MT
Biocides (Amendment No. 2) Regulations, 2013
Statutory Text (3 Articles)
L.N. 318 of 2013
PESTICIDES CONTROL ACT
(CAP. 430)
Biocides (Amendment No. 2) Regulations, 2013
IN exercise of the powers conferred by articles 4 and 5 of the
Pesticides Control Act, the Minister for Sustainable Development, the
Environment and Climate Change, in consultation with the Minister
for Health, has made the following regulations:-
(1) The title of these regulations is the Biocides
(Amendment No. 2) Regulations, 2013, and these regulations shall be
read and construed as one with the Biocides Regulations, hereinafter
referred to as "the principal regulations".
(2) The scope of these regulations is to transpose the following
Directives
(a)
Commission Directive 2013/3/EU of 14 February
2013 amending Directive 98/8/EC of the European Parliament
and of the Council to extend the inclusion in Annex I thereto of
the active substance thiamethoxam to product-type 18;
(b) Commission Directive 2013/4/EU of 14 February
2013 amending Directive 98/8/EC of the European Parliament
and of the Council to include Didecyldimethylammonium
Chloride as an active substance in Annex I;
(c)
Commission Directive 2013/5/EU of 14 February
2013 amending Directive 98/8/EC of the European Parliament
and of the Council to include pyriproxyfen as an active
substance in Annex I;
(d) Commission Directive 2013/6/EU of 20 February
2013 amending Directive 98/8/EC of the European Parliament
and of the Council to include diflubenzuron as an active
substance in Annex I;
(e)
Commission Directive 2013/7/EU of 21 February
2013 amending Directive 98/8/EC of the European Parliament
and of the Council to include Alkyl (C 12-16) dimethylbenzyl
ammonium chloride as an active substance in Annex I.
(3) These regulations shall come into force as from 1st
February 2015.
Part A of Schedule I to the principal regulations shall be Amends
Schedule I to
amended as follows
the principal
regulations.
(a)
the following shall be added to item 14 thereof,
immediately at the end of the said item
No
Common
IUPAC
Minimum
Date of
Deadline
Expiry
Prod
Specific provisions (*)
Name
Name
purity of
inclusion
for
date of
uct
Identifica
the active
complian
inclusion
type
-tion
substance
ce with
Numbers
in
the
Article
biocidal
16(3)
product
(except
as placed
for
on
the
products
market
containin
g more
than one
active
substanc
e,
for
which
the
deadline
to
comply
with
Article
16(3)
shall be
the one
set out in
the last
of
the
inclusion
decisions
relating
to
its
active
substanc
es)
"
980 g/kg
The Union level risk
February
January
January
assessment did not address
all potential uses; certain
uses, such as outdoor
application and use by
non-professionals, were
excluded. When assessing
the application for
authorisation of a product
in accordance with Article
5 and Annex VI, Member
States shall assess, where
relevant for the particular
product, those uses or
exposure scenarios and
those risks to human
populations and to
environmental
compartments that have
not been representatively
addressed in the Union
level risk assessment.
Products shall not be
authorised for application
by brushing, unless data
are submitted
demonstrating that the
product will meet the
requirements of Article 5
and Annex VI, if
necessary by the
application of appropriate
risk mitigation measures.
For products containing
thiamethoxam that may
lead to residues in food or
feed, Member States shall
verify the need to set new
or to amend existing
maximum residue levels
(MRLs) in accordance
with Regulation (EC) No
470/2009 or Regulation
(EC) No 396/2005, and
take any appropriate risk
mitigation measures
ensuring that the
applicable MRLs are not
exceeded. Products
applied in such a way that
emission via a sewage
treatment plant or directly
to surface water cannot be
prevented shall not be
authorised, unless data are
submitted demonstrating
that the product will meet
the requirements of Article
5 and Annex VI, if
necessary by the
application of appropriate
risk mitigation measures.
Member States shall
ensure that authorisations
are subject to the
following conditions
(1) Products authorised for
professional use shall be
used with appropriate
personal protective
equipment, unless it can
be demonstrated in the
application for product
authorisation that risks to
professional users can be
reduced to an acceptable
level by other means.
