Inquiry processing. 1. Purpose. 2. Scope. 3. Description

Transcription

1 1. Purpse T describe the assessment f inquiry dssiers submitted t ECHA accrding t Article 26(1) f the REACH Regulatin and the steps taken t ensure that the data sharing amng ptential and previus registrants can take place. This prcedure n inquiry prcessing als cvers the data requests submitted accrding t Article 12(2) f the REACH Regulatin. 2. Scpe This prcedure starts when the submissin f an inquiry dssier is cnsidered as cmplete after passing the autmated mandatry submissin checks cnducted by the Dssier Submissin & PIC Unit (C1). It ends when a cmmunicatin with the result f the assessment is sent t the ptential registrant via REACH-IT, and when applicable, t any previus (ptential) registrants. 3. Descriptin Inquiry dssiers can be divided in tw types: Inquiries accrding t Article 26(1): submitted by ptential registrants f nn-phasein substances r by ptential registrants f phase-in substances which were nt preregistered by the ptential registrant. Infrmatin requests accrding t Article 12(2): submitted by registrants which have reached their next tnnage threshld and require additinal infrmatin. Ptential registrants submit their inquiry dssiers by filling in a IUCLID dssier. Only the inquiry dssiers fr which the submissin is cnsidered as cmplete because they have passed the Business Rules check are accepted fr the inquiry prcess and enter the REACH- IT inquiry wrkflw. The handling f inquiry dssiers is divided int fur stages: Stage 1 Screening and allcatin f inquiries (see 3.1) The Inquiry Prcess Crdinatr (PC) screens the dssiers in rder t ensure a prper handling f ptential Cnflict f Interests (CI). During this screening, the PC als checks if there are inquiries that shuld be regarded as re-submissins (inquiry dssiers fr which the system can find previusly rejected inquiries fr the same substance frm the same legal entity). Based n the screening, an inquiry either is allcated t the relevant Scientific Dssier Manager (SDM) (allcatin might be dne fr initiating r verifying the case) r is made available fr being claimed by any SDM. Uncntrlled cpy nce printed. Ensure that the right versin is in use. Page 1 f 10

2 Stage 2 Assessment f the scientific and technical infrmatin regarding the substance identity (see 3.2) A SDM with Substance Identificatin (SID) expertise will be respnsible fr the dssier. The SDM will assess the dssier in rder t identify the substance inquired abut and t verify its identity. Previus registrants r previus ptential registrants f the same substance are als identified at this stage and cmparisns are made between the infrmatin prvided in their submitted dssiers. These cmparisns help t establish substance sameness in rder t bring all previus ptential registrants and ptential registrants f the same substance int cntact. This will enable the data sharing t take place amng ptential and previus registrants. After the assessment and the identificatin f any ptential previus registrants and/r previus ptential registrants fr the same substance, the SDM either accepts r rejects the inquiry. The SDM prepares the cmmunicatin and the relevant annexes fr the ptential registrant, which are then verified by anther SID expert. The results f the assessment and its verificatin (quality check) are recrded in REACH-IT. Stage 3 Prcessing f data requests (see 3.3) A SDM with Data Sharing (DS) expertise claims the task n a vluntary basis. REACH registratin dssiers are subject t an autmated search prcess, which prduces a table cntaining the relevant data t be shared. The SDM might crrect manually the autmated results. Ntificatin f New Substances (NONS) submitted under Directive 67/548/EEC, which are nt available in REACH-IT because they had nt been updated, are prcessed manually by the SDM. A SDM with DS expertise prepares the cmmunicatin and the relevant annexes fr the ptential registrant, which are then verified by anther SDM with DS expertise. The results f the assessment and its verificatin (quality check) are recrded in REACH-IT. Stage 4 Cmmunicatin f the inquiry results (see 3.4) The assessment f any inquiry dssier will result in the sending via REACH-IT f a cmmunicatin t the ptential registrant with relevant annexes. In case the inquiry is accepted and previus registrants and/r previus ptential registrants exist, cmmunicatin t these relevant parties is als autmatically sent ut via REACH-IT Stage 1 - Screening and allcatin f inquiries (step 1 n the flwchart) All inquiry dssiers, which have passed the BR checks (PRO-0002), are accepted fr prcessing. Uncntrlled cpy nce printed. Ensure that the right versin is in use. Page 2 f 10

