Pesticide containers guidance on operator exposure
considerations.(Version 1/2015):
This document does not replace the approach outlined in the European Food
Safety Authority (EFSA) guidance document[1] on the assessment of operator,
worker and resident & bystander exposure to plant protection products,
however it may be used in the absence of relevant guidance. The content of
this document is to be reviewed and may be amended at any time. The
applicant should ensure that where relied upon, the guidance reflects the
latest edition issued on the HSE website.
This guidance describes:



how different types of packaging can affect the level of operator
exposure during mixing and loading operations;
the container-related data requirements and specific conditions of use
for different container types; and
how to assess the level of operator exposure resulting from situations
where a ready-to-use pesticide is applied directly from the container.
Contents.
1.
Single-trip (non-returnable) containers ..................................................... 3
1.1
Single-trip (non-returnable) containers for liquids .............................. 3
1.1a Effect on operator exposure of pack size and design of single-trip
containers for professional liquid products ................................................ 3
1.1b Packaging for home garden products formulated as liquids........... 6
1.1c Pre-pressurised aerosol cans and hand-held trigger spray
containers ................................................................................................. 7
1.1.1
Data requirements for single-trip containers for liquids............... 7
1.1.2
Label phrases for single-trip containers for liquids...................... 8
1.1.3
Container description (Notice of Approval) phrases for single-trip
containers for liquids ................................................................................. 9
1.2
Single-trip (non-returnable) containers for solids ............................... 9
1.2a Effect of pack size of single-trip containers for solids on operator
exposure ................................................................................................... 9
1.2b Puffer packs and shaker packs .................................................... 12
1.2.1
Data requirements for single-trip containers for solids.............. 12
1.2.2
Label phrases for single-trip containers for solids .................... 12
1.2.3
Container description (Notice of Approval) phrases for single-trip
containers for solids ................................................................................ 13
2. Returnable containers ............................................................................. 14
2.1
Returnable containers for liquids ..................................................... 14
2.1.1
Data requirements for returnable containers for liquids ............ 15
2.1.1a Operator exposure data requirements for small volume
returnable (SVR) containers for liquids ................................................... 15
[1]
Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk
assessment for plant protection products: EFSA Journal 2014;12(10):3874
2.1.1b Operator exposure data requirements for intermediate bulk
containers (IBC) .........................................................................
15
2.1.2
Label phrases for returnable containers for liquids ................... 16
2.1.3
Container description (Notice of Approval) phrases for
returnable containers for liquids .............................................................. 17
2.2
Returnable containers for solids ...................................................... 17
2.2.1
Data requirements for returnable containers for solids ............. 18
2.2.2
Label phrases for returnable containers for solids .................... 18
2.2.3
Container description (Notice of Approval) phrases for
returnable containers for solids ............................................................... 20
1.
Single-trip (non-returnable) containers
Single-trip containers are those with no label requirement to be returned to the
supplier for refilling or recycling, even though individual users may have
arrangements for the recovery, recycling or disposal of these containers.
1.1
Single-trip (non-returnable) containers for liquids
1.1a Effect on operator exposure of pack size and design of single-trip
containers for professional liquid products
Data from the UK Predictive Operator Exposure Model (UK POEM) on levels
of hand contamination resulting from pouring operations using various types
of professional pesticide containers are summarised in Table 1 and Table 2,
below. The available spreadsheet for the UK POEM models automatically
selects the appropriate hand contamination value for the respective container
size/neck diameter.
.
Levels of hand contamination when handling the concentrate are affected by:

the number of containers which must be opened and used (this is
influenced by the size of the container, the application rate of the
product, the size of the area to be treated and/or the tank capacity
of the application equipment); and

the level of hand contamination arising from each container pouring
operation (this is influenced by the capacity and neck diameter of
the container).
Table 1
Levels of hand contamination resulting from individual pouring
operations using professional containers with narrow neck
diameters (< 45 mm).
Container capacity (litres)
Hand contamination (ml of formulation/pouring operation)*
1**
0.01
5
0.20
10
0.50
20
0.50
*
These values, based on tracer studies under laboratory conditions, represent the
upper limit of the class containing the 75th percentile measurement. Measurements
were taken when pouring the entire contents of the container directly into a simulated
sprayer tank (induction hoppers were not used). The monitored tasks did not involve
the removal of secondary (induction) seals or the rinsing of containers and closures.
**
The value for 1 litre containers is currently used for smaller professional containers
(for home garden products see Section 1.1b, below).
Table 2
Levels of hand contamination resulting from individual pouring
operations using containers with wide neck diameters (45 mm and
63 mm closures*).
Container capacity (litres)
Hand contamination (ml of formulation/pouring operation)**
1 all designs***
0.01
2 all designs
0.01
5 wide neck 45mm or 63mm
0.01
10 wide neck 45 mm
0.10
10 wide neck 63 mm
0.05
20 litre wide neck 63 mm
0.05
*
The ‘45 mm’ and ‘63 mm’ measurements refer to standard closure sizes for screw
caps, not the inner diameter of the container neck (which will be smaller).
**
These values, based on tracer studies under laboratory conditions, represent the
upper limit of the class containing the 75th percentile measurement. Measurements
other than those for the wide neck 20 litre container were taken when pouring the
entire container contents directly into a simulated sprayer tank (induction hoppers
were not used). In subsequent studies for 5 and 10 litre containers, measurements
were taken during part pouring operations (i.e. dispensing several sequential doses
from a single container): in this situation, levels of hand contamination were lower than
the values reported above. Measurements for the wide neck 20 litre container were
taken when pouring both the entire contents of the container and incremental aliquots
into an induction hopper (pouring into the top of the sprayer tank was not considered
for this large container). In practice, it may be difficult to manipulate 20 litre containers
when using induction hoppers, especially when attempting to use integrated pressure
rinsing devices (which may not be fully effective on containers of greater than 10 litres
capacity). The monitored tasks did not involve the removal of secondary (induction)
seals or the rinsing of containers and closures.
***
The value for 1 litre containers is currently used for smaller professional containers of
similar design (for home garden products see Section 1.1b, below).
When comparing these contamination values it is necessary to bear in mind
that the use of larger container sizes will generally result in a lower number of
pouring operations (e.g. the use of a 10 litre container will generally result in
half the number of pouring operations that would be required for a 5 litre
container). However, for products which are applied using knapsack sprayers
or other equipment with a small tank, the number of pouring operations will
generally depend on the number of tank-loads required rather than size of the
pesticide container. Similarly, the tank capacity of the application equipment
rather than the size of the pesticide container may be the most important
factor when estimating the number of pouring operations for products applied
at relatively low doses (in comparison to the container size).
When selecting a representative container size from a range of packaging
options to use in an operator exposure model, it may not be appropriate to
consider the smallest container if it is unlikely that operators would use this
when treating the area assumed in the model (e.g. 50 ha/day for field crop
sprayers in the UK POEM).
For example, a product applied using field crop sprayers and knapsack
sprayers at a rate of 3 litres/ha is to be supplied in 1, 5, 10 and 20 litre
ECPA standard wide-neck containers (63 mm closure). The
recommended water volume is 200 litres of spray solution/ha. For field
crop sprayers, it is appropriate to estimate exposure using the 10 litre
container (as it is unrealistic to assume that operators will perform 150
pouring operations using 1 litre containers and, of the containers larger
than 1 litre, the 10 litre container will result in the highest level of
operator contamination when an equivalent quantity of product is
used). For knapsack sprayers, the number of mixing and loading
operations will be dependant on the size of the sprayer tank rather than
the container size (i.e. 14 mixing and loading operations would be
required when using a 15 litre knapsack sprayer to treat the UK POEM
default area of 1 ha at a water volume of 200 litres of spray solution/ha)
and a realistic worst case container size should be modelled (1 or 10
litre container).
The contamination values summarized in Table 1 and Table 2 can be used to
support an application for an extension of the packaging range for an
approved professional product where, for example:


the product is currently approved in a 1 litre container and
additional packaging in 2 litre (all designs) or 5, 10 or 20 litre wide
neck containers is required; or
the product is currently approved in 5, 10 or 20 litre narrow neck
containers and additional packaging in 1 litre (all designs), 2 litre
(all designs) or 5, 10 or 20 litre wide neck containers is required.
When filling certain types of application equipment, for example, the narrownecked reservoirs used with some spot guns and CDA lances, levels of
operator contamination may be higher than those predicted on the basis of
the pouring data summarised above.
