EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2020) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament 
and of the Council concerning the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH), as regards carcinogenic, mutagenic or reproductive 
toxicant (CMR)  substances, devices covered by Regulation (EU) 2017/745 of the 
European Parliament and of the Council, persistent organic pollutants, certain liquid 
substances or mixtures, nonylphenol and testing methods for azocolourants  
(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 2  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament 
and of the Council concerning the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH), as regards carcinogenic, mutagenic or reproductive 
toxicant (CMR) substances, devices covered by Regulation (EU) 2017/745 of the 
European Parliament and of the Cou ncil, persistent organic pollutants, certain liquid 
substances or mixtures, nonylphenol and testing methods for azocolourants  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having re gard to 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/EC1, and in particular Article s 
68(2) and 131 thereof,  
Whereas:  
(1) Entry 3 of Annex XVII to Regulation (EC) No 1907/2006 contains several references 
to labelling with R65 , which is one of the standard “R-phrases ” , indicating special 
risks arising from the dangers associated with  using the substance that were set out in 
Council Directive 67/548/EEC2. As that Directive has been repealed, the references to 
R65 should be deleted from entry  3. 
(2) Pursuant to paragraph 6 of entry 3 of Annex XVII  to Regulation (EC) No 1907/2006 , 
on 8 July 2015  the European Chemicals Agency prepared  a dossier in accordance with 
Article  69 of that Regulation  and conclud ed that there is  no need to  propose an 
amendment of the restriction  set out in that entry . Accordingly, paragraph 6 of entry 3 
has become superfluou s and should  be deleted.  
(3) Entries 22, 67 and 68 of Annex XVII to Regulation (EC) No 1907/ 2006 lay down 
restrictions as regards  pentachlorophenol  and its salts and esters , 
bis(pent abromophenyl)ether and perfluoroocta noic acid  and its salts. As more severe 
restrictions  are laid down for those substances in  Regulation  (EU) 2019/1021 of the 
                                                 
1 OJ L 396, 30.12.2006, p. 1.  
2 Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and 
administrative provisions relating to the classification, packaging and labelling of dangerous substances 
(OJ 196, 16.8.1967, p.  1).  
EN 3  EN European Parliament and of the Council3, entries 22, 67 and 68 of Annex XVII to 
Regulation (EC) No 1907/2006 should be deleted . 
(4) Entry 46  of Annex XVII to Regulation (EC) No  1907/2006 , as first included in 
Regulation (EC) No 1907/2006, contained no CAS or EC number s for nonylphenol. 
Commission Regulation (EC) No 552/20094 added a CAS number and an EC number 
to that entry, with the intention of clarifying it and allowing operators and enforcement 
authorities to apply it correctly. That addition  however  had the unintended effect that 
not all isomers of nonylphenol  are now covered by entry  46. The intention of the 
legislator at the time of adopti on of  the restriction should  therefore  be reflected by 
deleting th ose numbers.  
(5) Entries 28 , 29 and  30 of Annex XVII to Regulation (EC) No 1907/2006 prohibit the 
placing on the market and use, for supply to  the general public , of substances that are 
classified as carcinogenic, mutagenic or reproductive toxicant (CMR), categories 1A 
or 1B , and listed in Appendices 1 to 6 to that Annex  and of mixtures containing such 
substances above  specified concentration s. 
(6) Substances classified as  CMR are listed in Part 3 of Annex VI to  Regulation  (EC) No 
1272/2008 of the European Parliament and of the Council5. 
(7) After  the last amendment to Appendices 1 to 6 to Annex XVII to Regulation (EC) No 
1907/2006  by Commission Regulation (EU) 2018/6756 to take into account  new 
classifications of substances as CMR under Regulation (EC) No 1272/2008, Part 3 of 
Annex VI to Regulation  (EC) No 1272/2008  has been amended by Commission 
Regulation (EU)  2018 /14807 and by Commission Delegated Regulation (EU) 
2020 /2178. It is appropriate to add the newly classified CMR substances of categories 
1A or 1B listed in Regulations (EU) 2018/1480 and (EU) 2020/217 to Appendices 1 to 
6 to Annex XVII to Regulation (EC) No 1907/2006.  
