Using REACH and CLP data to prioritise substances

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1 Using REACH and CLP data to prioritise substances EFSA FCM Network July 2017 Henna Piha Scientific officer, PhD Classification and prioritisation European Chemicals Agency

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3 REACH & CLP: main processes & actors Registration Substances manufactured and imported into EEA are registered with ECHA Information for safe use is communicated in the supply chain Member States Evaluation Testing proposal examinations Compliance checks of registration dossiers Substance evaluations Regulatory risk management Authorisation Restriction Harmonised classification and labelling 3

4 Towards minimising adverse effects of chemicals WSSD 2020 goal SVHC Roadmap 2020 Circular economy Chemicals produced & used minimizing significant adverse impacts on human health & environment by 2020 All relevant currently known SVHCs (substances of very high concern) included in Candidate List by 2020 Tackling all phases in the lifecycle of products Ensuring safe use of recycled materials REACH and CLP key regulatory tools helping to achieve these goals 4

5 Regulatory strategy for substances that matter most Focus on substances with biggest impact on protection of people & environment through regulatory action Substances that matter the most Integrated selection and priority setting Effective use of the evaluation process Predictable follow-up with regulatory action where needed 5

6 Using REACH and CLP data to prioritise substances Available data Prioritising substances Dialogues with sectors 6

7 Available data Substances of Very High Concern Risk management proposals Dossiers for high prod. vol. chemicals checked for compliance Substances registered under REACH Substances classified by industry 2 million Study summaries on properties and effects of chemicals 7

8 Available data 8

9 Available data: information requirements Requirements depend on tonnage Chemical safety assessment covers a substance s whole life cycle CSA aims to demonstrate how substance can be used safely Substance properties Phys.chem. Tox. Ecotox. Chemical safety assessment Hazard assessment Exposure assessment Supply chain communic. 9

10 Available data: supply chain communication Chemical safety assessment needs information on substance properties and conditions of use Manufacturer Knows the properties of a substance Downstream user Knows how the substance is used Types of activities Foreseen products Concentrations and amounts Operational conditions Risk management measures Communication in the supply chain is key Allocation of assessment responsibility 10

11 Available data: supply chain communication Registrants Uses Existing conditions Exposure Scenarios = Safe conditions of use What are the existing uses (customer groups)? Under which conditions do they take place? Downstream users Formulators Downstream users End users

12 Prioritising substances 12

13 Prioritising substances 13

14 Prioritising substances: screening The objective is to identify among the (potentially) hazardous substances those which have: A high tonnage for wide dispersive uses within the scope of substance evaluation, CLH, authorisation, restriction Combination of information P, B and T properties, carcinogenicity, mutagenicity, reprotoxicity, endocrine disruption, sensitisation & Use and exposure information 14

15 Prioritising substances: screening Priority is given to substances which have At least one suspected data gap in the higher tier human health/env. endpoints and/or Indication of hazard in the endpoints of concern AND High potential for exposure of humans or environment and hence relevance for safe use Maximises the impact on the safe use of chemicals 15

16 Prioritising substances: current directions Need to find effective ways to improve quality of registration data Sufficient data needed to prioritise and deprioritise substances More information needed especially on use and exposure Shifting focus from working with single substances to groups of substances Dialogues with sectors 16

17 Dialogues with sectors 17

18 Concrete form release agents Essential oils Petrolium & coal subst. Dialogues with sectors UV filters Plastic additives Organotin comp. 18

19 Dialogues with sectors: plastic additives Objectives Ensuring sufficient data Common priorities for updating registration dossiers Avoiding overlapping activities Supporting sustainable substitution 19

20 Dialogues with sectors: plastic additives Inventory of plastic additives Use maps for plastic additives (incl. service life) Method development for ranking based on release potential Way forward to dealing with substance data gaps 20

21 Dialogues with sectors: plastic additives Substances included in the initial inventory Antioxidants Antistatics Flame retardants Nucleating agents Other stabilisers Pigments Plasticisers UV stabilisers Total no subst

22 Dialogues with sectors: plastic additives Approaches and criteria to determine release potential from plastic articles Harvest knowledge from industry and other stakeholders Rank substances for regulatory work 22

23 ECHA has REACH and CLP data on over chemicals. Goal to focus regulatory measures on substances that matter most. Sector activities support to improve data quality and reach the goals efficiently! 23

24 Addressing substances of concern is our common goal! Subscribe to our news at echa.europa.eu/subscribe Follow us on Follow us on Facebook Facebook.com/EUECHA