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Introduction Webinar: Registering nanoforms practical advice 24 - PowerPoint PPT Presentation

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Introduction Webinar: Registering nanoforms practical advice 24 February 2020 Jenny Holmqvist, ECHA New REACH requirements for nanoforms Updated information requirements for nanoforms of substances under REACH apply as of 1 January

  1. Introduction Webinar: Registering nanoforms – practical advice 24 February 2020 Jenny Holmqvist, ECHA

  2. New REACH requirements for nanoforms • Updated information requirements for nanoforms of substances under REACH apply as of 1 January 2020. • Companies must have a registration compliant with these requirements to manufacture or import nanoforms of substances. 4

  3. What you can expect from today • Overview of registration activity • Practical advice for reporting nano- specific information in IUCLID • Expectations for completeness of data • Extensive Q&A session with experts 4

  4. Agenda 12:00 Introduction and general observations on nanoform registrations Jenny Holmqvist, ECHA 12:10 Practical advice based on received registrations Abdelqader Sumrein, ECHA 12:30 Conclusions Jenny Holmqvist, ECHA 12:30 – 14:00 Webinar open for questions

  5. Q&A panel 3

  6. Q&A panel • Send questions at any time • We can only answer questions related to the scope of the webinar • If your question is not answered by the end of the webinar, send it via our contact form: echa.europa.eu/contact 4

  7. Nanoform registrations Webinar: Registering nanoforms – practical advice 24 February 2020 Jenny HOLMQVIST

  8. New REACH requirements for nanoforms • New REACH requirements for nanomaterials as of 1 January 2020. • Concerns all new and existing registrations for substances with nanoforms in scope of REACH. • Registrations for nanoforms to be submitted with IUCLID version 6.4 or above. 8

  9. Registration activity • Since 1 November 2019, ECHA has started to receive dossiers for substances covering nanoforms. • As of 1 January 2020, import or manufacture of nanoforms of a substance is not compliant with REACH without a valid registration for these nanoforms. • The EUON estimates that ca 300 substances are manufactured/imported as nanoforms in the EEA. EUON : European Union Observatory for Nanomaterials https://euon.echa.europa.eu/ 9

  10. Important to keep in mind • To register a nanoform or set of nanoforms of a substance, you must submit a dossier in IUCLID version 6.4 or above. • You must explicitly indicate in section 1.2 of the dossier that the legal entity composition is for a nanoform in the ’State/ form ’ field. • Not valid registrations for nanoforms: • Dossiers with only attachments or remarks indicating manufacture/import of substances as nanoforms • Dossiers submitted with older IUCLID versions. 10

  11. Completeness check • If your submission fails the completeness check, you are given one attempt within a deadline of four months to submit a complete dossier. • If you submit a complete dossier by the deadline, it is considered that the first submission has been amended with the missing information and this first submission date is the date of registration/update. • If you do not submit a complete dossier by the deadline, your submission is rejected. • Submissions to register nanoforms before 1 January 2020 are considered as registered while the completeness check is pending. 11

  12. Rejection after incompleteness • Rejection means that the new information is not added to ECHA’s databases. • For existing registrations: the registration number is not revoked, but it covers only the information that was in a dossier that passed the completeness check. • If you are updating your bulk registration to cover nanoforms, then the nanoforms are only covered once the new submission passes the completeness check. • After rejection: amend the failures and prepare a new submission without delay to comply with REACH. 12

  13. Bulk and nanoforms of the substance • There can only be one dossier for a given substance by the same registrant. • If you have an existing registration covering the bulk form of the substance: update your existing dossier for bulk by adding information concerning the nanoform(s) of the substance that you manufacture/import. • This can be done either by reporting your nanoforms individually or by reporting set(s) of nanoforms covering your nanoforms. 13

  14. Joint submission lead and member registrants REACH Article 11(1): information set out in Annex VII to X • is first submitted by the lead registrant. Information required by Annex VI, including the • characterisation of nanoforms or sets of nanoforms, is thereafter submitted separately by each registrant. When existing registrations are updated to cover • nanoforms, this submission sequence is not enforced. ➢ Members submitting before the lead need to ensure that they are covered by the lead’s submission. ➢ Member registrants are sent a disclaimer to inform them that the completeness check decision they received only covers the Annex VI information. 14

