Information Requirements REACH 2018 - Europa

Information Requirements REACH 2018 - Europa

REACH 2018 Assess hazards and risks of your chemicals Purpose of this presentation This presentation, with notes, was prepared by ECHA, the European Chemicals Agency, to assist you in preparing a presentation about REACH 2018, i.e. the last registration deadline of phase-in substances. The intention is that you can select relevant slides and modify them as necessary to suit your audience, whether it is management, workers, environmental health and safety professionals, authorities etc. You may use it without additional permission. This presentation gives a brief overview of phase 4 (Assess hazards and risks) of ECHAs REACH 2018 Roadmap. It belongs to a series of presentations relating to REACH 2018, which are on ECHAs website. We welcome your comments and suggestions at: [email protected] Legal notice: The information contained in this presentation does not constitute legal advice and does not necessarily represent in legal terms the official position

of the European Chemicals Agency. The European Chemicals Agency does not accept any liability with regard to the contents of this document. Release: May 2017 2 REACH registration 2018 Phase 4 activities 1. Understand your information requirements 2. Gather hazard data 3. Fill data gaps 4. Gather information on uses 5. Assess risks and set risk management measures Understand your information requirements Information requirements

Information requirements for your registration depend on your registration type and annual volume you manufacture/import intermediate under strictly controlled conditions all available data standard registration depends on your tonnage band Tip: Practical Guide for SME managers and REACH coordinators: How to fulfil your information requirements at tonnages 1-10 tpa and 10-100 tpa 4 Understand your information requirements Standard registration If you manufacture/import 1-10 tonnes/year Annex VII to REACH

Physico-chemical properties Toxicological properties Ecotoxicological properties If you manufacture/import 10-100 tonnes/year Annex VII to REACH Annex VIII to REACH: Additional Toxicological properties Ecotoxicological properties Chemical safety assessment 5 Understand your information requirements Low risk substances

Low risk substances in the 1-10 tonnage band can benefit from reduced information requirements only physico-chemical properties in Annex VII as a minimum Annex III to REACH sets the criteria for deciding on low risk You need to fill in a justification to benefit from reduced requirements Tip: Inventory of substances likely to need the full dataset on

ECHAs website 6 Gather hazard data Hazard information 7 Fill data gaps Animal testing as last resort Avoid unnecessary animal testing by: sharing data and using adaptations, based on general or specific rules

How to ensure scientific and regulatory acceptance Submit good and reliable information Provide a robust justification for not running the test, e.g. explain in the dossier why the prediction obtained using a computer model is reliable for your substance show that two existing studies cover the same criteria as what is required in a newly performed study Tip: Read ECHAs Practical Guides How to use alternatives to animal testing to fulfil your info requirements for REACH and How to use and report QSARs. 8 Fill data gaps Regulatory alternatives Adaptations Column 2: Specific rules for each property

No need to perform a test, if properly justified meets all criteria Annex XI General rules, based on welldocumented and science-based justification 9 Fill data gaps Adaptations WoE:

If a single piece of evidence not sufficient to fulfil the need If individual studies give conflicting results, or are not of the highest quality Fulfil the requirement for a property by combining in vitro, read-across and (Q)SAR results ensure you submit the justification and evidence (Q)SAR: For simpler properties (e.g. physico-chemical properties) For more complex properties (e.g. repeated dose toxicity) In vitro tests: If environment is compatible with substance (e.g. solubility) If method is well described On its own Grouping and read across: If data is of good quality; if I can classify If source substances are similar/relevant to target If data on source is not (yet) available

10 Fill data gaps Adaptations - Tips Prepare a well-documented and valid scientific justification if you adapt the standard information requirements and submit it in your registration dossier. The approach you choose must deliver reliable information that is comparable to that from the standard test. If not, then you need to run the test as required. The approach you choose must allow you to classify your substance. When you have classified and labelled your substance, additional testing may not be needed. 11

Fill data gaps Strategy for testing Have a scientific expert to plan testing based on substance properties Case: Your substance is used in solutions and will break down rapidly in water test the properties of breakdown products If UVCB or multi-constituent substance - test the representative sample Test relevant routes of exposure Case: Workers will be exposed to vapours of your substance test by inhalation route Tip: On ECHAs website, there is information on how much time it takes to do certain studies, what quantity of the substance you need to send for testing and also indicative costs of the tests.

12 Fill data gaps Strategy for testing 13 Gather information on uses Uses and conditions of use 14 Assess risks and set risk management measures Classification and labelling

Collect all available information Consider information needs Identify missing information Generate new information Classification and labelling 15

Assess risks and set risk management measures Assess risk and ensure safe use Why? To ensure that the risks posed by your substance are controlled How? Assessing hazard and risk Hazard x Exposure = Risk Physico-chemical properties, environmental fate and (eco)toxicological information Uses Chemical safety assessment

Hazard: any source of potential damage, harm or adverse effects Exposure: chemical agent in contact with an organism or the environment Risk: likelihood that a hazard will cause its adverse effects 16 Assess risks and set risk management measures Assess risk and ensure safe use 1-10 tonnes/year chemical safety report NOT needed Substance not classified, not PBT/vPvB Substance

classified, or PBT/vPvB 10-100 tonnes/year chemical safety report needed Hazard assessment PBT/vPvB assessment Information on use and exposure Guidance on safe use + Exposure assessment

Exposure scenarios Risk characterisation PBT= persistent, bioaccumulative and toxic vPvB= very persistent and very bioaccumulative 17 Ensure safe use of your chemical and register Collect all available information Consider information needs Classification and labelling

Assess risk and ensure safe use Identify missing information Generate new information Prepare registration dossier 18 Take away messages Know your substance and understand what data you need

to submit Set up strategy and find good support: in your company, in your SIEF or outsourced Animal testing as last resort: Share data use adaptations Generating information is a joint effort of the SIEF Collect information on uses, from the sector organisations of your customers, as a starting point Testing and preparation of the dossier take time but good quality information reduces future work and costs Make sure that you and your customers use the substance safely Support is available at 19

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