(8) Regulation (EU) 2017/745 of the European Parliament and of the Council9 lays down 
rules concerning the placing on the market, making available on the market or putting 
                                                 
3 Regulation (EU) 2019/1021 of the European Parliament and of the C ouncil of 20 June 2019 on 
persistent organic pollutants  (OJ L 169, 25.6.2019, p.  45). 
4 Commission Regulation (EC) No 552/2009 of 22 June 2009 amending Regulation (EC) No 1907/2006 
of the European Parliament and of the Council on the Registration, Evaluati on, Authorisation and 
Restriction of Chemicals (REACH) as regards Annex XVII (OJ L 164, 26.6.2009, p.  7). 
5 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packa ging 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). 
6 Commission Regulation (EU) 2018/675 of 2 May 2018 amending the Appendices to Annex XVII to 
Regul ation (EC) No 1907/2006 of the European Parliament and of the Council concerning the 
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards CMR 
substances (OJ L 114, 4.5.2018, p. 4). 
7 Commi ssion Regulation (EU) 2018/1480  of 4 October  2018 amending, for the purposes of its 
adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European 
Parliament and of the Council on classification, labelling and packaging of substances and mixtures and 
correct ing Commission Regulation (EU) 2017/776 (OJ L 251, 5.10.2018, p. 1). 
8 Commission Delegated Regulation (EU) 2020 /217 of 4 October 2019 amending, for the purposes of its 
adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European 
Parliament and of the Council on classification, labelling and packaging of substances and mixtures and 
correcting that Reg ulation (OJ L 44, 18.2.2020 , p. 1). 
9 Regulation (EU) 2017/745 of the European Parliament and of the Council of 7 April 2017 on medical 
devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 
1223/2009 and repealing Counc il Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1) .  
EN 4  EN into service of medical devices for human use, accessories for such devices and certain 
groups of products without an intended me dical purpose. As the level of protection of 
human health provided by Regulation (EU) 2017/745 is comparable with that afforded 
by Regulation (EC) No 1907/2006 , devices  within the scope of Regulation (EU) 
2017/74 5 should be exempted from the restrictions l aid down in entries 28 -30 of 
Annex XVII to Regulation (EC) No 1907/2006.  
(9) Deletion of entry 68 of Annex XVII to Regulation (EC) No 1907/2006 should apply  
from  the date of application of the relevant provision of Commission Delegated 
Regulation (EU ) …/...10, including perfluorooctanoic acid and its salts in Annex I to 
Regulation (EU) 2019/1021 . 
(10) The classifications of substances introduced by Regulation (EU) 2018/1480 apply 
from  1 May 2020. Stakeholders  should be allowed sufficient time to take appropriate 
measures to comply  with the  restriction  introduced by this Regulation as regards 
substances classified  as CMR  category 1A or 1B  by Regulation  (EU) 2018/1480 . Six 
months period should be sufficient. The date of application  does not prevent operators  
from  apply ing the restriction s related to the CMR substances category 1A or 1B 
classified under Regulation  (EU) 2018/1480 earlier . 
(11) Delegated Regulation (EU) 2020/217 will apply  from  1 October  2021. The restriction 
introduced by this Regulation as regards substances classified as CMR category 1A or 
1B by Regulation  (EU) 2020/217 should therefore  apply from 1 Oc tober 2021.  The 
date of application  does not prevent operators from  apply ing the restriction s related to 
the CMR substances category 1A or 1B classified under  Regulation (EU) 2020/217 
earlier . 
