Data Submission Manual. Part 18 - How to report the substance identity in IUCLID 5 for registration under REACH

Transcription

1 Part 18 - How to report the substance identity in IUCLID 5 for registration under REACH

2 Document history Version Changes 1.0 First version Reference: ECHA-10-B-27-EN Issue date: 06/2010 Language: English If you have questions or comments that relate to this document, please send them using the information request form to ECHA helpdesk. Quote the reference and issue date as stated above. The information request form can be accessed via the ECHA web site under the section for the REACH helpdesk at the following address: European Chemicals Agency, Reproduction is authorised provided the source is fully acknowledged in the form "Source: European Chemicals Agency, and provided written notification is given to the ECHA Communication Unit Version 1.0 Page 2 of 32

3 Table of Contents 1 Introduction Substance identity in IUCLID Reference substances Substance identification in IUCLID sections 1.1 and Well-defined substances Mono-constituent substances Multi-constituent substances Registration of individual constituents of a multi-constituent substance UVCB substances Specific considerations Substance identity in REACH-IT REACH-IT management of substance identity in registrations Specific considerations...30 Table of Figures Figure 1: Where to report specific and related information in a reference substance....6 Figure 2: Profile of a reference substance for a known constituent or a mono-constituent substance...7 Figure 3: Profile of a reference substance for a multi-constituent substance...8 Figure 4: Profile of a reference substance for a UVCB substance named in accordance with the manufacturing process...9 Figure 5: Profile of a reference substance for a group of unknown constituents defined by a generic description of their chemical nature in a UVCB substance...10 Figure 6: IUCLID sections 1.1 and 1.2 profile for a mono-constituent substance...12 Figure 7: IUCLID sections 1.1 and 1.2 profile for a multi-constituent substance...14 Figure 8: IUCLID sections 1.1 and 1.2 profile for the registration of an individual constituent of a multi-constituent substance...16 Figure 9: IUCLID sections 1.1 and 1.2 profile for the registration of an individual constituent of a multi-constituent substance...17 Figure 10: IUCLID sections 1.1 and 1.2 profile for a UVCB substance Figure 11: Reporting of the justification for the deviation from the 80%...21 Figure 12: How to report EINECS information not specifically corresponding to a substance Figure 13: IUCLID section 1.2 profile of for the reporting of 2 compositions Figure 14: IUCLID sections 1.1 and 1.2 profile for a registration with application of Annex V(6) of REACH...25 Figure 15: IUCLID sections 1.1 and 1.2 profile for a registration with application of Annex V(6) of REACH...26 Figure 16: Illustrative example on how to report unknown impurities in the composition of a welldefined substance...27 Figure 17: Decision tree for the identification of a substance in the joint submission in REACH-IT and in IUCLID sections 1.1 and 1.2 of a registration dossier...29 Version 1.0 Page 3 of 32

4 1 Introduction The purpose of this manual is to provide detailed and illustrative technical assistance in how to report and structure the substance identification in a IUCLID 5 dossier, in particular a registration dossier. This manual also clarifies the verifications REACH-IT does to ascertain that the information on the substance identification of a registered substance is consistent with other related information specified in REACH-IT in the context of other processes (pre-registration; inquiry; joint submission). Registrants should follow the recommendations provided in this manual to ensure that there is no technical ambiguity on the identity of the registered substance. Such ambiguity may otherwise prevent them from successfully submitting a registration for the specific substance they intend to register. It should be noted that this manual does not provide guidance on how to correctly identify a substance in accordance with the REACH Regulation. For further information on how to identify a substance under REACH, please refer to the Guidance for identification and naming of substances under REACH available on the ECHA website at Further guidance on how to create and submit a dossier can be found in Data Submission Manual 4: How to Pass Business Rule Verification ("Enforce Rules") and Industry User Manual - Part 6: Dossier Submission available at 2 Substance identity in IUCLID A registration dossier is created in IUCLID from a Substance dataset. A substance dataset can be defined as a repository of data in IUCLID for a particular substance. Information on the substance identity is reported in IUCLID sections 1.1 and 1.2 of the substance dataset: The data on the substance identity (including substance name, description and type) is reported in Section 1.1. The data related to the composition of the substance (i.e. identification and concentration of the (main) constituents/impurities/additives) is reported in Section 1.2. The Guidance for identification and naming of substances under REACH specifies the guidelines, including systematic rules, for identifying substances under REACH. The Guidance also provides explanations on how to report the information in IUCLID (see Chapter 8 of the Guidance). In addition, technical rules (IT business rules) for the reporting of the substance identity in IUCLID sections 1.1 and 1.2 have also been defined to facilitate the proper management of the substance identity once the dossier has been submitted to REACH-IT. These technical rules, which are consistent with the Guidance, need to be taken into account when reporting the substance identity in IUCLID. In this chapter, technical instructions on how to correctly report the substance identity in IUCLID in line with both the Guidance and REACH-IT are provided. 2.1 Reference substances Information on the chemical identity of individual constituents, specific groups of constituents (if appropriate) and the substance itself is stored in IUCLID in reference substances. It is important to note that the information reported in a reference substance should accurately identify the substance or constituent(s) of the substance covered by that reference substance. Two types of information can be reported in a reference substance, as illustrated in Figure 1: Version 1.0 Page 4 of 32

5 Information specific to the reference substance: such information exactly corresponds to the substance/constituent(s) covered by that reference substance; Information related to the reference substance: this information does not accurately correspond to the substance/constituent(s) covered by that reference substance for any of the following reasons: o o o The information is generic as it also covers other substances/constituents; The information only covers some of the constituents of a reference substance for a substance or a group of constituents; The information refers to a similar constituent/substance; o The information is not the latest available information to identify the substance/constituent(s). Related information should only be reported under the Related CAS information as it may create an ambiguity on the identity of the substance or constituent(s) which a reference substance corresponds to. The screenshots provided in Figures 2-5 illustrate the level of detail in the information to be provided for the following representative reference substances: Reference substance for a mono-constituent substance or a known constituent; Reference substance for a well-defined multi-constituent substance; Reference substance for a UVCB substance; Reference substance for a group of unknown constituents of a UVCB substance. Please note that the level of information to be provided in a reference substance always needs to be adapted to the specificities of the substance/constituent(s) covered by that reference substance. Version 1.0 Page 5 of 32

6 Figure 1: Where to report specific and related information in a reference substance. Version 1.0 Page 6 of 32

7 Figure 2: Profile of a reference substance for a known constituent or a mono-constituent substance - Example of o-xylene. Version 1.0 Page 7 of 32

8 Figure 3: Profile of a reference substance for a multi-constituent substance - Example of the Reaction mass of ethylbenzene and m-xylene and p-xylene. Version 1.0 Page 8 of 32

9 Figure 4: Profile of a reference substance for a UVCB substance named in accordance with the manufacturing process - Example of the Oligomerisation reaction products of phenol with formaldehyde. Version 1.0 Page 9 of 32

10 Figure 5: Profile of a reference substance for a group of unknown constituents defined by a generic description of their chemical nature in a UVCB substance - Example of (2 to 17)-Monochlorooctadecan-1-yl acetate. Version 1.0 Page 10 of 32

11 2.2 Substance identification in IUCLID sections 1.1 and Well-defined substances Mono-constituent substances A mono-constituent substance is a well-defined substance for which one constituent is present at a concentration of at least 80 %(w/w). This constituent is the main constituent of the substance. A mono-constituent substance is named according to the chemical name of that main constituent. Check-list for IUCLID sections 1.1 and 1.2 of a mono-constituent substance: Select Mono constituent from the dropdown list of the composition field under the Type of substance header in section 1.1. Assign the reference substance corresponding to the main constituent of your substance in section 1.1. Report only one constituent, the main constituent, under the Constituents header in section 1.2. Assign the same reference substance for this constituent as the reference substance assigned in section 1.1. Report individually any other constituent under the Impurities header of the composition. Report any additive necessary to stabilise your substance under the Additives header. Specify the stabilising function of additive. Report the concentration of the main constituent, any impurity and any additive as a concentration range and typical concentration. NB: The concentration/concentration range reported for the main constituent should normally not be less than 80%(w/w). 1 Report a degree of purity for your substance corresponding to the concentration range of the main constituent. The screenshots provided in Figure 6 illustrate the typical profile of sections 1.1 and 1.2 of a monoconstituent substance. 1 Any deviation from the 80% rule should not be applied, unless a valid justification is provided. For further information, please refer to the Q&A5 in chapter 2.3 of this manual. Version 1.0 Page 11 of 32

12 Figure 6: IUCLID sections 1.1 and 1.2 profile for a mono-constituent substance - Example of Styrene.

13 Multi-constituent substances A multi-constituent substance is a well-defined substance for which more than one constituent is present at a concentration 10 % and < 80 %(w/w). These constituents are the main constituents of the substance. A multi-constituent substance is normally named as a reaction mass of the main constituents. 2 Check-list for IUCLID sections 1.1 and 1.2 of a multi-constituent substance Select Multi constituent from the dropdown list of the composition field under the Type of substance header in section 1.1. Assign the reference substance corresponding to the reaction mass of the main constituents of your substance in section 1.1. Report the main constituents under the Constituents header in section 1.2. NB: The main constituents should be the same for all compositions reported. Report any other constituent below 10% under the Impurities header of the composition. Report any additive necessary to stabilise your substance under the Additives header. Specify the stabilising function of the additive. Report the concentration of the main constituents, any impurity and any additive as a concentration range and typical concentration. NB: The concentration/concentration range of each main constituent should normally be 10 and < 80%. 3 Report a degree of purity for your substance corresponding to the overall concentration range of the main constituents. The screenshots provided in Figure 7 illustrate the typical profile of section 1.1 and 1.2 of a multiconstituent substance. 2 Certain multi-constituent substances corresponding to reaction masses of isomers may sometimes be more conveniently named using a chemical name where the isomeric form is not specified rather than as a reaction mass. For further information, please refer to the Q&A7 in chapter 2.3 of this manual. 3 Any deviation from the 80% rule should not be applied, unless a valid justification is provided. For further information, please refer to the Q&A5 in chapter 2.3 of this manual. Version 1.0 Page 13 of 32

14 Figure 7: IUCLID sections 1.1 and 1.2 profile for a multi-constituent substance - Example of the Reaction mass of ethylbenzene and m-xylene and p-xylene.

15 Registration of individual constituents of a multi-constituent substance Under very specific and exceptional circumstances (see chapter of the Guidance for identification and naming of substances under REACH), registrants may register the individual constituents of a multi-constituent substance instead of the multi-constituent substance itself. Check-list for IUCLID sections 1.1 and 1.2 of a registration dossier for a constituent of multi-constituent substances: Select Mono constituent from the dropdown list of the Composition field under the Type of substance header in section 1.1. Assign the reference substance corresponding to the constituent to be registered in section 1.1. For technical reasons, report as first composition in section 1.2 the composition of the corresponding mono-constituent substance. Important remarks: If you manufacture or import such a mono-constituent substance, you should report the composition of that substance as the first of the listed compositions (see illustrative example in Figure 8). If you do not manufacture or import such a mono-constituent substance, you will still need to report as the first composition in section 1.2 a composition corresponding to the mono-constituent substance. We therefore recommend you to report the composition of the appropriate substance used as test material in the registration. In the Brief description field of that composition, please indicate the following: This composition is neither manufactured nor imported but corresponds to the substance used as test material in the registration (see illustrative example in Figure 9) Report all other relevant compositions where the constituent, to which the registration dossier refers, is present. Include in the Brief description field: Composition covered by the registration of the individual constituents. Follow the instructions in chapter and on how to report the compositions. Version 1.0 Page 15 of 32

16 Figure 8: IUCLID sections 1.1 and 1.2 profile for the registration of an individual constituent of a multi-constituent substance - Example of Aniline from a registrant manufacturing the following substances 4 : - Aniline; - Reaction mass of aniline and naphthalene; - Reaction mass of aniline and 1-naphthalenamine and naphthalene; - 1-Naphthalenamine. 4 The registrant will need to submit separate registrations for each individual constituent present in the well-defined substances for which this registration approach is applied.