Although various ‘closed transfer systems’ are available for use with singletrip containers, laboratory studies commissioned by HSE demonstrate that
some of these systems may not result in reduced levels of operator
contamination when handling the pesticide. In particular, systems which
require adaptors to be connected to, and removed from, individual pesticide
containers may occasionally result in higher levels of contamination than
those arising from conventional open pouring operations. Therefore, it is not
currently considered appropriate to reduce the exposure estimates predicted
by the UK POEM when estimating the level of exposure resulting from the use
of ‘closed transfer systems’ for single-trip containers.
1.1b
Packaging for home garden products formulated as liquids
Regulatory Update 04/2005 provides guidance on maximum pack size limits
for amateur products. The aim is to discourage householders from storing
pesticides for long periods by ensuring that home garden products are
supplied in quantities which will typically be used up within 1 or 2 seasons.
Applicants are required to justify their proposed maximum pack size for each
product based on the proposed application rate, the number of applications
and the following default assumptions for the size and design of a large UK
garden.
The following areas are considered as representative areas for home garden
use
 Lawn = 200 m2
 Ornamentals = 50 m2
 Fruit and vegetables = 50 m2
 Patio and paths = 50 m2
These requirements apply to all new product applications. For existing
products, the requirements will be applied either when changes to the
conditions of approval are made which require technical evaluation by HSE or
at re-registration.
In addition to these specific requirements, the following maximum size limits
have been established for containers for liquid home garden products.




Liquid concentrate formulations for home garden use = 1 litre.
Ready-to-use formulations in trigger spray containers with integral
trigger spray heads = 1.5 litre.
Ready-to-use formulations in trigger spray containers with hose and
trigger spray attachments = 5 litre.
Pre-pressurised aerosol cans = 1 litre.
Research commissioned by HSE has shown that levels of operator exposure
when decanting home garden concentrates may differ from the UK POEM
pouring values used for professional products as described in Section 1.1a.
These studies demonstrate that:


containers with integral squeeze-to-fill measuring chambers are likely
to result in lower levels of contamination, and may be easier for
amateurs to use, than containers which require the use of separate
measuring equipment; and
containers with measuring caps (or separate measures which are
stored inverted on the cap after use) may result in higher levels of
contamination from contact with product draining from the measure
down the outside of the container).
Based on these data, the following values have been agreed for the level of
hand contamination when handling home garden liquid concentrates. These
values have been included in the UK POEM.



Containers with in-cap measure: 1 ml of formulation per pouring
operation.
Containers with separate measure: 0.1 ml of formulation per pouring
operation.
Containers with integral squeeze-to-fill measuring chamber: 0.01 ml of
formulation per pouring operation.
Also, it is generally recognised that:


unit-dose packaging (for example, in sachets containing the correct
amount of concentrate to prepare sufficient spray solution for a typical
garden sprayer or watering can) is likely to result in lower levels of
contamination and be easier to use than containers which require the
dose to be measured; and
water-soluble unit-dose packaging is likely to result in a negligible level
of user contamination when handling the concentrate.
To ensure that the use of unit-dose packaging and water-soluble unit-dose
packaging results in these benefits, it is important that the size of the unitdose is appropriate considering the conditions of use and typical application
equipment.
1.1c
Pre-pressurised aerosol cans and hand-held trigger spray containers
Levels of operator exposure for non-professionals when using products
packaged in pre-pressurised aerosol cans and hand-held trigger spray
containers can be estimated on the basis of the following data published on
the European Chemicals Bureau website. These data were generated by the
UK Health and Safety Laboratory (HSL) in 2001 and have been considered by
the UK Advisory Committee on Pesticides (ACP).
Operator exposure models (Microsoft Excel spreadsheets) based on these
values are available on the HSE website. For further details please refer to
the guidance document on the assessment of amateur (home garden) user
exposure to pesticide products.
1.1.1 Data requirements for single-trip containers for liquids
Any proposed changes in container size or design should be supported by a
statement addressing the implications of the change for operator exposure.
For a novel packaging design, detailed drawings should also be supplied,
possibly with an empty unused example of the proposed container.
1.1.2 Label phrases for single-trip containers for liquids
Detailed guidance on labelling requirements for single-trip containers is
provided in the HSE’s Chemicals Regulation Directorate’s (CRD) Labelling
Handbook.
