EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2019) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
on the application of certain registration and data -sharing provisions of Regulation (EC) 
No 1907/2006 of the European Parliament and of the Council after the expiry of the final 
registration deadline for phase -in substances  
(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 IMPLEMENTING REGULATION (EU) …/...  
of XXX  
on the application of certain registration and data -sharing provisions of Regulation (EC) 
No 1907/2006 of the European Parliament and of the Council after the expiry of the final 
registration deadline for phase -in substances  
(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 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 a nd Commission 
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC1, and in particular 
Article  132 thereof,  
Whereas:  
(1) In order t o avoid overloading authorities and natural or legal persons with the work 
arising from the registration of substances that were already on the internal market  
when Regulation (EC) No 1907/2006  entered into force, Article 23 of that Regulation  
established a transitional regime for phase -in substances . Consequently, a number of 
different transitional deadlines  for the regis tration  of such substances were  laid down . 
It follows from  Article 23(3) of that Regulation  that the final registration deadline in 
that transitional regime expired  on 1 June 2018 . 
(2) In order to ensure  equality between market operators  manufacturing or placi ng on the 
market  phase -in and non -phase -in substances , it is necessary  to specify  the  
applicability , after the expiry of the transitional regime, of provisions that laid down  
favourable conditions for the registration of phase -in substances . Therefore , for those 
provisions , an appropriate, reasonable and clear cut -off date  should be  set, after which 
those  provisions should either no longer apply  or only apply in specific circumstances . 
To take into account  the definition of "per year" in Article 3(3 0) of Regulation (EC) 
No 1907/2006  while also ensuring that market operators have enough time to adapt , it 
is appropriate to set the cut-off date at the end of this calendar year  (31/12/2019) .  
(3) Article 3(30) of Regulation (EC) No 1907/2006  sets conditions  for the calculation  of 
the quantities per year of phase -in substances based on the  average production or 
import volumes for the three preceding calendar years . In order to  ensure that market 
operators have sufficient time to make the necessary adjustments to t heir calculation 
methods , those conditions  should , as a first measure,  continue to apply until the 
specified cut -off date . 
                                                 
1 OJ L 396 30.12.2006, p.  1.  
EN 2  EN (4) In order to reduce the possible impact of registration obligations on low volume 
substances,  Article  12(1)(b) of Regulation (EC) No 1 907/2006  lays down less 
stringent  information requirements for the registration of certain low volume phase -in 
substances. The deadline for registration of those low volume phase -in substances 
expired on 1 June 2018 , but new toxicological and ecotoxicologi cal information on 
substances in the lowest tonnage band between 1 and 10 tonnes should only be 
submitted for priority substances in that tonnage band. In order to put Article  12(1)(b) 
efficiently into effect, that provision should  therefore, as a second m easure,  continue to 
apply after 1  June 2018 . 
(5) On 1 June 2018 , the formal operation of substance information exchange fora (SIEFs) 
ceased . However, as a third measure,  the continuing data -sharing obligations of 
registrants should be reinforced and registrants should be encouraged  to use similar 
informal communication platforms to enable them to meet their continuing registration 
and data -sharing obligations under both R egulation (EC) No 1907/2006 and 
Commission Implementing Regulation (EU) 2016/92. 
(6) It is appropriate to set out , as a fourth  measure,  that a potential registrant who pre-
registered a phase -in substance in accordance with Article 28  of Regulation (EC) 
No 1907 /2006  should , until the specified cut -off date, not be required  to follow the 
inquiry process set out in Article 26 of that Regulation  because  the objective of the 
inquiry process has already been fulfilled  through the pre -registration . 
(7) It is necessary to ensure that data -sharing dispute processes are clearly identifiable . 
The data -sharing rules set out in Article 30  of Regulation (EC) No 1907/2006  should  
therefore continue to apply until the specified cut -off date. After that cut -off date , only 
the data-sharing rules in Articles 26 and 27 of that Regulation should  apply.   
(8) The measures provided for in this Regulation 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 
Calculation of quantities of phase -in substances  
1. The specific method  for calculating quantities per year of phase -in substances, as set out  
in Article 3(30)  of Regulation (EC) No 1907/2006 , shall continue to apply  only until 31 
December 2019 . 
2. Once  a registrant has completed the registration  of a substance , that registrant shall  
subsequently  calculate his quantity of that substance per calendar year  in accordance with 
Article 3(30)  of Regulation (EC) No 1907/2006 . 
                                                 
2 Commission Implementing Regulation (EU) 2016/9 of 5 January 2016 on joint submission of data 
and data-sharing in accordance with Regulation (EC) No 1907/2006 of the European Parliament and 
of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals  
(OJ L 3, 6.1.2016, p. 41).  
  
EN 3  EN Article 2 
Registration requirements for certain low volume phase -in substances  
The expiry  of the transitional regime for phase -in substances in Regulation (EC) No 
1907/2006  shall not affect the applicability of Article 12(1)(b) of that Regulation.  
Article 3 
Data-sharing obligations after registration  
After registering a substance, registrants , including those who jointly submit data with other 
registrants,  shall continue to fulfil their data -sharing obligations in a fair, transparent and non -
discriminatory way as specifie d in Title III of Regulation (EC) No 1907/2006  and in 
Implementing Regulation (EU) 2016/9.  In that con text, registrants  may use informal 
communication platforms similar to the substance information exchange fora referred to in 
Article 29 of Regulation (EC)  1907/2006.  
Article 4 
Duty to inquire and sharing of data for phase -in substances  
1. Where data -sharing negotiations conducted in accordance with Article 30  of Regulation 
(EC) No 1907/2006  result in failure to reach an agreement, the provisions of that Article shall 
apply only until 31 December 2019.  
2. After 31 December 2019 , pre -registrations made in accordance with Article 28 of 
Regulation (EC) No 1907/2006  shall no longer be valid and Articles 26 and 27 shall apply to 
all phase -in substances.   
Article 5 
Entry into force  
This Regulation shall enter into force on the  twentieth 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  
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