17 Figure 9: IUCLID sections 1.1 and 1.2 profile for the registration of an individual constituent of a multi-constituent substance - Example of Naphthalene from a registrant manufacturing or importing the following substances 5 : - Aniline - Reaction mass of aniline and naphthalene; - Reaction mass of aniline and 1-naphthalenamine and naphthalene; - 1-Naphthalenamine. 5 The registrant will need to submit separate registrations for each individual constituent present in the well-defined substances for which this registration approach is applied.

18 2.2.2 UVCB substances UVCB substances (i.e. substances of Unknown or Variable composition, Complex reaction products or Biological materials) are substances which can typically not be sufficiently identified by their chemical composition. Check-list for IUCLID sections 1.1 and 1.2 of a UVCB substance Select UVCB from the dropdown list of the Composition field under the Type of substance header in section 1.1. Assign the reference substance corresponding to the UVCB substance in section 1.1. Report the appropriate individual constituents or group of constituents under the Constituents header in section 1.2. Important remarks: In order for you to provide information on the constituents/groups of constituents of your substance, please do not reuse, in section 1.2, the reference substance already assigned for your substance in section 1.1. Do not report any constituent under the Impurities header of the composition (the terms main constituents and impurities are not considered relevant for UVCBs). Report any additive necessary to stabilise your substance under the Additives header. Specify the stabilising function of the additive. Report the concentration of the individual constituents, groups of constituents and any additive as a concentration range and typical concentration. Report the appropriate degree of purity for your UVCB substance (the degree of purity should normally be 100% for UVCBs which do not include any additive, as the concept of impurity is not considered relevant for these substances). Figure 10 illustrates the typical profile of IUCLID sections 1.1 and 1.2 of a dossier for the registration of a UVCB substance. Version 1.0 Page 18 of 32

19 Figure 10: IUCLID sections 1.1 and 1.2 profile for a UVCB substance - Example of Acetylated 7-methylocta-1,6-diene.

20 2.3 Specific considerations Q&A1: I pre-registered a substance which was not listed in the EINECS. In the list of preregistered substances published by ECHA, a list number has been assigned to my substance. Should I report this list number in my registration dossier? The list numbers published by ECHA are not official EC entries and should therefore only be regarded as equivalent to provisional EC entries. However, we recommend you to assign such an entry to the phase-in substance you intend to register provided this list number is linked to a CAS number (list numbers starting with 6) or a chemical name (list numbers starting with 9) corresponding to a correct and specific identifier for your substance. If this entry is too generic for your substance and there is no other appropriate (provisional) EC entry available, you should not assign such an entry to your substance. Q&A2: What happens if I do not assign an EC entry to my phase-in substance? REACH-IT will provide you with a provisional EC entry once your registration passes the business rules (for further information on business rules. You will be able to download this automatically created EC entry as an i5z file from REACH-IT. For further information, please follow the instructions given in Appendix of the Data submission manual 4). You will be requested to assign this provisional EC entry when submitting any update of your registration. Q&A3: I intend to register a non-phase-in substance. How can I find out whether a (provisional) EC entry is available for my substance? Before submitting the registration for a non-phase-in substance, you will need to submit an inquiry (Article 26 of the REACH Regulation). Upon the successful processing of your inquiry, ECHA will provide you with a (provisional) EC entry which you will be requested to use when submitting your registration. Please note that you will also need to submit an inquiry for an EINECS-listed substance which you did not pre-register. Q&A4: My substance includes configurational isomers. Should I regard it as a monoconstituent substance? Configurational isomers (e.g. enantiomers, diastereoisomers, regioisomers) are regarded as different constituents. Therefore your substance may only be regarded as a mono-constituent substance if one specific isomeric form is present at a concentration of at least 80%. Q&A5: How should I document any deviation from the 80% rule for the naming of my welldefined substance? The Guidance for identification and naming of substances under REACH sets concentration thresholds for the identification of the constituents which contribute to the naming of the substance (i.e. the main constituents). Any deviation from these conventions must be justified. A justification should be provided for each constituent where such a deviation is applied to. This justification should be included in the Remarks field in the repeatable block that constituent (see Figure 11). Version 1.0 Page 20 of 32

