Questions and answers on inquiry and substance
Contents
1. inquiry number before submitting your registration as you may have legal obligations to submit a joint registration and share data The communication will also contain details of previous registrants and inquirers if any as well as a list of robust study summaries available in ECHA as appropriate 3 need to update my registration as a result of a tonnage band increase do I need to submit an inquiry If you do not need additional information as a result of a tonnage band increase you should not submit an inquiry to ECHA However in the case where you need additional information to meet the requirements for the new tonnage band you are requested to submit an inquiry to ECHA 4 How do submit an inquiry due to tonnage band increase For inquiries as a result of a tonnage band increase ECHA strongly recommends use of the online dossier creation tool as only the registration number for which the tonnage band increase relates to the tonnage band and the information requirements need to be specified For guidance on how to create online an inquiry dossier for a tonnage band increase please refer to chapter 4 4 1 of the Industry User Manual Part 11 Online dossier creation and submission for inquiries which you can find on the following website http echa europa eu doc reachit industry user manual reachit online dossier creation ing uiry en pdf Alternatively you can submit the inquiry as a IUCLID dossier via REACH IT The IUC2. that the substances are in fact the same This is only possible if the inquirer addresses all the information requirements detailed in Annex VI point 2 of the REACH Regulation this includes spectral data and analytical information point 2 3 5 2 3 6 and 2 3 7 of Annex VI Therefore irrespective of the type of registration all inquirers have to address the information requirements according to Article 26 1 of the REACH Regulation for an inquiry SUBSTANCE IDENTITY 1 Why do I need to provide analytical information Is CAS IUPAC name not enough to verify the substance identity ECHA needs to verify that the chemical identifiers such as IUPAC name or CAS name are appropriate for your substance In order to do this we require spectral and chromatographic dataset generated on your substance In general a combination of an infra red IR ultra violet UV and nuclear magnetic resonance NMR spectrum allows ECHA to verify your substance identity with a high degree of certainty A high pressure liquid chromatogram or gas chromatogram are separation techniques that effectively separate the constituents in your substance such that they can be quantified and a degree of purity and concentration s of impurities and additive s can be determined Please note that spectral and chromatographic data is usually enough for ECHA to verify the substance identity of most substances However for some substances notably inorganic substances other id
3. AECHA http echa europa eu Questions and answers on inquiry and substance identification For the latest news and the most up to date information please consult the ECHA website LEGAL NOTICE This Questions and Answers document contains information on obligations under the REACH Regulation hereafter referred to as REACH or the REACH Regulation explaining how to fulfil them This Q amp A document has been generated by the European Chemicals Agency ECHA However users are reminded that the text of the REACH Regulation Regulation EC No 1907 2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration Evaluation Authorisation and Restriction of Chemicals REACH establishing a European Chemicals Agency amending Directive 1999 45 EC and repealing Council Regulation EEC No 793 93 and Commission Regulation EC No 1488 94 as well as Council Directive 76 769 EEC and Commission Directives 91 155 EEC 93 67 EEC 93 105 EC and 2000 21 EC is the only authentic legal reference and that the information in this document does not constitute legal advice The European Chemicals Agency does not accept any liability with regard to the contents of this document Questions and answers on inquiry and substance identification Reference ECHA 11 QA 02 EN Publ date June 2011 Language EN The European Chemicals Agency ECHA is producing this document to inform interested readers about the background to a
4. LID inquiry dossier needs to contain as a minimum the following information Questions and answers on notifications on inquiry and substance identification o Section 1 1 of the substance dataset The IUPAC name and EC number o Section 1 2 of the substance dataset The full information on the composition of your substance o Section 1 3 of the substance dataset The notification or registration number o Section 14 of the substance dataset Request for information When creating your dossier please ensure that it is clear that the inquiry relates to an update of a registration by choosing Type 4 Inquiry for tonnage band increase as Type of Inquiry in section 14 of your IUCLID substance dataset Note If you have notified your substance under Directive 92 32 EEC then please note that when submitting your inquiry dossier for a tonnage band increase you must use the same Reach IT legal entity as you have used when claiming the relevant registration number 5 What is the confidentiality of the information submitted for an inquiry The information submitted for the purposes of inquiry Article 26 1 will be treated as confidential and will not be published on the dissemination website in accordance with Article 77 2 e This information is solely used by ECHA to ascertain whether the same substance has been previously registered or whether there are other inquirers for the same substance In accordance with Article 26 3 and 4 ECHA will provid
