EU REACH Registration Update

The REACH registration dossier has to reflect the current knowledge on how registered substance can be used safely at production sites and by users throughout the supply chain.

This means that after successfull submission of a substance registration and receiving a registration number, there are still things to do.

The duty to update REACH registration – or contribute to the update of the joint part of the registration should be managed when:

  1. there is a knowledge on the substance or its use changes e.g. higher tonnage band, new uses, change in composition of the substance, etc.;
  2. receiving an evaluation decision requesting to add information to the registration.

The duties to keep the REACH registration dossier up-to-date is defined mostly by the COMMISSION IMPLEMENTING REGULATION (EU) 2020/1435 of 9 October 2020 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).

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 (ECHA).

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 of Regulation (EC) No 1907/2006 and is covered by the data-sharing and cost-sharing provisions laid down in Commission Implementing Regulation (EU) 2016/9.

Deadline of 3 months applplies for:

  • Changes in a registrant’s status or in his identity (Article 1)
  • Changes in the composition of the substance (Article 2)
  • Changes in tonnage band (Article 3)
  • New identified uses and new uses advised against (Article 4)
  • Changes in the access granted to information in the registration (Article 9)

Deadline of 6 months applies for:

  • New knowledge of the risks to human health and/or the environment (Article 6)
  • Testing proposals prior to conducting a test listed in Annex IX or X (Article 8) …no later than 6 months from the date when the registrant identifies the need to perform one or more of the tests listed in Annex IX or X to that Regulation.

Deadline of 12 months appies for:

  • Updates or amendments of the chemical safety report or the guidance on safe use (Article 7)
  • Testing proposals prior to conducting a test listed in Annex IX or X (Article 9) …in case of group of substances…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 Regulation (EC) No 1907/2006.

Changes in the classification and labelling of the registered substance (Article 6)

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 Council, 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.

Updates involving further testing (Article 10)

The deadlines specified in Articles 1, 2, 4, 5 and 6 of this Regulation shall not apply if any circumstance falling within point (a), (b), (d), (e) or (f) of Article 22(1) of Regulation (EC) No 1907/2006 triggers the need to generate data to satisfy the information requirements laid down in Annex VII or VIII to Regulation (EC) No 1907/2006.

In this case, the update to the registration as a result of that circumstance and the update to the registration as a result of satisfying the data requirements of Annex VII or VIII to Regulation (EC) No 1907/2006 shall be submitted to the Agency together by no later than 3 months from the date when the final test reports needed for the update have been received.

In such a circumstance:

(a) the contract negotiation with a testing laboratory shall be initiated for the relevant tests by no later than 3 months from the date when the need to conduct further tests is identified;
(b) the need to conduct further tests referred to in point (a) shall be identified within the relevant deadline specified in Article 1, 2, 4, 5 or 6 of this Regulation.

Other combined updates (Article 11)

1.   In a case covered by Article 10 of this Regulation or falling within points (a) to (f) or (i) of Article 22(1) of Regulation (EC) No 1907/2006 that also triggers the need to update or amend the chemical safety report or the guidance on safe usein accordance with point (g) of Article 22(1) of that Regulation, the update to the registration as a result of that circumstance and the update to the registration as a result of updating or amending the chemical safety report shall be submitted to the Agency together by no later than 12 months from the date when the final test reports needed for the update have been received.

2.   Without prejudice to paragraph 1 of this Article, an update of a registration that is the result of a circumstance falling within more than one of the points (a) to (i) of Article 22(1) of Regulation (EC) No 1907/2006 shall be submitted to the Agency together by no later than the longest deadline specified in Articles 1 to 10 of this Regulation, counting from the date when the first need to update the registration was identified.

Updates of joint submissions (Article 12)

1.   By way of derogation from the preceding Articles 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:

(a) no later than 3 months, in a case requiring an update as a result of a circumstance falling within points (a) to (f), or (i) of Article 22(1) of Regulation (EC) No 1907/2006;
(b) no later than 9 months, in a case requiring an update or amendment of the chemical safety report or the guidance on safe use, in accordance with point (g) of Article 22(1) of Regulation (EC) No 1907/2006;
(c) no later than 9 months, in case a circumstance falling within points (a) to (f) or (i) of Article 22(1) of Regulation (EC) No 1907/2006 that also triggers the need to update or amend an existing chemical safety report or the guidance on safe use, in accordance with point (g) of Article 22(1) of that Regulation. In that situation, the update to the registration as a result of that circumstance and the update to the registration as a result of updating or amending the chemical safety report or the guidance on safe use shall be submitted to the Agency together.

2.   The deadlines specified in paragraph 1 of this Article shall apply from the date when the Agency informs the lead registrant, in accordance with Article 22(3) of Regulation (EC) No 1907/2006, and the other members of the joint submission that the registration dossier as updated by the lead registrant is complete.

3.   Where an update by a member of a joint submission pursuant to Article 22(1) of Regulation (EC) No 1907/2006 is not dependent on the lead registrant making a prior update to the registration, the deadlines specified in Articles 1 to 11 of this Regulation shall apply.

Updates following an amendment to the Annexes to Regulation (EC) No 1907/2006 in accordance with Article 131 of that Regulation (Article 13)

1.   In the case of an amendment to one or more Annexes to Regulation (EC) No 1907/2006 in accordance with Article 131 of that Regulation that results in a change to the information required to be submitted to the Agency in accordance with Article 10 or Article 12 of that Regulation, the registration shall be updated by the date from which that amendment is to apply, at the latest, unless otherwise provided in that amendment.

2.   By way of derogation from Articles 1 to 12 of this Regulation, where an amendment to one or more Annexes to Regulation (EC) No 1907/2006 in accordance with Article 131 of that Regulation engages an obligation to update a registration dossier pursuant to Article 22(1) of Regulation (EC) No 1907/2006 subject to a deadline specified in this Regulation, only the deadline laid down in paragraph 1 of this Article shall apply, unless otherwise provided in that amendment.

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