Slide background
Slide background

Guidance ECHA SR&D and PPORD

ID 4843 | | Visite: 1847 | Documenti Chemicals ECHAPermalink: https://www.certifico.com/id/4843

Guidance ECHA SR&D and PPORD

Update 28.11.2017

Traduzione IT

Orientamenti su ricerca e sviluppo scientifici (SR&D) e attività di ricerca e sviluppo orientate ai prodotti e ai processi (PPORD)

Guidance on Scientific Research and Development (SR&D) and Product and Process Orientated Research and Development (PPORD)

Version 2.1 October 2017

This document describes specific provisions under REACH for substances manufactured, imported or used in Scientific Research and Development (SR&D) and Product and Process Orientated Research and Development (PPORD). It is part of a series of guidance documents that are aimed to help all stakeholders with their preparation for fulfilling their obligations under the REACH Regulation.

These documents cover detailed guidance for a range of essential REACH processes as well as for some specific scientific and/or technical methods that industry or authorities need to make use of under REACH.

The guidance documents were originally drafted and discussed within the REACH Implementation Projects (RIPs) led by the European Commission services, involving all stakeholders from Member States, industry and non-governmental organisations. The European Chemicals Agency (ECHA) updates these guidance documents following the Consultation procedure on guidance. These guidance documents can be obtained via the ECHA website.

This document relates to the REACH Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006.

Version 2.1 October 2017 - Corrigendum covering the following:

- Update of the references to ECHA Manuals on preparing REACH and CLP dossiers;
- Section 3.1.6: Update of the text to reflect the full implementation of the CLP Regulation;
- Section 4.1.1: Shortening of the text and replacing the technical instructions with the references to ECHA Manual on preparing registration and PPORD notification dossier;
- Deletion of sub-sections 4.1.1.1 and 4.1.1.2 containing technical instructions on the preparation of the PPORD dossier;
- Section 4.1.2: Change of the section title. Minor clarification regarding the process of invoicing,
completeness check and issuing a notification number;
- Section 4.1.4: Improvement of wording concerning Article 9 provisions;
- Section 5.4: Removal of the redundant text on Validation Assistant plug-in;
- Minor corrections to update hyperlinks and typographical errors.
_________
Table of Contents
1. INTRODUCTION
2. DEFINITIONS
3. TASKS AND OBLIGATIONS
3.1 Substances used in scientific research and development (SR&D)
3.1.1 Absence of obligation to register under REACH
3.1.2 Exemption from authorisation under REACH
3.1.3 Exemption from restrictions under REACH
3.1.4 Classification, labelling and packaging
3.1.5 Notification to the C&L Inventory
3.1.6 Information in the supply chain
3.2 Substances used in product and process orientated research (PPORD)
3.2.1 Exemption from registration obligation for PPORD substances in quantities of 1 tonne per year or more
3.2.1.1 Information that needs to be notified to ECHA in order to benefit from an exemption for PPORD
3.2.2 Authorisation under REACH
3.2.3 Restrictions under REACH
3.2.4 Classification according to CLP
3.2.5 Notification to the C&L Inventory
3.2.6 Information in the supply chain
3.2.7 Downstream use of substances for PPORD
3.2.8 Considerations before making a PPORD notification
3.2.8.1 Deciding whether to submit a notification for use of a substance in PPORD activities that take place outside the EU/EEA and whether to list non-EU/EEA customers
3.2.9 Compliance with conditions imposed by ECHA
4. PPORD NOTIFICATION DOSSIER
4.1 Information requirements
4.1.1 Preparation of the PPORD notification dossier
4.1.2 Invoicing, completeness check and notification number
4.1.3 Fees
4.1.4 When can the manufacture/import of the substance be started?
5. PPORD NOTIFICATION UPDATE FOR NEW INFORMATION
5.1 Change of information or new information available
5.2 Cessation of the PPORD
5.3 Types of PPORD notification updates
5.4 Using IUCLID for PPORD notification update
6. EXTENSION OF THE EXEMPTION FROM THE OBLIGATION TO REGISTER
6.1 Request for an extension
7. REQUEST FOR INFORMATION AND CONDITIONS THAT MAY BE IMPOSED BY ECHA
7.1 Request by ECHA for additional necessary information from a PPORD notifier
7.2 Examples of possible conditions that may be imposed
8. CONFIDENTIALITY
APPENDIX 1: SUMMARY OF THE OBLIGATIONS FOR SUBSTANCES USED IN SR&D AND PPORD
APPENDIX 2: TEXT OF ARTICLE 9 OF REACH

