Implementing Regulation on registration updates

Date: 8 January 2019

In the course of the 28th Meeting of Competent Authorities for REACH and CLP (CARACAL) the European Commission published a document (CA/114/2018) regarding the scope of an Implementing Regulation on registration updates.

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The Commission is of the opinion that an Implementing Regulation would clarify for all actors under REACH how the duties concerning dossier updates as referred to in Article 22 should be understood in more detail. Especially, how the timing indication “without undue delay” should be understood in the context of the different cases requiring an update, and to provide clarification on the actual trigger for the updates where required.

The Commission proposes the following timeframes for the different scenarios as given in REACH article 22.


Changes triggering updates as per Article 22 (1)

 

Timeframe

 

(a) any change in his status, such as being a manufacturer, an importer or a producer of articles, or in his identity, such as his name or address

 

Within 6 months
(b) any change in the composition of the substance as given in Section 2 of Annex VI

Within 3 months for substance composition if the new composition is covered by current joint submission

Within 1 year if updated CSR or new Classification & Labelling, triggered by composition change

Within 6 months after the completion of any additional study needed based on composition change but where results do not trigger C&L or CSR changes

 

(c) changes in the annual or total quantities manufactured or imported by him or in the quantities of substances present in articles produced or imported by him if these result in a change of tonnage band, including cessation of manufacture or import

Quantities should be reviewed at least once a year.
If quantities changed or manufacture or import ceased, updates shall be done:
- Within 3 months if the change in tonnage band relates to a decrease in tonnage band or an intermediate use under strictly controlled conditions
If change of quantities trigger higher tonnage band:
- submission of testing proposal within 6 months for update of tonnage band leading to Annex IX or X requirements
- within 6 months after the completion of any additional study needed at Annex VII or when increasing to Annex VIII, and latest within 2.5 years after the end of the calendar year in which the tonnage threshold was reached or exceeded

 

 (d) new identified uses and new uses advised against as in Section 3.7 of Annex VI for which the substance is manufactured or imported

Within 3 months for registrations not requiring a CSR or if current CSR is concluded to cover new use(s)
Within 1 year for registrations requiring a CSR where the current CSR does not cover new use(s)

 

 (e) new knowledge of the risks of the substance to human health and/or the environment of which he may reasonably be expected to have become aware which leads to changes in the safety data sheet or the chemical safety report

 

 Within 1 year
 (f) any change in the classification and labelling of the substance

 Within 1 year

 

 (g) any update or amendment of the chemical safety report or Section 5 of Annex VI

 Within 1 year

 

 (h) the registrant identifies the need to perform a test listed in Annex IX or Annex X, in which cases a testing proposal shall be developed

 

 Within 6 months
 (i) any change in the access granted to information in the registration  Within 6 months






 


The planned Implementing Regulation is in connection with the announced change that ECHA will no longer inform registrants or grant a chance for dossier updates prior to regulatory measures, starting 1 January 2019. It is the declared intention of the Commission and ECHA that in case of a compliance check or dossier evaluation the registrant needs to defend the dossier as it is. ECHA stressed that it is the registrant’s duty to keep the dossiers up-to-date (e.g. remove or add uses) and not to file updates upon incident. Please also check our news item regarding changed compliance check procedure from January 2019 onwards for more details.

After seeking stakeholder input following the November CARACAL meeting, the Commission plans to bring a proposal for an Implementing Regulation to the REACH Committee in February 2019. After a first discussion of the legal text at this meeting, the Commission plans to bring it back for a vote in April 2019. Thus, it may be possible that the Implementing Regulation will enter into force already in 2019.

SCC has a lot of experience in preparing and updating REACH dossiers according to the current REACH requirements. In case you are planning to update your REACH dossiers we can provide you with support. Please get into contact with This email address is being protected from spambots. You need JavaScript enabled to view it..