Draft Guidance on Annex VIII to CLP | Emergency health response

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Draft Guidance on Annex VIII to CLP

Draft Guidance on Annex VIII to CLP (Emergency health response)

Draft Version 1.0 June 2018

ECHA 20 June 2018

Guidance on harmonised information relating to emergency health response – Annex VIII to CLP Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures

This Guidance document is structured to present, after a general introduction, the main information. The main elements relevant to all the operators involved are then clarified before going into the details of the specific legal obligations.

The obligations are then described by following the same section structure of Annex VIII.

- Section 1, presents the legal background, scope and target of this document in general terms.
- Section 2 provides a list of definitions and clarifies the main terms used throughout the Guidance.
- Section 3 provides relevant information for the reader to understand whether they have obligations under Annex VIII of CLP. Therefore, section 3 clarifies who is required to submit information and to whom, by when and which mixtures fall under the scope of Annex VIII.
- Section 4, presents the need to identify the mixture using a unique formula identifier, the harmonised European categorisation system (EuPCS) and the possibility to opt for a limited or a group submission. This section further explains the basic elements and options linked to the submission of information, which should be known before the duty holder starts preparing the submission.
- Section 5 describes in detail the information to be submitted to the appointed body, as required in Annex VIII.
- Section 6 presents the available tools and the system put in place to allow industry and authorities to comply with the legal obligations.
- Section 7 explains what happens after the submission. This includes a description of the possible uses of the information submitted to the appointed bodies, the requirement that the submitter must keep the information up to date, and which changes trigger the obligation to update the submission.
- Section 8 lists the main available additional supporting tools.

Fonte: ECHA


Approfondimenti normativi

Informazioni armonizzate in materia di risposta di emergenza sanitaria

ConsultaRegolamento (UE) 2017/542 della Commissione del 22 marzo 2017 che modifica il regolamento (CE) n. 1272/2008 (CLP) del Parlamento europeo e del Consiglio relativo alla classificazione, all'etichettatura e all'imballaggio delle sostanze e delle miscele mediante l'aggiunta di un allegato relativo alle informazioni armonizzate in materia di risposta di emergenza sanitaria.


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