5. as a potential registrant you shall in the case of information involving tests on vertebrate animals and you may in the case of information not involving tests on vertebrate animals request information required for the registration directly from the previous registrants Therefore ECHA provides in the communication to the inquirer the contact details of the previous registrants ECHA also provides a list of the relevant robust study summaries already submitted by the previous registrants only if information requirements in the inquiry are specified 3 am having difficulty gaining cooperation from a previous registrant What can do In the case of information submitted less than 12 years prior to the inquiry REACH as per Article 27 2 and 3 requires that you inform the previous registrant in order to enter into negotiation to reach an agreement on the sharing of this information and associated costs Article 27 5 of REACH defines the context under which you may need to contact ECHA in case you are failing to gain co operation from the previous registrant s For more details please consult the Questions and Answers on data sharing and related disputes document available at http echa europa eu datasharing en asp Questions and answers on notifications on inquiry and substance identification 4 as a previous registrant have received a letter from ECHA informing me about an inquiry on a substance registere
6. d What to do next This communication is for your information as per Article 26 3 so you do not need to take any action yet However in the case of information you submitted less than 12 years prior to the inquiry REACH as per Article 27 2 3 and 4 requires that you respond to any request from a potential registrant in order to enter into negotiation to reach an agreement on the sharing of this information and associated costs Questions and answers on notifications on inquiry and substance identification INTERMEDIATES 1 am a potential registrant of an intermediate Where can specify this fact in my inquiry dossier Inquiry as per Article 26 of the REACH Regulation and registration of intermediates as per Articles 17 and 18 of the REACH Regulation are considered two distinct processes For this reason it is not necessary to specify in your inquiry dossier the type of registration you plan to submit as the same information requirements Art 26 of the REACH Regulation apply for all substances regardless of the type of the registration 2 am a potential registrant of an intermediate Do have to submit spectral data and analytical information as part of my inquiry dossier even though I do not require this information for the registration As the outcome of the inquiry process may result in the release of contact details of previous registrants and other inquirers to the new inquirer it is necessary to be certain
7. e the previous registrants and other inquirers with the name and address of the inquirer and a list of information requirements specified by the inquirer in addition to the name of the substance being inquired about No other substance identification information is disclosed 6 When will receive the details of other potential and previous registrants ECHA will release details of other inquirers and previous registrants once ECHA has received sufficient information to enable your substance to be identified and this information is consistent with the information requirements of Article 26 1 Questions and answers on notifications on inquiry and substance identification 7 ECHA was not able to process my first inquiry due to missing and insufficient information and requested me to submit a new one Do I have to state the submission number from my previous inquiry in my re submission There is no requirement to state the previous submission number s in your new submission However we recommend to specify the previous submission number s in the dossier header as such information is useful to ECHA and it may facilitate the processing of your inquiry 8 My inquiry could not been processed by ECHA due to insufficient inconsistent information Is there a deadline for re submitting an inquiry No there is no deadline for re submitting an inquiry dossier to ECHA 9 How does the Third Party Representative TPR function work for inquiry As
8. ebrate testing before receive the result of my inquiry No You need to wait until you have received the communication from ECHA which states your inquiry number together with a list of the requested robust study summaries that are available to ECHA and details of previous registrants and inquirers Depending on the data required i e whether it has been submitted more or less than 12 years prior to the inquiry you may need to request information directly from the previous registrants For studies that are less than 12 years old and submitted as part of a notification under the previous legislation or as part of a registration under REACH you are obliged to request information involving test on vertebrate animals from previous registrants You may also request information on tests not involving vertebrate animals Note REACH requires that new testing of a substance involving vertebrate animals is only carried out as a last resort For chemicals manufactured or imported in a quantity of 100 tonnes or more no testing shall be conducted for the information specified in Annexes IX and X of the REACH Regulation Instead a testing proposal must be submitted in the registration dossier The Agency shall then evaluate whether the testing proposal is adequate before such a test is performed 2 We have received an inquiry number and contact details of previous registrants What to do next In accordance with Article 27 1 of the REACH Regulation
