Active substance(s) proposed for approval under the EU Biocidal Products Regulation
1. Are any of the active substances in the table below and/or biocidal products containing them currently on the UK market? (NB:
You do not need to tell us about any active substances or biocidal products approved under the Control of Pesticides Regulations,
as we will already be aware of these)
2. If yes, can you provide details of what these actives/products are, and the level of distribution in the UK?
3. Do you foresee any problems with the specific provisions relating to the Approval of the active substance(s)? Please give details.
4. Are any of these active substances and/or biocidal products currently on the EU market other than the UK? Please give details.
5. If you have any other comments on the proposed approval of these active substances, please list them here.
Common name
IUPAC Name & Identification
Numbers
Cu-HDO
IUPAC Name:
bis(N-cyclohexyl-diazeniumdioxy)-copper
EC n° : N/A
CAS n° : 312600-89-8
1
Minimum
purity of
active
substance1
981 g/kg
Date of approval
and expiry date
Product type
(PT)
Specific provisions2
1 September 2015 –
31 August 2025
PT 8
The product assessment shall pay particular
attention to the exposures, the risks and the
efficacy linked to any uses covered by an
application for authorisation, but not
addressed in the Union level risk assessment
of the active substance.
Authorisations are subject to the following
The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU)
No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the
evaluated active substance.
2
For the implementation of the common principles of Annex VI of Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the
Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm
conditions:
(1)
For
industrial
users,
safe
operational
procedures
and
appropriate
organizational
measures shall be established.
Where exposure cannot be reduced
to an acceptable level by other
means, products shall be used with
appropriate personal protective
equipment.
(2) Appropriate risk mitigation measures shall
be taken to protect the terrestrial
compartment. In particular, labels
and, where provided, safety data
sheets of products authorised shall
indicate that industrial application
shall be conducted within a
contained area or on impermeable
hard standing with bunding, that
freshly treated timber shall be
stored after treatment under shelter
or on impermeable hard standing,
or both, 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.
S-methoprene
IUPAC Name :
Isopropyl-(2E,4E,7S)-11methoxy-3,7,11-trimethyl-2,4dodecadienoate
EC No : N/A
CAS No : 65733-16-6
950 g/kg
1 September 2015 –
31 August 2025
PT 18
The product assessment shall pay particular
attention to the exposures, the risks and the
efficacy linked to any uses covered by an
application for authorisation, but not
addressed in the Union level risk assessment
of the active substance.
Authorisations are subject to the following
conditions:
(1) When formulated as a bait, products shall
contain an aversive agent.
Octanoic acid
IUPAC Name :
n-Octanoic acid
EC No : 204-677-5
CAS No : 124-07-2
993 g/kg
1 September 2015 –
31 August 2025
PT 4
(2) For products that may lead to residues in
food or feed, the need to set new or to amend
existing maximum residue levels (MRLs) in
accordance with Regulation (EC) No
470/2009 of the European Parliament and of
the Council* or Regulation (EC) No
396/2005 of the European Parliament and of
the Council** shall be verified, and any
appropriate risk mitigation measures shall be
taken to ensure that the applicable MRLs are
not exceeded.
The product assessment shall pay particular
attention to the exposures, the risks and the
efficacy linked to any uses covered by an
application for authorisation, but not
addressed in the Union level risk assessment
of the active substance.
Authorisations are subject to the following
conditions:
(1)
For industrial or professional users,
safe operational procedures and
appropriate
organizational
measures shall be established.
Where exposure cannot be reduced
to an acceptable level by other
means, products shall be used with
appropriate personal protective
equipment.
(2)
PT 18
For products that may lead to
residues in food or feed, the need
to set new or to amend existing
maximum residue levels (MRLs)
in accordance with Regulation
(EC) No 470/2009 of the European
Parliament and of the Council* or
Regulation (EC) No 396/2005 of
the European Parliament and of the
Council** shall be verified, and
any appropriate risk mitigation
measures shall be taken to ensure
that the applicable MRLs are not
exceeded.
