EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2021) XXX  draft 
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes VI to X to Regulation (EC) No 1907/2006 of the European 
Parliament and of the Council concerning the Registration, Evaluation, Authorisation 
and Restriction of Chemicals (REACH)  
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes VI to X to Regulation (EC) No 1907/2006 of the European 
Parliament and of the Council concerning the Registration, Evaluation, Authorisation 
and Restriction of Chemicals (REACH)  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 1907/20 06 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 (1), and in particular Article 
131 thereof,  
Whereas:  
(1) Regulation (EC) No 1 907/2006 lays down  specific registration duties and obligations 
on manufacturers, importers and downstream users to generate data on substances they 
manufacture, import or use , to assess the risks related to th ose substances and to 
develop and recommend ap propriate risk management measures.  
(2) Annex VI  to Regulation (EC) No 1907/2006 set s out information requirements 
referred to in  Article 10 , point  (a)(i) to (v) and (x) , of that Regulation . Annexes VII to 
X to that Regulation  set out standard information requirements for substances 
manufactured or imported in quantities of one tonne or more, 10 tonnes or more, 100 
tonnes or more and 1  000 tonnes or more.  
(3) In June 2019 , the Commission and the European Chemicals Agency ( ‘the Age ncy’) 
concluded in the REACH Evaluation Joint Action Plan2 that certain information 
requirements  in the Annexes to Regulation (EC) No 1907/2006 should be amended to 
provide more clarity on the obligations of registrants  regarding the submission of 
informat ion.  
(4) Requirements concerning  the general registrant information and substance 
identification information which  a registrant is to  submit for general registration 
purposes , laid down in Annex VI , sections 1 and 2,  to Regulation (EC) No 1907/2006  
should therefore be amended .  
(5) Certain specific rules for adaptation from the standard information requirements  set 
out in Annexes VII to X  to Regulation (EC) No 1907/2006  should be amended to align 
                                                 
1 OJ L 396, 30.12.2006, p. 1.  
2 European Commission and European Chemicals Agency REACH Evaluation Joint Action Plan  of June 2019  ( 
https://echa.europa.eu/documents/10162/21877836/final_echa_com_reach_evaluation_action_plan_en.pdf/0003c9f
c-652e -5f0b-90f9-dff9d5371d17 ).   
EN 2  EN the terminology of the classification  of hazardous substa nces to  that used in  Annex  I, 
parts 2 to 5,  to Regulation (EC) No 1272/2008  of the European Parliament and the 
Council3.  
(6) Specific  rules for  adaptation from the standard information laid down  in Annex VII  to 
Regulation (EC) No 1907/2006  on mutagenicity and  aquatic toxicity should be 
amended  for reasons of  clarity  and to ensure that  useful information  is provided . In 
particular,  subsection 8.4 should be amended to clarify the consequences of a positive 
result in the  in vitro  gene mutation study , as well as the situations when the study 
required under point 8.4.1 does not need to be conducted . In addition, parts not 
referring to standard information required should be remove d from column 1 of point 
9.1.1 , while column 2 of that point should describe  more accurately the situations 
where  the study does not need to  be conducted  and where  long-term aquatic toxicity 
testing is required. Point 9.1.2  should  also be modified to clarify when  the study does 
not need to be conducted . 
(7) The information requirements on testing for mutagenicity  and for reproductive 
toxicity, and on ecotoxicological information in Annex VIII  to Regulation (EC) No 
1907/2006  should be amended  in order  to clarify the obligations of registrants. In 
particular, the r ules on testing for mutagenicity  in subsection 8.4 should specify  the 
situations that do not require testing referred to in that Annex and the situations that 
require further testing referred to in Annex IX.  Furthermore, t he nomenclature  of the  
studies in point 8.4.2 should be aligned with that of the  corresponding  technical 
guidance documents  of the  Organisation for Economic Co -operation and Development  
(OECD)4. In addition, to ensure that useful information on reproductive and 
developmental toxicity  is ge nerated , the preferred animal species and the preferred 
administration routes for testing should be added  to point 8.7.1 , while certain specific 
rules for adaptation from the standard information requirements should be clarified . 