21 Figure 11: Reporting of the justification for the deviation from the 80% - Example of deviation for a substance with a constituent having a concentration overlapping 80%. Q&A6: Where can I report relevant EINECS information which does not specifically correspond to my substance? CAS information is available for each EINECS entry. If your substance is covered by a broad/generic EINECS entry, you should not use this entry to identify your substance. You may however refer to such an EINECS entry by reporting the associated CAS number and CAS name under the Related CAS information header of the reference substance assigned to your substance (see Figure 12). Version 1.0 Page 21 of 32

22 Figure 12: How to report EINECS information not specifically corresponding to a substance Example of the reference substance for mono-constituent substance (3R)-3-Methylhexan-2-one (CAS number ; not listed in EINECS; EINECS entry for 3-Methylhexan-2-one available (EC number ; CAS number )). Q&A7: My substance is a multi-constituent substance which consists of a reaction mass of all the possible stereoisomeric forms for my substance. Am I technically required to name my substance as a reaction mass in section 1.1? Provided your well-defined substance consists of all possible stereoisomeric forms as the main constituents of that substance, you can identify your substance in section 1.1 using only the IUPAC name of the substance without specifying the stereochemistry. However you should still identify your substance as a multi-constituent substance. Information on the identity and concentration of each of the individual stereoisomers should be reported in section 1.2. Q&A8: I manufacture or import different grades of the same substance. How should I report the different compositions in IUCLID section 1.2? IUCLID enables you to report several compositions in section 1.2. If you manufacture compositions of the same substance with different purity profiles, you should report each composition individually in section 1.2 (see Figure 13). Should your substance be a well-defined substance, you should ensure that the same main constituents are listed under the Constituents header of each composition. Version 1.0 Page 22 of 32

23 For clarity, report a meaningful and representative name for each composition reported in section 1.2. Figure 13: IUCLID section 1.2 profile of for the reporting of 2 compositions Example of the (3R)-3-Methylhexan- 2-one mono-constituent substance with different purity profiles. Q&A9: I want to make use of the specific provision in Annex V(6) of the REACH Regulation for the registration of hydrates. How should I report the different compositions which can be covered in one registration? The anhydrous form of a substance and any of its hydrated forms are regarded as different substances. If you want to make use of the specific provision for the registration of hydrated forms of a substance in Annex V(6) of the REACH Regulation, you should prepare a registration for the anhydrous form of the substance and report all the different compositions covered by the registration in section 1.2. Please follow the instructions in the check-list below: Version 1.0 Page 23 of 32

24 Check-list for IUCLID sections 1.1 and 1.2 of a registration dossier for the anhydrous form of a substance and covering also hydrated forms: Select the substance type corresponding to the anhydrous form of your substance from the dropdown list of the Composition field under the Type of substance header in section 1.1. Assign the reference substance corresponding to the anhydrous form of your substance in section 1.1. For technical reasons, report as first composition in section 1.2 the composition of the anhydrous form of your substance. Important remarks: If you manufacture or import the anhydrous form of the substance, you should report the composition of that substance as the first of the listed compositions (see illustrative example in Figure 14). If you do not manufacture or import the anhydrous form, you will still need to report as the first composition in section 1.2 a composition corresponding to the anhydrous substance. We therefore recommend you to report the composition of the anhydrous substance used as test material in the registration. In the Brief description field of that composition, please indicate the following: This composition is neither manufactured nor imported but corresponds to the substance used as test material in the registration (see illustrative example in Figure 15). Report all other relevant compositions, including the different hydrated forms of the substance which are covered by this registration. Specify in the Brief description field: Composition covered by the registration of the anhydrous form of the substance. Follow the instructions given in chapter 2.2 of this manual on how to report the compositions. Version 1.0 Page 24 of 32

25 Figure 14: IUCLID sections 1.1 and 1.2 profile for a registration with application of Annex V(6) of REACH Example of a registrant manufacturing the following substances: - 2H-Tetrazol-5-amine (anhydrous); - 2H-Tetrazol-5-amine monohydrate.