(3)
Biocidal products containing
octanoic acid shall not be incorporated in
materials and articles intended to come into
contact with food within the meaning of
Article 1(1) of Regulation (EC) No
1935/2004, unless the Commission has
established specific limits on the migration of
octanoic acid into food or it has been
established pursuant to that Regulation that
such limits are not necessary
The product assessment shall pay particular
attention to the exposures, the risks and the
efficacy linked to any uses covered by an
application for authorisation, but not
addressed in the Union level risk assessment
of the active substance.
Authorisations are subject to the following
conditions:
(1)
Decanoic acid
IUPAC Name :
n-Decanoic acid
EC No : 206-376-5
CAS No : 334-48-5
985 g/kg
1 September 2015 –
31 August 2025
PT4
Authorisations of products for nonprofessional use are subject to the
packaging being designed to
minimise user exposure, unless it
can be demonstrated in the
application
for
product
authorisation that risks for human
health can be reduced to acceptable
levels by other means.
(2)
For products that may lead to
residues in food or feed, the need to set new
or to amend existing maximum residue levels
(MRLs) in accordance with Regulation (EC)
No 470/2009 of the European Parliament and
of the Council* or Regulation (EC) No
396/2005 of the European Parliament and of
the Council** shall be verified, and any
appropriate risk mitigation measures shall be
taken to ensure that the applicable MRLs are
not exceeded.
The product assessment shall pay particular
attention to the exposures, the risks and the
efficacy linked to any uses covered by an
application for authorisation, but not
addressed in the Union level risk assessment
of the active substance.
Authorisations are subject to the following
conditions:
(1) For industrial or professional users, safe
operational procedures and appropriate
organizational measures shall be established.
Where exposure cannot be reduced to an
acceptable level by other means, products
shall be used with appropriate personal
protective equipment.
(2) For products that may lead to residues in
food or feed, the need to set new or to amend
existing maximum residue levels (MRLs) in
accordance with Regulation (EC) No
470/2009 of the European Parliament and of
the Council* or Regulation (EC) No
396/2005 of the European Parliament and of
the Council** shall be verified, and any
appropriate risk mitigation measures shall be
taken to ensure that the applicable MRLs are
not exceeded.
PT 18
(3) Biocidal products containing decanoic
acid shall not be incorporated in materials and
articles intended to come into contact with
food within the meaning of Article 1(1) of
Regulation (EC) No 1935/2004, unless the
Commission has established specific limits on
the migration of decanoic acid into food or it
has been established pursuant to that
Regulation that such limits are not necessary.
The product assessment shall pay particular
attention to the exposures, the risks and the
efficacy linked to any uses covered by an
application for authorisation, but not
addressed in the Union level risk assessment
of the active substance.
Authorisations are subject to the following
conditions:
(1)
Authorisations of products for nonprofessional use are subject to the
packaging being designed to
minimise user exposure, unless it
can be demonstrated in the
application
for
product
authorisation that risks for human
health can be reduced to acceptable
levels by other means.
PT 19
Iodine
IUPAC Name :
Iodine
EC No : 231-442-4
CAS No : 7553-56-2
995 g/kg
1 September 2015 –
31 August 2022
PT 1
PT 3
(2) For products that may lead to residues in
food or feed, the need to set new or to amend
existing maximum residue levels (MRLs) in
accordance with Regulation (EC) No
470/2009 of the European Parliament and of
the Council or Regulation (EC) No 396/2005
of the European Parliament and of the
Council shall be verified, and any appropriate
risk mitigation measures shall be taken to
ensure that the applicable MRLs are not
exceeded.
The product assessment shall pay particular
attention to the exposures, the risks and the
efficacy linked to any uses covered by an
application for authorisation, but not
addressed in the Union level risk assessment
of the active substance.
The product assessment shall pay particular
attention to the exposures, the risks and the
efficacy linked to any uses covered by an
application for authorisation, but not
addressed in the Union level risk assessment
of the active substance.
The product assessment shall pay particular
attention to the exposures, the risks and the
PT 4
efficacy linked to any uses covered by an
application for authorisation, but not
addressed in the Union level risk assessment
of the active substance.