(2) Where appropriate,
measures shall be taken to
protect honey bees. ".
(b) immediately after item 60 thereof, there shall be added the
following new items
No
Common
IUPAC
Minimum
Date of
Deadline
Expiry
Prod
Specific provisions (*)
Name
Name
purity of
inclusion
for
date of
uct
Identifica
the active
complian
inclusion
type
-tion
substance
ce with
Numbers
in
the
Article
biocidal
16(3)
product
(except
as placed
for
on
the
products
market
containin
g more
than one
active
substanc
e,
for
which
the
deadline
to
comply
with
Article
16(3)
shall be
the one
set out in
the last
of
the
inclusion
decisions
relating
to
its
active
subst-
ances)
" 61
Didecyl-
N,N-
Dry
The Union level risk
dimethyl-
Didecyl-
weight
February
January
January
assessment did not address
ammo-
N,N-
870 g/kg
all potential uses and
nium
dimethyla
exposure
scenarios;
Chloride;
mmoniu
certain uses and exposure
DDAC
m
scenarios, such as use by
Chloride
non-professionals
and
Ż
exposure of food or feed,
EC No
were excluded. When
230-525-
assessing the application
for authorisation of a
CAS No
product in accordance
7173-51-
with Article 5 and Annex
VI, Member States shall
assess, where relevant for
the particular product,
those uses or exposure
scenarios and those risks
to human populations and
to
environmental
compartments that have
not been representatively
addressed in the Union
level risk assessment.
Member
States
shall
ensure that authorisations
are
subject
to
the
following conditions
(1) For industrial or
professional users safe
operational
procedures
shall be established, and
products shall be used
with appropriate personal
protective
equipment,
unless
it
can
be
demonstrated
in
the
application for product
authorisation that risks can
be
reduced
to
an
acceptable level by other
means.
(2) Products shall not be
used for treatment of wood
with which children may
enter in direct contact,
unless
it
can
be
demonstrated
in
the
application for product
authorisation that risks can
be
reduced
to
an
acceptable level.
(3) Labels and, where
provided, safety data
sheets
of
products
authorised shall indicate
that
industrial
or
professional application
shall be conducted within
a contained area or on
impermeable
hard
standing with bunding,
and that freshly treated
timber shall be stored after
treatment on impermeable
hard standing to prevent
direct losses to soil or
water, and that any losses
from the application of the
product shall be collected
for reuse or disposal.
(4) Products shall not be
authorised for treatment of
wood that will be in
contact with fresh water or
used
for
outdoor
constructions near or
above water, continually
exposed to the weather or
subject
to
frequent
wetting, unless data is
submitted to demonstrate
that the product will meet
the requirements of Article
5 and Annex VI, if.
necessary
by
the
application of appropriate
mitigation measures
pyripro-
4-
970 g/kg
The Union level risk
xyfen
phenoxy-
February
January
January
assessment did not address
phenyl
all potential uses and
(RS)-2-
exposure
scenarios;
(2-
certain uses and exposure
pyridylox
scenarios, such as use by
y) propyl
non-professionals,
were
ether
excluded. When assessing
EC No
the
application
for
429-800-
authorisation of a product
in accordance with Article
CAS No
5 and Annex VI, Member
95737-
States shall assess, where
68-1
relevant for the particular
product, those uses or
exposure scenarios and
those risks to human
populations
and
to
environmental
compartments that have
not been representatively
addressed in the Union
level risk assessment. For
products
containing
pyriproxyfen that may
lead to residues in food or
feed, Member States shall
verify the need to set new
or to amend existing
maximum residue levels
(MRLs) in accordance
with Regulation (EC) No
470/2009 or Regulation
(EC) No 396/2005, and
take any appropriate risk
mitigation
measures
ensuring
that
the
applicable MRLs are not
exceeded. Member States
shall
ensure
that
authorisations are subject
to
the
following
conditions
(1) Products authorised for
professionals shall be used
with appropriate personal
protective
equipment,
unless
it
can
be
demonstrated
in
the
application for product
authorisation that risks can
be
reduced
to
an
acceptable level by other
means.