Container-specific operating instructions may be required in some situations,
for example for containers:
 which need to be opened in a special way such as those fitted with
additional ‘anti-glug’ closures or child-resistant closures;
 which need to be used in a specific manner such as those with squeezeto-fill measuring chambers, spray heads or outlets with variable settings,
or those which are connected directly to the application equipment; or
 which are novel designs such as trigger spray packs with pre-pressurised
internal reservoirs.
Containers with a capacity of over 20 litres must have advisory labelling to
indicate that they are to be handled with mechanical assistance. Where
appropriate, these containers must also have label guidance on how to:
 agitate the contents of the container before opening to ensure that the
contents are homogenous; and
 dispense or transfer the required amount of product from the container to
the application equipment.
In general, the disposal phrases:
 ‘Wash out container thoroughly, empty washings into the spray tank
and dispose of safely’ or ‘Rinse container thoroughly by using an
integrated pressure rinsing device or manually rinsing three times.
Add washings to sprayer at time of filling and dispose of container
safely’ are specified for containers for liquid pesticide concentrates
which are applied as a spray solution.
 ‘Empty container completely and dispose of safely’, ‘Empty container
completely and dispose of it in the specified manner’ or ‘Wash out
container thoroughly and dispose of safely’ are specified for
containers for ready-to-use liquid products or for liquid pesticide
concentrates which are not applied as a spray solution.
HSE has issued guidance on container disposal requirements for home
garden products to improve householders’ practice in the disposal of such
chemicals. This guidance states all amateur plant protection products
(irrespective of the CHIP 3 classification) should be labelled ‘Do not empty
into drains’ and ‘Do not contaminate water with the product or its container’.
In addition, the following phrases must appear, as appropriate.
 For all products other than those containing ferrous sulphate alone or
mixed with a fertiliser, ‘Dispose of unused product in its container at a
household waste site (civic amenity site). Contact your local council
(local authority) for details.’


For products containing ferrous sulphate alone or mixed with a
fertiliser, ‘Unused product in its container may be disposed of in the
dustbin.’
For all products, ‘Dispose of empty container in the dustbin.’
1.1.3 Container description (Notice of Approval) phrases for single-trip
containers for liquids
The Notice of Approval descriptions for single-trip containers are normally
non-specific (for example, the container description for a product supplied in
1, 5 and 10 litre containers with 63 mm closures may read ‘1 to 10 litre HDPE
containers’). However, if revised packaging is to be used other than that
considered in HSE’s evaluation (for example, with a reduced neck diameter)
an application will be required even though the new packaging falls within the
broad description used on the Notice of Approval.
More specific container descriptions are given in some situations, for
example:
 for trigger spray packs to ensure that containers fitted with integral spray
heads are no larger than 1 litre and that containers from 1 litre to 5 litres
are fitted with a delivery hose and trigger spray attachment; and
 for novel types of packaging (multi-packs, kangaroo packs etc.) and
applicator packs.
1.2
Single-trip (non-returnable) containers for solids
1.2a Effect of pack size of single-trip containers for solids on operator
exposure
For pesticides formulated as solids (such as WP and WG formulations) the
level of operator exposure during mixing and loading operations is estimated
on the basis of the total amount of active substance handled rather than the
number and type of containers opened. Although, on this basis, no case to
address the risk to operators is required in support of a change in pack size
for an approved product, an increase in pack size may result in an increased
risk of caking or a loss of granule integrity, leading to an increase in dustiness
of the product. If such problems are identified during evaluation, the applicant
may be asked to submit a reasoned case to confirm that the extended range
of packaging will not result in a significant increase in levels of operator
exposure. Similar concerns may arise if a solid formulation which is approved
in a rigid container (such as a jar or lined carton) is to be packaged in flexible
container (such as a bag or sack).
In all cases, the size of the container must be appropriate for the product
application rate and usage. Regulatory Update 04/2005 provides guidance on
maximum pack size limits for amateur products to ensure that these products
are supplied in quantities which will typically be used up within 1 or 2 seasons
(see Section 1.1b for full details). The maximum size for containers designed
for manual handling should not exceed 25 kg for both professional products
and ready-to-use home garden products (such as granular lawn treatments)
when a container of this size can be justified. In addition to these specific
requirements, the maximum container size for amateur products in the form of
solid concentrates (such as WP and WG formulations) or ready-to-use solid
formulations in puffer packs and shaker packs (such as some DP, GR, FG,
PT or RB formulations) is typically 1 kg.