3 The Inquiry PC screens all the inquiry dssiers received, and checks if there is any ptential CI (WIN-0105). A recrd is made in ECHA s Dcument Management System indicating whether a ptential CI was fund r nt. The Inquiry PC als checks fr each inquiry if it relates t a re-submissin. In such cases, whenever pssible, the inquiries are allcated t the same SDM and t the same verifier wh dealt with the riginal case. Any inquiry dssier that is nt allcated t a specific SDM by the PC, is available t be claimed by any SDM Stage 2 - Assessment f the scientific and technical infrmatin regarding the substance identity The SDM assesses the infrmatin given in the IUCLID dssier in rder t identify the substance and verify its identity. If the identity f the substance is clear and can be verified based n the analytical infrmatin given, previus registrants r previus ptential registrants f the same substance are identified in ECHA databases (REACH-IT and IUCLID) and listed. Ntifiers under Directive 67/548/EEC (NONS) are cnsidered as previus registrants and referred t as such in this prcedure Assessment f the dssier (step 2 n the flwchart) The infrmatin given in the inquiry dssier is assessed based n the infrmatin requirements set in Annex VI sectin 2 f the REACH Regulatin, using as needed the interpretatin prvided in the Guidance fr identificatin and naming f substances under REACH and CLP. T enable the data sharing amng ptential and previus registrants, the SDM searches in ECHA databases (REACH-IT and IUCLID) if there are ther registratin r inquiry dssiers fr the same substance. Typically, chemical identifiers such as EC/list number, EC/list name, CAS number, CAS name, IUPAC name, structural frmula are used as searching criteria. The infrmatin required depends als n the type f the substance being inquired abut. The infrmatin prvided n the identity f the substance needs t be sufficient t enable ECHA t identify previus registrants and previus ptential registrants, if existing, s that data sharing can take place. When the prvided infrmatin is nt sufficient and additinal infrmatin is required in rder t identify the substance r t verify its identity, the inquiry is rejected (step 2 n the flwchart). In case f requests fr additinal infrmatin submitted accrding t Article 12(2), if the inquiry dssier des nt cntain the infrmatin necessary t identify the substance, the infrmatin given in the registratin dssier (r in the ntificatin in the case f NONS) is taken int accunt during the scientific assessment. During the assessment, the SDM takes int accunt the infrmatin cntained in the fllwing public dcuments: Guidance fr identificatin and naming f substances under REACH and CLP Questin and Answers related t Inquiry at: Questin and Answers n inquiry: /qadisplay/5s1r/view/reach/inquiry Uncntrlled cpy nce printed. Ensure that the right versin is in use. Page 3 f 10