Finally, a subsection head ing 9.1 for aquatic toxicity that was missing should be added 
and the information requirement  on short -term toxicity testing on fish  in point 9.1.3  
should be amended in order to  remov e the parts  that do  not list standard information  
from column 1  and to clarify the situations when the test is not required  in column 2 . 
Subsection s 9.2 on degradation and 9.3 on fate and behaviour in the environment  
should also be modified in order to better describe the situations requiring further 
information on degradation  and bioaccumulation as well as further  degradation and 
bioaccumulation studies .  
(8) Information requirements on testing for mutagenicity in Annex IX to Regulation (EC) 
No 1907/2006  should be amended to specify in points 8.4.4 and 8.4.5 the studies to be 
cond ucted in mammalian somatic cells and, when relevant, in mammalian germ cells, 
as well as the cases where  such studies  need to be conducted . In addition, the 
information requirements  in point 8.7.2 on testing for pre -natal developmental toxicity  
in a first and second species  and in point 8.7.3 for Extended One -Generation 
Reproductive Toxicity studies should be clarified with regard to the preferred animal 
species and the preferred  administration routes for testing, as well as with regard to the 
possible  deviations from the general rules.  Finally , as regards the section  on 
ecotoxicological information, certain information requirements  on long -term toxicity 
testing on fish should be removed due to animal welfare reasons.  The s ubsection 9.2 
                                                 
3 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, l abelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC 
and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008 , p. 1).  
4 OECD TG 473 and 487 .  
EN 3  EN on degradation sh ould also be amended to align  the wording  of point 9.2.3 concerning 
identification of degradation products  with that of the related provision in Annex XIII , 
and to reflect  the amended requirement on  further degradation testing accordingly . The 
subsection  9.4 on effects on terrestrial organisms should also be amended to clarify 
that a long -term toxicity study  should be proposed  by the registrant or may be required 
by the Agency for substances that have a high potential to adsorb to soil or that are 
very per sistent.  
(9) Annex X  to Regulation (EC) No 1907/2006  should be amended to clarify certain 
information requirements on mutagenicity, developmental and reproductive toxicity 
and ecotoxicological information. In particular, the amendments should describe the 
situations meeting  the requirement for a second in-vivo somatic cell study or a second 
in-vivo germ cell study and specify the need to conduct such studies in mammalian 
species . Those studies should be listed together with the mutagenicity concerns they 
are to  address . In addition, t he information requirements  on pre -natal developmental 
toxicity  and Extended One -Generation Reproductive Toxicity studies should be 
amended to clarify the need for a study in, and the choice of, a second species, as well 
as the preferred administration routes for testing and the deviations from the general 
rules.  Furthermore, the reference to a specific requirement on biotic degradation in 
point 9.2.1 is no longer necessary and should therefore be deleted, while relevant 
specific  rules for adaptation  in subsection 9.2  should be amended accordingly.  Finally, 
it should be clarified in sub section 9.4 , as well as point 9.5.1  that in addition to 
degradation products , long-term toxicity testing of transformation products is required 
to investigate their effects on terrestrial and sediment organisms . 
(10) Regulation (EC) No 1907/2006 should therefore be amended accordingly.  
(11) The proposed amendments aim at providing clarifications of certain standard 
information requirements and specific rules for their adaptation, as well as at 
increasing the legal certainty of the evaluation practices already applied by the 
Agency. Nevertheless, it cannot be discarded that as a result of the amend ments , 
certain registration dossiers  will need to  be updated . The application of this Regulation 
should therefore be deferred . 
(12) The measures provided for in this Regulation are in acc ordance with the opinion of the 
Committee  established under Article 133 of Regulation (EC) No 1907/2006,  
HAS ADOPTED THIS R EGULATION:  
Article 1  
Annexes VI to X  to Regulation (EC) No 1907/2006 are amended in accordance with the 
Annex to this Regulation.  
Article 2  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journ al of the European Union .  
It shall apply from … [OP, please insert the date: 6 months after the entry into force of this 
amending Regulation ]. 
This Regulation shall be binding in its entirety and directly applicable in all Member States.   
EN 4  EN Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN