposure  assessment  and  risk  characterisation  are  drawn  from 
Phase 3 and CSES impact monitoring studies and are provided in the tables below. 

In  relation  to  the  number  assessments  that  would  be  required  for  each  substance,  one  exposure 
scenario  may  be  sufficient  to  cover  multiple  uses  and  processes  and  so,  depending  on  the  uses, 
multiple assessments covering each use may not be required. At the same time, for a number of cases, 
the exposure scenario for one use may not cover other identified uses.   

For the purpose of this analysis, it is assumed that the exposure scenario for the manufacturer’s own 
use  covers  all  downstream  uses  in  50%  of  cases.  For  the  remainder  it  is  assumed  that  the  exposure 
scenario  for  a  manufacturer’s  use  does  not  cover  any  other  uses  and  that  an  exposure  scenario  is 
required for each and every additional use.  In reality, as per paragraph 0.8 of REACH Annex I, some 
grouping of uses will be possible.  As such, this represents a ‘worst case/highest cost’ assumption. 

The  assumptions  on  the  number  of  uses  of  each  substance  and  the  estimated  costs  of  undertaking 
exposure assessment and risk characterisation are provided in the table below. 

Table  2.4  Costs  and  assumption  for  Human  Health  and  Environmental  exposure  assessments  and  risk 
characterisation 

Low 

High 

Average 

Cost  of  Human  Health  Exposure  Assess  and  Risk  Characterisation  per 
use 
Cost  of  Environmental  Exposure  Assess  and  Risk  Characterisation  per 
use 
Note: in these estimates it is assumed that for 50% of the substances, the exposure scenario of the MI’s uses also cover 
the DUs’ uses.  
Source: Phase 3 and CSES impact monitoring studies 

€ 1 000 

€ 1 500 

€ 5 000 

€ 3 000 

€2 000 

€3 250 

iii. 

1-10 tonnes substances also registered at higher tonnages 

For the 1-10 tonnes CMR 1A/1B substances also registered at higher tonnages, a CSA/CSR already 
exists and will cover most uses including the manufacturer’s own use.  For some substances, however, 
some  of  the  uses  registered  at  1-10  tonnes  may  not  be  covered  by  the  existing  CSA  and  additional 
exposure assessment and risk characterisation would be required for these uses.  This would represent 
a cost of the CSA/CSR option for the substances and not a ‘transfer payment’.   

Costs are calculated as follows: 

  The  percentage  of  the  downstream  uses  of  the  1-10  tonnes  registrants  that  will  already  be 
covered by the existing CSA/CSR is assumed to be proportional to the percentage of the total 
number  of  registrants  that  have  registered  at  above  10  tonnes.  For  example,  if  the  total 
number of registrants (1-10 tonnes and higher) is 10 and 8 of those are registrants at above 10 
tonnes, then 80% of the registrants are at above 10 tonnes. It is assumed that this equates to 

15 

 
 
  
 
80%  of  1-10  tonnes  uses  already  having  been  included  in  the  existing  CSA  (and  20%  not 
being included and requiring assessment). 

The assumptions concerning the numbers of 1-10 tonnes substances’ uses, the costs of the exposure 
assessment/risk characterisation are the same as those in the table above. 

2.4.7  Communication with DUs 

Undertaking the exposure assessments and risk characterisation requires communication with each of 
the DUs on all uses of a substance not already covered by an existing CSA.   

In Phase 3 and  CSES impact  monitoring studies it was assumed that there were between 20 and 40 
downstream users per use with this equating to between 20 and 200 downstream users per substance 
regardless of the number  of  manufacturers of the substance. This wide range  of estimates  produced 
problems with the estimates of both costs to DUs and also the benefits of the options.  

To improve the assessment, a more realistic approach has been adopted based on the assumption that 
a substance with more manufacturers is likely to have more downstream users (and vice versa).  The 
analysis now estimates that there are an average of between 1 and 10 (averaging 6) DUs per MI per 
substance.   

Data from ECHA provide information on the number of manufacturers of each substance. For each 
individual substance, the number of DUs is calculated by multiplying the number of registrants by the 
average number of DUs per MI  (6). This is then applied  in the calculation of costs tailored  to each 
substance. Whilst for 244 (82%) of the substances there are only between 1 and 5 registrants at 1-10 
tonnes,  there  are  three  substances  with  more  than  99  registrants.   When  combined  with  the  average 
number  of  DUs  per  MI  (6)  this  produces  an  extremely  large  number  of  assumed  DUs  for  those 
substances with the highest number of registrants.  This, in turn, translates into extremely high costs 
for  only  a  few  substances.  Only  a very  small  number  of  substances  have  a  large  number  of 
downstream users. Only 10% of substances have DU costs above € 9 212, 5% above € 23 696, 1% 
above € 66 633. So the range of costs given in table 2.7 describes outliers in the extreme. 

i. 

Substances registered at 1-10 tonnes only 

The  estimated  cost  of  communication  with  each  individual  DU  used  in  Phase  3  and  CSES  impact 
monitoring studies is provided in the table below. 

Table 2.5  Cost of DU communications 

Human Health Exposure Scenario (per DU) 
€ 200 
€ 500 
€ 350 

Low 
High 
Average 
Source: Phase 3 and CSES impact monitoring studies 

Environmental Exposure Scenario (per DU) 
€ 200 
€ 500 
€ 350 

ii. 

1-10 tonnes substances also registered at higher tonnages 

For the 1-10 tonnes substances also registered at higher tonnages, as noted above, a percentage of uses 
will already be covered by the existing CSA and this is taken as being equal to the percentage of total 
registrants that have registered above 10 tonnes. This same percentage is applied to the total number 
of  DUs  to  calculate  the  number  of  DUs  needing  to provide  information  to  the  exposure  assessment 
and  risk  characterisation.  As  in  the  previous  example,  if  80%  of  the  registrants  have  registered  a 

16 

 
 
 
 
substance  at  above  10  tonnes,  then  80%  of  uses  are  assumed  to  already  be  covered  in  the  existing 
CSA.  New  assessments  are  therefore  required  for  20%  of  the  uses  of  the  substance,  requiring 
communication with 20% of DUs of the 1-10 tonnes registrants.  

2.4.8  Cost of producing an extended Safety Data Sheet (eSDS) 

It is a requirement under REACH to provide an SDS for all substances and mixtures with hazardous 
properties  (i.e.  including  those  produced  in  quantities  of  1-10  tonnes  per  year).  The  SDS  must  be 
consistent  with  the  information  provided  in  the  registration  generally.  Where  a  CSA/CSR  has  been 
completed for a substance, the following additional requirements apply in respect of SDS to produce 
an extended SDS (eSDS): 

 

 

adding the results of the PBT/vPvB assessment to the SDS; 

expanding  sections  of  the  SDS  in  relation  to,  in  particular,  Sections  7  and  8  (Handling  and 
storage;  Exposure  controls/personal  protection)  to  reflect  the  relevant  risk  management 
measures and the technical means to achieve them; and 

 

including the relevant exposure scenario(s) in an annex to the SDS. 

The  estimated  costs  of  these  components  used  in  Phase  3  and  CSES  impact  monitoring  studies  are 
provided  in  the  table  below.  To  these  costs  must  be  added  the  cost  of  translation  of  the  eSDS  into 
different  languages.  As  with  Phase  3  and  CSES  impact  monitoring  studies,  this  is  assumed  to  be 
required  for  50%  of  substances  for  all  uses  and  exposure  scenarios  with  the  number  of  language 
translations  being  between  one  and  three  (an  average  of  two).  Translation  into  other  languages  is 
assumed to cost of € 150 per language (as for previous studies). 

Table 2.6 Costs of Communication eSDS components 

Cost of adding the results of the PBT/vPvB assessment to the SDS 
per substance 
Cost of expanding sections of the SDS in relation to Sections 7 and 
8  (Handling  and  storage;  Exposure  controls/personal  protection) 
per use 
Cost of including the relevant exposure scenario(s) in an annex to 
the SDS per use 
Percentage of substances where translation of eSDS will be needed 
Number of languages to translate into 

Cost of translation per language 
Source: Phase 3 and CSES impact monitoring studies 

€ 10 

€ 50 

€ 300 

50% 
Low=1 
High = 3 
Average = 2 
€ 150 

These costs apply to both the substances registered only at 1-10 tonnes and the 1-10 tonnes substances 
also registered at higher tonnages (since all 1-10 tonnes registrants would have to update their current 
SDSs). 

17 

 
 
 
2.4.9  Number of substances and companies affected 

i. 

Total number of substances in ‘scope’ 

Information from the REACH Registration database reveals that a total of 294 substances are CMR 
substances registered at 1-10 tonnes. The table below provides a breakdown of these in terms of their 
exact C, M or R hazard, as well as in terms of their status of being a NONs or phase-in substance. 
This is of interest as the NONs registrations will already have an assessment similar to a CSA based 
on previous requirements. 

Table 2.7 Breakdown of 1-10 tonnes CMRs 1A/AB 

NONs29 1-
10t and 
above 
3 
0 

0 

3 

NONS 1-10t 
only 

11 
6 

0 

5 

Phase-in30 1-
10t and 
above 
206 
125 

37 

113 

113 

Phase-in 1-
10t only 

Total 

74 
32 

8 

46 

25 

294 
163 

45 

167 

138 

Number of CMRs 1A/1B 
Number classified as 
Carc. 1A/1B 
Number classified as 
Mut. 1A/1B 
Number classified as 
Repr. 1A/1B 
Phase-in CMR1/A/1B 
registered in 2010 

As can be seen from the table: 

  206  of  the  CMRs  fully  registered  at  1-10  tonnes  are  phase-in  substances  also  registered  at 
above 10 tonnes. For these substances, a CSA will have already been completed and exposure 
scenarios  and  risk  characterisation  will  have  been  undertaken  for  the  downstream  uses 
connected with the higher tonnage registrants;   

  14  of  the  CMRs  are  NONs  registrations  under  the  older  requirements  of  Directive 
67/548/EEC which required a ‘base set’ of information (almost) equivalent to that in Annex 
VIII of REACH and assessments comparable to CSA under REACH; 

  74 CMRs are fully registered at 1-10 tonnes only (i.e. not also at higher tonnages). For these 
substances, no CSA will have been carried out to date and no exposure assessments and risk 
characterisation  will  have  been  undertaken  for  the  downstream  uses  connected  with  the 
registrants market. 

ii. 

Total number of companies in ‘scope’ 

Information from the REACH Registration database reveals that a total of 929 companies would be 
affected  by  a  new  requirement  to  produce  a  CSA  for  1-10  tonnes  CMRs  across  1  653  dossiers  (of 
which 983 were submitted in 2010). The following table provides a breakdown of these and the final 
results provide costs of the CSA for CMR substances for each of these companies individually. 

29  NONs  =  substances  previously  notified  under  Directive  67/548/EEC  (Notification  of  New  Substances)  and 
regarded as registered under REACH.  
30  Phase-in substances = substances that were already being manufactured or placed on the market before the 
entry into force of the REACH Regulation (i.e. 01 June 2007). 

