Slide background
Slide background




Guidance ECHA SR&D and PPORD

ID 4843 | | Visite: 2048 | 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


Tags: Chemicals Reach Abbonati Chemicals Guida ECHA

Articoli correlati

Ultimi archiviati Chemicals

Practical Guide on Biocidal Products Regulation
Nov 15, 2019 24

Practical Guide on Biocidal Products Regulation

Practical Guide on Biocidal Products Regulation The basic principle in the Biocidal Products Regulation ((EU) No 528/2012 (BPR)) is that a biocidal product (BP) must be authorised before it can be made available on the market or used in the European Union (EU)/ European Economic Area (EEA). This… Leggi tutto
Rettifica Decreto 9 maggio 2019 n  72
Nov 14, 2019 37

Rettifica Decreto 9 maggio 2019 n. 72

Rettifica decreto del Ministro della salute 9 maggio 2019 n. 72 Avviso di rettifica - Comunicato relativo al decreto del Ministro della salute 9 maggio 2019, n. 72 concernente il «Regolamento recante l'aggiornamento al decreto del Ministro della sanita' 21 marzo 1973, recante: "Disciplina igienica… Leggi tutto
RapportoISTISAN 1918
Nov 11, 2019 37

Metalli in prodotti cosmetici | Valutazione dei rischi per la salute

Metalli in prodotti cosmetici: procedure raccomandate per la determinazione e valutazione dei rischi per la salute ISTISAN 19/18 Il Regolamento (CE) 1223/2009 sui prodotti cosmetici contiene le disposizioni armonizzate per proteggere la salute dei consumatori (art. 3) e garantire il buon… Leggi tutto
Regolamento CE  428 2009
Nov 08, 2019 45

Regolamento (CE) N. 428/2009

Regolamento (CE) N. 428/2009 Regolamento (CE) N. 428/2009 del Consiglio del 5 maggio 2009 che istituisce un regime comunitario di controllo delle esportazioni, del trasferimento, dell’intermediazione e del transito di prodotti a duplice uso GU L 134/1 del 29.5.2009 Data di entrata in… Leggi tutto
Micotossine alimenti
Ott 30, 2019 61

Relazione controllo delle micotossine negli alimenti | anno 2018

Relazione riguardante il controllo delle micotossine negli alimenti anno 2018 A cura di Ministero della Salute Anno 2019 Il Ministero della Salute, in collaborazione con l’Istituto superiore di sanità, ha predisposto a partire dall’anno 2016 il Piano nazionale di controllo ufficiale delle… Leggi tutto
Pridina
Ott 21, 2019 105

Piridina

Piridina Monografie IARC vol 77 (2000) e Vol 119 (2019) E' usata come solvente nella sintesi di prodotti chimici e nell'industria. E anche usata come denaturante in miscele di alcol e antigelo, come solvente per vernice, gomma e resine in policarbonato, come intermedio nella produzione di… Leggi tutto

Più letti Chemicals

Regolamento  CE  852 2004
Mar 06, 2019 21426

Regolamento (CE) N. 852/2004

Regolamento (CE) N. 852/2004 Regolamento (CE) N. 852/2004 del Parlamento europeo e del Consiglio del 29 aprile 2004 sull'igiene dei prodotti alimentari GU L 139/1 del 30.4.2004 Testo consolidato 2009Modificato da: Regolamento (CE) n. 1019/2008 della Commissione del 17 ottobre 2008 (GU L 277 7… Leggi tutto
Mar 02, 2019 20573

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