EN   EN  
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2019) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
on the duties placed on registrants to update their registrations under 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 re levance)  
 EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
on the duties placed on registrants to update their registrations under 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 Eur opean 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 and Commission 
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC1, and in particul ar Article 
132 thereof,   
Whereas:  
(1) Article 22(1) of Regulation (EC) No 1907/2006 places a responsibility on registrants 
(whether individual registrants or the lead registrant and other members of a joint 
submission) to update their registrations without undue delay with relevant new 
information and submit them to the European Chemicals Agency (‘the Agency’). 
Information counts as ‘new’ if the registrant has become aware of it or may reasonably 
be expected to have become aware of it since the last update or, in the absence of any 
updates, since initial registration, whether or not the information actually existed 
before then. The responsibility to update their registrations requires registrants to 
monitor and track all relevant information in order to ensure their registrations remain 
up-to-date at all times. In the case of joint submissions, the responsibility to update the 
registration is, for information that was jointly submitted , the responsibility of all the 
registrants in accordance with Article 11 o f Regulation (EC) No 1907/2006 and is  
covered by the data -sharing and cost -sharing provisions laid down in Commission 
Implementing Regulation (EU) 2016/92. 
(2) The latest general report published by the Commission in accordance with Article 
117(4) of Regulatio n (EC) No 1907/2006 indicated a need to improve compliance with 
the obligation placed on registrants in Article 22(1) of that Regulation . Compliance 
with that obligation is important to ensure that registration dossiers reflect the current 
situation at all  times , so that the Agency and Member States can evaluate dossiers and 
substances in an efficient  manner  and advice on safe use is based on up -to-date and 
                                                 
1 OJ L 396, 30.12.2006, p. 1 . 
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 (R EACH) , 
OJ L 3, 6.1.2016, p . 41–45.  EN 2  EN reliable data. Therefore, i n order to facilitate compliance with and enforcement of 
Article 22(1) of Regulation (EC) No 1907/2006 and improve efficiency in giving 
effect to the provisions of that Regulation, it is appropriate to specify  deadlines  by 
which that obligation is to be complied with .  
(3) The deadlines specified by this Regulation should be as shor t as possible , taking into 
account what, based on past practice, is reasonably  attainable by  registrants . On th at 
basis, a deadline of three months should be specified for updates of a more 
administrative nature and  deadline s of six or twelve months for more complex 
updates , such as  those requiring the generation of data or changes to the safety 
assessment. In cases  where a member of a joint submission cannot make a particular 
update until the lead registrant has first updated the registration , that membe r should 
be given three months  from the date when the Agency confirm ed that the registration  
as updated by  the lead registrant is complete.  
(4) The deadlines specified by this Regulation should operate as upper limits . In other 
words , registrants should be required to provide update s as swiftly as possible and in 
any event by no later than the relevant specified deadline. E xceeding the deadline 
would automatically lead to the conclusion that  an undue delay had occurred in 
updating the registration . Howeve r, for the purposes of point (c) of Article 22(1) of 
Regulation (EC) No 1907/2006, no deadline should be specified for the update 
triggered by a change to a lower tonnage band, given that such a change in tonnage 
may be of a temporary nature and the update  would not  have any negative 
consequence for the protection of human health and the environment.  
(5) The deadlines specified by this Regulation should apply only to the obligation in 
Article 22(1) of Regulation (EC) No 1907/2006, not to other updating obligations in 
that Regulation for which deadlines are specified elsewhere. It follows that the 
deadlines specified by this Regulation will not affect the deadlines for updates 
requested by the Agency in accordance with Article 22(2) of that Regulation , nor the 
specific deadlin es laid down in Articles 31 and 32 and in Title V of that Regulation , 
nor the deadlines for updates as a result of amendments to any of the Annexes to that 
Regulation . 
(6) In order to  allow registrants sufficient time to adapt to introducti on of the deadlines 
specified by this Regulation , this Regulation should not enter into force until the 
sixtieth day following that of its publication.  
(7) The measures provided for in this Regulation are in accordance with the opinion of the 
Committee  establi shed by Article 133(1) of Regulation (EC) No 1907/2006,  
HAS ADOPTED THIS REGULATION:  
Article 1 
Changes in a registrant’s status or in his identity  
In the case of a change falling within point (a) of Article 22(1) of Regulation (EC) No 
1907/2006, the registration shall be updated and submitted to the Agency  by no later than 3 
months from the date when that change takes effect.  
 EN 3  EN Article 2 
Changes in the composition of the substance  
In the case of a change falling within point (b) of Article 22(1) o f Regulation (EC) No 
1907/2006, the registration  shall be updated and submitted to the Agency  by no later than 6 
months from the date when manufactur e or import begins with that change in substance 
composition.  
Article 3 
Changes in  tonnage band  
1. In the case of a change falling within point (c) of Article 22(1) of Regulation  (EC) No 
1907/2006 that results in a higher tonnage band, the registration shall be update d and 
submitted to the Agency  by no later than 3 months from the following date:  
(a) in a case where new data is generated for an update  derived from the 
application of  Annex VII or Annex VIII  to that Regulation , the date when all 
the final test reports needed for the update have been received ; 
(b) in all other cases, the date when the higher tonnage band is reached.  
