Download details of actives substances for approval votes Mar 2015.

Biocides are essential to control pests, infectious agents and bacteria and for
many other purposes, but can pose risks to humans, animals and the
environment. They are regulated at EU level by the EU Biocidal Products
Regulation (528/2012).
The EU BPR regime operates in two stages:

First, rigorous scientific evaluation takes place of a dossier of
data on active substances provided by applicant companies (typically
costing between £2.5m and £4m, recoverable from subsequent sales
of products and charges for use of the data). Where this assessment
indicates that risks are acceptable and the substance is sufficiently
effective for the proposed use, this leads to voting by qualified majority
vote in the Standing Committee for Biocidal Products whether to
approve it and put it on a Union list;

Once an active substance is put on the Commission list
companies may apply for authorisation to sell biocidal products (the
formulations containing active substances that actually go on the
market) in individual Member States.
The routine, non-regulatory option is a ‘yes’ vote in favour of approval,
allowing the substance to be put (or remain) on the market.
The six active substances being considered for approval and listing are set
out in the following table. The first two active substances are scheduled for a
vote at the Standing Committee on 20 March. The remaining four active
substances will be subject to an opinion by written procedure shortly after this,
once the required consultation with the World Trade Organisation ends on 23
March:
Active substance/use
Specific conditions of approval
Current position for the UK market
Folpet
For all uses: Approval subject to risk mitigation
measures being established to ensure safe
operational procedures for industrial users.
Labelling requirements on the risk of skin
sensitisation.
These uses are not covered by the existing
national legislation (The Control of
Pesticides Regulations - COPR) or any
other specific chemicals authorisation
schemes so companies marketing products
in the UK have not previously required an
approval via HSE. However, approval of
folpet would allow these preservative
products to remain on the market pending a
successful application for product
authorisation under the EU Biocidal
Products Regulation.
An in-can preservative, a film
preservative, and a plastic
preservative, to control fungal growth
in each case
For in-can preservative and film preservative
uses: labelling requirements and conditions on
application outdoors by spraying or brushing to
protect the soil.
Copper pyrithione
Approval subject to risk mitigation measures
being established to ensure safe operational
procedures; and to ensure that Maximum
Residue Levels (MRLs) are not exceeded for
products that may lead to residues in food or
feed. Label advice on keeping children away
until treated surfaces are dry; on the risk of skin
sensitisation; and on treatment in a contained
area where appropriate risk mitigation measures
are in place to protect the environment.
There are 46 products containing copper
pyrithione approved under COPR by HSE.
Conditions common to all uses; approval subject
to risk mitigation measures being established to
A disinfectant for use in a range of
ensure safe operational procedures for users;
situations, including for veterinary
hygiene, food and feed area treatment, and specific conditions or restrictions on
application or use to mitigate risk to humans or
and where direct application to
These uses are not covered under COPR.
A ‘booster biocide’ for industrial and
professional use in antifouling control
products to control the growth and
settlement in the marine environment
of fouling organisms on pleasure craft,
commercial ships and fishing nets
Glutaraldehyde
Approval of copper pyrithione would allow
these antifouling products to remain on the
market
Approval of Glutaraldehyde for these uses
would allow products to remain on the
market pending a successful application for
product authorisation under the EU Biocidal
humans or animals is not intended; a
preservative for products during
storage, and for liquid-cooling and
processing systems; and in products
used for prevention or control of slime
growth in industrial processes
the environment. Conditions specific to certain
uses: risk mitigation measures to ensure that
Minimum Residue Levels are not exceeded for
products that may lead to residues in food or
feed; label advice on the risk of skin
sensitisation.
Products Regulation.
N,N-Methylenebismorpholine
Approval subject to risk mitigation measures
being established to ensure safe operational
procedures for users; for metal working fluids,
label advice on the risk of skin sensitisation.
These uses are not covered under COPR
Approval subject to risk mitigation measures
being established to ensure safe operational
procedures for professional users
This use is not covered under COPR
Approval subject to risk mitigation measures
being established to ensure safe operational
procedures for industrial or professional users;
and to ensure that MRLs are not exceeded for
products that may lead to residues in food or
feed. Restrictions on use in animal housings
where emission to a sewage treatment plant or
surface water cannot be prevented, or where
Currently there are no insecticide products
containing clothianidin approved under
COPR by HSE.
A bactericide for the preservation of
fuels and for metal working fluids
2-methylisothiazol-3(2H)-one
A preservative for metal working fluids
for application by professional users
only
Clothianidin
An insecticide for use in paint-on
formulations (brushing on card) to
control house flies in animal housings
and domestic premises
Approval of N,N- Methylenebismorpholine
for these uses would allow products to
remain on the market pending a successful
application for product authorisation under
the EU Biocidal Products Regulation.
Approval of 2-methylisothiazol-3(2H)-one
for these uses would allow preservative
products to remain on the market pending a
successful application for product
authorisation under the EU Biocidal
Products Regulation.
Approval of Clothianidin for use as an
insecticide would allow applications for
product authorisation under the EU Biocidal
Products Regulation.
there is an unacceptable risk to the soil
environment.
Clothianidin is already approved for use in
wood preservative products