EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2020) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes VII to XI 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 VII to XI 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 imposes  specific registration duties and obligations on 
manufacturers, importers and downstream users with a view to generate data on 
substances they manufacture, import or use , to assess the risks related to th ose 
substances and to develop and re commend appropriate risk management measures.  
(2) Annexes VII to X to Regulation (EC) No 1907/2006 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, respectively. 
Annex XI to  that Regulation sets out the general rules for adaptation of the standard 
testing regime set out in Annexes VII to X  thereto .  
(3) In June 2019  the Commission and the European Chemicals Agency ( ‘the Agency ’) 
concluded in REACH Evaluation Joint Action Plan2 that certain provisions in the 
Annexes to Regulation (EC) No 1907/2006 should be amended to provide more clarity 
on the obligations of registrants and on the role and responsibilities of the Agency 
under Title s II and VI of that Regulation , respectively . 
(4) Experience has shown that the introductory texts of Annexes VII to X to Regulation 
(EC) No 1907/2006  are insufficient and that additional requirements  should be 
introduced for human health and environmental purposes as regards  the chosen study 
design where  a test method offers flexibility.  This should , among others,  ensure that 
animal testing is performed at appropriately high dose levels .  
(5) In order to ensure the provision of useful information, c ertain  provisions on 
information on the physicochemical prope rties of the substance in Annex VII to 
                                                 
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) .   
EN 2  EN Regulation (EC) No 1907/2006 should be clarified as regards the  information 
requirement s for surface tension and water solubility of metals and sparingly soluble 
metal compounds.  
(6) Certain  provisions on toxicological in formation in Annex VII to Regulation (EC) No 
1907/2006 should be modified  with a view to clarifying the obligations for registrants 
and the responsibilities of the Agency  as regards the performance of in vitro studies  
for eye irritation . 
(7) Various provisions on toxicological information in Annex VIII to Regulation (EC) No 
1907/2006 have been found to be unclear and should be rephrased. Those provisions 
concern, i n particular, the performance of  in vivo studies for skin or eye irritation and 
of the 28 -day repeated dose toxicity stud y.  
(8) Certain provisions on information on the physicochemical properties of the substance 
in Annex IX  to Regulation (EC) No 1907/2006  should be clarified in order to add new 
specific rules for adaptation for dissocia tion constant and viscosity.  
(9) The provisions on toxicological information in Annex IX to Regulation (EC) No 
1907/2006  require certain clarifications on when the  sub-chronic toxicity study  does 
not need to be conducted . In addition, it is necessary to amend the specific rules laid 
down in Annex es IX and X  to Regulation (EC) No 1907/2006  about  adaptation for the 
reproductive toxicity stud ies in order to better specify the cases where  testing does not 
need to be conducted. It should also be clarified how to demonstrate low toxicological 
activity of a substance in order to adapt testing. Finally, the provision setting out the 
conditions under which no further testing is necessary for sexual function and fertility 
or developmental toxicity s hould be simplified.  
(10) Annex IX  to Regulation (EC) No 1907/2006  should also be amended in order to 
exclude the waiving of conducting  relevant studies on fate and behaviour in the 
environment on the sole basis of a low octanol water partition coefficient.  
(11) The general rules for adaptation of the standard testing regime in Annex XI to 
Regulation (EC) No 1907/2006  should be modified in order to update them and to 
avoid ambiguity of certain provisions. Those  changes concern, in particular,  the 
provisions on use o f existing data, weight of evidence and grouping of substances.  
(12) Given uncertainty with regard to what can be considered as existing data, that term as 
used in Annex XI, subsection 1.1., to Regulation (EC) No 1907/2006  should be 
clarified by aligning it to Article 13(3) and (4) of  that Regulation. The reference to 
good laboratory practice  should be deleted to ensure consistency  with the enacting 
terms of that Regulation.  
(13) In Annex XI to Regulation (E C) No 1907/2006 , it should be clarified how a weight of 
evidence adaptation can be applied to sp ecific information requirements and how it 
should be documented.  
(14) It is necessary to clarify the rules laid down in Annex XI to Regulation (E C) No 
1907 /2006  concerning the establ ishment of  structural similarity. It should further be 
clarified what documentation is required for read -across, including specifically for 
substances of unknown or variable composition, complex reaction products and 
biological materials . In addition, t he reference to the Agency issuing guidance on this 
topic should be removed as the guidance  has already  been published .  
(15) The footnote  in the  section “Substance -tailored exposure -driven testing ” of Annex XI 
to Regulation (EC) No 1907/2006 should be moved to the main text to enhance its  
EN 3  EN visibility . Finally, the provisions of that section should be amended to clarify the legal 
text and align it to the changes on toxicological information.  
(16) Regulation (EC) No 1907/2006 should therefore be amend ed accordingly.  
(17) The proposed amendments aim at providing clarifications of certain information 
requirements and at increasing the legal certainty of the evaluation practices already 
applied by the Agency. Nevertheless, it cannot be discarded that the amend ed 
provisions might  trigger an update o f registration dossiers. Therefore,  the application 
of this Regulation should be deferred . 
(18) 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 REGULATION:  
Article 1  
Annexes VII to XI 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 f ollowing that of its publication in 
the Official Journal of the European Union .  
It shall apply from … [OP, please insert the date: 6 months after the entry into force of this 
Regulation ]. 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN