EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2015) XXX  draft 
  
COMMISSION REGULATION (EU) …/… 
of XXX  
amending Annexes VII and VIII to Regula tion (EC) No 1907/2006 of the European 
Parliament and of the Council on the Re gistration, E valuation, Authorisation and 
Restriction of Chemicals (REACH) as rega rds skin corrosion/irritation, serious eye 
damage/eye irritation, skin sens itisation and acute toxicity  
 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION REGULATION (EU) …/… 
of XXX  
amending Annexes VII and VIII to Regula tion (EC) No 1907/2006 of the European 
Parliament and of the Council on the Regi stration, Evaluation, Authorisation and 
Restriction of Chemicals (R EACH) as regards skin corro sion/irritation, serious eye 
damage/eye irritation, skin sens itisation and acute toxicity  
 
(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 1907/2006 of the European Parliament and of the 
Council of 18 December 2006 concerning the Regi stration, Evaluation, Authorisation and 
Restriction of Chemicals (REA CH), 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 Articles 
13(2) and 131 thereof, 
Whereas: (1) Article 13(2) of Regulation (EC) No 1907/200 6 provides that test methods used to 
generate information on intrinsic properties of substances require d by that Regulation 
are to be regularly reviewed and impr oved with a view to reducing testing on 
vertebrate animals and the number of anim als involved. When appropriate validated 
test methods become available, the Commission Regulation (EC) No 440/2008
2 and 
the Annexes to Regulation (EC) No 1907/2006 should be amended, if relevant, so as 
to replace, reduce or refine animal testi ng. The principles of replacement, reduction 
and refinement, enshrined in Directive 2010/63 /EU of the European Parliament and of 
the Council3 should be taken into account.  
(2) Regulation (EC) No 1907/2006 establishes requirements for the registration of 
substances manufactured or imported in the Union on their own, in mixtures or 
articles. The registra nts have to provide the informa tion required by Regulation (EC) 
No 1907/2006, as appropriate, in order to  fulfil the registration requirements. 
(3) Pursuant to Regulation (EC) No 1907/2006, in vivo studies are required for the 
generation of information on skin sensitisati on in point 8.3 of Annex VII to Regulation 
(EC) No 1907/2006 and for skin irritation and eye irritation in po ints 8.1 and 8.2 of 
Annex VIII to Regulation (EC) No 1907/2006. 
                                                 
1 OJ L 396, 30.12.2006, p. 1.  
2 Council Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to 
Regulation (EC) No 1907/2006 of the European Pa rliament and of the Council on the Registration, 
Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 142, 31.5.2008, p. 1). 
3 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the 
protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).  
EN 3   EN (4) In recent years, significant scientific pr ogress has been made in the development of 
alternative test methods for skin corrosion/  irritation, serious eye damage/eye irritation 
and skin sensitisation. A number of test gui delines for alternativ e test methods have 
been internationally agreed by the Or ganisation for Economic Co-operation and 
Development (OECD), and have been, or are foreseen to be, incl uded in Commission 
Regulation (EC) No 440/2008. 
(5) For skin corrosion/skin irritation, adequate information for the classification and/or 
risk assessment of a substance may be obtained in most cases solely on the basis of in 
vitro  studies. A conclusion may be drawn on the basis of one test, if the result allows 
immediate classification, or from a combinati on of two tests, one fo r skin irritation and 
one for skin corrosion. In vivo  studies may still be required in some exceptional cases, 
e.g. when the substance tested falls outsi de the applicability domain of the test 
methods or when no conclusive results can be  obtained from a comprehensive set of in 
vitro tests.  
(6) For serious eye damage/e ye irritation, a set of in vitro  test methods exists which would 
be sufficient in many cases to obtain inform ation adequate for classification and/or 
risk assessment of substances. A conclusion a bout the potential of a substance to cause 
such eye effects may be drawn on the basis of  one test, if the result allows immediate 
classification, or from a combination of two or more tests. In vivo  studies may still be 
required in some cases, e.g. when the substa nce tested falls outsi de the applicability 
domain of the test methods or when no c onclusive results can be obtained from a 
comprehensive set of in vitro tests.  
(7) Points 8.1 and 8.2 of Annex VIII should thus be amended in order to remove the 
standard information requirement for an in vivo  study for skin irritation/corrosion and 
serious eye damage/eye irritation.  
(8) For skin sensitisation, several alternative test methods ha ve been validated by the 
European Union Reference Laboratory for Alternatives to Animal Testing (EURL 
ECVAM) and/or internationally agreed  by the Organisation for Economic Co-
operation and Development  (OECD). These test methods may allow the generation of 
adequate information to assess whether a s ubstance causes skin sensitisation without 
the need to resort to in vivo  testing, when applied in an appropriate combination in the 
framework of an integrated approach to testing and assessment (IATA). To reduce 
animal testing, point 8.3 of Annex V II to Regulation (EC) No 1907/2006 should 
explicitly allow waiving the in vivo test for skin sensitisation, if adequate information 
may be obtained through non-animal test methods. 
(9) In addition, the sta ndard information requirements an d adaptation rule s in points 8.1, 
8.2  and 8.3 of Annex VII, and the adapta tion rules in points 8.1 and 8.2  of Annex  
VIII should be revised in order to remove  redundancies with rules set by Annex VI 
and Annex XI and in the introductory part s of Annexes VII and VIII as regards the 
review of available data, the waiving of studies for a toxicological endpoint if the 
available information indicates that the subs tance meets the criteria for classification 
for that toxicological endpoint, or to cl arify the intended meaning as regards the 
waiving of studies for substa nces that are flammable under  certain conditions. Where 
reference is made to the classification of substances, adaptation rules should be 
updated to reflect the terminology us ed in Regulation (EC) No 1272/20084.  
                                                 
4 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives  
EN 4   EN (10) Point 8.5 of Annex VIII to Regulation (EC) No 1907/2006 provides  a standard 
information requirement for substances othe r than gases on acute toxicity by the oral 
route and, depending on the lik ely route of human exposure,  by at least one additional 
route (inhalation or dermal). Recent scient ific analysis of available data from in vivo  
acute toxicity studies have shown that substa nces that are not toxic via the oral route 
may be expected with high certainty to be also non-toxic via the dermal route. 
Therefore, testing those substances via th e dermal route does not provide essential 
information for their safety assessment. Po int 8.5 of Annex VIII to Regulation (EC) 
No 1907/2006 should thus be amended to pr ovide for the possibility to waive the 
dermal test for such substances. 
(11) ECHA, in cooperation with Member States and stakeholders, should further develop 
guidance documents for the application of the test methods and waiving possibilities 
for the standard information requirements provided by this Regulation for the purposes 
of Regulation (EC) No 1907/2006. In doing s o, ECHA should take full account of the 
work carried out in OECD, as well as in ot her relevant sc ientific and expert groups.  
(12) Regulation (EC) No 1907/2006 should therefore be amended accordingly. 
(13) The measures provided for in this Regulati on are in accordance with the opinion of the 
Committee established under Article 133 of Regulation (EC) No 1907/2006,  
HAS ADOPTED THIS REGULATION: 
Article 1 
Annexes VII and VIII 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 […] day following that of its publication in the 
Official Journal of the European Union . 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
 
 For the Commission 
The President  […] 
                                                                                                                                                        
 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 
1)