18 

 
 
  
  
  
 
                                                            
Table 2.8 Breakdown of registrants of 1-10 tonnes CMRs 1A/1B 

Number 
companies 

of 

Number 
of 
1A/1B dossiers 

CMR 

which 

...of 
submitted in 2010[1]

were 

Large 

Importer 
Importer, Only 
Representative 
Manufacturer 
Manufacturer, Importer 
NA 
Only Representative 
Sub-total 

Medium 

Importer 
Manufacturer 
Manufacturer, Importer 
Only Representative 
Sub-total 

Small 

Importer 
Manufacturer 
Manufacturer, Importer 
Only Representative 
Sub-total 

Micro 

387 
1 

58 
16 
1 
303 
766 

41 
4 
2 
32 
79 

39 
12 
3 
14 
68 

718 
1 

96 
44 
14 
571 
1 444 

58 
4 
2 
43 
107 

48 
12 
5 
19 
84 

453 
0 

41 
24 
1 
355 
874 

35 
0 
1 
22 
58 

28 
4 
2 
7 
41 

Importer 
Manufacturer 
Only Representative 
Sub-total 
Grand Total 
[1] Phase-in CMR substances had to be registered by the 2010 deadline. After 2022, any relevant data are expected to be free 
owing  to  the  '12-year  rule'.  However,  for  1-10  tonnes  CMR  substances  the  CSA  can  be  based  on  Annex  VII  data  as  the 
exposure  scenario  and  risk  characterisation  will  be  based  on  closed  systems  because  all  substances  can  be  assumed  to  be 
non-threshold substances (i.e. there is no DNEL).   

14 
3 
1 
18 
1 653 

12 
3 
1 
16 
929 

8 
1 
1 
10 
983 

As is apparent from the table, large companies represent 82% of all registrants and 87% of all CMR 
dossiers registered, whereas small and micro companies constitute 7 and 2% of all companies and 5 
and 1% of all dossiers, respectively, thus a very minor portion only. It is noteworthy as well that 90% 
of large companies are importers and/or only representatives, and that pure manufacturers represent 
only 7%. 

Interestingly enough, importers and only representatives own 67% of all CMRs registrations (197 out 
of 294), which allows concluding that a large majority of the CMRs in the EU comes from outside the 
EU. This is a low bound figure, since it does not comprise ECHA’s category ‘manufacturer/importer’, 
which covers manufacturing companies that are also importers of CMR substances.   

2.4.10  The resulting costs of producing the CSA  

The  following  table  provides  an  overview  of  all  costs  described  in  the  previous  sections  that  have 
been considered for assessing the costs of expanding this obligation to produce a CSR.  

19 

 
 
 
  
Table 2.9 Summary of all costs considered for development of a CSA/CSR per substance  

Average  cost 
1-10 tonnes 
only  

Cost range 

1-10 tonnes 
only 

Average  cost 
1-10 tonnes & 
higher  

Cost range 

Comment 

1-10 tonnes 
& higher  

2.4.2 

Information on 
the substance 

2.4.3 

Robust Study 
Summaries 

€ 175 

€ 100 - 250 

€ 175 

€ 100 – 250 

€ 550 

n.a. 

€ 550 

n.a. 

2.4.4  Hazard 

€ 225 

n.a.  

€ 0 

n.a. 

assessment / 
classification 

2.4.5 

PBT/vPvB 
screening and 
assessment 

2.4.6 

Exposure 
assessment/risk 
characterisation 

€ 750 
(screening) 
€ 29 000[1] 

(assessment) 

€ 11 506 

(For all uses of 
each substance: 

Human Health = 
€ 3 250 
Environmental = 
€ 2 000 
Total € 5 230 

Number of uses 
of each 
substance is 
from 
registration 
data.  Average 
number of uses 
is 2.2 per 
substance) 

n.a. 

n.a.  

€ 0 

€ 5 250 -  
€ 52 500 

€ 8 400 

€ 5 250 - 
€ 63 000 

(up to 10 
uses per 
substance in 
registration 
data) 

(Up to 12 
uses per 
substance 
need 
assessment) 

(For all uses of 
1-10t 
registrants: 

Human Health 
= € 3 250 
Environmental  
= € 2 000 
Total € 5 230 

Number of uses 
per substance is 
from 
registration and 
adjusted.  Avera
ge number of 
uses is 1.6 per 
substance) 

Documentation 
needed for each 
manufacturer.  

Cost for generating 
these or buying 
access to them 
estimated to be 
equal.  

See explanation in 
Section 2.4. Overview 
why costs are zero 
for substances also 
registered at > 10 
tonnes.  

See explanation in 
Section 2.4. Overview 
why costs are zero 
for substances also 
registered at > 10 
tonnes. 

For 1-10t and above 
substances, the 
number of uses for 
assessment is taken 
as  
(No. 1-10t 
registrants/ No. total 
registrants) x Total 
number of uses of 
substance. 

2.4.7 

Communication 
with DUs 

€ 6 034 

€ 700 - 
€ 72 540 

€ 6 063 

€ 700 -  
€ 279 300 

Based on € 350 (€ 
200 – 500) cost per 

20 

 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
DU for each of the 
two assessments 
(human health and 
environmental) The 
max. number of 
downstream 
users/substance in 
the data is 399 = 279 
300) 
Range reflects 
differences in 
numbers of uses and 
need for translation 
(range 1 – 3 
languages) 

 2.4.8  Production of 
eSDS 

€ 930  

€ 360 –  
€ 3 810 

€ 720  

€ 360 –  
€ 4 510 

(€ 350 per use 
(average 2.2 
uses = € 770) 
plus € 150 for 
translation and 
€ 10 for adding 
PBT results) 

Based on 
range of 1-
10 uses from 
data on 
substances 

(€ 350 per 
use (average 1.6 
uses = € 560) 
plus € 150 for 
translation and 
€ 10 for adding 
PBT results)  

Based on 
range of 1-
10 uses from 
data on 
substances 

[1] Costs for assessment occur only for est. 2.7 % identified in screening as requiring assessment. 

This  table  illustrates  that  the  most  significant  costs  may  come  from  the  exposure  assessment/risk 
characterisation  (€  11  500),  from  the  PBT/vPvB  screening  and  assessment  (as  high  as  €  29  000, 
although only in very few cases) and communication with DUs (€ 6 000, or higher in isolated cases). 
The rest of the costs are in the range of an average of € 225 (hazard assessment/classification) – € 930 
(production of eSDS). The effective costs will though vary depending on the specific case. 

The different cost elements and assumptions laid out above have been applied in the 2020 RPA study 
to the information available per substance in ECHA’s database.  

For our purpose, the main outcome of the table below is that the average cost of a CSA per substance 
is  less  than  €  17  000.  Speaking  of  an  average,  one  needs  to  bear  in  mind  evidently  that  there  are 
companies for which this cost would be higher, while it will be lower for others. The median value 
cost is € 11 943with a range of € 888 to € 293 000  

Table 2.10 Numbers of 1-10 tonnes substances classified as CMR 1A/1B 

Number of CMRs 1A/1B 

Number classified as Carc. 1A/1B 

Number classified as Mut. 1A/1B 

Number classified as Repr. 1A/1B 

Phase-in CMR1/A/1B registered 
in 2010 
Percentage of phase-in CMRs 
1A/1B registered in 2010 [1] 
Average total cost of CSA per 
CMR 1A/1B substance 

NONs 1-
10t and 
above 
3 

0 

0 

3 

NONS 1-
10t only 

Phase-in 1-
10t and above 

Phase-in 1-
10t only 

Grand Total 

11 

6 

0 

5 

206 

125 

37 

113 

113 

74 

32 

8 

46 

25 

294 

163 

45 

167 

138 

55% 

34% 

47% 

€ 20 114 

€ 12 398 

€ 16 193 

€ 19 610 

€ 16 951 

[1] After 2022, any relevant data are expected to be free owing to the '12-year rule'. However, for 1-10 tonnes substances the 
CSA can  be  based  on  Annex  VII  data  as  the  exposure  scenario and  risk  characterisation  will  be  based  on  closed  systems 
because all substances can be assumed to be non-threshold substances (i.e. there is no DNEL).   

21 

 
 
  
  
  
  
  
  
 
  
  
  
  
It is to be noted regarding the percentage of phase-in CMRs 1A/1B registered in 2010 that, after 2022, 
any  relevant  data  are  expected  to  be  free  owing  to  the  '12-year  rule',  which  means  that,  from  then 
onwards,  companies  will  not  be  able  to  charge  others  for  the  Letter  of  Access.  This  will  of  course 
have a significant impact on these costs estimations. However, for 1-10 tonnes substances, the CSA 
can be based on Annex VII data, as the exposure scenario and risk characterisation will be based on 
closed systems because all substances can be assumed to be non-threshold substances (i.e. there is no 
DNEL).   

The following table shows that the total costs, for MIs and DUs combined, is of less than € 5 million, 
with DUs bearing slightly more than a third of them, the large majority of costs (64%) being on the 
side of MIs.  

Table 2.11 Total cost of CSA 

Total costs of CSA for MIs 
(excluding further PBT studies) 
DU costs for CSA 

MI + DU Costs 

Percentage of total cost 
contributed by DUs 

NONs 1-
10t and 
above 
€ 30 008 

NONS 1-
10t only 

Phase-in 1-
10t and above 

Phase-in 1-
10t only 

Grand Total 

€ 101 968 

€ 2 098 985 

€ 972 730 

€ 3 203 691 

€ 30 335 

€ 34 410 

€ 1 236 778 

€ 478 440 

€ 1 779 963 

€ 60 343 

€ 136 378 

€ 3 335 763 

€ 1 451 170 

€ 4 983 654 

50% 

25% 

37% 

33% 

36% 

Considering the total costs of a CSA/CSR for MIs and downstream users and dividing that total cost 
by the number of downstream users for the CMR substances, one arrives at a value that would justify 
the measure based on benefits for downstream users (DU’s break even value, see table below).  

Table 2.12 Number of uses and of DUs 

Total number of uses 

Number of uses not covered by 
existing exposure assessments (and 
needing one) 
Total number of DUs over all uses 

Total number of DUs needing to 
contribute to new exposure 
assessments for their uses (a) 
MI + DU Costs (b) 

NONs 1-
10t and 
above 
8 

5 

120 

81 

NONS 1-
10t only 

Phase-in 1-
10t and above 

Phase-in 1-
10t only 

Grand Total 

14 

14 

102 

102 

1 267 

329 

8 520 

2 593 

177 

177 

1 176 

1 176 

1 466 

525 

9 918 

3 952 

€ 60 343 

€ 136 378 

€ 3 335 763 

€ 1 451 170 

€ 4 983 654 

DUs’ 'break even' value (b/a) 

€ 745 

€ 1 337 

€ 1 286 

€ 1 234 

€ 1 261 

This value expresses that the action of having a CSR done and provided by the MIs is economically 
justified if it provides a break even value of minimum € 1 261 per downstream user. The value should 
be  compared  to  the  costs  a  downstream  user  incurs  for  compliance  with  parallel  legislation  (see 
section 2.3 for the different types of parallel legislation). In the 2017 study, those costs were estimated 
through expert judgment for a low, medium and high cost estimated scenario. The costs per substance 

22 

 
 
 
 
 
 
in the low estimate scenario were € 1 500 (and €2 500 and € 3 500 for the medium and high scenarios 
respectively), where € 1 500 corresponds to 1.5 days of work for a consultant toxicologist. 

There are basically two different scenarios:  

a)  The baseline one, which reflects the situation as is at the moment, where no obligation exists 
for companies to provide a CSR, but where DUs need to comply with parallel legislation, by 
providing very similar information to that in the CSR.  

b)  An alternative scenario, which is the one this report focusses on, where companies would be 
requested to provide a CSR, consequently incurring costs, which they do not face at present. 
The  cost  of  this  scenario,  according  to  the  information  available  at  the  moment,  thus  in  a 
retrospective manner, would have been of circa. €5 million in total, to be carried by MIs and 
DUs.  

Under  scenario  a),  the  cost  for  a  DU  to  generate  the  information  is  €1  500  as  a  lower  bound,  per 
substance per use (and € 2 500 and € 3 500 for the medium and high scenarios respectively). To be 
able to compare the two scenarios, one would assume under scenario b) that all costs would be borne 
by DUs solely.31 Considering that there are  9 918 DUs and that the total cost is  € 4 983 654, every DU 
would  then  need  to  incur  €  1  261  costs  per  substance  per  use  under  b).  This  figure  is  then  to  be 
compared to that of scenario a), € 1 500. From this comparison, one can obviously conclude that there 
is a saving for DUs under scenario b) compared to a): all potential costs incurred by DUs above € 1 
261 under parallel legislation imply a saving. Which is further underpinned by the fact that: 

  The cost of a) is a lower bound, the saving is even bigger if one considers the medium or the 

high bounds. 

  Under scenario b), most of the responsibilities would fall under the MIs, which are assumed 

to have better expertise than DUs on risk assessment and risk management.   

Note that the cost figure under b) expresses a  cost based  on past  data.  It does  not refer to  what the 
actual cost would be, should the CSR obligation be imposed on companies from now onwards. But it 
helps having an indication of a potential future cost scenario, compared to the baseline scenario.  

2.4.11  Affordability 

From the previous calculations, one can conclude that savings for a downstream user are lower than 
the  estimated  costs  for  compliance  with  parallel  legislation.  Put  differently,  it  suffices  that  each 
downstream user spends a minimum of € 1 261 in contributing to a CSA/CSR, or a minimum of 1.26 
days of work, for the measure to be justified for the purpose of complying with parallel legislation. 

Table 2.13 Savings to contributing DUs to ‘breakeven’ 

€s per DU 
€ 1 261 

Expressed as working days @ 

1.000  per day 

1.26  days saved on each DU workplace assessment to breakeven 

€ 

The  figure  below  shows  graphically  that  most  of  the  costs  of  the  measure  would  be  borne  by  large 
companies (circa. 83% of the total) and only a very small portion by SMEs (circa. 17%). 

31 This is not realistic, since the cost under b) is to be borne by both MIs and DUs, but it helps for the purpose of 
a theoretic comparison. 

23 

 
 
  
 
                                                            
Fig. 2.1 Total cost of CSA to MIs 

Small

Micro

Medium

Large

€0,0k 

€500,0k 

€1.000,0k 

€1.500,0k 

€2.000,0k 

€2.500,0k 

€3.000,0k 

Total

Large
€2.733,4k 

Medium
€202,5k 

Micro
€37,9k 

Small
€229,9k 

The  tables  below  provide  a  more  disaggregated  distribution  of  costs  incurred  by  companies  of 
different sizes.  

For the purpose of the assessment, it is useful to look at the distribution of costs on a per substance per 
company basis. The first table shows that large companies are the ones incurring the highest costs of 
CSA per substance. All other three company sizes are below the average, with micro companies being 
the least impacted ones of the three and small ones the most.  

Table 2.14 Distribution of costs incurred by different company sizes of the MI 

Large 
Medium 
Small 
Micro 
Grand Total 

Cost of CSA per registrant across all of the CMRs registered by them 

Average 

€ 3 568 
€ 2 564 
€ 3 380 
€ 2 371 
€ 3 449 

Median (50 percentile) 

90 percentile 

€ 933 
€ 1 276 
€ 1 293 
€ 714 
€ 1 050 

€ 7 974 
€ 6 283 
€ 6 489 
€ 8 212 
€ 7 694 

The  following  table  informs  on  the number  of  companies  carrying  different magnitudes  of  the  total 
costs. For example, at the 50%-ile, 50% of the companies incur costs below the percentile value (€ 1 
050).  95%  of  companies  bear  costs  of  less  than  €12  000  and  50%  of  less  than  €1  100.  Of  those 
spending  more  than  €100  000,  only  one  is  a  small  company,  all  the  others  being  large  ones.  And, 
among the top 10%, who spend more than €8 000, only 6% are small and micro companies.  

24 

 
 
 
 
 
 
 
Table 2.16 Number of companies with different magnitudes of total costs (percentile ranges) 

Percentile  

Percentile value 

Large 
companies 

Medium 
companies 

Small 
companies 

Micro 
companies 

5,0% 

10,0% 

20,0% 

30,0% 

40,0% 

50,0% 

60,0% 

70,0% 

80,0% 

90,0% 

95,0% 

99,0% 

99,9% 

100,0% 

€ 94 

€ 137 

€ 232 

€ 425 

€ 714 

€ 1 050 

€ 1 504 

€ 2 726 

€ 4 803 

€ 7 694 

€ 11 993 

€ 37 678 

€ 103 410 

€ 115 053 

71 

17 

93 

69 

73 

74 

67 

79 

74 

67 

39 

34 

8 

1 

3 

2 

4 

9 

10 

6 

10 

8 

13 

9 

4 

1 

0 

0 

0 

1 

4 

6 

3 

9 

15 

4 

6 

16 

2 

1 

1 

0 

1 

0 

2 

2 

3 

3 

1 

1 

0 

1 

1 

1 

0 

0 

Total 

75 

20 

103 

86 

89 

92 

93 

92 

93 

93 

46 

37 

9 

1 

The very low values on the top part of the table can be explained by the fact that several companies 
have undertaken the registration of one single substance. In this manner, the overall cost is distributed 
among all contributing parties, thus reducing the individual share. For instance, 188 companies have 
participated to the registration of the substance with EC number 200-849-9, which explains why the 
cost for the 5%-ile is only €9432.   

The three parameters above  - i) the savings to contributing DUs and ii) the distribution of costs per 
substance and iii) per size of registrant - allow concluding that the measure should be considered as 
affordable for a large majority of companies.  

On the side of the uncertainties, it was not possible to assess what cost a MI would have to incur in 
order  to  decide  that  he  would  rather  withdraw  his  substance  from  the  market  than  bearing  the  cost. 
This could be a potential consequence of the measure, especially if the added costs would fall only 
upon a single MI.  

2.5.  Benefits of extending this obligation (not quantified) 

The expected non-quantifiable benefits include:  

2.5.1. 

Implementation  of  consistent  and  adequate  risk  management 

measures in relation to worker exposure 

The extension of the CSA/CSR obligation to 1-10 tonnes CMRs would, for each substance, result in 
the identification of consistent and robust risk management measures for implementation by DUs and 
manufacturers alike and communication of these and other important information to all multiple DUs 
of the substances. Under the current regulatory regime, each individual manufacturer and downstream 

32 To avoid confusion, please note that of those 188 companies, 75 have that substance as the only one they have 
registered,  which  is the  figure  that the  table  shows  (73  large,  3  medium  and  1  micro), whereas  the  other  133 
have registered 2 or more substances. 

25 

 
 
 
 
                                                            
user is required to assess their own situation individually with the aid of only the general information 
provided in the SDS (as opposed to that of an extended SDS including DNELs where they have been 
established  for  substances).  This  is  a  duplication  of  effort,  and  with  the  more  limited  information 
available  to  conduct  assessments,  the  result  may  be  the  implementation  of  a  range  of  different  risk 
management measures by different manufacturers and different downstream users. Some of these may 
provide adequate control and some may not.  

2.5.2.  Adequate risk management measures in relation to articles 

In  the  case  of  1-10  tonnes  CMRs  used  in  articles,  there  is  currently  no  obligation  to  perform  a 
CSA/CSR  and  whilst  the  safety  of  the  article  may  be  considered  under  specific  product  legislation 
where it is applicable to the article and its use, it is otherwise only a consideration under the general 
product safety regulation, which may be insufficient. 

If the CSA/CSR obligation were to be extended to 1-10 tonnes CMRs, the use of a substance in an 
article  above  1  tonne  per  year  would  have  to  be  included  in  the  CSA/CSR.  This  would  facilitate 
identification and the recommendation of consistent and robust risk management measures or, where 
the  use  cannot  be  supported  ‘for  reasons  of  protection  of  human  health  or  the  environment’,  risk 
assessors including ECHA and policy makers would be alerted to this fact and action concerning these 
articles on the market or about to be put onto the market could be implemented. Consequently, more 
information on hazardous substances in articles would become available.  

2.5.3.  Control of environmental risks  

Extending  the  CSA  obligation  to  1-10  tonnes  CMRs  would  require  consideration  of  environmental 
exposure,  its  likely  effects,  and  appropriate  risk  management  for  identified  uses.  Under  the  current 
requirements, this would not otherwise be considered for these substances other than when action was 
identified as being required by Member States or the Commission under Union legislation. 

2.5.4.  Benefits for Member States and the Commission 

Extending  the  CSA/CSR  obligation  to  1-10  tonnes  CMR  substances  and  the  subsequent  consistent 
documentation of appropriate risk management measures for the concerned substances would simplify 
and  improve  the  control  on  safe  handling  of  substances  in  the  workplace  under  all  applicable 
legislation enforced by all relevant authorities. This is because there would only be one set of RMM 
as described in the CSR, and not potentially differing ones proposed by the DUs themselves in their 
individual  CSRs.  It  would  also  facilitate  the  identification  of  cases  for  which  the  Commission  or 
Member States would consider that the manufacture, placing on the market or use of a substance, on 
its own, in a mixture or in an article poses a risk to human health and for which a restriction procedure 
should be initiated, or where consideration could be given to  risk management measures in product-
specific legislation. 

In  addition,  the  extended  CSA/CSR  obligation  would  further  ensure  the  generation  of  robust  study 
summaries  on  selected  human  and  environmental  health  endpoints.  Currently,  these  robust  study 
summaries  must  be  generated  by  Member  States  during  the  development  of  a  harmonised 
classification and not by MIs (as they would, were the CSA obligation to be extended). 

26 

 
 
2.5.5.  Comparison  of  the  total  CSA/CSR  costs  to  health  benefits  of 

avoided CMR risks 

In addition to the benefits described until now, one could consider how the total costs for developing a 
CSA/CSR for 1-10 tonnes CMR substances compare to the benefit estimates for avoiding one or more 
of the health risks associated with the respective classifications by using the willingness to pay (WTP) 
values  that  the  Committee  for  Socio-economic  Analysis  (SEAC)33  determined  for  monetising 
chemicals health impacts. 

From  the  ECHA  database,  the  following  distribution  of  Carcinogenicity,  Mutagenicity,  or 
Reproductive toxicity hazard category 1A/1B for the 1-10 tonnes CMRs could be extracted: 

Table 2.15 Distribution of Carcinogenicity, Mutagenicity, or Reproductive toxicity hazard of 1-10 tonnes 
CMRs 

Number of 
substances 

At 1-10 
tonnes only 
At 1-10 
tonnes and 
higher 
Total 

CMRs (1A/1B) 

C 1A/1B 

M 1A/1B 

R 1A/1B 

85 

209 

294 

38 

125 

163 

8 

37 

45 

51 

116 

167 

R 1A/1B but 
not C or M 
44 

83 

127 

The  SEAC  document  provides  the  following  willingness  to  pay  (WTP)  values  for  avoiding  the 
morbidities that are most likely to be linked to CMR hazards listed in the table below:  

Table 2.18 WTP values for morbidities relevant for CMR substances 

Premature Death 

Cancer morbidity 

Statistical pregnancy 

Very low birth weight 

Minor birth defect 

External birth defect 

Internal birth defect 

Lower 

Upper 

€ 3 500 000 

€ 5 000 000 

€ 410 000 

€ 22 000 

€ 126 000 

€ 4 300 

€ 26 000 

€ 128 000 

€ 410 000 

€ 41 000 

€ 405 000 

€ 43 000 

€ 330 000 

€ 712 000 

Average 

€ 4 250 000 

€ 410 000 

€ 31 500 

€ 265 500 

€ 23 650 

€ 178 000 

€ 420 000 

Dividing the total costs of requiring a CSA/CSR for 1-10 tonnes substances registered at this and at 
higher tonnage levels (€ 4 983 654) by the WTP values above, one can consider  how many morbidity 
incidences  avoided  would  justify  the  cost  of  requiring  CSA/CSR  (see  the  table  below).  While  also 
parallel  legislation  will  provide  health  protection  benefits  with  respect  to  substances  carrying  these 
classifications, it was considered  when REACH  was drafted that the CSR can aid  in realising these 
health benefits, and can help DUs that normally have lower expertise than the MI for risk assessment 
and risk management. The obligation to develop a CSR also aimed to ensure a better communication 

33  Willingness-to-pay  values 
https://echa.europa.eu/documents/10162/13637/seac_reference_wtp_values_en.pdf/403429a1-b45f-4122-ba34-
77b71ee9f7c9 

for  various  health  endpoints  associated  with  chemicals  exposure 

27 

 
 
 
 
 
                                                            
in the supply chain on the most relevant Risk Management Measures that are also communicated via 
eSDS.  

This argument further strengthens the conclusion that there are benefits from MIs generating a CSR 
under  REACH  for  CMRs  in  the  1-10  tonnes  tonnage  band.  This  does  not  imply  that  parallel 
legislation does not work, but that if implemented, the obligation to generate a CSR would contribute 
to the general REACH objective of protecting human health. 

The benefit is as well that the effort would not be only on DUs, as is the case at the moment under 
parallel  legislation,  but  mostly  on  MI,  who  have  better  expertise  on  risk  assessment  and  risk 
management than DUs do.  

Furthermore, this exercise serves as a means to put into perspective the € 5 million cost of the action. 

Table 2.19 Comparison of total CSA/CSR costs with the WTP values from table 2.18 

Total Nr of cases to avoid for all 
294 CMR substances to break 
even 

Nr of cases to avoid per CMR 
substance to break even 

Premature Death 

Cancer morbidity 

1.17 

12.16 

Statistical pregnancy 

158.21 

Very low birthweight 

18.77 

Minor birth defect 

210.73 

External birth defect 

Internal birth defect 

28.00 

11.87 

0.0040 

0.0413 

0.5381 

0.0638 

0.7168 

0.0952 

0.0404 

This table provides the number of morbidity cases that would need to be avoided at the minimum to 
breakeven  with  the  costs  of  the  CSA/CSR.  It  shows  that  action  could  be  considered  “economically 
justified”  if  only  ONE  of  these  figures  is  within  the  bounds  of  probability  (the  figures  are  not 
additive), e.g. if only by implementing this amendment two premature deaths or 13 cancer cases are 
avoided, the action could be considered justified. This is of course not a central argument to justify the 
action, but a supporting one, to contextualise the cost impact of the action compared to the benefits in 
terms of protection of human health it will provide.  

2.6.  Conclusion 

Based on the analysis presented in section 2.4, the costs for manufacturers and importers of drawing 
up  the  chemical  safety  reports  for  1-10 tonnes  CMRs  is  estimated  at  €  3  203  691,  whereas  that  for 
downstream users is € 1 779 963, for a combined total of € 4 983 654.   

On  the  basis  of  this  cost  estimate,  it  was  calculated  that  if  the  fact  of  having  MIs  performing  the 
CSA/CSR provides a break even value of a minimum of € 1 261 per downstream user, the measure 
can be considered economically justified. This value need to be compared to the cost a downstream 

28 

 
 
 
 
user  incurs  today  for  complying  with  parallel  legislation,  which  is  estimated  to  be  €  1  500  (lower 
bound).  So,  this  comparison  confirms  that  the  measure  is  economically  justified.  The  measure  can 
also  be  considered  affordable,  both  for  larger  and  smaller  companies.  Large  importers  and  only 
representatives would bear most of the costs. However, it cannot be excluded that the costs carried by 
a manufacturers or importer could be impacting competitiveness, especially if a substance is marketed 
only  by  one  or  few  registrants.  Thus,  withdrawal  of  some  substances  from  the  market    can  not  be 
excluded. 

In  addition,  benefits  are  also  expected  for  human  health  and  the  environment,  as  of  all  294  1-10 
tonnes  CMR  substances  (registered  at  this  tonnage  band  and  higher),  163  are  carcinogenic,  45 
substances  are  mutagenic  and  167  substances  are  toxic  for  reproduction34.  Due  to  upgraded  risk 
management measures, the extension of the requirements are expected to lead to benefits in terms of 
reduced  morbidity,  only  from  CMR-related  health  effects.  The  number  of  adverse  human  health 
events that would need to occur to offset the costs of registering these substances is admittedly low 
(e.g. the avoidance of 2 premature deaths or 13 cancer morbidities).  

In light of the above, the introduction of a CSA/CSR requirement for the MIs for all 1-10 tonnes CMR 
substances  seems  justified,  even  if  only  considering  the  quantifiable  costs  and  the  unquantified 
benefits. It seems therefore highly recommendable to extend the obligation to develop a CSA/CSR to 
1-10 tonnes CMR 1A/1B substances. 

In  order  to  implement  an  extension  of  the  obligation  to  provide  a  CSA/CSR  also  to  1-10  tonnes 
substances that are CMR 1A/1B would require amending Article 14 of REACH. 

34 Numbers do not add up because one substance can have more than one classification 

29 

 
 
 
 
                                                            
3.  Review according to Article 138 (8) 

3.1. 

Introduction 

Article  33  of  the  REACH  Regulation  sets  up  a  duty  to  communicate  information  on  articles 
containing substances of very high concern (SVHC) identified pursuant to Article 57 (and as a result 
listed in the Candidate List)35 in a concentration above 0.1 % weight by weight (w/w).  

In  accordance  with  Article  33(1),  the  supplier  of  an  article  is  required  to  provide  to  its  recipient 
sufficient  information,  available  to  the  supplier,  to  allow  safe  use  of  the  article  including,  as  a 
minimum,  the  name  of  the  SVHC  present  in  the  article.  Consumers  can  also  request  that  same 
information in accordance with Article 33(2). When this occurs, the supplier of the article is obliged 
to provide such information free of charge within 45 days.  

The inclusion of these provisions in the REACH Regulation aimed to ensure safe use of articles by 
end-users, including consumers. In this regard, the Court of Justice has further clarified the scope and 
objectives of Article 33 in its Judgment in Case C-106/1436. In particular, the Court has stated that this 
obligation,  read  together with  recitals  56  and  58  of  the  REACH  Regulation, is  aimed  to  enable  ‘all 
operators in the supply chain  to  take, at their stage, those risk management measures which follow 
from the presence of [SVHC] in articles in order to guarantee their completely safe use’. The Court 
has  also  considered  that  ‘the  duty  to  provide  information  is  aimed  indirectly  at  allowing  those 
operators and consumers to make a supply choice in full knowledge of the properties of the products, 
including those of articles forming part of their composition’.  

In its judgment, the Court has also clarified the scope of the obligations on information on SVHC in 
articles, by still considering components of complex products as individual articles if they fulfil the 
definition  of  an  article  under  the  REACH  Regulation.  Consequently,  the  Court  has  considered  that 
‘the  supplier  of  a  product  one  or  more  constituent  articles  of  which  contain(s)  a  substance  of  very 
high concern [...] [must] inform the recipient and, on request, the consumer, of the presence of that 
substance by providing them, as a minimum, with the name of the substance in question’.  

In  view  of  the  above,  the  purpose  of  this  review  according  to  Article  138 (8)  of  the  REACH 
Regulation  is  to  consider  the  practical  experience  in  implementing  this  Article  in  order  to  assess 
whether  or  not  to  extend  its  scope  to  other  dangerous  substances.  Based  on  the  review,  the 
Commission may, if appropriate, present legislative proposals to extend that obligation. 

3.2   Reviews and reports on the implementation of Article 33 of the REACH 
Regulation 

Since the entry into application of Title IV, and consequently Article 33, of the REACH Regulation in 
June  2007,  several  reports  and  initiatives  have  assessed  the  level  of  implementation  of  this  Article, 
focusing  on  both  the  supply  chain  and  consumer  angles  of  the  communication  obligations.  This 
section aims at summarising the views of the Commission, Member States and relevant stakeholders 
with a view to assess the current level of implementation of Article 33. 

35 Further information can be found on ECHA website. 
36 Judgment of the Court (Third Chamber) of 10 September 2015, Case C-106/14.  

30 

 
 
                                                            
3.2.1  Reports on the operation of REACH 

In  2011,  the  European  Chemicals  Agency  (ECHA)  submitted  the  first  report  on  the  operation  of 
REACH  in  accordance  with  Article  117(2)37.  In  this  report,  ECHA  considered  that  diverse  legal 
interpretations of Article 33 were causing business uncertainty and hampering its implementation.  

Subsequently,  ‘effective  communication  through  the  supply  chain  of  information  on  substances  and 
how to use them safely’ was listed as one of the three main areas for improvement in the first General 
Report on the operation of REACH adopted by the Commission in accordance with Article 117(4)38 – 
the  first  REACH  review.  This  report  also  mentioned  the  challenging  nature  of  these  provisions  for 
industry, which had to develop new tools and information management systems. 

The next ECHA report on the operation of REACH in 201639 found that companies had commenced 
to  document  and  communicate  their  use  of  substances  in  articles.  However,  despite  the  increasing 
availability of tools (e.g. the IUCLID 6 release) to generate and transmit information on the presence 
of chemicals in articles, the overall quality of such information remained very limited. ECHA called 
on all actors involved with substances in articles to ‘become active and allocate more resources for 
real progress to be achieved in this field. Increased enforcement efforts could activate companies to 
improve their knowledge on substances in articles and, where relevant, take action to ensure safe use 
or look for safer alternatives’. 

In  2018,  the  second  ‘General  Report  on  the  operation  of  REACH  and  review  of  certain  elements’ 
adopted by the Commission (the second REACH review)40 still reflected difficulties for actors of the 
supply  chain  to  fulfil  the  obligations  on  the  presence  of  substances  of  very  high  concern  in  articles 
(Articles 7 and 33 of the REACH Regulation).  

Among  the  key  findings,  the  second  REACH  review  noted  the  development  of  information 
management  tools  by  companies  promoted  by  EU  projects  or  activities  of  some  Member  States.  It 
also  stated  that  ‘however,  it  remains  difficult  for  actors  in  the  supply  chain  to  retrieve,  verify  and 
communicate information on SVHCs in articles’. This is still the case despite the fact that stakeholders 
consider  the  efficient  functioning  of  these  obligations  as  ‘necessary  for  economic  operators  to 
implement  appropriate  risk  management  measures  and  to  make  informed  purchasing  decisions  as 
well as for the ability of suppliers to respond to consumer requests’. Finally, it was stated that ‘the 
information  generated  in  the  supply  chains  through  Article  33  is  not  available  for  national  or  EU 
authorities. [...] The information communicated following consumer requests is not centrally collected 
and  accessible,  thereby  potentially  increasing  the  burden  for  suppliers  by  repetitive  consumer 
requests’. 

The  second  REACH  review  also  identified  areas  for  future  action,  in  particular  better  tracking  of 
chemicals  of  concern  in  products  to  ‘facilitate  recycling  and  improve  the  uptake  of  secondary  raw 
materials’.  

37 ECHA, The operation of REACH and CLP, 2011.  
38 COM(2013) 49 - first REACH review. 
39 ECHA, Report on the operation of REACH and CLP, 2016. 
40 COM(2018) 116 and accompanying Staff Working Documents – second REACH review.  

31 

 
 
                                                            
3.2.2  The findings of pilot projects on enforcement  

ECHA  FORUM41  organised  in  201942  a  pilot  project  on  enforcement  of  Articles  7(2)  and  33  of 
REACH  in  15  Member  States,  targeting  a  few  candidate  list  substances  in  about  700  high-risk 
products  or  materials.  While  12 %  of  the  articles  contained  candidate  list  substances  in  a 
concentration  above 0.1 % w/w, the project showed that for about 90 % of these articles  containing 
candidate list substances, suppliers were found to have missed their information obligations laid down 
in Article 33(1). In addition, about 55 % of the 400 inspected companies were unable to provide the 
requested  information  to  consumers  in  accordance  with  Article  33(2).  The  pilot  project  found  a  big 
gap  in  communication  throughout  the  supply  chain,  partly  attributed  to  the  location  of  many  of  the 
suppliers outside the EU.  The report recommends companies that buy products to ask actively their 
suppliers for the information on the presence of candidate list substances, thus ensuring the flow of 
information in the supply chain. 

Further findings of this report indicate that about 30 % of the inspected companies were not aware of 
the actual list of the Substances of Very High Concern (SVHC), the Candidate List. In many cases, 
the lack of compliance with Article 33 happened in SMEs, less aware of their legal obligations, more 
reliant on the information received from their suppliers and with less capacity to perform their own 
chemical analyses.  

The  ‘first  and  most  important  suggestion  to  ECHA,  COM,  and  National  helpdesks’,  given  by  the 
FORUM  pilot  project,  was  to  organise  a  comprehensive  awareness-raising  campaign  on  the  duties 
related to substances in articles. As another recommendation to improve the situation, the pilot project 
of the FORUM suggested ECHA to ‘develop more guidance on what specific information to provide 
in the supply chain beyond the name of the substance(s) and when’.  

Another  study  prepared  by  the  Swedish  Chemicals  Agency  and  published  in  May  202043  reached 
similar conclusions, showing that recipients of articles have generally no information on the presence 
of  substances  of  very  high  concern  in  the  articles  supplied  to  them.  The  situation  is  even  more 
challenging  when  it  comes  to  e-commerce,  where  a  recent  study  from  the  Nordic  Council44  has 
exposed  a  lack  of  information  on  the  presence  of  substances  of  concern  in  products,  with  non-
compliance rates varying between 20 % and 60 %. It has to be noted, however, that this project was 
not exclusively focused on compliance with Article 33 of REACH.  

3.2.3  Other projects 

In 2017, the Commission launched a study to review tools to track hazardous substances in articles45. 
The study provided an overview of the different types of available tools that support the tracking and 
communication of hazardous substances in articles in supply chains and to consumers, and evaluated 
them  with  regard  to  their  ability  to  support  the  implementation  of  Article  33  of  REACH  and  their 
potential contributions to the circular economy and a non-toxic environment. The results showed that 
there was noticeable progress over time in data management and development of supporting tracking 
tools; and that companies used a wide range of tools to ensure compliance with legal requirements. 

41 The Forum for Exchange of Information on Enforcement. 
42 FORUM - Substances in Articles. Pilot project report. Harmonised Enforcement Project.  
43 KEMI Enforcement 9/20: Information on hazardous substances in articles. 
44 Nordic Council of Ministers: project on enforcement of internet trade. 
45 Publications Office of the EU, Scientific and technical support for collecting information on and reviewing available tools 
to  track  hazardous  substances  in  articles  with  a  view  to  improve  the  implementation  and  enforcement  of  Article  33  of 
REACH, 2016.  

32 

 
 
                                                            
These tools vary with regard to the information content and the means of conveying such information, 
spanning from product marking through compliance declarations, restricted substance lists, third party 
certification  and  generic  material  databases  to  complex  IT-tools.  The  study  also  pointed  to  sector-
specific  differences  in  the  implementation  of  these  tools,  depending  on  the  complexity  of  products, 
degree of supply chain control and extent of overall regulatory requirements for technical aspects.  

The  EU-funded  Life  project  AskREACH46  also  referred  to  similar  concerns  about  the  compliance 
with the Article 33(2) provisions. The surveys on consumer awareness and communication on SVHCs 
in  articles  done  in  the  context  of  this  project  found  that  awareness  of  the  ‘right  to  know’  was  low 
among respondents. The survey results showed that ‘only in three of 14 countries were a majority of 
respondents aware of their ‘right to know’; and that of the few respondents who were aware of this 
right, the majority had never sent a request of information to a company’. On the other hand, there are 
indications that the awareness by consumers about their "right to know" may be slowly increasing. In 
a 2016 Eurobarometer survey47, 66 % of EU citizens said that they are aware that ‘if you ask whether 
a product contains particularly hazardous chemicals, the seller is required by law to provide you with 
this information’. 

The  surveys  carried  out  in  the  context  of  the  AskREACH  project  also  confirmed  that  a  large 
proportion  of  companies  are  not  well  prepared  to  respond  to  consumers  ‘right  to  know’  requests. 
About 40 % of the about 200 consulted companies had received at least one request from consumers, 
and  about  half  of  these  companies  did  not  have  the  information  needed  to  respond  to  consumers 
without  consulting  their  suppliers.  About  40  %  of  the  companies  surveyed  did  not  have  any  IT-
solution  in  place  to  collect  and  manage  information  on  SVHCs  in  articles,  depending  on  the 
information  sent  by  their  suppliers  on  paper  or  within  the  product  information.  Around  half  of  the 
companies  also  considered  that  it  is  technically  difficult  to  comply  with  the  legal  obligations  laid 
down in Article 33. 

On  a  more  positive  note,  a  majority  of  companies  considered  the  current  provisions  on 
communication  through  the  supply  chain  as  an  incentive  to  substitute  SVHCs  with  less  hazardous 
alternatives.  

Stakeholders,  and  particularly  consumer  associations,  have  also  developed  their  own  projects  on 
Article 33. All of them highlight severe compliance issues with regard to consumer enquiries. As an 
example, a French consumer association in 2018 found that almost 70 % of the selected companies 
provided incorrect or incomplete information48. A Danish consumer association had found a similar 
pattern in 2017, with several companies replying that articles did not include SVHCs although they 
did49.  The  European  consumer  organisation  (BEUC)  already  presented  similar  results  in  a 
transnational study back in 201150. 

Business  associations  have  shared  at  many  occasions  their  view  on  the  lack  of  an  efficient 
implementation  of  Article  33,  pointing  at  low  enforcement  of  imports  as  one  of  the  main  factors51. 
Despite  these  problems,  the  European  industry  is  contributing  to  a  better  implementation  of  these 

46  The  project  LIFE  AskREACH  (No.  LIFE16  GIE/DE/000738)  addresses  the  ‘right  to  know’  pursuant  to  Art.  33(2)  of 
REACH, providing a claim for consumers to ask companies about substances of very high concern (SVHCs) in articles. The 
Commission is co-funding AskREACH, together with the German Environmental Agency, the Baltic Environmental Forum 
and the Administration of the Latvian Environmental Protection Fund. 
47 European Commission, Special Eurobarometer 456.  
48 Que choisir - Substances toxiques : Nos analyses sur 39 produits du quotidien (available only in French). 
49 Kemi - Test: Plastic products contained unwanted phthalates (summary in English, text in Danish). 
50 BEUC – How much are we told? 
51  Not  exclusively  regarding  Article  33  of  REACH,  but  also  for  the  chemicals  legislation  in  general.  See  e.g.  ‘More  than 
90% of all chemicals in consumer products non-compliant with REACH come from outside of the EU’. 

33 

 
 
                                                            
provisions. The European Chemicals Association (CEFIC) committed in 2018 to work together with 
ECHA to improve the means of communication of safety information in the supply chain52.  

3.3   The  current  level  of  implementation  of  Article  33  and  ongoing 
actions to put it more efficiently into effect 

The  documentation  and  projects  summarised  in  the  previous  section  allow  the  conclusion  that  the 
challenges to meet the obligations laid down in Article 33 of REACH remain for suppliers of articles, 
as compliance with the communication duties vis-à-vis recipients of those articles and consumers is 
limited throughout the Union. 

The reports and reviews summarised in the previous section can help explain why there has been little 
improvement in the implementation during the last decade. These include lack of awareness of duty 
holders,  absence  of  adequate  information  management  systems  in  certain  companies,  technical 
difficulties derived from the complexity of articles and their chemical content and scarce information 
on imported articles.  

The  situation  varies  depending  on  the  nature  of  value  chains,  companies’  size  or  the  existence  of 
stable  relationships  with  suppliers.  Many  companies  are  well  aware  of  their  legal  obligations 
regarding  Article  33  and  can  more  easily  adapt  their  information  systems  in  order  to  comply  with 
them. Other companies focus on the import of low-value/high-volume products, have limited contact 
with chemical regulations and requirements, and are therefore less aware of obligations such as those 
laid down by Article 33. They generally also have limited control over their supply chains.  

To address the issues identified, the Commission, ECHA and stakeholders have already been working 
on possible solutions to improve particularly the awareness of duty holders and consumers.  

For instance, the Life project AskREACH has developed a mobile application to check the presence 
of SVHCs in products. The Scan4Chem53 App was launched at the end of 2019. In its six first months 
of implementation it has been downloaded more than 35 000 times, with 66 000 barcodes scanned in 
12  countries.  More  than  17  000  products  such  as  clothing,  sports  equipment  or  toys  have  been 
registered  in  the  application  database,  from  hundreds  of  producers  and  importers.  Under  the  same 
project,  a  supply  chain  tool54  is  being  developed  to  help  companies  fulfil  their  supply  chain 
communication duties. Suppliers of the selected companies will receive training and case studies for 
real articles from various sectors will be prepared. 

The  recent  revision  of  the  Waste  Framework  Directive  may  also  bring  further  changes  for  the 
implementation  of  Article  33  of  REACH.  Pursuant  to  Article  9(1)(i)  of  Directive  2008/98/EC  on 
waste55,  Member  States  shall  take  measures  to  ‘ensure  that  any  supplier  of  an  article  as  defined  in 
point  33  of  Article  3  of  [REACH]  provides  the  information  pursuant  to  Article  33(1)  of  that 
Regulation to the European Chemicals Agency as from 5 January 2021’.  