  15. Thank you! echa.europa.eu/contact Subscribe to our news at echa.europa.eu/subscribe Follow us on Twitter @EU_ECHA Follow us on Facebook Facebook.com/EUECHA

  16. Practical advice based on received registrations Webinar: Registering nanoforms – practical advice 24 February 2020 Abdelqader SUMREIN

  17. Sets of nanoforms

  18. Nanoforms vs. sets of nanoforms In principle each nanoform must be reported separately, including characterisation as per Annex VI and information on nanoform properties as per Annex VII-X. However, REACH allows reporting of a set of similar nanoforms when two conditions are fulfilled: 1. The registrant reports clearly defined boundaries in terms of characterisation parameters of the nanoforms, which are part of the set; 2. The registrant justifies that the hazard, exposure and risk assessment of the nanoforms can be performed jointly . 18

  19. Observations Based on the available information, the approach to • register nanoforms via sets of similar nanoforms seem to have been used in ca. half of the dossiers. Characterisers for sets of nanoforms in many cases • not realistic, e.g. particle size distribution given as 1-100 nm for D10, D50, and D90. Justifications are often not addressing the points • requested in the IUCLID template, and only stating an opinion/strategy without any scientific evidence. Justifications are manually verified at completeness check. • 19

  20. Advice for sets of nanoforms (1) • Report real boundaries for characterisers; • describe the smallest/largest values for nanoforms included in the set. • Ensure that you can justify that each nanoform of the set can rely on the same Annex VII-X information, for each endpoint. • Support each statement by reference to relevant data which can be traced back/found in the IUCLID dossier (i.e. hazard information, literature studies) 20

  21. Advice for sets of nanoforms (2) • For a comprehensive justification you need to provide evidence that the hazard profile is unchanged for test data representing nanoforms in the set with: • Smallest and largest d50 value and surface area • Different shape(s) and crystal structure • Surface-treatment inducing the lowest and highest impact on hazard assessment • Hazardous surface-treatment agent present as such in the nanoform 21

  22. Advice for sets of nanoforms (3) • If you register your nanoforms relying on a set of similar nanoforms that has been agreed at the level of the joint submission and is covered with a joint set of Annex VII-X information: • Provide the same justification for the set as the justification provided by the other registrants relying on the same set. • A diverging justification suggests that the set may not have been agreed on jointly and may put in doubt the use of a joint set of hazard data for the sets. 22

  23. Advice for sets of nanoforms (4) • Incomplete justifications for sets: • Explanation of why registrant decided to use the set approach instead of registering nanoforms . X • Characterisers are overlapping and it is not possible to register separate nanoforms . X • Statement that there is no difference in the ecotoxicological and toxicological profiles of the nanoforms in the set . X • Reference to data on nanomaterials in general, but not specific for the substance and nanoforms in question . X 23

  24. Compositions

  25. Composition types IUCLID section 1.2 compositions: legal entity compositions describe registrant’s own • manufactured/imported compositions and forms boundary compositions describe compositions and forms • that are covered by hazard data and assessments: (robust) study summaries from Annex VII-XI as reported in • endpoint study records in IUCLID sections 4-7 classification and labelling in IUCLID section 2.1 • PBT assessment and hazard assessment conclusions in • IUCLID sections 2.3, 6 and 7 endpoint summaries 25

  26. Linking of compositions Each nanoform or set of nanoforms must be reported • separately, including Annex VI characterisation and Annex VII-X information on nanoform properties Critical to link legal entity compositions to boundary • compositions in IUCLID to demonstrate coverage by data: ’ Related composition’: electronic link from legal entity • composition to boundary composition when both are present in the same dossier (JS lead; JS member opting out) ’ Reference to related composition(s)’: textual link from legal • entity composition to related boundary composition name when boundary composition is in a different dossier (JS member) 26

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