(2) Products shall not be
authorised for direct use
on surface water, unless it
can be demonstrated in the
application for product
authorisation that risks can
be
reduced
to
an
acceptable level.
(3) Products intended to be
used in waste treatment
facilities shall be subject
to
appropriate
risk
mitigation measures to
avoid contamination of the
area outside the waste
treatment site.
difluben-
1-(4-
960 g/kg
The Union level risk
zuron
chloro-
February
January
January
assessment did not address
phenyl)-
all potential uses and
3-(2,6-
exposure
scenarios;
difluoro-
certain uses and exposure
benzoyl)
scenarios, such as outdoor
urea
use,
use
by
non-
EC No
professionals,
and
252-529-
exposure of livestock were
excluded. When assessing
CAS No
the
application
for
35367-
authorisation of a product
38-5
in accordance with Article
5 and Annex VI, Member
States shall assess, where
relevant for the particular
product, those uses or
exposure scenarios and
those risks to human
populations
and
to
environmental
compartments that have
not been representatively
addressed in the Union
level risk assessment. For
products
containing
diflubenzuron that may
lead to residues in food or
feed, Member States shall
verify the need to set new
or to amend existing
maximum residue levels
(MRLs) in accordance
with Regulation (EC) No
470/2009 or Regulation
(EC) No 396/2005, with
special consideration to
the in vivo genotoxic
metabolite PCA, and take
any
appropriate
risk
mitigation
measures
ensuring
that
the
applicable MRLs are not
exceeded.
Member
States
shall
ensure that authorisations
are
subject
to
the
following
conditions
unless
it
can
be
demonstrated
in
the
application for product
authorisation that the risks
can be reduced to an
acceptable level
(1) Professional users shall
wear appropriate personal
protective equipment.
(2) Product information
shall
include
the
requirement that products
shall only be used on dry
manure, and that the
manure must undergo
complete
aerobic
composting
by
professionals prior to
application on arable land.
(3) Products shall not be
used in water systems.
Alkyl (C
IUPAC
Dry
The Union level risk
12-16)
name
weight
February
January
January
assessment did not address
dimethyl-
Not
940 g/kg
all potential uses and
benzyl
applicabl
exposure
scenarios;
ammo-
e
certain uses and exposure
nium
EC No
scenarios, such as use by
chloride;
270-325-
non-professionals
and
C 12-16-
exposure of food or feed,
ADBAC
CAS No
were excluded. When
68424-
assessing the application
85-1
for authorisation of a
product in accordance
with Article 5 and Annex
VI, Member States shall
assess, where relevant for
the particular product,
those uses or exposure
scenarios and those risks
to human populations and
to
environmental
compartments that have
not been representatively
addressed in the Union
level risk assessment.
Member
States
shall
ensure that authorisations
are
subject
to
the
following conditions
(1) For industrial or
professional users safe
operational
procedures
shall be established, and
products shall be used
with appropriate personal
protective
equipment,
unless
it
can
be
demonstrated
in
the
application for product
authorisation that risks can
be
reduced
to
an
acceptable level by other
means.
(2) Products shall not be
used for treatment of wood
with which children may
enter in direct contact,
unless
it
can
be
demonstrated
in
the
application for product
authorisation that risks can
be
reduced
to
an
acceptable level.
(3) Labels and, where
provided, safety data
sheets
of
products
authorised shall indicate
that
industrial
or
professional application
shall be conducted within
a contained area or on
impermeable
hard
standing with bunding,
and that freshly treated
timber shall be stored after
treatment on impermeable
hard standing to prevent
direct losses to soil or
water, and that any losses
from the application of the
product shall be collected
for reuse or disposal.
(4) Products shall not be
authorised for treatment of
wood that will be in
contact with fresh water or
used
for
outdoor
constructions near or
above water, continually
exposed to the weather or
subject
to
frequent
wetting, unless data is
submitted to demonstrate
that the product will meet
the requirements of Article
5 and Annex VI, if
necessary
by
the
application of appropriate
mitigation measures. ".
€1.17