26 Figure 15: IUCLID sections 1.1 and 1.2 profile for a registration with application of Annex V(6) of REACH Example of a registrant manufacturing only 2H-Tetrazol- 5-amine monohydrate.

27 Q&A10: I have reported the identity of all known constituents and the constituents I am required to identify for my well-defined substance. Still the total concentration of these constituents does not reach 100%. How should I reflect this in the composition of my substance? If your well-defined substance includes impurities which you are not required to identify and for which the structure is unknown, we recommend you to create a generic reference substance called Unknown impurities and indicate unknown impurities in the IUPAC name field. Create a repeatable block under the Impurities header of a composition and assign this reference substance. Report the overall typical concentration and concentration range. In the remarks field please indicate the number of these unknown impurities (see Figure 16). For further information on the constituents of well-defined substance, please refer to chapters 4.2 and 4.3 of the Guidance for identification and naming of substances under REACH. Figure 16: Illustrative example on how to report unknown impurities in the composition of a well-defined substance. Q&A11: Information on the chemical composition of my well-defined substance alone is not sufficient to identify my substance. Where should I report this information - in the description field of the reference substance assigned in section 1.1 or in the Brief description field of the composition in section 1.2? Additional parameters such as physical parameters which are determinant for the identification of your substance (e.g. crystalline structure) should be reported in section 1.1 as they are specific to the substance which your dossier refers to. This information should be reflected as far as possible in the chemical name of your substance (for instance by reporting the mineral name). It may in addition be further detailed in the Description field of the reference substance assigned in section Substance identity in REACH-IT 3.1 REACH-IT management of substance identity in registrations REACH-IT links information on the substance identity to a number of objects which are relevant for the registration process: Version 1.0 Page 27 of 32

28 During the processing of a registration submitted to ECHA, REACH-IT completes the following cross-checks of the information on the substance identity: The pre-registration number assigned to a pre-registration is linked to the identity of the substance as pre-registered; The inquiry number is linked to the (provisional) EC entry provided by ECHA for the substance which was inquired about; The joint submission created in REACH-IT by the lead registrant is linked to the identity of the substance as specified in REACH-IT: o o A registration dossier is linked to the identity of a substance as defined in IUCLID section 1.1 or 1.2: o o o o If the joint submission is created using a pre-registration/inquiry number, the identity of the substance linked to the joint submission is the same as the identity linked to the pre-registration/inquiry number; If the joint submission is not created using a pre-registration/inquiry number, the information on the identity of the substance is entered manually during the creation of the joint submission. If the registration is for a mono-constituent or a UVCB substance, the registration is linked to the information reported in IUCLID section 1.1 according to the following priority order: EC number > CAS number > IUPAC name. If the registration is for a multi-constituent substance for which a (provisional) EC entry has been reported in section 1.1, the registration is linked to that EC entry If the registration is for a multi-constituent substance for which a (provisional) EC entry has not been assigned in section 1.1 because it is not yet available, the registration is linked to a substance identified as the reaction mass of the main constituents reported in the 1 st composition of IUCLID section 1.2; For all other cases, the registration is linked to the substance identity information in section 1.1. REACH-IT verifies that the identity of the substance as defined in a joint submission in REACH-IT is consistent with the identity of the substance in the registration; If an inquiry number is reported in IUCLID section 1.3 of the registration dossier, REACH-IT also verifies that the identity of the substance linked to the inquiry number matches the (provisional) EC entry assigned by ECHA for the substance in section 1.1. It should be noted that REACH-IT does not verify whether the substance identity information linked to a pre-registration number reported in IUCLID section 1.3 matches the information reported in IUCLID sections 1.1 and 1.2. Further information on important considerations to ensure that the dossier will pass the substance identity business rules is presented in Data Submission Manual 4: How to Pass Business Rule Verification ("Enforce Rules"). A decision tree on how to correctly identify a substance during the joint submission creation in REACH-IT and in a registration dossier is provided in Figure 17. Version 1.0 Page 28 of 32