For this, ECHA is required to establish a database containing the information provided by suppliers of 
articles, making it available to waste operators and, upon request, consumers. By using the database as 
interface,  communication  by  companies  through  the  supply  chain  may  be  facilitated,  as  it  could, 
among others, reduce the need for individualised IT systems for many SMEs. In the long-term, this 

52 ECHA-CEFIC: Joint statement of 14 June 2018. 
53 LIFE AskREACH, Scan4Chem app. 
54 LIFE AskREACH, Supply chain tool for communication on SVHCs in articles.  
55 Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain 
Directives: consolidated text.  

34 

 
 
                                                            
may also contribute to ensuring better control of incompliant imports of products, as it will  allow to 
concentrate enforcement activities on articles suspected to contain SVHCs, but not notified to ECHA. 

Communication  of  information  through  the  supply  chain  and  to  waste  operators  on  the  presence  of 
SVHCs  and  other  substances  of  concern  will  also  require  other  efforts,  using  mechanisms  such  as 
those  explained  in  the  recently  adopted  study  on  ‘Information  flows  on  substances  of  concern  in 
products from supply chains to waste operators’56. 

3.4   Conclusion  

Although the implementation of Article 33 of the REACH Regulation has gradually improved in the 
last decade, overall it remains limited. This low level of implementation is affecting the achievement 
of the main objectives of these provisions, making it more difficult for operators further down in the 
supply chain to take the necessary risk management measures.  

The  situation  is  particularly  worrying  for  imported  goods  and  articles  placed  on  the  market  via  e-
commerce, where there is a general lack of information on the presence of SVHCs.  

In view of the challenges with its implementation and the low level of compliance with Article 33, as 
it  stands  now,  the  benefits  of  any  extension  of  its  scope  to  cover  other  dangerous  substances  are 
questionable. The extension of obligation would rather result in additional challenges, adding burden 
on companies and not further contributing to the objectives of REACH.  

The Commission and stakeholders should continue working together to improve the implementation 
of  the  provisions  already  in  force.  Recent  regulatory  developments  in  the  context  of  the  waste 
legislation  (particularly,  the  development  of  the  ECHA  SCIP  database57)  could  also  improve  the 
general implementation of Article 33 in the coming years.  

4.  Review according to Article 138 (9) 

4.1.    Introduction 

Section 8.7 of Annex VIII of REACH concerns screening-level information on reproductive toxicity 
for substances manufactured or imported in quantities of 10 tonnes or more per registrant. The only 
sub-point  of section  8.7  in  Annex  VIII,  point  8.7.1. (see  Annex  II  to  this  report),  lays  down,  as  the 
standard  requirement  for  such  substances,  a  screening  study  for  reproductive  and  developmental 
toxicity in one species, according to either Organisation for Economic Co-operation and Development 
(OECD) test guideline (TG) 421 or 422. OECD TG 421 is for a reproduction/developmental toxicity 
screening  study,  while  TG  422  is  for  a  combined  repeated  dose  toxicity  28-day  study  with  the 
reproduction/developmental toxicity screening. The screening study is only required in the absence of 
evidence  from  structurally  related  substances,  (Q)SAR  estimates  or  in  vitro  methods  that  the 
substance may be a developmental toxicant.  

However, column 2 of point 8.7.1. sets out specific rules for adaptation of the above requirement and 
specifies  that  the  study  does  not  need  to  be  conducted  if  the  substance  is  known  to  be  either  a 
genotoxic  carcinogen  or  a  germ  cell  mutagen  and  appropriate  risk  management  measures  are 
implemented. It also does  not need  to be conducted if relevant human  exposure can be excluded  in 
accordance  with  Annex  XI,  section  3,  or  if  a  higher  tier  (i.e.  according  to  Annex  IX)  pre-natal 
developmental toxicity study or reproductive toxicity study is available.  

56  European  Commission,  Information  flows  on  substances  of  concern  in  products  from  supply  chains to  waste  operators, 
2020. 
57 ECHA, SCIP database website.  

35 

 
 
                                                            
Furthermore,  if  the  substance  meets  the  criteria  for  hazard  classification  as  toxic  for  reproduction 
category 1A or 1B for effects on sexual function and fertility, and the available data are adequate for a 
robust risk assessment, the study does not need to be conducted but testing for developmental toxicity 
must be considered. Likewise, if the substance meets the criteria for hazard classification as toxic for 
reproduction category 1A or 1B for developmental effects, and the available data are adequate for a 
robust  risk  assessment,  the  study  does  not  need  to  be  conducted  but  testing  for  effects  on  sexual 
function and fertility must be considered. 

Annex  VIII  does  not  explicitly  prescribe  further  testing  on  reproductive  toxicity  to  follow-up  on 
effects seen in the screening study. Further information on reproductive and developmental toxicity is 
obligatory according to Annex IX and X for substances registered in the higher tonnage bands (≥ 100 
tonnes per year). However, Annex VIII, section 8.7.1. provides that in cases where there are serious 
concerns for adverse effects on development or reproduction, a prenatal developmental toxicity study 
(according  to  Annex  IX,  section  8.7.2;  TG  414)    or  an  Extended  One-Generation-Reproductive 
Toxicity  Study  (EOGRTS;  TG  443)  may,  as  appropriate,  be  proposed  by  the  registrant  instead  of 
conducting a reproduction/developmental toxicity screening test.   

Reproductive  toxicity  refers  to  adverse  effects  on  sexual  function  and  fertility  in  adult  males  and 
females,  as  well  as  to  adverse  effects  on  the  development  of  the  offspring.  According  to  ECHA’s 
endpoint  specific  guidance58,  the  purpose  of  the  reproduction/developmental  toxicity  screening  tests 
(OECD  TGs  421  and  422)  is  to  provide  initial  information  of  the  effects  on  male  and  female 
reproductive performance such as gonadal function, mating behaviour, conception and parturition and 
histopathological information on reproductive organs. Initial information on the offspring is limited to 
mortality,  abnormal  behaviour  and body  weight  of pups  after  birth,  a  macroscopic  examination  and 
additional parameters for detection of possible endocrine disrupting modes of action as given in the 
revised  TGs  (2016).  These  screening  tests  do  not  provide  complete  information  on  all  aspects  of 
reproduction and development.  

To clarify the legal text and improve the effectiveness of the compliance check in REACH, the data 
waivers and triggers of point 8.7.1 in Annex VIII are currently under revision. Possible amendments 
and their potential impact on the animal testing are discussed in a sub-group to the CARACAL expert 
group dedicated to the update of information requirements in the REACH Annexes.  

4.2.   State  of  development  of  alternative  test  methods  for  reproductive 

toxicity 

The  test  methods  used  to  fulfil  regulatory  requirements,  including  the  standard  information 
requirements under REACH, are generally based on internationally agreed standard protocols. In the 
area  of  test  methods  for  human  health,  such  standard  protocols  are  laid  down  in  test  guidelines 
developed and adopted by the OECD, and, according to Article 13(3), the test methods applicable for 
the  purpose of  REACH  are  included  in  Regulation  (EC)  No  440/200859  or  otherwise  recognised  by 
the Commission or ECHA.  

For the assessment of reproductive toxicity for human health, OECD test guidelines addressing effects 
on sexual function, fertility and development of offspring currently only include  in vivo studies (TG 
421:  Reproduction/Developmental  Toxicity  Screening  Test,  TG  422:  Combined  Repeated  Dose 

https://echa.europa.eu/documents/10162/13632/information_requirements_r7a_en.pdf/e4a2a18f-a2bd-4a04-ac6d-

58 
0ea425b2567f 
59 Commission Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the 
European  Parliament  and  of  the  Council  on  the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals 
(REACH). OJ L 142, 31.5.2008, p. 1 

36 

 
 
                                                            
Toxicity  Study  with  the  Reproduction/Developmental  Toxicity  Screening  Test,  TG  414:  Prenatal 
Developmental Toxicity Study, TG 443: Extended One-Generation Reproductive Toxicity Study, TG 
416:  Two-Generation  Reproduction  Toxicity  Study). No  test  guidelines  for  alternative  (non-animal) 
methods  that  directly  address  sexual  function,  fertility  or  developmental  effects  have  as  yet  been 
adopted by OECD. Two projects related to reproductive toxicity are currently included in the OECD 
work  programme,  a  feasibility  study  for  an  embryonic  stem  cell  assay  for  cardiotoxicity  and  a 
guidance document on in vitro assays for developmental neurotoxicity. Several TGs are available for 
in  vitro  tests  addressing  possible  endocrine  modes  of  action  that  are  i.a.  relevant  for  reproductive 
toxicity, like (anti)oestrogenicity (TG 455, TG 493), steroidogenesis (TG 456) and (anti)androgenicity 
(TG  458).  Methods  for  identifying  chemicals  with  thyroid  activity  are  undergoing  EURL  ECVAM 
(EU Reference Laboratory for alternatives to animal testing) validation. 

Recognising the importance of reliable alternative methodologies for the assessment of reproductive 
toxicity,  the  European  Commission  has  funded  a  number  of  research  projects  to  develop  such  tools 
under  past  and  ongoing  framework  programmes.  Projects  with  a  particular  focus  on  reproductive 
toxicity are listed in Annex III to this report. 

Given the diversity of physiological processes associated with the mammalian reproductive cycle and 
the complexity of the underlying regulatory networks, it is currently not possible to model chemical 
effects  on  the  whole  cycle  with  a  single  or  limited  number  of  non-animal  approaches.  Therefore, 
research in the area has aimed at identifying the main biological processes and improving mechanistic 
understanding,  in  order  to  develop  mechanistically-based  in  vitro  tests.  A  comprehensive  review  of 
the  state-of-the-art  in  the  development  of  alternative  methods  for  all  toxicological  endpoints, 
including  reproductive  and  developmental  toxicity,  has  been  published  in  2014  by  JRC  (European 
Commission’s Joint Research Centre)60. According to the report, the available in vitro models cover 
only a small part of the reproductive cycle, with many steps of the cycle not yet addressed at all. The 
existing in vitro tests include cell-based models (primary cultures and stem cells), organ cultures and 
whole  embryo  cultures.  Some  non-mammalian  models  for  developmental  toxicity  are  being 
developed using zebrafish embryos or the nematode worm C. elegans as model organisms, but have 
not yet reached the stage of validation. A recent workshop report61 reviewed the available models and 
acknowledged their potential as screening tests, but also highlighted the need of understanding better 
the  advantages  and  limitations  of  these  tests  before  they  may  be  considered  suitable  to  replace 
mammalian test systems. 
According to the JRC report, most of the methods that have been developed are not (yet) used in the 
regulatory  assessment  of  reproductive  toxicity.  In  vitro  models  like  primary  cell  or  organ  cultures 
have  mainly  been  used  for  mechanistic  research  and  have  not  been  optimised  for  toxicity  testing. 
Three  in  vitro  methods  for  embryotoxicity,  the  mouse  embryonic  stem  cell  test,  the  micromass  test 
and  the  whole  embryo  culture,  have  been  scientifically  validated  and  endorsed  by  the  ECVAM 
Scientific Advisory Committee (ESAC)62. However, the participants of a workshop on their practical 
application identified limitations and considered them not ready for regulatory use63. These limitations 

http://publications.jrc.ec.europa.eu/repository/bitstream/JRC91361/echa_jrc_sla_report_public_05-09-

60 
14_withcover%20ipo.pdf 
61 Solecki R, Rauch M, Gall A, Buschmann J, Kellner R, Kucheryavenko O, Schmitt A, Delrue N,  Li W, Hu J, Fujiwara M, 
Kuwagata M, Mantovani A, Makris SL, Paumgartten F, Schönfelder G, Schneider S, Vogl S, Kleinstreuer N, Schneider M, 
Schulze  F,  Fritsche  E,  Clark  R,  Shiota  K,  Chahoud  I  (2019).  Update  of  the  DevTox  data  database  for  harmonized  risk 
assessment  and  alternative  methodologies  in  developmental  toxicology:  Report  of  the  9th  Berlin  Workshop  on 
Developmental Toxicity. Reproductive Toxicology 89:124-29 
62 
https://tsar.jrc.ec.europa.eu/test-method/tm1999-03    
63 The Practical Application of Three Validated In Vitro Embryotoxicity Tests. ATLA 34, 527–538, 2006 

https://tsar.jrc.ec.europa.eu/test-method/tm1999-01; 

https://tsar.jrc.ec.europa.eu/test-method/tm1999-02; 

37 

 
 
                                                            
concerned  i.a.  difficulties  of  the  three  tests  to  discriminate  between  weak  and  non-embryotoxicants 
and uncertainties over the applicability of the tests for a broad range of chemicals (important chemical 
classes  were  not  included  in  the  validation,  the  chemicals  tested  covered  only  a  limited  number  of 
mechanisms of toxicity and only 20 chemicals were tested during the validation). 