9. entification techniques may need to be applied see also question 3 page 7 2 How do specify unknown impurities of well defined substances When your substance contains impurities that you are unable to identify you need to create a reference substance dataset for them in section1 2 of your IUCLID dataset State Questions and answers on notifications on inquiry and substance identification unknown impurities in the IUPAC name field and indicate the number and the individual concentration range of each unknown impurity in the remarks field The concentration range of impurities in the substance has to be consistent with the results of any analysis conducted on the substance An illustrative example on how to report unknown impurities in IUCLID is available on page 27 Q amp A10 of the Data Submission Manual Part 18 How to report the substance identity in IUCLID 5 for registration under REACH which is available at http echa europa eu doc reachit dsm18 substance id report iuclid en pdf 3 What spectral data does ECHA require for inquiry The information requirements for an inquiry are according to Article 26 of the REACH Regulation which in part refers to Annex VI of the REACH Regulation The purpose of the spectral data submitted is to enable each substance to be identified Based on point 2 3 5 of Annex VI as a minimum ultra violet UV infra red IR and nuclear magnetic resonance NMR spectra are required If
10. ification 5 The substance contains an anionic and cationic part Do I have to provide analytical data for the identification of each ion To confirm the presence of the ions analytical data analytical method and the result for the quantification and identification of each ion is required If it is not technically possible to determine the ion a scientifically based justification can be provided This justification will be assessed by ECHA for its scientific validity 6 Is it possible to get access to the analytical information for the substance we inquire about No because analytical data has to be generated on the substance as manufactured by each manufacturer as it is company specific Article 26 1 b of the REACH Regulation says that the identity of the substance as specified in section 2 of Annex VI shall be submitted to the Agency with the inquiry As the outcome of the inquiry process may result in the release of the contact details of previous registrants and inquirers as well as details of robust study summaries it is necessary to be certain that your substance is the same as that previously registered and or inquired about This is only possible if the potential registrant provides the information as detailed in Annex VI point 2 of the REACH Regulation If you do not have analytical information or spectral data on your substance it is then not possible for ECHA to confirm the identity of your substance Furthermore
11. it is not envisaged that a company would need to share spectral data or analytical information in order to identify its substance moreover each company should identify its substance individually 7 Where can find further information which would help me in preparing my inquiry dossier When preparing your inquiry dossier we recommend that you also read the following documents Guidance for identification and naming of substances under REACH http guidance echa europa eu docs guidance document substance id en htm Data Submission Manual Part 2 How to prepare and submit an inquiry dossier http www echa europa eu doc reachit how_to prep sub inquiry doss en pdf Data Submission Manual Part 18 How to report the substance identity in IUCLID 5 for registration under REACH http echa europa eu doc reachit dsm18 substance id report iuclid en pdf Industry User Manual Part 11 Online dossier creation and submission for inquiries http echa europa eu doc reachit industry user manual reachit online dossier creation ing uiry en pdf Question and answers on Data sharing and related disputes http echa europa eu doc datasharing datasharing q a pdf European Chemicals Agency Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 6861 80 Fax 358 9 6861 8210 http echa europa eu info echa europa eu
12. n submitted for an inquiry ra 2 6 When will receive the details of other potential and previous registrants 2 7 ECHA was not able to process my first inquiry due to missing and insufficient information and requested me to submit a new one Do have to state the submission number from my previous inquiry in my re submission ER CERs PRE ii RR DES PR a RP E E or sae cuore sau RS o RR ERRORS RD RR RE 3 8 My inquiry could not been processed by ECHA due to insufficient inconsistent information Is there a deadline for re submitting an MGUY 22255 otic tie itl ei aie sadias dn niece ee tetas 3 9 How does the Third Party Representative TPR function work for inquiry eecceeeceeeeeeeeneeeeeeeteneeeeeeeeenes 3 10 ECHA has indicated some changes to be done in our inquiry dossier but has provided us with an inquiry number Do have to re submit my dossier ser 3 11 What is the deadline for processing inquiries en 3 12 Do have to specify a production site if am an importer or only representative 3 STUDY SUMMARIES AND DATA SHARING ccccccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeseeeeeeeseeeeeseeeeeeeeees 4 1 Can begin vertebrate testing before receive the result of my inquiry 4 2 We have received an inquiry number and contact details of previous registrants What to do next 4 3 am having difficulty gaining c
13. nd basic provisions of Regulation EC No 1272 2008 If you have questions or comments in relation to this document please submit them quote the reference and issue date using the information request form quote the reference and issue date The information request form can be accessed via the Contact ECHA page at http echa europa eu about contact form_en asp European Chemicals Agency 2011 Reproduction is authorised provided the source is fully acknowledged in the form Source European Chemicals Agency http echa europa eu and provided written notification is given to the ECHA Communication Unit info echa europa eu European Chemicals Agency Mailing address P O Box 400 F1 00121 Helsinki Finland Visiting address Annankatu 18 Helsinki Finland Questions and answers on notifications on inquiry and substance identification Table of contents G N RAL eer eer rer erry ay conn Re ean Da dadas anos ERE ih Pee RanE Se a Sadia onan pee ane Pe enone Pt 1 1 submit my inquiry dossier to ECHA What happens next 1 2 Do have to wait for the result of my inquiry before submitting my registration ceeeeeeeeeeeeeeeteeeeeeeteaes 1 3 need to update my registration as a result of a tonnage band increase do need to submit an inquiry 1 4 How do submit an inquiry due to tonnage band increase ccecceeeeeeseneeeeeeeteneeeeaeeeeeeeeeeeeeeeeeeeeeeeeaeeee 1 5 What is the confidentiality of the informatio
