Document zzkgK3NmjQ1rXo3pjdLyaKVX0
=
-- nm
Lo
Ce:
Subject:
Questions
--
in-AstraZeneca
(ENV)
meeting26/09 -StockholmConvention andREACHPFOARestriction -
producer of pharmaceuticals, next Tuesday 26 September, to discuss a derogation request under the and the questions we would be grateful to clarify with you with respect to the REACH PFOA Restriction.
ln Background:
Japan. PFOB is then exported to different countries (including in the EU) to be used by AstraZeneca in `the productionofcertain pharmaceuticals for lung/respiratory diseases. All stages of the process take
SI nS PFOA-related substances (para 216 (k)), attached) and will be discussed at the next POPRC in October.
Only PFOB raises a concern in termsofthreshold (the PFOI level in the pharmaceutical products is ofa few ppb, so far from 1 ppm).
J`the EU POP Regulation (that will repeal the REACH PFOA Restriction) but this may not happen before
does not take place in 2020 as currently foreseen but is postponed? Based on the Stockholm Convention decision-making cycle, any postponement would be of at least two years. - Would a revision of the REACH PFOA restriction follow the same process as the adoption of a new restriction (preparation of an Annex XV dossier, assessment by RAC and SEAC) and how long would the revision process take? At least two years? - How could Daikin and AstraZeneca support the process? - Would a derogation for the use of PFOB for the purpose of producing pharmaceuticals be a good first basis for a derogation request? - Can the thresholds which are currently included in the REACH PFOA Restriction be lowered in the EU POP Regulation? Would that require another risk assessment under the EU POP Regulation? We hope that you will be available for the meeting and to have the opportunity to discuss further these issues with you. Kind regards,
Kreab 2/4, Rond-Point Schuman, BE-1040 Brussels, Belgium Tel +32 2 Mob +32
@kreab.com www.kreab.com
EU Transparency Register ID Number: 1078390517-54 This communication is only intended for the use of the individual or entity, to which it is directed and may contain information that is privileged, confidential and exempt from disclosure under applicable law. If received in error please notify us immediately, delete this e-mail and destroy all copies.
2