With respect to QSAR (quantitative structure-activity relationship) models for developmental toxicity, 
the  JRC  report  points  to  the  limited  availability  of  models  due  to  the  inherent  difficulty  to  relate 
chemical  structures  to  complex  toxicological  endpoints  and  to  the  lack  of  high  quality  data  sets  to 
train the models. It refers to an earlier JRC study done for EFSA (European Food Safety Authority) 
(published in 201064) which had evaluated several available models and found them potentially useful 
for  supporting  hazard  identification  and  prioritising  substances  for  further  assessment,  but  not  for 
predicting the absence of developmental toxicity. While QSAR models may not be able to completely 
replace  in  vivo  testing,  a  range  of  structural  features  have  been  associated  with  developmental  and 
reproductive toxicity65, and could be used as supporting evidence in the context of priority setting, as 
well as providing elements for chemical grouping, read-across, and weight of evidence assessments. 

The focus in recent years has been on connecting different types of data within testing strategies and 
weight of evidence approaches to support hazard and risk assessment. This has been formalised within 
the OECD's programme on Integrated Approaches to Testing and Assessment (IATA). Underpinning 
the IATA approach are Adverse Outcome Pathways (AOPs) which capture mechanistic knowledge by 
describing how a chemical interacting at molecular and cellular level can ultimately lead to adverse 
effects at the organ and organism level. This mechanistic knowledge can be used to develop relevant 
in vitro assays or in silico models addressing specific key events within different AOPs, which can be 
combined in testing strategies or used to support weight of evidence approaches within IATAs. 

With regard to reproduction and fertility, the focus of AOP development within the OECD has mainly 
been  on  fish-specific  pathways  related  to  endocrine  disruption,  with  two  AOPs  endorsed  by  the 
OECD. For developmental effects in mammals, AOPs exist for adverse effects on brain development 
(three  AOPs  endorsed  by  the  OECD)  and  vascular  effects  (one  AOP  endorsed)66.  Moreover,  many 
other  AOPs  within  the  field  of  reproductive  toxicity  are  currently  under  development.  In  addition 
there is an ongoing OECD project (4.124) co-led by the European Commission, Denmark and USA 
on  assessing  the  performance  of  a  range  of  different  in  vitro  assays  related  key  events  relevant  to 
developmental neurotoxicity with the objective of developing an OECD guidance on how the assays 
could be used within different IATAs.67 

While  there  are  examples  of  promising  AOPs  concerning  developmental  and  reproductive  toxicity, 
these focus on specific mechanisms and cannot, individually, be used to prove the absence of relevant 
toxicity  through  other  mechanisms.  Before  such  approaches  are  suitable  for  regulatory  use,  further 
development will be needed to develop sets of tests covering all relevant developmental pathways, as 
well  as  defined  approaches68  to  allow  their  use  for  hazard  identification  and  risk  assessment. 
Information from internationally accepted AOPs or other in vitro and non-animal data, however, can 
already be valuable in supporting read-across or weight of evidence assessments.  

64 https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2010.EN-50  
65 Wu S, Fisher J, Naciff J, Laufersweiler M, Lester C, Daston G, Blackburn K. (2013). Framework for identifying chemicals 
with structural features associated with the potential to act as developmental or reproductive toxicants. Chem Res Toxicol. 
26:1840-61. 
66 http://www.oecd.org/chemicalsafety/testing/adverse-outcome-pathways-molecular-screening-and-toxicogenomics.htm 
67 https://www.oecd.org/chemicalsafety/testing/TGP%20work%20plan_September%202018.pdf 
68 
in 
http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2016)28&doclanguage=en  

document 

described 

guidance 

OECD 

255: 

As 

38 

 
 
                                                            
With  regard  to  the  information  on  reproductive  toxicity  to  be  provided  in  REACH  registration 
dossiers,  ECHA’s  endpoint  specific  guidance69  provides  a  comprehensive  overview  of  the  available 
testing  methods,  as  well  as  other  information  sources  that  can  be  used  in  the  evaluation  of 
reproductive toxicity in the context of read-across or weight of evidence assessments.  

In addition, a 2017 report by ECHA70 describes in detail the current status of non-animal approaches 
and  their  regulatory  applicability  for  REACH  and  other  chemical-related  EU  legislation.  The  report 
states that presently there is no animal-free/in vitro method that can provide information equivalent to 
the information generated by the reproduction/developmental toxicity screening test. It points out that, 
in  cases  where  information  on  both  repeated  dose  toxicity  and  reproductive  toxicity  needs  to  be 
generated,  registrants  can  reduce  the  number  of  animals  needed  by  performing  a  combined  study 
according to OECD TG 422, instead of two separate studies. According to the ECHA report, current 
in  vitro  and  in  silico  methods  investigate  only  partially  the  embryonic  development  (e.g.  rodent  in 
vitro cultures) or part of the potential mechanisms/MoA. Likewise, with respect to (Q)SAR models, 
the report states that  not all the necessary aspects for reproductive toxicity can be covered by a QSAR 
prediction.    Thus,  information  from  these  prediction  methods  is  not  appropriate  to  establish  the 
absence  of  an  effect,  but  may  be  used  as  supportive  evidence  to  strengthen  read-across,  substance 
categories and weight of evidence. 

In  principle,  the  available  non-animal  approaches  thus  could  be  used  to  detect  a  potential  to  cause 
adverse  effects  and  conclude  on  the  presence  of  a  hazard  if  supporting  information  is  available. 
However,  as  these  methods  do  not  provide  information  on  maternal  toxicity  or  allow  to  deduce  at 
which doses the effects would occur in an in vivo test, it is challenging to establish whether relevant 
effects could occur in humans. Moreover, non-animal predictive methods do not provide information 
for risk assessment (e.g. NOAEL value) and toxicokinetic information would be needed to support the 
dose level considerations.  

In line with the above assessments of the state of alternatives to animal testing by JRC and ECHA, the 
Report  from  the  Commission  to  the  European  Parliament  and  the  Council  on  the  development, 
validation  and  legal  acceptance  of  methods  alternative  to  animal  testing  in  the  field  of  cosmetics 
(2018)71 concluded that, while considerable progress is being made in the development, validation and 
legal acceptance of alternative methods, the current level of alternative methods does not yet make it 
possible to fully replace in vivo (animal) tests for all toxicological endpoints in the safety assessment 
of  cosmetic  products,  and  that  challenges  still  remain  for  the  most  complex  endpoints,  where  more 
research is needed. 

4.3. Information  on  reproductive/developmental 

toxicity  submitted 

for 

REACH 

The  fourth  edition  of ECHA’s  report  (2020)  on  the  use  of  alternatives  to  testing on animals for the 
REACH  Regulation72  provides  an  overview  of  the  studies  and  alternative  data  that  have  been 
submitted by registrants in order to fulfil the information requirements of Annex VIII, section 8.7.  

https://echa.europa.eu/documents/10162/22931011/non_animal_approcches_en.pdf/87ebb68f-2038-f597-fc33-

https://echa.europa.eu/documents/10162/13632/information_requirements_r7a_en.pdf/e4a2a18f-a2bd-4a04-ac6d-

69 
0ea425b2567f 
70 
f4003e9e7d7d  
71 https://ec.europa.eu/transparency/regdoc/rep/1/2018/EN/COM-2018-531-F1-EN-MAIN-PART-1.PDF  
72 
5ccc5ae11026  

https://echa.europa.eu/documents/10162/0/alternatives_test_animals_2020_en.pdf/db66b8a3-00af-6856-ef96-

39 

 
 
                                                            
 
For substances manufactured or imported in quantities of 1-100 tonnes, the final registration deadline 
was in June 2018, so a large number of registrations were submitted only after the cut-off date for the 
previous,  third  report  in  March  2016.  The  fourth  report  therefore  provides,  for  the  first  time,  a 
comprehensive  coverage  of  data  used  in  registration  dossiers  across  all  tonnage  bands.  ECHA 
performed, for the purpose of this report, an analysis covering 12184 substances for which registration 
dossiers  containing  toxicological  data  had  been  submitted  before  31  July  2019,  including  2642 
substances  manufactured  or  imported  in  quantities  of  10-100  tonnes,  which  have  to  fulfil  the 
requirements of Annex VIII. ECHA examined, on a per substance basis, which approaches registrants 
used to fulfil the information requirements. The distribution of the use of various approaches, i.e. the 
use  of  experimental  studies,  submission  of  testing  proposals,  read-across  and  weight  of  evidence 
assessments, (Q)SAR-based conclusions, data waiving and others, is shown in Figure 1.  

For  the  endpoint  of  reproductive  toxicity,  for  ca  31%  of  substances  an  experimental  study  was 
available.  For  ca  44%  of  substances,  registrants  performed  a  read-across  assessment.  For  ca.  17%, 
registrants  waived  the  data  requirement.  For  the  remaining  substances,  registrants  provided 
information based on QSAR, Weight of Evidence assessments or other type of information. While a 
separate developmental toxicity study is not a standard information requirement at Annex VIII level, 
for ca 50 % of the substances, registrants also submitted information for this endpoint. This comprised 
experimental studies for 12% of the substances, read-across for ca 30%, and other approaches for ca 
8% of substances. 

Fig.  4.1  Relative  proportions  of  the  options  used  by  registrants  to  cover  REACH  information 
requirements for reproductive toxicity for substances manufactured or imported in quantities of 10-100 
tonnes. 

information requirements  experimental 

read-
across/categor
y 

QSAR 

weight of 
evidence 

other 

data 
waiver 

testing 
proposal 

no 
informatio
n 

toxicity to reproduction 

31.4 

44.3 

0.9 

2.4 

3.4 

16.6 

0.2 

0.7 

developmental toxicity  

12.5 

29.9 

0.5 

2.0 

2.0 

3.5 

0.8 

48.8 

From these analyses, it is evident that registrants have made extensive use of adaptation possibilities 
following the provisions in column 2 of Annex VIII, section 8.7. or in Annex XI. Read across is by far 
the most frequently used adaptation, followed by data waiving.  Weight of evidence assessments and 
other approaches play a rather minor role for this endpoint and tonnage level. 