4 Questin and Answers n Substance Identificatin: /qadisplay/5s1r/view/reach/substanceidentificatin Questin and Answers n Data Sharing: Questin and Answers fr the registrants f previusly ntified substances: Registrants+f+Previusly+Ntified+Substances The utcme f the scientific assessment f the substance identity infrmatin is a cnclusin whether r nt the infrmatin given in the inquiry dssier is sufficient and cnsistent in rder t identify the substance and verify its identity. Based n the result f the scientific assessment f the substance identity, the inquiry is either: Accepted: The identity f the substance inquired abut is clear, the infrmatin given is cnsistent and the identity f the substance can be verified based n the analytical infrmatin given. Rejected: The identity f the substance inquired abut is ambiguus due t missing and/r incnsistent data and/r the identity f the substance cannt be verified based n the analytical infrmatin r due t the absence f analytical infrmatin. When the identity f the substance inquired abut is clear and the identity can be verified, the SDM accepts the inquiry and cnfirms the prpsed EC/list entry r prpses a new EC/list entry fr the substance subject f the inquiry (step 3 n the flwchart). The SDM als checks if the substance has already been previusly inquired abut, registered, ntified under Bicidal Prduct Regulatin (BPR, Regulatin (EU) 528/2012) r under Plant Prtectin Prducts Regulatin (EC) N 1107/2009. The numerical identifiers, name f the substance and structural frmula (if available) are used as search criteria. If several previus registrants and/r previus ptential registrants are identified, the infrmatin given in the inquiry dssier is cmpared t the infrmatin given in the existing dssiers fr the same substance. Based n the infrmatin given in the dssiers (identifiers used, cmpsitin given and analytical infrmatin) it is decided whether the substance can be cnsidered the same. When an inquiry is rejected, an annex is drafted listing the deficiencies f the dssier that prevent the substance identificatin (step 4 n the flwchart) Preparing the cver letter (step 5 n the flwchart) Depending n the result f the assessment, the type f the inquiry and whether r nt previus registrants r previus ptential registrants exist fr the substance, the relevant cver letter is autmatically created by REACH-IT. When an inquiry is accepted, infrmatin cncerning the EC/List number and EC/List name is included in the cver letter. When an inquiry is rejected, the cver letter will infrm that the identity f the substance subject f the inquiry culd nt be cnfirmed. The reasns fr rejecting the inquiry and instructins n hw t crrect the deficiencies present in the submitted dssier are stated in an annex (step 4 n the flwchart) t the cver letter. Uncntrlled cpy nce printed. Ensure that the right versin is in use. Page 4 f 10

5 Quality check f the assessment (step 6 n the flwchart): The result f the assessment and the cmmunicatin prepared by the SDM are verified by anther SDM with SID expertise. The verifier checks that the assessment has been dne crrectly by fllwing the steps described in sectins and Fr accepted inquiries, the verifier checks if the cver letter was crrectly created (step 5 n the flwchart). Mre specifically, depending n whether there are previus registrants, previus ptential registrants, ntifiers under the Bicidal Prduct Regulatin (BPR, Regulatin (EU) 528/2012) r under Plant Prtectin Prducts Regulatin (EC) N 1107/2009, different paragraphs are included in the letter. In the case f rejected inquiries, the verifier checks that all the reasns fr rejecting the inquiry and the instructins n hw t crrect the identified deficiencies (step 4 n the flwchart) are clearly explained in the relevant annex that is prvided with the cver letter. When the verifier agrees with the SDM and the inquiry is cnsidered as accepted (flwchart: frm step 7 nwards) the fllwing utcmes are pssible: If the dssier des nt cntain data request: the cmmunicatin is autmatically sent ut via REACH-IT t the ptential registrant, as well as t any previus registrants and previus ptential registrants, if the case may be. If the dssier cntains data request but there are neither previus registrants nr ntifiers under the Bicidal Prduct Regulatin (EU) 528/2012 r under Plant Prtectin Prducts Regulatin (EC) N 1107/2009: the cmmunicatin is autmatically sent ut via REACH-IT t the ptential registrant as well as t any previus ptential registrants, if the case may be. If the dssier cntains data request and there are previus registrants r ntifiers under the Bicidal Prduct Regulatin (EU) 528/2012 r under Plant Prtectin Prducts Regulatin (EC) N 1107/2009: REACH-IT frwards the case t a SDM with DS expertise. When the verifier agrees with the SDM and the inquiry is cnsidered as rejected the cmmunicatin is autmatically sent ut via REACH-IT t the ptential registrant (frm step 7 t step 15). If the verifier disagrees with the assessment and/r has cmments, the case returns t the SDM wh perfrmed the initial assessment. The SDM revises the assessment and the crrespnding cmmunicatin. When the reassessment is cncluded, the case returns fr the verificatin t the same verifier that was assigned initially t the case. The cycle cntinues until the verifier agrees with the SDM assessment Stage 3 - Prcessing f data requests Assessment f the availability f the requested data (step 10 n the flwchart) The SDM with DS expertise checks if the data requested in the inquiry dssier is available in the existing infrmatin ECHA has fr the same substance. The system autmatically retrieves the available infrmatin in existing IUCLID dssiers in REACH-IT. In sme specific cases, the results displayed autmatically might be amended manually by the SDM. Fr the claimed NONS that are nt available in REACH-IT because they have nt yet been updated, Uncntrlled cpy nce printed. Ensure that the right versin is in use. Page 5 f 10

