Substance identification and how to report it in IUCLID 6

Transcription

1 Substance identification and how to report it in IUCLID 6 Chemical Watch Expo 26 April 2017 Berlin Laszlo Majoros Scientific Officer European Chemicals Agency

2 Improved IT tool Easier and more transparent way to report information, giving better guidance on what is expected Manuals integrated Installation simplified 2

3 IUCLID 6 released 3

4 Content Reference substance Other regulatory substance identifiers in section 1.1. Section 1.2 Type of composition State / form Description of composition Justification for deviations Function (of additive) Section 1.4 4

5 5

6 Reference substance A IUCLID entity that collects chemical (scientific) identifiers on a particular chemical Purpose is to store the information once in the database, and link to it from any IUCLID document and section needed. Not related to a particular location; can be used to describe: The registered substance in section 1.1 A constituent of the substance in section 1.2 An impurity or additive of the substance in section 1.2 A surface treatment agent of nanomaterials in section 1.2 The assessed substance in the PBT assessment in section 2.3 A component of the test material in endpoint study records in sections 4 9 The identity of a transformation product in section 4.17, 4.18, 4.19, 5.1.1, 5.1.2, 5.1.3, 5.1.4, 5.2.2, 5.2.3, 5.4.1, 6.5, 9.3 The identity of reaction products of an intermediate in section The component of an assessment entity in section 0.4 6

7 Reference substance Use it for storing chemical and scientific identifiers; not regulatory information Linked from different places, exchanged by companies Important not to store information inside the reference substances that is specific to its IUCLID section, to the company, or to the registered substance i.e.: No description of scope of registered substance No company-specific manufacturing process 7

8 Reference substance Pre-filled reference substances and a limited inventory can be searched and downloaded from the website. 8

9 Reference substance - Creating a new reference substance A new reference substance can be created in IUCLID 6 1. In the IUCLID 6 home view, by right-clicking the reference substance icon 2. Inside the reference substance inventory: 9

10 Reference substance Chemical inventories The EC inventory is now called Chemical inventories Currently only EC inventory exists Each reference substance can only link to one inventory entry of each inventory type. E.g. cannot link to two EC numbers. 10

11 Reference substance Chemical inventories To link an EC inventory file to a reference substance, you search and assign: 11

12 Section Identification 12

13 Section 1.1: Identification 13

14 Section 1.1: Identification 14

15 Section 1.1: Identification- Submission checks A reference substance must be linked As a minimum, the IUPAC name must be given. If IUPAC name is not available, then a chemical name must be given in that field. EC number must be given if exists (JS identifier, inquiry) Molecular and structural information must be given; extent depends on type of substance Type of substance (mono-constituent, multi-constituent, UVCB) must be indicated 15

16 Section Composition 16

17 Section 1.2: Composition 17

18 Section 1.2: Composition - Type of composition Picklist values: legal entity composition boundary composition (SIP) composition generated upon use other: Mandatory for all dossiers (BR) Legal entity composition is selected by default for new or migrated compositions At least one LE composition must exist LE compositions subject to TCC (Annex VI.2 requirements) Boundary composition has to provided by the LEAD registrant 18

19 Section 1.2: Composition - Description of composition Existing field: char Supporting attachments (e.g. flowchart) can be provided below Mandatory for UVCB substances - it is the only place to report registrant-specific process description Free-text templates can be loaded into the field to support a meaningful process description ECHA verifies that a UVCB manufacturing process description has been given in this field 19

20 Section 1.2: Composition - Justification for deviations Must be used to give justification when deviating from substance identity conventions: Mono-constituent substance > 1 constituent < 80 % constituent > 20% impurity Multi-constituent substance < 2 constituents > 80 % constituent > 10% impurity UVCB 1 constituent ECHA verifies that a relevant justification has been given in this field. 20

21 Section 1.2: Composition 21

22 Section 1.2: Composition Full concentration range always required; except if reporting exactly 100% or 0% 22

23 Section 1.2: Composition - Function (of additive) Mandatory to select a value starting with stabiliser 23

24 Section 1.2: Composition Submission checks UVCB manufacturing process must be given for each LE composition Any deviation from the conventions for identifying and naming a substance must be justified in the Justification for deviations field of each LE composition Only one constituent for multi or UVCB More than one constituent for mono Deviation from 80-20% rules for mono-constituent and 80-10% rule for multi-constituent substances A full concentration range must be given for each constituent, additive, impurity The stabilising function of the additive must be indicated 24

25 Section 1.2: Composition Remaining Submission checks At least one legal entity composition of the substance must exist Degree of purity must be given (one value and unit) Each composition must have at least one constituent A reference substance must be linked to each constituent, impurity, additive Each reference substance must contain EC, CAS and/or IUPAC information Molecular and structural information must be given; extent depends on type of substance (well-defined vs. UVCB) 25

26 Section 1.4 Analytical information 26

27 Analytical information 27

28 Analytical information Picklist fields support user in reporting relevant information 28

29 Analytical information 29

30 Analytical information Mandatory to provide analytical results on at least one determination to quantify, and one determination to identify the substance. Each created row must be complete: Provide the Purpose of analysis and Analysis type Provide either an attachment in the field Attached methods/results OR explain why this analysis type was not used in the fields Rationale for no results and Justification 30

31 Analytical information 31

32 Analytical information Optical activity reported through picklist field Possible to link the analytical information record to the relevant composition(s) in section 1.2 Not mandatory to provide either 32

33 Validation assistant (VA) It should always be used before submitting a dossier to ECHA. All failures in the Submission checks tab should be corrected as they will lead to failures during submission. The VA also contains the Quality checks tab with rules that warn against inconsistencies in the dossier. These warnings will not lead to failures during submission, but may lead to clarification needs later on in other regulatory processes. Recommended to fix them before submitting. Passing the VA does not automatically mean that the registration passes the technical completeness check. 33

34 Validation assistant Use the Validation Assistant on your substance dataset 34

35 Validation assistant an example showing potential failures and inconsistencies 35

36 Manual verification ECHA performs a completeness check on each incoming registration to ensure that the required information is provided (Article 20 of the REACH Regulation). As of 21 June 2016, the automated completeness check is complemented with additional manual checks of certain elements of the registration dossier that cannot be checked automatically, to ascertain that all the information required by the legislation has been included. 36

37 Manual verification ECHA performs the manual verification on both new registrations and updates of existing dossiers. Validation assistant cannot show the outcome of the manual checks as they are done by ECHA staff. The manual checks are integrated in the completeness check process. Detailed information on the areas of the manual verification is available and published on the ECHA website under Support -> Manuals: 37

38 Support Dossier preparation manuals Available on ECHA website (Support >> Manuals) Integrated in IUCLID 6 help system (F1 key) 38

39 Support If after consulting the manual and the document there are still questions, please contact ECHA using the following link: ECHA also organised a webinar on the completeness check on 20 April The recording will be available on the webinar website. 39

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