40 

 
 
 
 
 
From these analyses, it is evident that registrants have made extensive use of adaptation possibilities 
following the provisions in column 2 of Annex VIII, section 8.7. or in Annex XI. Read across is by far 
the most frequently used adaptation, followed by data waiving.  Weight of evidence assessments and 
other approaches play a rather minor role for this endpoint and tonnage level. 

The experience of ECHA in general when evaluating compliance of registration dossiers for different 
information  requirements  and  across  all  tonnage  levels  is  that  adaptations  can  have  quality 
deficiencies.  In  particular,  read-across  adaptations  frequently  suffer  from  poor  documentation  and 
shortcomings in the data used as well as the scientific justification.  It is currently difficult to estimate 
whether  or  to  what  extent  this  is  also  the  case  for  the  information  on  reproductive/developmental 
toxicity  submitted  for  substances  in  the  tonnage  range  of  10-100  tonnes  per  year.  However,  it  is 
possible that additional studies will have to be requested for those substances if adaptations are found 
to be inadequate. 

Concerning the type of test submitted for substances at Annex VIII level, 529 (20%) had been tested 
in  a  combined  repeated  dose  toxicity  28-day  study  with  the  reproduction/developmental  toxicity 
screening (OECD TG 422), and 309 (11.7%) had been tested in a reproduction/developmental toxicity 
screening  study  (OECD  TG  421).  Furthermore,  for  some    substances,  higher  tier  studies  for 
reproductive toxicity or developmental toxicity were available (2.5% or 4.9% respectively).  

Fig. 4.2: Percentage of substances for which guideline studies were used to fulfil the standard information 
requirements for each information requirement at different tonnage levels. 

Of  the  screening  tests  according  to  OECD  TG  421  and  422  that  were  available  across  all  tonnage 
levels, the majority have been performed after REACH entered into force. Of the combined repeated 
dose  toxicity  28-day  study  with  the  reproduction/developmental  toxicity  screening  according  to 
OECD TG 422 (or equivalent),  432  of the submitted studies date  from before  2009 (“old studies”), 
1640 are “new” studies, performed from 2009 onwards.  Of the reproduction/developmental toxicity 
screening study according to OECD TG 421 (or equivalent), 181 were “old” and 678 “new” studies. 
These analyses indicate that, when new studies are needed for both repeated dose toxicity and toxicity 
to  reproduction  screening,  data  was  frequently generated  using  the  combined  repeated  dose  toxicity 

41 

 
 
 
study  with  the  reproduction/developmental  toxicity  screening  test  (OECD  422).  This  significantly 
reduces the number of animals and costs. 

4.4. Conclusion 

Despite vast research efforts undertaken in the EU and internationally, and the development of some 
alternative  approaches  that  model  individual  parts  of  the  reproductive  cycle,  there  are  currently  no 
alternative test methods or other non-animal approaches available that could fully replace the required 
screening  test  for  reproductive/developmental  toxicity  in  REACH  Annex  VIII,  section  8.7.1. 
However, the mechanistic understanding of reproductive toxicity has increased in recent years and a 
range  of  alternative  methods  and  approaches  has  been  developed  based  on  this  knowledge.  Such 
approaches  can  be,  and  are  being,  used  on  a  case-by-case  basis  as  elements  in  the  assessment  of  a 
chemical’s potential to cause reproductive toxicity effects, e.g. in the context of read-across or weight 
of evidence assessments. REACH already contains extensive provisions for the flexible use of such 
approaches  in  adaptations  to  the  standard  information  requirements  based  on  Annex  XI.  The 
and 
possibility 
reproductive/developmental  toxicity  in  order  to  reduce  the  number  of  animals  needed  is  already 
foreseen  in  the  current  requirement  in  REACH  Annex  VIII,  section  8.7.1,  and  this  combined 
screening  study  is  widely  used  by  registrants.  Therefore,  a  revision  of  this  section  with  the  aim  to 
introduce alternative test methods or approaches as the standard information requirements is currently 
not warranted.  

repeated  dose 

combined 

screening 

to  use 

toxicity 

study 

for 

a 

42 

 
 
 
 
5.  Annex I: Elements of a CSA/CSR 

5.1. 

The Chemical safety assessment (CSA) 

1.  Human  health  hazard  assessment:  to  determine  the  classification  of  a  substance  and  to  derive 
levels of exposure to the substance above which humans should not be exposed; 

2. Human health hazard assessment of physicochemical properties: to determine the classification 
of a substance in relation to, as a minimum, explosivity, flammability and oxidising potential; 

3. Environmental hazard assessment: to determine the classification of a substance and to identify 
the Predicted No-Effect Concentration (PNEC); 

4. PBT and vPvB assessment: to determine if the substance fulfils the criteria for PBT/vPvB (given 
in Annex XIII of REACH) and, if so, to characterise the potential emissions of the substance; 

5.  Exposure  assessment:  quantitative  or  qualitative  estimation  of  the  dose/concentration  of  the 
substance to which humans and the environment are or may be exposed. This considers all stages of 
the  life-cycle  of  the  substance  resulting  from  its  manufacture  and  identified  uses  and  covers  any 
exposures that may relate to the hazards identified in the above hazard and PBT/vPvB assessments; 

6.  Risk  characterisation:  for  each  exposure  scenario,  this  step  considers  the  human  populations 
(exposed  as  workers,  consumers  or  indirectly  via  the  environment  and  if  relevant  a  combination  of 
those)  and  the  environmental  spheres  for  which  exposure  to  the  substance  is  known  or  reasonably 
foreseeable.  Characterisation assumes that  the risk  management  measures described in the exposure 
scenarios have been implemented. In addition, the overall environmental risk caused by the substance 
is reviewed by integrating the results for the overall releases, emissions and losses from all sources to 
all environmental compartments. 

5.2. 

The Chemical Safety Report (CSR) 

The  CSR  documents  the  CSA  and  also  provides  a  summary  of  all  the  relevant  information  used  in 
addressing each of the aspects of the CSA. 

5.3. 

The Extended Safety Data Sheet (eSDS) 

Where a CSA/CSR has been completed the following are added to the SDS to form an extended SDS 
(eSDS): 
  SDS made consistent with the information in the CSA; 
  results of the PBT/vPvB assessment must be reported; and 
  the relevant exposure scenario(s) must be included in an annex to the SDS. 

43 

 
 
 
 
6.  Annex II 

Information requirements for reproductive toxicity in REACH Annex VIII 

COLUMN 1 
STANDARD 
INFORMATION 
REQUIRED 

8.7. Reproductive 
toxicity  

8.7.1. Screening for 
reproductive/ 
developmental toxicity, 
one species (OECD 421 
or 422), if there is no 
evidence from available 
information on 
structurally related 
substances, from 
(Q)SAR estimates or 
from in vitro methods 
that the substance may 
be a developmental 
toxicant 

COLUMN 2  
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 

8.7.1. This study does not need to be conducted if:  

— the substance is known to be a genotoxic carcinogen and 
appropriate risk management measures are implemented, or  

— the substance is known to be a germ cell mutagen and 
appropriate risk management measures are implemented, or  

— relevant human exposure can be excluded in accordance with 
Annex XI section 3, or  

— a pre-natal developmental toxicity study (Annex IX, 8.7.2) or, 
either an Extended One-Generation Reproductive Toxicity Study 
(B.56, OECD TG 443) (Annex IX, section 8.7.3) or a two-
generation study (B.35, OECD TG 416), is available.  

If a substance is known to have an adverse effect on fertility, 
meeting the criteria for classification as toxic for reproduction 
category 1A or 1B: May damage fertility (H360F), and the 
available data are adequate to support a robust risk assessment, 
then no further testing for fertility will be necessary. However, 
testing for developmental toxicity must be considered. 

 If a substance is known to cause developmental toxicity, meeting 
the criteria for classification as toxic for reproduction category 1A 
or 1B: May damage the unborn child (H360D), and the available 
data are adequate to support a robust risk assessment, then no 
further testing for developmental toxicity will be necessary. 
However, testing for effects on fertility must be considered.  

In cases where there are serious concerns about the potential for 
adverse effects on fertility or development, either an Extended 
One-Generation Reproductive Toxicity Study (Annex IX, section 
8.7.3) or a pre-natal developmental toxicity study (Annex IX, 
section 8.7.2) may, as appropriate, be proposed by the registrant 
instead of the screening study.  

44 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
7.  Annex III 

Projects funded by EU research framework programmes with a particular focus 
on developing methodologies to test for and assess reproductive toxicity   

• 

• 

• 

• 

• 

• 

• 

The FP6 ReProTect project (2004-2009) aimed to integrate existing and newly developed 
in vitro models into a testing strategy that could provide detailed information about the 
potential hazard of compounds to reproduction73.  
The  FP6  NHR  DEVTOX  project    (2005)  performed  a  prospective  analysis  of  the 
mechanisms of nuclear hormone receptors and their potential as tools for the assessment 
of developmental toxicity74. 
The FP7 ESNATS  (2007-2013) project developed a battery of tests based on embryonic 
stem cells, in particular human embryonic stem cells75.  
The FP7 ChemScreen  (2010-2013) project aimed to generate a simple, rapid screening 
system  for  reproductive toxic  chemicals,  integrating  in  silico  and  in  vitro  methods  as  a 
means to identifying potential reproductive toxicants76.  
The  FP7  COSMOS    (2011-2015)  project  built  a  freely  accessible  database    with 
information on a range of toxicological endpoints, including reproductive-developmental 
toxicity of cosmetic ingredients and other substances77.  
The  Integrated  European  ‘Flagship’  Programme  EU  ToxRisk  (2016-2021)  under  the 
Horizon 2020 programme aims to advance the mechanism-based toxicity testing and risk 
assessment and to enable the move towards a toxicological assessment based on human 
cell responses and a comprehensive mechanistic understanding of causal relationships of 
chemical  adverse  effects.  The  focus  of  this  project  is  on  two  areas:  repeated  dose 
systemic  toxicity,  using  the  lung,  kidney,  liver  and  nervous  system  as  examples  of 
potential target organs; and developmental and reproductive toxicity78. 
The  H2020  EURION  project  2019  -  202479  is  a  cluster  of  8  projects  for  endocrine 
disruption testing. Amongst them, the FREIA project80 focuses on female reproduction, 
and  includes  animal  and  non-animal  methods,  the  ATHENA  project81  concerns  brain 
development  in  relation  to  thyroid  toxicity  and  the  project  ENDpoiNTs82  addresses 
developmental neurotoxicity. 

https://ecvam-dbalm.jrc.ec.europa.eu/projects-and-studies/eu-integrated-projects/eu-integrated-project/eu-integrated-

73 
project-reprotect-development-of-a-novel-approach-in-hazard-and-risk-assessment-for-reproductive-toxicity-by-a-
combination-and-application-of-in-vitro,-tissue-and-sensor-technologies./key/eup_102 
74 https://cordis.europa.eu/project/rcn/74090/factsheet/en  
75 https://cordis.europa.eu/project/rcn/87281/reporting/en  
76 http://chemscreen.eu/  
77 https://cordis.europa.eu/project/rcn/97712/factsheet/en  
78 http://www.eu-toxrisk.eu/  
79 http://www.eurion-cluster.eu  
80 http://freiaproject.eu/wp/about/  
81 https://cordis.europa.eu/project/rcn/219094/factsheet/en  
82 https://endpoints.eu/  

45