some chemicals used to harm or eliminating microorganisms in the environment.
Under the legislation biocides are defined as any substance “destroying, deterring, rendering harmless or exerting
a controlling effect” on fungi, viruses,
bacteria, yeasts, moulds, algae and other
microscopic organisms.
“For industry, the BPR is a worse piece
of legislation than REACH mainly be-
cause of political influence,” said Didier
Leroy, technical director at the European
Council of Paints, Printing Inks and Artists
colours (CEPE), the main European trade
association for coatings. “Decisions under
the legislation are likely to be taken for po-
litical rather than scientific reasons.”
The biggest immediate danger is that
key chemicals used as fungicides in wa-
terborne paints could be banned under
the legislation.
“The result could be that no water-
based coatings could be used in or as
consumer products,” Leroy warned. “A
decision at the EU level on the future of
waterborne coatings could be taken as
early as the end of this year.”
In addition, the marketing of coatings
combating microorganisms, such as anti-
fouling paints, are being jeopardised by
antagonism to the products among indi-
vidual EU member states.
The EU legislators made the BPR
extra strict because the 1998 Biocides
Products Directive – the EU’s first legislation specifically on biocides, which it was
designed to replace – was considered to
be too lax. But they retained a decentralized system allowing authorizations to
be made by the EU’s 28 member states
because of their knowledge of local environments and public health issues.
The BPR fills in gaps by laying down
rules on the safety of imports and on data
to be provided on efficacy and on the impact of biocides on non-target organisms.
Under the new regulations, approvals
are needed for active substances, biocidal
products such as anti-microbial coatings
which are intended to combat microorganisms, and ‘treated articles’, essentially
finished products containing biocides.
Active substance have to be authorized
at the EU level through the Helsinki-based
European Chemicals Agency (ECHA)
which makes recommendations to the
European Commission, the EU executive
so that it can take the final decision.
Biocidal products have to be approved
by each of the EU’s 28 member states or
through a mutual recognition scheme
under which an approval of a product in
one state is accepted by other countries.
“A company can make a mutual recog-
nition application to cover the countries
in which it wants to market a product,”
explained Richard Roy, a toxicologist at
REACHReady, a London-based consul-
tancy which provides advice on the BPR.
“The country carrying out the evaluation
of the applicant’s dossier will usually co-
ordinate closely with the other countries
covering the submission so approval can
take time.”
However, even within the process
for approving active substances, coun-
tries can shape the recommendations
made by ECHA, because the agency’s
expert committees comprise member
states specialists.
This is what is happening with two
groups of fungicides – formaldehyde re-
leasers and isothiazolinones – which are
applied as preservatives in waterborne
coatings. Individual EU countries have
been calling for bans on their use on the
grounds of their being health hazards.
Formaldehyde-releasing compounds
which emit small amount of the chemi-
cals are considered to be carcinogenic
while isothiazolinones are regarded as
skin sensitisers. ECHA is likely to make
a recommendation on the approval of the
two fungicides in the next few months for
the Commission’s consideration.
“Under the BPR carcinogens have to
be phased out in active substances while
the same approach can be taken with skin
sensitisers,” said Leroy. “Without these
fungicides, waterborne coatings will rap-
idly degrade. The only alternative is to
switch to solvents whose use is retricted
by the EU’s regulations on emissions of
volatile organic compounds. (VOCs).
We’re hoping the Commission will rule
out a ban because of its impact.”
With coatings like anti-fouling and
other anti-microbial products, manufac-
turers face a difficult decision of deciding
whether to seek approval state by state
or through the mutual recognition route.
“Mutual recognition can be difficult
because of the hostility to biocides in cer-
tain states,” said Leroy. “In some coun-
tries they can be regarded as dangerous
to the environment no matter what the
evidence is. In Scandinavia some experts
say that, instead of using chemicals, foul-
ing organisms can be scraped off the hulls
of ships.”
CEPE’s tactic with anti-fouling paints
is to concentrate the resources of its na-
tional associations on a minority of
member states to persuade their health
and safety agencies of the social and eco-
nomic importance of the coatings.
“Long-haul cargo and other large
ships which are served by shipyards in the
main global centres of South Korea and
China will still be able to enter EU waters
with unauthorised anti-fouling coatings,”
Leroy added.
It is not just inconsistencies in the
BPR’s application which is annoying
European industry but also small tech-
nical details which will be difficult to
comply with. Active substances have
to be tested, for example, to Good
Laboratory Practice (GLP) standards to
show that they are produced in batches
of uniform quality and once incorporat-
ed in biocidal products are technically
equivalent to the original.
“For SMEs, testing to GLP standards
could be expensive,” said Nina McGrath,
scientific advisor at Euro Chlor, the
European association of chlorine and
chlorine derivatives producers. “Also,
some countries, even in the EU, do not
have any GLP-certified laboratories.”
Already before the BPR was intro-
duced the numbers of biocidal active
substances on the market is estimated to
have been reduced by around 60 percent
to around 400 because of the require-
ments of the previous legislation.
With the new regulation being even
more stringent, the number of active
substances and consequently of biocidal
products is likely to go down even further. “Coatings producers will have even
less choice and will almost certainly have
to pay more for biocides,” said commercial manager at one European distributor
of coatings raw materials. CW