The current version of the UK POEM includes data on inhalation and dermal
exposure for operators mixing and loading solid formulations for application as
a spray. These exposure values, which are based on 75th percentile
exposure values from the German model (or maximum values where the
number of data points is limited), are summarised below.
A comparison of the German model mixing and loading data with data
available within EUROPOEM and the US Pesticides Handlers Exposure
Database (PHED) has resulted in the adoption of two new values for
inhalation exposure when mixing/loading a WG and WP formulation for
vehicle mounted application. These data are also summarised below.
Table 3 Summary of inhalation and hand exposure data for mix/load of
WG/WP formulations for application with vehicle mounted/hand-held
equipment
Inhalation
exposure
(mg/kg a.s.)
Hand exposure
(mg/kg a.s.)
WG
Vehicle mounted
equipment
0.0358
(EUROPOEM
data)
5.72
(German model
data)
Hand-held
equipment
0.0628
(German
model data)
171.4
(German
model data)
WP
Vehicle mounted
equipment
0.21
(PHED data)
13.6
(German model
data)
Hand-held
equipment
1.534
(German
model data)
171.4
(German
model data)
In situations where solid concentrates are contained in water-soluble unitdose packaging it is assumed that the level of operator contamination when
handling the concentrate will be negligible. However, in situations where it is
necessary for a professional operator to handle individual water-soluble bags
there is usually a requirement for suitable protective gloves to be worn. To
ensure that the use of water-soluble unit-dose packaging results in these
benefits, it is important that the size of the unit-dose is appropriate considering
the conditions of use of the product, the type of application equipment being
used and the likely areas to be treated.
Levels of operator exposure when loading and applying granule (GR and FG)
formulations may be estimated on the basis of 75th percentile surrogate
values for dermal and inhalation exposure derived from a detailed analysis of
relevant data contained within the Pesticide Handlers' Exposure Database
(PHED). These surrogate values are summarised below. As the dermal
exposure values are based on studies in which operators wore protective
gloves and normal work wear, it is not appropriate to use these data to predict
exposure in situations where personal protective equipment is not used (such
as for amateur products: see Section 1.2b).
LOADING TASKS USING TRACTOR-MOUNTED MACHINERY
mg a.s./kg a.s. handled
(75th percentile values)
Hands actual dermal exposure*
0.00141
Body actual dermal exposure *
0.0161
Total actual dermal exposure *
0.0175
Inhalation
0.0208
APPLICATION TASKS USING TRACTOR-MOUNTED MACHINERY
mg a.s./kg a.s. applied
(75th percentile values)
Hands actual dermal exposure
0.000346
*
Body actual dermal exposure *
0.00478
Total actual dermal exposure *
0.00513
Inhalation
0.000999
LOADING AND APPLICATION TASKS USING HAND-HELD MACHINERY**
mg a.s./kg a.s. handled and applied
(75th percentile values)
Hands actual dermal exposure
28.532
*
Body actual dermal exposure *
65.320
Total actual dermal exposure *
93.852
Inhalation
0.468
*
**
gloves and normal workwear were worn when handling and applying the
granules
combined data set for loading and application tasks using a variety of carried
(eg. ‘belly grinders’) and wheeled (e.g. push-along lawn spreaders) equipment.
An exposure model (Microsoft Excel spreadsheet) based on these values is
available on the HSE website.
1.2b
Puffer packs and shaker packs
Levels of operator exposure for non-professionals when using DP
formulations packaged in puffer packs and GR or FG formulations packaged
in shaker packs can be estimated on the basis of data published on the
European Chemicals Bureau website. These data were generated by the UK
Health and Safety Laboratory (HSL) in 2001 and have been considered by the
UK Advisory Committee on Pesticides (ACP). For further details please refer
to the guidance document on the assessment of amateur (home garden) user
exposure to pesticide products.
1.2.1 Data requirements for single-trip containers for solids
Any proposed changes in container design should be supported by a
statement addressing the implications of the change for operator exposure.
For a novel packaging design, detailed drawings should also be supplied,
possibly with an empty and unused example of the proposed container.
Although no case to address the risk to operators is required in support of a
change in pack size for an approved solid product (see Section 1.2a), an
increase in pack size may result in a greater risk of caking or loss of granule
integrity which may lead to an increase in the dustiness of the product. If
such problems are identified during evaluation, the applicant may be asked to
submit a reasoned case to confirm that the extended range of packaging will
not result in a significant increase in levels of operator exposure.
