Managing the risk of industrial chemicals and biocides TOWARDS A NON-TOXIC FUTURE Handling chemical risks across consumer products, environment and food 24 November 2016  Sørup Herregård, Ringsted Jack de Bruijn European Chemicals Agency

7th environment action plan ……….Horizontal chemicals legislation (REACH and the Classification, Labelling and Packaging Regulations), as well as legislation on biocidal products and plant protection products, provides baseline protection for human health and the environment…..

Supply chain communication Basic pillars of Chemicals legislation Safe use Supply chain communication Regulatory action Knowledge The key REACH objective is to ensure a high level of protection of human health and the environment for present and future generations whilst Ensuring the efficient functioning of the internal market and the competitiveness of the European chemical industry Based on a system that places the burden of proof on the industry who should demonstrate with responsibility and care that chemicals can be used in a way that human heath and the environment are not adversely affected. Achieving these key objectives of REACH is foreseen to take place by two main mechanisms; Getting much better information on all substances commercially in use developing a system of up supply chain communication that ensures that the actual users down the supply chain get the best risk management advice for their companies which ultimately must lead to reduced exposures and hence less negative impacts. Then the legislators build in additional legislative processes to allow authorities to intervene in cases where the self-responsibility of industry is not properly executed; restrictions and authorisation Finally, of course apart from the legislative drivers there can be other ones as well such as ; consumer demands and pressure from the retail sector

9 years of REACH and CLP; The journey so far ECHA published in May 2016 its second report on the progress with REACH and CLP Overall REACH is working Good progress made! There’s still a lot of work to do ! 56 Recommendations and 18 ECHA commitments

Do we know more on chemicals? Substances of Very High Concern 169 460 Risk management proposals 1 500 Dossiers for HPV chemicals checked for compliance 14 000 Substances registered under REACH 130 000 Substances classified with GHS >2million Study summaries on properties and effects of chemicals

? Options used to meet the information requirements ~75% of registrations contain read-across ?

Good quality registration dossiers Quality is improved, but more needs to be done! Industry to update: Annual and total volumes that change New identified uses, uses advised against New knowledge on hazard (including C&L) and risks leading to changes in the CSR Improved justifications for data-waiving But this is not being done consistently 64 % of registration dossiers submitted since 2008 were never updated! As per 15 April 2016, the number of active or inactive (annulled and revoked registrations are excluded) REACH registrations (full + TII + OSII), excluding the NONS, in our database is 45 022. 28 807 registrations of these have never been updated (64%) the bad news is that 2/3 are not updated. The good news is that out of the 1/3 the majority does it spontaneous and hence seems to take this seriously? You have heard a lot this morning about developing good quality dossiers. I would like to stress here specifically the problems we see with volume, use and exposure related information which in many dossiers is not f good qilauty and therefore hampers us in taking the right decisions on the need for follow up actions.

Manufacturer/ Importer Chemical and DU industry should improve supply chain communication Registrant (CSR) Manufacturer/ Importer Formulator DU End user Downstream Upstream Communication on uses and use conditions to the registrant with use maps The diagram depicts an idealised view of how supply chain communication should work. However, supply chain communication is not working as it should and needs improving. REACH sets out duties and mechanisms to ensure a proper communication on uses and conditions of use up and down the supply chain. Such communication is necessary to ensure a proper description of the uses and the chemical safety assessment (CSA) at the top of the supply chain and that the end users of chemicals are adequately informed about the risk management measures that they need to take. Supply chain communication is done using safety data sheets (SDSs) that may also include exposure scenarios (extended or eSDS). Upstream communication flow: there are a number of options, even more than displayed in the picture, but information about the substance uses needs to flow upstream to the registrant. It can be directly from each actor (end-user, DU, or formulator), or via a sector organisation etc. Depending on the supply chain, information can also flow from a DU to a formulator to a registrant, and may also include distributors. Downstream communication flow (obligation): information flows downwards to the relevant actor(s), following the substance supply chain. If the substance becomes part of a mixture, then the formulator has to take some action with the substance information he receives to make it applicable for his mixture, before passing it down to his customers (DUs). Communication on safe use to downstream users: exposure scenarios

Substitution of hazardous substances is happening Authorisation provides incentive to substitute. Innovation is taking place. Retailers demand supply of ‘SVHC-free’ products Consumers use the art 33 ‘right to ask’ info on SVHC content of products (helped by easy scanning tools)

Substances in articles/products Awareness on obligations is limited (imported articles) Need cooperation with, action in third countries Step up enforcement (imported articles) Support development/implementation of consumers right to know tools? → Ultimately we need to understand in which material streams and articles substances end up in!

Some food for thought

→ Assessing all possible exposure combinations is a dead end route How to deal with combination effects? (in a legislative context) Science is sufficiently clear (for many decades!) Effects of exposure to mixtures generally well described by concentration addition Actors cannot be held responsible for the use of other substances by other actors → Assessing all possible exposure combinations is a dead end route

Exposure < 1 No-effect level Reduce the probability that effects through combined exposure occur by reducing the overall toxic pressure Exposure < 1 No-effect level Reduce to 0.1 or 0.01 Divide by 10 or 100 ?

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