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ECHA - Guida alla registrazione REACH

ID 835 | | Visite: 8882 | Documenti Chemicals ECHAPermalink: https://www.certifico.com/id/835

Guidance on registration REACH

Guida alla registrazione REACH / ECHA August 2021 EN

August 2021 | Version 4.0  / Guida allegata EN  - Cambiamenti Ed. 4.0 in calce 

La guida descrive le modalità di registrazione di una sostanza ai sensi di REACH.

Essa è suddivisa in due parti: una sui compiti e sugli obblighi di registrazione e l’altra sulla preparazione e trasmissione di un fascicolo. La guida fa parte di una serie di documenti di orientamento volti ad aiutare le parti interessate nell’adempimento dei propri obblighi ai sensi del regolamento REACH. Questi documenti contengono indicazioni dettagliate relative a una serie di processi fondamentali di REACH nonché a taluni metodi scientifici e/o tecnici specifici che le imprese e le autorità devono utilizzare conformemente alle disposizioni del regolamento REACH. I documenti di orientamento sono stati redatti e discussi nell’ambito dei progetti di attuazione di REACH (REACH Implementation Projects - RIP) diretti dai servizi della Commissione europea, coinvolgendo tutte le parti interessate: Stati membri, industria e organizzazioni non governative.

I documenti orientativi possono essere reperiti sul sito web dell’Agenzia europea per le sostanze chimiche (ECHA) (http://echa.europa.eu/).

Altri documenti orientativi saranno pubblicati su questo sito web una volta ultimati o aggiornati. Il presente documento fa riferimento al regolamento REACH (CE) n. 1907/2006 del Parlamento europeo e del Consiglio, del 18 dicembre 20061 e alle relative modifiche introdotte a decorrere dal 31 agosto 2011.

Il documento descrive quando e come registrare una sostanza secondo le disposizioni REACH.

Consiste di due parti:
- compiti e obblighi relativi alla registrazione
- redazione dei fascicoli tecnici.
...
documenti in allegato

Fonte ECHA

Matrice Revisioni:

Version Changess Date
Version 0 First edition June 2007
Version 1 First revision February 2008
Version 1.1 Warning added on Only Representative issue April 2008
Version 1.2 ‘‘Only Representative’’ and the ‘‘Assigning a registration number’’ chapters amended May 2008
Version 1.3 Clarification on ‘‘Only Representative’’ added September 2008
Version 1.4 Clarification on ‘‘Only Representative’’ added November 2008
Version 1.5 Clarification on information that needs to be submitted for updating dossiers of previously notified substances (NONS) November 2009
Version 1.6 Corrigendum covering the following:- Amendment of Annex IV and Annex V of REACH by Commission Regulation (EC) No 987/2008 of 8 October 2008.
- Amendment of Annex XI of REACH by Commission Regulation (EC) No 134/2009.
- Amendment of REACH by the CLP Regulation ((Regulation (EC) No 1272/2008 of 16 December 2008).
- Amendment of Annex II of REACH by Commission Regulation No 453/2010 of 20 May 2010.
- Ratification of REACH under the EEA Agreement.
- Clarification on the registration, updating and classification and labelling notification processes.
- Reference to the Data Submission Manuals, REACH-IT Industry User Manuals and Practical Guides published by ECHA.
- Editorial corrections.
January 2011
Version 2.0 Revision of the document covering the following:- Restructuring of the content of the guidance:
- Part I focuses on the explanation of the regulatory requirements.
- Part II provides practical information for registrants.
- Further clarifications and examples of the registration requirements added.
The changes are listed in Appendix 3 of the guidance.
May 2012
Version 3.0 Revision of the document addressing the content and structure. Main changes include the following:− Removal of Part II and Appendix 3;
− Clarification of the registration scope in section 2.2.1;
− Update of the text on substances regarded as registered (section 2.2.4.1 and 2.2.4.2);
− Clarification of the text and addition of new examples on calculation of tonnage in section 2.2.3;
− Change in the sequence of chapters 3 and 4;
− Update of information on data sharing procedures (chapter 3);
− Update of the information on the inquiry process (section 3.4);
− Update of the text on standard information requirements in section 4.1.1;
− Update of the text about joint submission of data in section 4.3;
− Clarification of opt-out possibilities (section 4.3.2);
− Explanation of ‘one substance – one registration’ principle and of the SIP concept (section 5.2.1);
− Inclusion of special considerations for 1-10 tonnes dossiers in section 5.2.4;
− Update of the information about CHESAR in section 5.3.2;
− Addition of a new section 6.1.3;
− Revision of Appendix 1 and 2 in relation to outdated, incorrect or missing information;
− Inclusion of references to updated technical manuals with practical instructions on how to prepare, submit and update registration dossiers.
November 2016
Version 4.0 Revision of the document addressing the content and structure. Main changes include the following:− Alignment with the Commission Implementing Regulation (EU) 2019/1692) on the application of certain registration and data-sharing provisions of REACH after the expiry of the final registration deadline for phase-in substances:
o Changes in the whole document related to the deadlines for registration of phase-in substances;
o Removal of references to pre-registration of substances;
o Clarification of the calculation of tonnages after the end of phase-in;
o Removal of the obsolete sections as the one on non phase-in substances or the one on deadlines for registration of phase-in substances;
o Clarification on when it is needed to declare the phase-in status of a substance (section 2.3.2);
o Clarification on when the IUPAC name can be claimed confidential (section 4.4) after the end of phase-in;
o Clarification of when reduced information requirements for low tonnage dossiers can be provided (section 5.2.4);
− Alignment with the Implementing Regulation (EU) 2020/1435 on the duties placed on registrants to update their registrations under REACH (section 7.2)
o Explanation and examples on the timelines to update a dossier on the registrants’ own initiative;− Extended information on the notification of a cease of manufacture or import (section 7.2);
− New section explaining when a registration is no longer valid (section 8)
− Alignment with the Guidance on data sharing:
o Data-sharing section has been reduced and instead references have been made to the Guidance on data-sharing that is being updated in parallel to this guidance (section 3);
o Information on joint submission from the old Guidance on data-sharing such us joint submission of data, joint submission obligation and conditions for opting out from the joint submission, has been added and updated: (section 4.3).
− Streamlining of sections to make it more readable:
Removal of Annex V in section 2.2.3.4 and Annex VII in section 4.1. The reader is advised to consult the text directly in the REACH text;
Explanation of the examples for re-imported substances in section 2.2.3.6;
Chemical Safety Report section is more concise (section 5.3)
Further explanation of the technical completeness check step, what refers to automated and manual checks (section 11.3.1)− Adaptation of the text to a gender-inclusive language;
− Links added to the cross-references within the document;
− Definitions added to Appendix 1;
− Roles and duties of only representatives added to Appendix 2. 
August 2021

 

Collegati

Descrizione Livello Dimensione Downloads
Allegato riservato Guidance on registration v. 4.0 EN.pdf
ECHA - V. 4.0
1430 kB 35
Allegato riservato Guida alla registrazione v. 3.0 IT.pdf
ECHA - V. 3.0
1146 kB 15
Allegato riservato Guida alla registratione v. 1.5 IT.pdf
ECHA - V. 1.5
1889 kB 760

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