CA-May16-Doc.5.1.a
Svaz chemického průmyslu České republiky
Association of Chemical Industry of the Czech Republic
Rubeška 393/7, 190 00 Praha 9
director
Position of Association of Chemical Industry of the Czech Republic on the
inclusion of in situ generated free radicals as active substance under the BPR
and
information requirements for in situ generated free radicals for
substance approval in the context of the BPR.
The in situ generation of free radicals was not considered as falling within the scope of
the BPD, but now is under the scope of the BPR, applications for the approval of free
radicals as active substance and the authorisation of biocidal products will have to be
made on the basis of and in accordance with Article 93 of the BPR.
Guidance to specify information requirements for in situ generated free
radicals for substance approval in the context of the BPR is being prepared
by Netherlands. Last version of guidance (CA-March16-Doc.5.1) contains
many inaccuracies and assumptions concerning essential issues, eg.
definition of active substance: “ The in situ generation of free radicals is
understood to aim at generating hydroxyl radicals (.OH) and its associated radicals
(hydrogen atom H., oxide radical anion .O-, hydrated electron eaq-), as well as singlet
oxygen (1O2) (which, although not a free radical in the strict sense, is a
highly reactive form of oxygen)” and
“4. Free radicals. A free radical is
chemically defined as an atom, molecule or ion that contains at least one unpaired
electron. These unpaired electrons make free radicals highly chemically reactive, and
as a consequence short-lived. For matters of convenience, singlet oxygen is also
considered in scope of this guidance”.
Association of Chemical Industry of the Czech Republic disagrees with the
inclusion of singlet oxygen under the item free radical because singlet
oxygen is not a free radical. At singlet oxygen generation the new substance
is not generated. It is not the case of in situ generation of chemical
substance, but only short term (tens to hundreds microseconds) change of
the physical state of molecular oxygen O2 occurs. We also disagree with the
opinion, that free radicals fulfil the definition of a chemical substance
according to REACH.
Workshop held in EDE, Netherlands on 8 February 2016 on the Guidance to specify
information requirements for in situ generated free radicals for substance approval in
the context of the BPR raised the question of free radicals inclusion in Article 95 and
how it should be named on labels and in SDSs among many other questions. Many
questions also were forwarded to European Commission/ECHA. The conclusion of
workshop was, that all open issues raised in the worskshop would not give
industry any legal certainty as to whether what is needed and expected by 1
September 2016.
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CA-May16-Doc.5.1.a
Based on the above, we require singlet oxygen to be excluded from the scope
of the BPR. If singlet oxygen is included under item free radicals under the
scope of the BPR, we urge proper justification of this fact.
We also urge quick setting of clear legal
procedure incl. release
of
information requirements for free radicals generated in situ and all other
required information for precursors of free radicals. This represents another
problem - as noted at the workshop: “current efficacy testing is only
available for liquids. The coatings are dealing with do not work in this way
and their efficacy cannot be tested with the existing protocols. We should
recognize that there are no appropriate tests available. Agreed protocols are
needed”.
Ivan Souček
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