1.2.2 Label phrases for single-trip containers for solids
Container-specific operating instructions may be required in some situations,
for example containers:
 which need to be opened in a special way such as those fitted with childresistant closures;
 which need to be used in a specific manner such as puffer packs or shaker
packs, especially those with variable outlets; or
 which are novel designs.
Containers with a net weight of over 25 kg must have advisory labelling to
indicate that they are to be handled with mechanical assistance. Where
appropriate, these containers must also have label guidance on how to
dispense or transfer the required amount of product from the container to the
application equipment.
In general, the disposal phrases:
 ‘Wash out container thoroughly, empty washings into the spray tank
and dispose of safely’ or ‘Rinse container thoroughly by using an
integrated pressure rinsing device or manually rinsing three times.
Add washings to sprayer at time of filling and dispose of container
safely’ are specified for washable containers for solid pesticide
formulations which are applied as a spray solution.
 ‘Wash out container thoroughly and dispose of safely’ is specified for
washable containers for solid pesticide formulations which are not
applied as a spray solution.
 ‘Empty container completely and dispose of safely’ or ‘Empty
container completely and dispose of it in the specified manner’ are
specified for non-washable containers for solid pesticide formulations.
HSE has issued guidance on container disposal requirements for home
garden products to improve householders’ practice in the disposal of such
chemicals. These requirements are described in Section 1.1.2, above.
1.2.3 Container description (Notice of Approval) phrases for single-trip
containers for solids
The Notice of Approval descriptions for single-trip containers for solid
formulations normally refer only to the packaging material and the size range.
More specific container descriptions may be given in some situations, for
example, for novel types of packaging and applicator packs.
2.
Returnable containers
There are two main types of returnable containers:
 Small Volume Returnable (SVR) containers; and
 Intermediate Bulk Containers (IBC).
IBCs are normally considered to be containers with a volume of approximately
1000 litres (1 m3). Although returnable drums with a capacity of about 200
litres do not fall within this description, IBC operator exposure data
requirements (rather than the more extensive SVR operator exposure data
requirements) are normally applied to these types of returnable drums.
2.1
Returnable containers for liquids
SVR containers for liquid formulations are normally of two types.
 A graduated container (normally HDPE or FHDPE of 5 to 10 litres
capacity) with an integral valve and dry-break coupling which is
inverted and coupled directly to an adaptor mounted on the sprayer
(normally positioned on the lid of the induction hopper). After coupling,
the container is then rotated to open the valve and dispense (by
gravity) the required amount of product.
 A drum (normally HDPE or FHDPE of 25 to 30 litres capacity) with an
integral drum valve connected to a dip leg. The required amount of
pesticide is transferred from the container to the application equipment
using a compatible closed transfer/metering system which connects to
the drum valve using a dry-break extractor valve. After use, the closed
transfer system is normally connected to a rinse socket for flushing.
These containers are overfilled to compensate for the residual amount
of formulation left after emptying.
IBCs for liquid formulations normally consist of a stainless steel or
HDPE/FHDPE container of approximately 1000 litres (1 m3) capacity.
Containers may be mounted on an integral pallet and may have an integral
protective cage. When used for pesticides, IBCs must only be provided with a
top-mounted outlet (normally a dip leg with a drum valve) for use with a
closed-transfer/metering system. If, due to manufacturing requirements, the
container has a low-level outlet, this must be securely blanked off to prevent
use/misuse. IBCs are often equipped with additional top-mounted closures to
permit the product to be re-circulated before use to ensure homogeneity.
Returnable packaging, when used with compatible closed transfer equipment,
is designed to achieve a lower level of operator contamination when handling
the pesticide than that resulting from pouring operations with conventional
packs. However, laboratory studies commissioned by HSE demonstrate that
some of these systems may not consistently result in the expected reduction
in operator exposure levels. Therefore, in the absence of specific data, it is
not currently considered appropriate to reduce the exposure values predicted
by the UK POEM when estimating the level of exposure resulting from the use
of closed transfer systems for returnable containers.
2.1.1 Data requirements for returnable containers for liquids
2.1.1a Operator exposure data requirements for small volume returnable
(SVR) containers for liquids
a. A copy of the draft label. This should include guidance on the type of
dispensing equipment required, how to transfer the required amount of
the product from the container to the application equipment and how to
treat nominally empty containers (i.e. the ‘empty’ container must be
sealed, must not be rinsed out and must be handled, transported and
stored as if still containing pesticide). The appropriate precautionary
phrases must appear (see ‘Labelling’ below).
b. A description of the proposed container with confirmation of whether it
is a new kind of container or is currently approved for other pesticides.
For novel containers, a diagram of the proposed system and details of
the compatibility of the container with typical closed transfer systems.
c. A brief statement on the likely level of operator contamination when
using the returnable container in comparison to that expected to result
from the use of conventional packaging.
d. Full details of the proposed system for returning, cleaning, inspecting
and refilling containers and details of where these operations will take
place. This should include details of the expected lifespan of
containers, and procedures for monitoring the movement of containers
(to ensure the recall of containers at end of their useful life) and their
contents and for ensuring the dedication of each container to a single
product with appropriate labelling.
In addition the following data may be required in some circumstances:
a. For new types of SVR containers, information on user experience
gained during commercial usage of the container with confirmation that
label instructions are appropriate.
b. Data on the levels of operator contamination resulting from the
complete dispensing operation using the refillable container with a
representative range of transfer equipment. Levels of contamination
should also be determined on the container and fittings and an
estimate should be made of how these levels increase with repeated
use. The risk to the operators from such contamination build-up (e.g.
from the re-use of part used packs) should be addressed. Information
must also be provided on the reliability of fittings (i.e. levels of
leakage/contamination from valves and couplings) and the accuracy
with which specified volumes can be dispensed.
2.1.1b Operator exposure data requirements for intermediate bulk containers
(IBC)
a. A full description of the proposed container and details of whether it is
currently approved for the supply of other pesticide products. Details
of how the product is to be agitated or recirculated before use and how
appropriate quantities of the product are to be dispensed. This type of
container must only be used in conjunction with a closed transfer
system which draws product through the top surface of the container
via a fixed dip tube, and the empty container must remain sealed and
unrinsed.
b. If the container is intended to be returnable/refillable full details are
required of the proposed system for the return, cleaning, inspection
and refilling of containers. This should include details of the expected
lifespan of containers, and procedures for monitoring the movement of
containers and their contents and for ensuring the dedication of a
container to a single product.
c. The product label must include full details of how the product is to be
agitated/recirculated before use and dispensed using a closed transfer
system, and how nominally empty containers are to be treated.
d. A short statement addressing the likelihood of operator exposure when
handling the product in view of the proposed use of the container and
the label instructions.
2.1.2 Label phrases for returnable containers for liquids
Detailed guidance on labelling requirements for returnable containers is
provided in the HSE’s Chemicals Regulation Directorate’s (CRD) Labelling
Handbook.
The product label (or, in some cases, a separate label supplied with the SVR
container or IBC) should provide detailed advice on how to use the container.
This should describe how to:
 open the container (including advice on removing tamper-evident seals
and not attempting to remove valves etc.);
 agitate or recirculate the product before use to ensure homogeneity
(for containers of greater than 20 litres capacity, it is not appropriate to
use the phrase ‘shake well before use’ and alternative instructions to
agitate the container well before use by rolling or recirculate the
contents, as appropriate, may be required);
 transfer the required amount of product using a closed transfer system
(or the closed transfer system built into the container/adaptor);
 reseal the container after use; and
 return the empty container for refilling or recycling.
The ‘Precautions’ section of the SVR container or IBC label must include the
phrases:
 ‘Do not rinse out the container’ (this replaces the rinsing instructions
on single-trip packs);
 ‘Open the container only as directed’;
 ‘Return the empty container to the supplier’ and
 ‘Do not re-use the container for any other purpose’ (this replaces the
phrase ‘Do not re-use the container for any purpose’ which appears on
certain single-trip packs).
In addition, the following phrases must be identified as ‘other specific
restrictions’:
 ‘The empty container must be returned to the supplier.’; and
 ‘The empty container must not be re-used for any other purpose.’
The SVR container or IBC label should also advise, where appropriate, that:
 empty and unrinsed packs should be treated as full packs;
 where partial refilling is intended, the refilled container may have a
range of possible fill volumes; and
 for containers above 20 litres, mechanical handling is required.
2.1.3 Container description (Notice of Approval) phrases for returnable
containers for liquids
The Notice of Approval descriptions for SVR containers are normally nonspecific (for example, ‘1 to 10 litre high density polyethylene refillable
container’ or ‘20 litre high density polyethylene refillable container’). However,
if revised packaging is to be used other than that considered in PSD’s
evaluation (for example, a modified design of container) an application will be
required even though the new packaging falls within the broad description
used on the Notice of Approval.
