Blue sky, sun already set high. Madrid, one of the finest hotels in the city. Crowd starts to gather in the nice conference room with high ceilings. The scene is set.
This first day of ChemCon starts with the usual greetings of colleagues and friends from all over the world, who haven't seen their peers for a few months, meeting in or around the conference room. The core content of the conference begins tomorrow, today are pre-seminars dedicated to specific topics.
The morning session was dedicated to the risk assessment in the EU, and the document that contains all the precious information, the Chemical Safety Report (CSR).
The first big message of the day is that the CSR is a communication media. It consolidates all of the risk assessment results and indicates the conditions for use that are safe.
Therefore, insists Andreas Ahrens of ECHA (European Chemicals Agency), it is of utmost importance to the Authorities and must be considered as important as the Registration Dossier.
When a member of a Joint Submission receives the CSR from the Lead Registrant, they should immediately:
- compare that the Exposure Scenarios are compatible with their own process;
- compare the reported Uses with what they do and how their products are used.
Also good to mention, any Downstream User should know how much volume they use at their site. They should also know how much can be used according to volumes taken into account in the CSR, based on the Operational Conditions communicated in the Exposure Scenarios.
Regarding studies not performed, Registrants must bear in mind that waivers are allowed when two conditions are met:
- They demonstrate that the exposure is not likely
- They provide the report with a DNEL (Derived No-Effect Level) value that is well below 1
Exposure Scenarios are reported in the extended Safety Data Sheets, or e-SDS, for communicating down the supply chain.
Jan Urbanus pointed out a big challenge for the industry which is that Exposure Scenarios have no legal format, leading to a disaster in terms of data management, storage and exchange.
As any Downstream User receiving an e-SDS has one year in front of him to confirm they are compliant, it is essential to track the reception date of e-SDS.
Steven Signs from Lubrizol brought also valuable clarification on when an Exposure Scenario is required for a mixture and what to put in it.
Basically you have three options,
- having an Exposure Scenario for all constituents Substance, which is partly wrong
- having a consolidated Exposure Scenario combining data from Exposure Scenarios for all constituents Substances, which looks better
- having no Exposure Scenario at all, and insert the information into the relevant sections of the SDS.
About e-SDS length, it is not uncommon to have e-SDS from 20-30 pages long to more than 100 pages, mainly due to the fact that first CSR's were developed with too many Exposure Scenarios.
ECHA expects to see a decreasing number of Exposure Scenarios now that Registrants and consultants in toxicology gained experience. Indeed, one Exposure Scenario can cover many more exposures than what has been done so far.
The last message of the morning was for the Industry in general—a strong encouragement to suggest their phrases to the EuPhraC database (http://content.euphrac.eu/
), a database of standard phrases that was set up by the Federation of German Industries BDI (Bundesverband der deutschen Industrie).
And indeed, anyone can participate; so if you want your phrases to become part of the standards, it is in your interest to contribute.
The afternoon session transported us into the former Middle Empire, with talks dedicated to the news or particular details of the regulations there.
Sessions where very practical and technical, providing latest developments in China. This included practical advice specifically against decree 591, Global Harmonised Standard (GHS) implementation and an overview of all the registration schemes for chemicals by Gao Yingxin from Ministry of Environmental Protection (MEP).
To me, the main message was delivered by Andy Burgess—data sharing is possible for registration under New Chemical Substance Notification, but then the tonnage band is made up of the sum of all those contributing.
Therefore, you can end up with the obligation of providing data for a higher tonnage band for which no company in the group as a match.
The main consequence is of course that nobody tends to share data.