For cases referred to in point (a) of the first subparagraph, a contract with a testing laboratory 
shall be concluded for all the relevant tests  by no later than 3 months from the date when the 
higher tonnage band is reached.  
2. In the case of a change falling within point (c) of Article 22(1) of Regulation (EC) No 
1907/2006 that involves cessation of manufacture or import , the registration shall be updated 
and submitted to the Agency  by no later than 3 months from the date when manufacture or 
import ceased.  
3. Paragraph 1 does not apply if the change occurs as a result of the registrant restarting 
manufacture or import in accordance with Article 50(2) of Regulation (EC) No 1907/2006. 
Instead , in that situation, the registration shall be update d and submitted to the Agency  before 
manufacture or import is restart ed. 
Article 4 
New identified uses and new uses advised against  
In a case falling within point (d) of Article 22(1) of Regulation (EC) No 1907/2006, the 
registration shall b e updated and submitted to the Agency  by no later than 3 months from : 
(a) in the case of a new identified use,  the date when the registrant receives  all the 
information  needed to carry out the risk assessment  for this new use ; 
(b) in the case of  a new use advised against , the date when the  information on the 
risks associated with that use is available to the  registrant.   
Article 5 
New knowledge of the risks to human health and/or the environment  
In a case falling within point (e) of Article 22(1) of Regulation (EC) No 1907/2006, the 
registration shall be updated and submitted to the Agency  by no later than 6 months from the 
date when the registrant becomes aware or may reasonably be expected to have become aware 
of the new knowledge in question.  EN 4  EN Article 6 
Chang es in the classification and labelling of the registered substance  
1. In the case of a change falling within point (f) of Article 22(1) of Regulation (EC) No 
1907/2006 that is due to the addition, modification or deletion of a  harmonised classification  
in Annex  VI to Regulation (EC) No 1272/2008 of the European Parliament and of the 
Council3, the registration shall be updated and submitted to the Agency  by no later than the 
date as of which  that change is to apply .  
2. In the case of a change falling within point (f) of Article 22(1) of Regulation (EC) No 
1907/2006 that is due to an adaptation in the classification of a substance as a result of a new 
evaluation  in accordance with Article 15 of Regulation (EC) No 1272/ 2008, the registration 
shall be updated and submitted to the Agency  by no later than 6 months from the date when  
the decision to change the classification and labelling of the substance has been taken .  
Article 7 
Updates or amendments of the chemical safety report  
1. In a case falling within point (g) of Article 22(1) of Regulation (EC) No 1907/2006, the 
registration shall be updated and submitted to the Agency  by no later than 12 months from the 
date when the need to update or amend the chemical safety report or the guidance on safe use 
referred to in Section 5 of Annex VI to that Regulation wa s identified . 
2. By way of derogation from Articles 1 to 6 and 9 of this Regulation, i f any  circumstance 
falling within points (a) to (f) or (i) of Article 22(1) of Regulation (EC) No 1907/2006 triggers 
the need to conduct a chemical safety assessment or revise an existing chemical safety 
assessment, the update to the registration as a result of that circumstance and the update to the 
registration as a result of completing, updat ing or amending the chemical safety report shall 
each be made by no later than the deadline specified in paragraph 1 of this A rticle  and the two 
updates shall be submitted to the Agenc y together . 
Article 8 
Testing proposals prior to conducting a test listed in Annex IX or Annex X  
1. In a case falling within point (h) of Article 22(1) of Regulation (EC) No 1907/2006, the 
registration shall be updated to include the testing proposal and submitted to the Agency  by 
no later than  6 months from the date when the registrant  identifies the need to perform one or 
more  of the test s listed in Annex IX or X to that Regulation.  
2. The deadline specified in p aragraph 1 shall not apply in the case of  a testing proposal 
developed as part of a testing strategy addressing a group of substances. Instead, in that 
situation the relevant registrations shall be updated and submitted to the Agency by no later 
than 12 months from the date when the registrant or  registrants identify the need to perform 
one or more of the tests listed in Annex IX or X to that Regulation.  
                                                 
3 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 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, p. 
1). EN 5  EN Article 9 
Changes in the access granted to information in the registration  
In the case of a change falling within point (i) of Article 22(1) of Regulation (EC) No 
1907/2006, the registration shall be updated and submitted to the Agency  by no later than 3 
months from the date when the change occurred.  
Article 1 0 
Updates of joint submissions  
By way of derogation from the preceding A rticles of this Regulation, where an update  by a 
member of a joint submission pursuant to Article 22(1) of Regulation  (EC) No 1907/2006 is 
dependent on the lead registrant making a prior update to the registration,  that member shall  
update  his registration  and submit it to the Agency  by no later than 3 months  from the date  
when  the Agency confirms to the lead registrant in accordance with Article 22(3) of that 
Regulation that the registration dossier as updated by the lead registrant  is complete . 
Article 11 
Entry into force 
This Regulation shall enter into force on the six tieth 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 
 Ursula von der Leyen  
 The President