6 and fr the unclaimed ntificatins, the availability f the data is manually checked by a SDM with DS expertise. The utcme f the assessment regarding the availability f the requested data is recrded in a table (step 11 n the flwchart) that is sent t the ptential registrant as an annex t the cmmunicatin. This table is ppulated accrding t the fllwing criteria: Prvisin f available data submitted at least 12 years previusly Where infrmatin has been submitted at least 12 years previusly, the (rbust) study summary is attached in the table tgether with the names f the previus registrants crrespnding t each endpint. Prvisin f available data submitted less than 12 years previusly If the data has been submitted less than 12 years previusly, the name f the legal entity that has submitted the infrmatin is indicated in the table Quality check f the prvided data (step 12 n the flwchart) The result f the assessment regarding the availability f the data requested, the relevant table and the study summaries attachments prepared by the SDM are verified by anther SDM with DS expertise (verifier). The verificatin ges thrugh the same steps as the initial assessment. When the verifier agrees with the SDM, the inquiry prcess is cncluded and the final cmmunicatin is sent ut via REACH-IT tgether with all relevant dcuments. If the verifier disagrees with the assessment and/r attachments and/r has cmments, the case returns t the SDM wh perfrmed the initial assessment. The SDM revises the assessment and the crrespnding dcuments. When the reassessment is cncluded, the case returns fr the verificatin t the same verifier that was assigned initially t the case. The cycle cntinues until the verifier agrees with the SDM assessment Stage 4 - Cmmunicatin f the inquiry results Cmmunicatin f the results t the ptential registrant (steps 13, 14 and 15 n the flwchart) The final cmmunicatins are prepared as fllws: Accepted inquiries: A REACH-IT message is sent t the ptential registrant. The message cntains: a link t the C-Registrant page in REACH-IT where all the cntact details f ptential and previus registrants fr the same substance subject f the inquiry are displayed. a link t the cmmunicatin. The cmmunicatin includes a cver letter with the relevant numerical identifiers (Inquiry number, EC/list number and EC/list name), an annex with the available data that was requested (if relevant), an annex with infrmatin regarding previus ntifiers under the Bicidal Prduct Regulatin (EU) 528/2012 r under Plant Prtectin Prducts Regulatin (EC) N 1107/2009 (if relevant). Uncntrlled cpy nce printed. Ensure that the right versin is in use. Page 6 f 10

7 Rejected inquiries: A REACH-IT message is sent t the ptential registrant. The message cntains: a link t the cmmunicatin. The cmmunicatin includes a cver letter and an annex where the reasns fr rejectin and instructins n hw t crrect the deficiencies are stated Cmmunicatin f the results t previus registrants and previus ptential registrants fr accepted inquiries (steps 13 and 14 n the flwchart) The cmmunicatin regarding the result f the inquiry assessment is sent t the relevant parties as fllws: Previus registrants Registrants under REACH wh have a REACH-IT accunt: A cmmunicatin is sent ut autmatically via REACH-IT cntaining a link t the C-Registrants page. Previus ntifiers that have nt claimed their registratin: A cmmunicatin is sent ut via registered mail. Ntifiers under Bicidal Prduct Regulatin (EU) 528/2012 r under Plant Prtectin Prducts Regulatin (EC) N 1107/2009: A cmmunicatin is sent ut via registered mail. Previus ptential registrants Ptential Registrants: A cmmunicatin is sent ut autmatically via REACH-IT cntaining a link t the C-Registrants page. Uncntrlled cpy nce printed. Ensure that the right versin is in use. Page 7 f 10

