Industry view on self-classification issues 23 October 2013, Vilnius Seminar on chemical substances self-classification issues in the context of the Seveso directive Dr. Erwin Annys

REACH and CLP obligations The REACH registration dossier has the classification and labelling as mandatory information A hazardous substance as such or in a mixture has to be communicated in the safety data sheet (if mixture is not hazardous, on request some information may be needed) The CLP Regulation requires To notify to classification and labelling inventory All substances to be registered under REACH All substances in the scope of CLP that are hazardous and manufactured/imported and that are put on the market To classify all substances/mixtures placed on the market

Problems? In principle manufacturer/importer should have the information to classify the substances they put on the market In reality every manufacturer of a chemical is a downstream user buying his raw materials, chemicals And he can have multiple suppliers And that’s where some problems start Different classifications from different suppliers This became even more clear since the dissemination of the Classification and Labelling Inventory

First look at the C&L inventory Industry was confronted with serious surprises as well Even for >1000 tpa substances everything was observed Less severe classifications Much more severe classifications But based on what? No control possible for industry or for authorities The deviations are clearly not always related to presence of impurities, different forms, …. Notification, just ar pre-registration was seen as a licence to be on the market for a certain period

93/115 entries

This should be the first line because normally seen based on the most reliable and controllable information

Potential problems For less than 30% of the substances a registration dossier is or will be available Even more than the REACH registration, the C&L inventory has been seen by many companies as a one shot activity In the pre-SIEFs for the 2010 registration deadline, we got reponse rates from 5 – 10% Will this be better now? What are the carrots and the sticks?

Can ECHA do something? Legally maybe not possible to skip entries But practical solutions could be found In case of harmonised classification and labelling Possible to indicate differing classifications (incorrect/not allowed by a note) in a different colour? In case of self-classified substances Bring the classification of the joint-submission under REACH on top Possibility to combine entries which give ultimately the same classification but different hazard statements?

How to organise the clean-up? CLP Article 41 - Agreed entries Where the notification in Article 40(1) results in different entries on the inventory referred to in Article 42 for the same substance, the notifiers and registrants shall make every effort to come to an agreed entry to be included in the inventory. The notifiers shall inform the Agency accordingly.

How to organise the clean-up? Again, more than 100.000 substances to be looked at Ad random versus prioritisation? First discussions took place with the sherpa’s of the Directors’ Contact Group and within industry on how to organise the clean-up Discussion on criteria

How to organise the clean-up? Possible criteria – no agreement yet Registered yet? > 100 tpa and CMR > 1 tpa Harmonised classification and labelling Only potential discussion on more restrictive classification Severe chronic effects for human health and environment versus less severe CMR versus acute toxicity cat 4

ECHA facilitation The scope of CLP and REACH are different: hazardous R&D substances below 1 ton are not falling under REACH but must be notified To protect research and innovation the company name can’t be disseminated Hence ECHA created « a chat box approach » Some legal issues are under discussion

First feelings Ultimately a possibility to clean up the mess we are in! But hardly no one is answering More than 5 million notifications for more than 100.000 substances, this will take time!

Can ECHA do more? Put the REACH joint submission classification first Indicate what classification is impossible if a harmonised classification exists (different colour?) Indicate if an entry is linked to an invalid e-mail adress after a message of the chat box was created Indicate if an entry is linked to a notifier not answering to chat box messages

Problems under Seveso As a downstream user of chemicals I buy from different suppliers One substance from different suppliers classified differently Checking SDS (impurities can explain) Checking disseminated information But ultimately what to do? For REACH registered substances and supplied by registrants, the problem should be smaller For substances not yet registered uncertainty will remain until registration, at latest until June 2018

Problems under Seveso Consequences of substances in mixtures Classification of nitric acid by RAC: Acute Tox 1 triggered by the presence of nitric oxide, but below 68% this is not present anymore but dilution rules lead to more severe classification than actually the case, having major consequences for downstream users Touching different industries Metal and surface treatment Dairy, distilleries Fertilisers Automotive Article 4 of Seveso Directive may offer an outcome

Thanks for your attention