The Notice of Approval description for IBCs is:
 ‘XXX litre HDPE returnable container with a top-mounted discharge
valve for use with a closed transfer system (the container must not be
fitted with any other type of outlet)’
2.2
Returnable containers for solids
Some solid formulations (currently WG and GR/FG formulations) are supplied
in SVR containers. There are currently two types:
 A graduated container for WG formulations (constructed of HDPE or
FHDPE of 5 to 10 kg capacity) with an integral valve. The container is
inverted and coupled directly to an adaptor mounted on the sprayer
(normally positioned on the lid of the induction hopper). After coupling
the container is then rotated to open the valve and dispense (by
gravity) the required amount of product.

A drum for GR/FG formulations (constructed of HDPE or FHDPE of 20
kg capacity) with an integral valve. The container is inverted and
coupled directly to an adaptor mounted on the granule application
equipment (normally positioned on the lid of the hopper). After
coupling the container is then rotated to open the valve and dispense
(by gravity) a sufficient (unmetered) quantity of product to refill the
hopper. There is a requirement for some types of these containers to
be emptied in a single operation.
IBCs for solid pesticide formulations are unusual. These may be rigid
containers or flexible bags. Unlike IBCs for liquid formulations, it may be
appropriate to dispense the product by gravity through a low-level outlet.
Approval for such containers will be considered on a case-by-case basis.
2.2.1 Data requirements for returnable containers for solids
The operator exposure data requirements for approval of solid formulations in
SVR containers are the same as those specified for liquid formulations (see
Section 2.1.1, above), although the wording will need to be adjusted in
situations where a spray solution is not being produced. However, the
following point must also be addressed.
In situations where the SVR container is calibrated (by volume) to indicate the
amount of product (by weight) dispensed:
 evidence should be submitted to confirm that the container markings
accurately represent the appropriate weight of product being dispensed for
the formulation under consideration; and
 the product label should describe how to dispense an accurate dose (for
example, by ensuring the product is level within the container before
opening the valve and by comparing the calibrations to the appropriate
part of the surface of the discharging product.
The operator exposure data requirements for IBCs for solid pesticide
formulations will be set on a case-by-case basis.
2.2.2 Label phrases for returnable containers for solids
Detailed guidance on labelling requirements for returnable containers is
provided in the PSD Labelling Handbook.
The product label (or, in some cases, a separate label supplied with the SVR
container or IBC) should provide detailed advice on how to use the container.
This should describe how to:
 open the container (including advice on removing tamper-evident seals
and not attempting to remove valves etc.);
 transfer the required amount of product using a closed transfer system
(or the closed transfer system built into the container/adaptor);


reseal the container after use; and
return the empty container for refilling or recycling.
The ‘Precautions’ section of the SVR container or IBC label must include the
phrases:
 ‘Do not rinse out the container’ (this replaces the rinsing instructions
on washable single-trip packs);
 ‘Open the container only as directed’;
 ‘Return the empty container to the supplier’ and
 ‘Do not re-use the container for any other purpose’ (this replaces the
phrase ‘Do not re-use the container for any purpose’ which appears on
certain single-trip packs).
In addition, the following phrases must be identified as ‘other specific
restrictions’:
 ‘The empty container must be returned to the supplier.’; and
 ‘The empty container must not be re-used for any other purpose.’
The SVR container or IBC label should also advise, where appropriate, that:
 empty and unrinsed packs should be treated as full packs;
 where partial refilling is intended, the refilled container may have a
range of possible fill volumes; and
 for containers with a net weight greater than 25 kg, mechanical
handling is required.
In some situations additional ‘Precautions’ phrases may be required, such as
‘Empty container completely in a single operation’.
2.2.3 Container description (Notice of Approval) phrases for returnable
containers for solids
In some situations the Notice of Approval descriptions for SVR containers for
solids are non-specific (for example, ‘1 to 10 kg high density polyethylene
refillable container’). However, if revised packaging is to be used other than
that considered in HSE’s evaluation (for example, a modified design of
container) an application will be required even though the new packaging falls
within the broad description used on the Notice of Approval.
The Notice of Approval description for IBCs for solid formulations will be
decided on a case-by-case basis.