Tips and tricks on applications for authorisation RIEF IV Dr. Erwin Annys

Tips and tricks on applications for authorisation
RIEF IV
19 June 2015, Brussels
Dr. Erwin Annys
End 2006
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End 2006
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What we observe in 2015
Surprise
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What NGO’s observe in 2015
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It starts with identification SVHC
• Public consultation takes place but
• Only comments in relationship to properties are
considered
• However comments on uses, exposures and
alternatives can be useful for priority setting
• If integrated as well in registration dossier
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Followed by prioritisation
• Another public consultation with particular
interest for uses to be exempt from authorisation
• Hardly succesful until now
• Workers’ legislation protects workers, not sure
it protects environment and consumers
• During the discussion on the 6th prioritisation,
industry gots the impression that the process
was more open and transparent and was more
than a pro forma contribution
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The application for authorisation
• You have a case to win, be convincing with clear
information
• Your jargon is not always well understood by the
members of RAC and SEAC
• Present it clearly, summarising tables tell more
than very long descriptions
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The Chemical Safety Report
• Although not mandatory, not using the DNEL or
dose response curve provided by RAC, makes it
more difficult to get acceptance
• A picture or a video tells more than thousand
words
• For the different worker contribution scenarios,
give the number of workers that are doing it and
the duration and frequency of the activity
• Use measured data, not only modelled data
• For upstream applications, get information on the
number of places where the substance is used
and are the conditions everywhere the same
• The lower the risk, the more chance that RAC is
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not saying something on the review period
Socio-economic analysis and
analysis of alternatives
• Run this in parallel, there is as well a combined
form for this
• Be realistic in your non-use scenario
• Explain clearly why the potential alternatives are
not feasible
• This will play a very important role in the
discussion on the review period for the
authorisation
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Substitution plan
• This plays a key role for the review period in socalled bridging applications for authorisations
• Explain your further efforts to find alternatives or
the status of the research activities ongoing
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The interactions during the process
• Pre-submission information session (PSIS)
• Trialogue
• Information coming from the public consultation
on alternatives
• Questions for clarification
• You need people that are knowing the different
aspects of the dossier, you need experts covering
all aspects
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A last recommendation
• Think twice before declaring some aspects
confidential
• There is an evolution, in the beginning more than
50% declared confidential, the most recent cases
more than 90% is not confidential
• The fact that the information is considered not
confidential, is however not giving other
companies the right to use it for free
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Leave the arena
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As a winner
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