Authorisations are subject to the following
conditions:
(1) For products that may lead to
residues in food or feed, the need to
set new or to amend existing
maximum residue levels (MRLs) in
accordance with Regulation (EC) No
470/2009
of
the
European
Parliament and of the Council* or
Regulation (EC) No 396/2005 of the
European Parliament and of the
Council** shall be verified, and any
appropriate risk mitigation measures
shall be taken to ensure that the
applicable MRLs are not exceeded.
The product assessment shall pay particular
attention to the exposures, the risks and the
efficacy linked to any uses covered by an
application for authorisation, but not
addressed in the Union level risk assessment
of the active substance.
Authorisations are subject to the following
conditions:
(1) For products that may lead to residues in
food or feed, the need to set new or to amend
existing maximum residue levels (MRLs) in
accordance with Regulation (EC) No
470/2009 of the European Parliament and of
the Council or Regulation (EC) No 396/2005
of the European Parliament and of the
Council shall be verified, and any appropriate
risk mitigation measures shall be taken to
ensure that the applicable MRLs are not
exceeded.
PT 22
Zineb
IUPAC Name :
Zinc
ethylenebis(dithiocarbamate)
(polymeric)
EC n° : 12122-67-7
CAS n° : 235-180-1
940 g/kg
1 January 2016 – 31
December 2025
PT 21
(2) Products containing iodine shall not be
incorporated in materials and articles
intended to come into contact with food
within the meaning of Article 1(1) of
Regulation (EC) No 1935/2004, unless the
Commission has established specific limits on
the migration of iodine into food or it has
been established pursuant to that Regulation
that such limits are not necessary.
The product assessment shall pay particular
attention to the exposures, the risks and the
efficacy linked to any uses covered by an
application for authorisation, but not adressed
in the Union level risk assessment of the
active substance.
Authorisations are subject to the following
condition:
For professional users, safe operational
procedures
and
appropriate
organizational measures shall be
established. Where exposure cannot
be reduced to an acceptable level by
other means, products shall be used
with appropriate personal protective
equipment.
The product assessment shall pay particular
attention to the exposures, the risks and the
efficacy linked to any uses covered by an
application for authorisation, but not
addressed in the Union level risk assessment
of the active substance.
Authorisations are subject to the following
conditions:
(1) For industrial or professional
users,
safe
operational
procedures and appropriate
organizational measures shall be
established. Where exposure
cannot be reduced to an
acceptable level by other means,
products shall be used with
appropriate personal protective
equipment.
(2) Products authorised for nonprofessional users shall be sold
with the appropriate protective
gloves. Labels and, where
provided, instructions for use
shall indicate whether other
personal protective equipments
shall be used.Labels and, where
provided, safety data sheets of
products
authorised
shall
indicate
that
application,
maintenance
and
repair
activities shall be conducted
within a contained area and on
impermeable hard standing with
bunding to prevent direct losses
and minimize emissions to the
environment, and that any
losses or waste containing zineb
shall be collected for reuse or
disposal..
(3) For products that may lead to
residues in food or feed, the
need to set new or to amend
existing maximum residue
levels (MRLs) in accordance
with Regulation (EC) No
470/2009 of the European
Parliament and of the Council*
or
Regulation
(EC)
No
396/2005 of the European
Parliament and of the Council**
shall be verified, and any
appropriate risk mitigation
measures shall be taken to
ensure that the applicable MRLs
are not exceeded.
Where a treated article has been treated with
or intentionally incorporates zineb, and
where necessary due to the possibility of
skin contact as well as the release of
zineb under normal conditions of use, the
person responsible for placing the treated
article on the market shall ensure that the
label provides information on the risk of
skin sensitisation, as well as the
information referred to in the second
subparagraph of Article 58(3) of
Regulation (EU) No 528/2012
The following notes apply to the entries for s-methoprene. octanoic acid, decanoic acid and zineb:
(*) Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of
residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive
2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152,
16.6.2009, p. 11).
(**) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food
and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).