1. 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

2. 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

3. 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

4. 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

5. 93/115
entries

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

7. 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?

8. 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?

9. 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.

10. How to organise the clean-up?
Again, more than 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

11. 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

12. 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

13. 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 substances, this will take time!

14. 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 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

15. 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

16. 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

17. Thanks for your attention