8 4. Flwchart Scientific and technical assessment regarding the substance identity Prcessing f data requests Cmmunicatin f the results- REACH IT 1- Screening and Allcatin f inquiries 7-Inquiry accepted? N 2- Assessment f SID infrmatin in the dssier and identificatin f any ptential dssiers fr the same substance (registratin r inquiry dssiers) Yes 15- Send cmmunicatin t: - ptential registrant Inquiry accepted Inquiry rejected 3- Prpse inquiry number (and EC r list number) 4- Draft the annex listing the deficiencies preventing the substance identificatin Ok 8-Previus registrants? N 5- Cver letter generatin 6- Quality check f the assessment Nt Ok Yes 14- Send cmmunicatin t: - ptential registrant -previus ptential registrants (if any) Yes 9- Infrmatin request? N 10- Assessment f availability f the requested data 13- Send cmmunicatin t: - ptential registrant - previus registrants - previus ptential registrants (if any) 11-Table preparatin < 12 years > 12 years List f available end pints with names f previus registrants and the (rbust) study summary List f available end pints with names f previus registrants 12- Quality check f the assessment Nt Ok Ok Uncntrlled cpy nce printed. Ensure that the right versin is in use. Page 8 f 10

9 5. Definitins Term r abbreviatin Business Rules CI DS IUCLID NONS PC Previus registrants REACH-IT SID SDM Definitin The business rules are autmatic checks dne in REACH-IT t establish that the submitted dssiers meet a set f minimum requirements. They will ensure that the dssiers can be handled prperly and that the required regulatry prcesses can be successfully carried ut. Cnflict f Interest Data Sharing Internatinal Unifrm Chemical Infrmatin Database Sftware applicatin used t capture and stre, submit, and exchange data n chemical substances. Substances that have been ntified under Directive 67/548/EEC Prcess Crdinatr Cvers previus registrants under REACH and NONS. Online platfrm t submit and prcess dssiers under the REACH and CLP regulatins. It als allws ECHA and the Member States authrities t review the dssiers. Substance Identificatin Scientific Dssier Manager with SID r DS expertise 6. Recrds Recrd name Security level Cmments Cmmunicatin t ptential registrantaccepted inquiries Cmmunicatin t ptential registrantrejected inquiries Cmmunicatin t ther relevant parties Internal Internal Internal Uncntrlled cpy nce printed. Ensure that the right versin is in use. Page 9 f 10

10 7. References Assciated dcument cde Regulatin (EC) N 1907/2006 Regulatin (EU) 528/2012 Regulatin (EC) N 1107/2009 Dcument name REACH Regulatin Bicidal Prduct Regulatin Plant Prtectin Prducts Regulatin Directive 67/548/EEC Directive n the apprximatin f laws, regulatins and administrative prvisins relating t the classificatin, packaging and labelling f dangerus substances. ECHA-11-G-10.2-EN Guidance fr identificatin and naming f substances under REACH and CLP Guidance n Data Sharing Questin and Answers n Substance Identificatin: /qadisplay/5s1r/view/reach/substanceidentificatin Questin and Answers n inquiry: Questin and Answers n Data Sharing: /qadisplay/5s1r/view/reach/data+sharing Questin and Answers fr the registrants f previusly ntified substances: /qadisplay/5s1r/view/reach/nons- Registrants+f+Previusly+Ntified+Substances N/A 8. Annexes Uncntrlled cpy nce printed. Ensure that the right versin is in use. Page 10 f 10