14. ooperation from a previous registrant What can do 4 4 as a previous registrant have received a letter from ECHA informing me about an inquiry on a substance registered Wh t todo NeXt essai scsi me neadhetadssanaceduae 4adhcnsksnsseschacectavesesdenescehecseeescegeecastaghaasdasateee 5 INTERMEDIATES 2 LAEE 6 1 am a potential registrant of an intermediate Where can specify this fact in my inquiry dossier 6 2 am a potential registrant of an intermediate Do have to submit spectral data and analytical information as part of my inquiry dossier even though do not require this information for the registration 6 SUBSTANCE IDENTITY sas aa aaa a ia anais areias asia 6 1 Why do I need to provide analytical information Is CAS IUPAC name not enough to verify the substance IO GNV css anais raros E E ROS asno ter tet etree cre E ARMAS RIA terere tet terre teeny teria cena pao re tree erence 6 2 How do specify unknown impurities of well defined substances 6 3 What spectral data does ECHA require for inquiry is 7 4 Why do you require ultra violet and nuclear magnetic resonance spectra when infra red spectrum is enough tOldehtify the SUBSTANCE a e eee eai eae eaa aeaea eea a aE E EEs EEEE 7 5 The substance contains an anionic and cationic part Do have to provide analytical data for the identification of each ion sise 8 6 Is it possible to get access to the analytical informa
15. per Article 26 3 and 4 of the REACH Regulation ECHA has the obligation to communicate information to the inquirer and not to a designated third party representative TPR Therefore the result of the inquiry process will always be communicated directly to the inquirer However as per Article 4 of the REACH Regulation when informing other registrants or other inquirers ECHA will use the contact details of the TPR in place of those of the inquirer 10 ECHA has indicated some changes to be done in our inquiry dossier but has provided us with an inquiry number Do I have to re submit my dossier No you do not need to submit another inquiry dossier for this substance However the changes requested should be addressed when preparing your registration dossier to avoid potential issues with substance identity when fulfilling your registration obligations 11 What is the deadline for processing inquiries The REACH Regulation does not indicate any timeframe for processing an inquiry ECHA responds to inquiries as quickly as possible 12 Do have to specify a production site if am an importer or only representative Yes we recommend this In the context of inquiry Article 26 of the REACH Regulation you should specify in section 3 3 of your IUCLID dataset production and use sites of the substance Questions and answers on notifications on inquiry and substance identification STUDY SUMMARIES AND DATA SHARING 1 Can I begin vert
16. this information is not sufficient to identify the substance or not appropriate for the kind of substance in question additional information such as mass spectrum and or other techniques may be required If it is not technically possible or if it does not appear scientifically necessary to give information on one or more of these items a scientifically based justification is required in section 1 4 of your substance dataset in the analytical methods and spectral data field or in the appropriate justification field if you submit your inquiry online in REACH IT This justification will be assessed by ECHA for its scientific validity For inorganic substances X ray diffraction XRD X ray fluorescence XRF atomic absorption spectroscopy AAS induced coupled plasma emission spectroscopy ICP AES induced coupled plasma mass spectrometry ICP MS etc may be more suitable techniques 4 Why do you require ultra violet and nuclear magnetic resonance spectra when infra red spectrum is enough to identify the substance Infra red spectroscopy can identify the presence of certain functional groups but on its own cannot verify the chemical structure as a whole For this reason in most cases a spectral dataset that includes an infra red ultra violet and nuclear magnetic resonance spectrum is required in order to verify the substance identity with a high degree of certainty Questions and answers on notifications on inquiry and substance ident
17. tion for the substance we inquire about 8 7 Where can find further information which would help me in preparing my inquiry dossier 8 Questions and answers on notifications on inquiry and substance identification GENERAL 1 submit my inquiry dossier to ECHA What happens next Once ECHA has received your inquiry dossier it will go through some mandatory submission checks and then the dossier will be assessed If ECHA is able to process your inquiry dossier you will receive via REACH IT a communication which states your inquiry number and information on previous registrants and other inquirers of the same substance as well as details of available robust study summaries as appropriate If ECHA is not able to process your inquiry dossier due to insufficient and or inconsistent information provided on substance identification you will receive via REACH IT a communication detailing additional information required You will then need to prepare a new inquiry dossier including the information requested in the communication and submit it to ECHA We recommend when submitting a new inquiry dossier to state the previous submission number in the dossier header as such information is useful to ECHA and it may facilitate the processing of your inquiry 2 Do I have to wait for the result of my inquiry before submitting my registration Yes you need to wait until you have received a communication from ECHA stating your
Download Pdf Manuals
Related Search