29 Figure 17: Decision tree for the identification of a substance in the joint submission in REACH-IT and in IUCLID sections 1.1 and 1.2 of a registration dossier. NO I should include in my registration dossier the correct information to unequivocally identify the substance. This information does not necessarily have to match the information specified at the pre-registration phase. YES Am I part of a SIEF? YES Has the lead registrant (LR) correctly pre-registered the substance? NO The LR should not use his/her pre-registration number to create the joint submission in REACH-IT. The LR should instead enter manually the correct substance identity when creating the joint submission. I should use in my registration dossier the same EC, CAS or IUPAC identifiers used by the LR to create the joint submission in REACH-IT.(*) Is the substance a phase-in substance which I pre-registered? YES The LR can use his/her pre-registration number to create the joint submission in REACH-IT. I should use in my registration dossier the same EC, CAS or IUPAC identifiers used to create the joint submission in REACH-IT.(*) NO I should submit an inquiry Has the substance already been registered? YES Is the registration part of a joint submission? YES I should become member of the joint submission. I should assign in my registration dossier the EC entry as specified by ECHA in the inquiry result for my substance.(*) NO NO Has the registrant preregistered the substance? YES I should form a joint submission with the registrant. If the LR is the existing registrant, he/she can use the pre-registration number to create the joint submission in REACH-IT, provided the substance was correctly preregistered.(**). If I am the LR, I should use the inquiry number to create the joint submission in REACH-IT. I should assign in my registration the EC entry as specified by ECHA in the inquiry result for my substance.(*) NO Is there another inquirer? YES I should form a joint submission with the other Company. The LR (the other Company or I) should create a joint submission in REACH-IT using the inquiry number. I should assign in my registration the EC entry as specified by ECHA in the inquiry result for my substance.(*) NO I should assign in my registration dossier the EC entry as specified by ECHA for my substance.(*) (*) Mandatory business rule in REACH-IT (**) A LR having incorrectly identified a substance at the pre-registration stage should enter manually the correct substance identity when creating the joint submission in REACH-IT

30 3.2 Specific considerations Q&A1: Following discussions with the pre-sief members, we realised that two pre- SIEFs need to be merged into one SIEF. How should we proceed? In order to merge pre-siefs, you will need to do the following: Contact the other pre-sief by following the instructions provided in the question 19 of the REACH-IT Frequently Asked Questions -Technical aspects available on the ECHA website at Establish which pre-registrant should be the lead registrant of the joint submission; The lead registrant should create a joint submission in REACH-IT for the substance. The lead registrant should use his/her pre-registration number to create the joint submission only if the identity of the substance as specified in his/her pre-registration specifically and correctly identifies the substance to be registered. Every member of the joint submission should use the same chemical identifiers used by the lead registrant to create the joint submission in REACH-IT. Members of a joint submission, as any other registrant, should provide individually the information on the identity and composition(s) of their own substance. This information should correspond to their substance as manufactured. Members of a joint submission should therefore not provide generic composition(s) or duplicates of composition(s) provided by other registrants, as appropriate. The lead registrant and any member of the joint submission should report the preregistration number in IUCLID section 1.3 of their registration. Q&A2: Following discussions within our pre-sief members, we realised that all preregistrants do not have the same substance. The pre-sief needs to be split into several SIEFs. How should we proceed? In order to split a pre-sief, you will need to do the following for each substance covered by the pre-sief: Establish, among those pre-registrants having the same substance, which preregistrant should be the lead registrant of the joint submission; The lead registrant should create a joint submission in REACH-IT for that substance. The lead registrant should ensure as far as possible that a distinction can be made between the identity of the substance as defined in the joint submission and the other substances also covered by the pre- SIEF. For this purpose, the lead registrant may need to enter manually the correct and specific identity of his/her substance rather than use his/her pre-registration number. Version 1.0 Page 30 of 32

31 Every member of the joint submission should use the same chemical identifiers used by the lead registrant to create the joint submission in REACH-IT. Members of a joint submission, as any other registrant, should provide individually the information on the identity and composition(s) of their own substance. This information should correspond to their substance as manufactured. Members of a joint submission should therefore not provide generic composition(s) or duplicates of composition(s) provided by other registrants, as appropriate. The lead registrant and any member of the joint submission should report the preregistration number in IUCLID section 1.3 of their registration. Version 1.0 Page 31 of 32

32 Version 1.0 Page 32 of 32