Fonte: ECHA

Correlati:

Pin It
Scarica questo file (Orientamenti su SRD e PPORD.pdf)Orientamenti su SR&D e PPORDVersione 2.1 Ottobre 2017IT424 kB(243 Downloads)
Scarica questo file (Guidance ECHA SRD and PPORD.pdf)Guidance ECHA SR&D and PPORDVersion 2.1 October 2017EN620 kB(264 Downloads)

Tags: Chemicals Reach Guida ECHA

Articoli correlati

Ultimi archiviati Chemicals

Regolamento UE 2019 1148
Lug 11, 2019 90

Regolamento (UE) 2019/1148

Regolamento (UE) 2019/1148 Regolamento (UE) 2019/1148 del parlamento Europeo e del Consiglio del 20 giugno 2019 relativo all’immissione sul mercato e all’uso di precursori di esplosivi, che modifica il regolamento (CE) n. 1907/2006 e che abroga il regolamento (UE) n. 98/2013 GU L 186/1 del… Leggi tutto
Giu 28, 2019 82

Regolamento di esecuzione (UE) 2019/1102

Regolamento (UE) 2019/1102 della Commissione del 27 giugno 2019 che modifica il regolamento (CE) n. 2003/2003 del Parlamento europeo e del Consiglio relativo ai concimi al fine di adeguarne gli allegati I e IV GU L 175/25 del 28.06.2019 Entrata in vigore: 18.07.2019 ...… Leggi tutto
Giu 27, 2019 62

Decreto 15 maggio 1996

Decreto 15 maggio 1996 Procedure e norme tecniche di sicurezza nello svolgimento delle attivita' di travaso di autobotti e ferrocisterne. (GU n.155 del 04-07-1996)________ IL MINISTRO DELL'AMBIENTE Visto l'art. 3 del decreto del Presidente della Repubblica 17 maggio 1988, n. 175; Visto l'art. 12 del… Leggi tutto
Regolamento UE 2019957
Giu 12, 2019 241

Regolamento (UE) 2019/957

Regolamento (UE) 2019/957 della Commissione dell'11 giugno 2019 recante modifica dell'allegato XVII del regolamento (CE) n. 1907/2006 del Parlamento europeo e del Consiglio concernente la registrazione, la valutazione, l'autorizzazione e la restrizione delle sostanze chimiche (REACH) per quanto… Leggi tutto
Giu 11, 2019 139

Regolamento (CE) n. 710/2009

Regolamento (CE) n. 710/2009 Regolamento (CE) n. 710/2009 della Commissione, del 5 agosto 2009, che modifica il regolamento (CE) n. 889/2008 recante modalità di applicazione del regolamento (CE) n. 834/2007 del Consiglio per quanto riguarda l'introduzione di modalità di applicazione relative alla… Leggi tutto

Più letti Chemicals

Mar 02, 2019 18317

Regolamento (CE) n. 2023/2006 (Regolamento GMP)

Regolamento (CE) n. 2023/2006 Regolamento (CE) N. 2023/2006 della Commissione del 22 dicembre 2006 sulle buone pratiche di fabbricazione dei materiali e degli oggetti destinati a venire a contatto con prodotti alimentari (Regolamento GMP - Good Manufacturing Practices) ... Il presente regolamento… Leggi tutto