(12) Commission Regulation  (EU) 2017/77611 made changes to titles and numbering in 
Part 3 of Annex VI to Regulation (EC) No 1272/2008 . Corresponding modifications to 
entries 28 , 29 and  30 in column 1 of Annex XVII to Regulation (EC) No 1907/2006 
were made by Regulation (EU) 2018/675 . Similar changes should be made to the titles 
of Appendic es 1 to 6 to  Annex XVII  to Regulation (EC) No 1907/2006.  
(13) Appendi x 10 to Annex XVII to Regulation (EC) No 1907/2006 lists testing methods 
for azocolourants for the purpo ses of entry 43 of that Annex. Several of th e listed 
testing methods are outdated and have been replaced by the European Committee for 
Standardization  with more up -to-date testing methods. Appendix 10 should therefore 
be amended to reflect those changes . 
(14) Regulation (EC) No 1907/2006 should therefore be amended accordingly . 
(15) The measures provided for in this Regulation are in accordance with the opinion of the 
Committee established by Article 133 (1) of Regulation (EC) No 1907/2006,  
                                                 
10 Commission Delegated Regulation (EU) …/… of 8 April 2020  amending  Annex I to Regulation (EU) 
2019/1021 of the European Parliament and of the Council as regards the listing of perfluorooctanoic 
acid (PFOA), its salts and PFOA -related compounds (OJ L …, …., p…).  
11 Commission Regulation (EU) 2017/776 of 4 May 2017 amending , for the purposes of its adaptation to 
technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the 
Council on classification, labelling and packaging of substances and mixtures  (OJ L 116, 5.5.2017, p.  
1).  
EN 5  EN HAS ADOPTED THIS REGULATION:  
Article 1  
Annex XVII to Regulation (EC) No 1907/2006 is amended in accordance with the Annex  to 
this Regulation . 
Article 2  
1. This Regulation shall enter  into force on the twentieth day following that of its 
publication in the Official Journal of the European Union . 
2. Point (6) of the Annex shall apply from [placeholder : same date as the date on which 
Commission Delegated Regulation (EU) …/… of 8 April 2020  amending  Annex I to 
Regulation (EU) 2019/1021 of the European Parliament and of the Council as 
regards the listing of perfluorooctanoic acid (PFOA), its salts and PFOA -related 
compounds  starts applying ]. 
Point ( 8)(b) of the Annex shall apply as follows:  
– rows concerning  cobalt , benzo[ rst]pentaphene  and dibenzo[ b,def ]chrysene ; 
dibenzo[ a,h]pyrene  shall apply from 1 October 2021 ; 
– rows  concerning 1,2-dihydroxybenzene ; pyrocatechol , acetaldehyde;  ethan al and 
spirodiclofen (ISO);  3-(2,4-dichlorophenyl) -2-oxo-1-oxaspiro[4.5]dec -3-en-4-yl 2,2 -
dimethylbutyrate  shall apply from … [six months following the entry into force of 
this amending Regulation ]. 
Point 11(b) of  the Annex shall apply from 1 October 2021 . 
Point (1 2)(b) of  the Annex  shall apply as follows:  
– rows  concerning cobalt , ethylene oxide ; oxirane , ethanol, 2,2' -iminobis -, N-(C13 -15 
branched and linear alkyl) derivs. , diisohexyl phthalate , halosulfuron -methyl (ISO);  
methyl 3-chloro -5-{[(4,6dimethoxypyrimidin -2yl)carbamoyl]sulfamoyl} -1-
methyl1 H-pyrazole -4-carboxylate , 2-methylimidazole  and dibutylbis(pentane -2,4-
dionato -O,O')tin  shall apply from 1 October 2021 ; 
– rows  concerning 2-benzyl -2-dimethylamino -4’-morpholinobutyropheno ne, 
propiconazole (ISO); ( 2RS,4RS;2RS,4SR )-1-{[2-(2,4-dichlorophenyl) -4-propyl -1,3-
dioxolan -2-yl]methyl} -1H-1,2,4 -triazole  and 1-vinylimidazole  shall apply from … 
[six months following the entry into force of this amending Regulation ]. 
This Regulation shal l be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen