Europe
Under the EU’s legislative system
regulations are binding in their entirety and enforced simultaneously in
all of the Union’s 28 member states.
Directives are binding in their objectives while it is left to the member
states to decide how to achieve these
through their own laws.
The Commission and the national regulatory authorities in the EU believe that
the regulation is a distinct improvement
on the directive because of the streamlining of authorization procedures at the EU
and national levels and moves to greater
uniformity of risk controls throughout
the Union.
However, these advances are offset
by drawbacks such as the complexity
of the legislation, particularly in the requirements for safety data to be included
in dossiers submitted by companies for
approvals of their products. Coatings
requiring authorization as biocidal products include anti-foulants, anti-bacterial
paints and various preservatives, such as
wood preservatives.
The authorization of existing active substances which is being done
centrally and under the directive was
supposed to be completed in 2010
has now been set to be finished in
2024 because of the difficulties of
evaluating their safety. New active
substances are effectively having to
go through an even more rigorous
authorization procedure.
The Helsinki-based European
Chemicals Agency (ECHA), which is
accountable to the Commission, has
taken over the task of dealing with
evaluations of active substances and
centrally approved biocidal products.
This should lead to greater consistency and efficiency in the assessment of
safety dossiers.
“Although the new regulation is sup-
posed to be an improvement on the
directive, overall it isn’t,” said Didier
Leroy, technical director at the European
Council of Paint, Printing Ink and Artists’
Colours industry (CEPE), Brussels. “The
demands for proof of safety are more se-
vere in the new legislation. Furthermore
providing the data to make this proof of
safety is very costly. There is a real threat
that a lot of products will be taken off
the market.”
SMEs, particularly in the coatings
market, will be the hardest hit by the ex-
pense of gaining authorization so they
are the most likely to pull products off
the market or to move out of the sector
altogether.
“The European Commission has
reduced the authorization fees for
SMEs—by 60 percent for micro-organi-
zations, 40 percent for small ones and
20 percent medium-sized companies,”
explained Marko Susnik, a spokesper-
son on biocides for the European as-
sociation of small and medium-sized
businesses (UEAPME). “But it fails to
realize that much of the cost of authori-
zation for companies is in the prepara-
tion of the safety dossiers.”
While authorization of biocidal prod-
ucts can be done centralled through
ECHA, they can also be approved by
national authorities—either individually
or through a mutual recognition system
under which an evaluation by a single
country will be accepted by groups of
other states.
“There should be greater use of mutual recognition schemes which will help to
harmonize the whole European market,”
said An Ghekiere, a biocides specialist at
Arche Consulting, Leuven, Belgium.
Nonetheless, the market will still be
liable to fragmentation as a result of individual states retaining powers to prohibit
or restrict individual biocidal products.
Consequently biocides can be banned
in one or more countries but permitted
in others. The Swedish Chemical Agency
(Kemi) last year banned anti-fouling coatings containing high levels of zinc oxide.
The agency decided they were pesticides,
rejecting claims by their producers that
they had a physical rather than chemical
effect and thus were exempt from biocidal regulatory controls.
Companies have been opting to have
new biocidal products approved by a
single national authority in the hope that
this would be cheaper and quicker.
However I-Tech, a Swedish startup, is
still waiting for an approval around 7-8
years after submitting a dossier to the
UK Health & Safety Executive (HSE) on
a new anti-foulant medetomidine, which
prevents barnacle larvae attaching them-
selves to the surfaces of ships.
“The authority seems to have
no idea what delays like this mean
for a company like ours,” said Lena
Lindblad, R&D manager of I-Tech.
“Fortunately we have a very faith-
ful Swedish venture capital company
backing us, otherwise we could have
had to go out of business.”
The longer companies have to wait
for approvals the greater the danger
they will not obtain it because of new
requirements.
“The authorities are in the early
stages of working out how to evaluate mixtures of more than one active
substance in a biocidal product,” said
Overall with innovation rates lagging well behind those of withdrawals, there will be fewer products and
fewer companies producing or importing them. “With less companies in the
market there will be less choice and
competition but higher prices,” warned
Susnik. CW
