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Lab-HB-Vol-1-Introduction

The Labelling Handbook provides comprehensive guidance on the labelling requirements for plant protection products (PPPs) in the UK, covering all product types including professional and amateur labels. It outlines the procedures for label authorisation, the necessary information to be included on labels, and the responsibilities of both the authorisation holders and users. The handbook also addresses legal requirements, legibility standards, and the prevention of misleading information on labels.

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crishina9legend
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0% found this document useful (0 votes)
4 views

Lab-HB-Vol-1-Introduction

The Labelling Handbook provides comprehensive guidance on the labelling requirements for plant protection products (PPPs) in the UK, covering all product types including professional and amateur labels. It outlines the procedures for label authorisation, the necessary information to be included on labels, and the responsibilities of both the authorisation holders and users. The handbook also addresses legal requirements, legibility standards, and the prevention of misleading information on labels.

Uploaded by

crishina9legend
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 37

Chemicals Regulation Division

The Labelling Handbook


(Version 3)

An Applicant’s Guide to Labelling


Requirements for
Plant Protection Products

Volume 1- Requirements for all Product Labels

Volume 2- Requirements for Professional Product Labels

Volume 3- Requirements for Amateur Product Labels

Volume 4- Requirements for Labels of Products used under


Permits for Trial Purposes
Chemicals Regulation Division
Labelling Handbook
Volume 1- Requirements for all Products

The Labelling Handbook


Volume 1

Requirements for all Product Labels


Contents
1. INTRODUCTION 3

1.1 Role of the Labelling Handbook 3


1.2. Products covered by this guidance 3
1.3 Legal basis for these labelling requirements 3
1.4. Responsibilities of an authorisation holder selling/supplying the label 4
1.5 Responsibilities of a user following the label 4

2. PROCEDURES FOR AUTHORISATION OF A LABEL 6

2.1 Stage 1 - Applicant submits a draft label 6


2.2 Stage 2 - HSE considers the draft label as part of an application 7
2.3 Stage 3 - HSE issues authorisation with label amendments to the draft 7
label

3. INFORMATION THAT MUST APPEAR ON THE LABEL 8

3.1 ‘Authorised Text’ 8


3.2 ‘Other Text’ 9
3.3 CLP requirements 9

4. LABELLING DIFFERENT PARTS OF THE PACKAGING 11

4.1 Components of a label 11


4.2 Physical requirements of a label 11
4.3 Labels directly affixed to container 12
4.4 Use of a separate leaflet for certain label text 12
4.5 Labelling outer packs 13
4.6 Labelling inner containers 13
4.7 Labelling water soluble bags 13
4.8 Labelling different authorised products in one outer pack 14
4.9 Labelling a single product containing two or more separate 15
components (for example twin-pack)

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5. LEGIBILITY OF INFORMATION 17

5.1 Language 17
5.2. Font and font size 17
5.3 Text and background colours 17
5.4 Hazard symbol size 17
5.5 Legibility of Product Label for refillable containers 17
5.6 Graphics and artwork 17
5.7 Use of ‘Child/Pet Logo’ 18

6. AVOIDING FALSE OR MISLEADING INFORMATION 20

6.1 What is ‘false and misleading information’? 20


6.2 Claims for a ‘biodegradable’ product 21
6.3. Claims of ‘eco-friendly’/‘natural’/‘organic’ 21
6.4 Misleading tradenames 22

7. MAKING ACCEPTABLE CHANGES TO ‘AUTHORISED TEXT’ 23

7.1 Amending text 23


7.2. Removal of text 23
7.3 Changes to ‘convenience tank-mix’ recommendations 23
7.4 ‘Other Text’ and ‘Advisory Information’ 23
7.5 Dual UK/Irish labelling 24
7.6 Unacceptable changes to ‘Authorised Text’ 24

APPENDICES 25

Appendix 1: Requirements for product tradenames 25

Appendix 2: Examples of acceptable alternatives to ‘Authorised Text’ 27

Appendix 3: Dual UK/Irish labelling 34

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1. INTRODUCTION

1.1 Role of the Labelling Handbook

1.1.1 The content and design of a plant protection product (PPP) label is important as it is the
main source of information for the user. Label information must be conveyed such that
the user can easily read, understand and follow to ensure that the product is used safely,
humanely and efficaciously.

1.1.2 This Handbook provides detailed guidance on preparing product labels. New applicants
are advised to read through the Handbook in full, but it should also be used as a
reference work for more experienced applicants. A glossary of some of the terms used
throughout is on our website.

1.2. Products covered by this guidance

1.2.1 This Handbook covers the legal requirements for labels of all amateur and professional
PPPs authorised by HSE.

1.2.2 It does not apply to:

(a) non-agricultural pesticides and biocides including those for wood preservation,
surface biocide treatment, anti-fouling products and animal husbandry) who have
their own labelling guidance

(b) adjuvant products (further details on adjuvant labelling can be found in 'The
Applicant Guide').

1.3 Legal basis for these labelling requirements

1.3.1 General labelling requirements were previously defined under the governing national
legislation (COPR/PPPR in the UK). Now that all products are authorised under the
directly acting Regulation (EC) 1107/2009, UK labelling requirements are implemented
under Regulation 547/2011.

1.3.2 The PPP authorisation includes requirements for the labelling of each product in the
‘conditions for sale and supply’. This includes reference to the agreed text and other
requirements in this Handbook.

1.3.3 Some label requirements are also specified under other non-PPP legislation, for
example:

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(a) The classification and labelling of a product is a requirement of Regulation


1272/2008 (Classification, Labelling and Packaging of Substances and Mixtures (the
CLP Regulation).

(b) The weight/amount of material must be specified in accordance with the Weights
and Measures Act 1985.

1.3.4 In addition labels may also include other information that is provided by the applicant at
their discretion (for example Company Advisory Information).

1.3.5 This Handbook provides advice on how all this information fits together with the PPP
Regulations and how it should all appear on the product label.

1.4. Responsibilities of an authorisation holder selling/supplying the label

The text and format of the label supplied with the authorised product must comply with the
following:

(a) The draft label text as identified in the product authorisation by date submitted,
company reference no. and an HSE reference no. Amendments to the draft label text
are specified on the covering letter to the authorisation (it is a requirement in the
authorisation document itself that these must be implemented)

(b) Classification and labelling under the CLP Regulation. (The authorisation will include,
based on the knowledge available to us, our understanding of the classification)

(c) Structure and format of the final printed label in line with this Labelling Handbook
Volumes 1 and 2 or 3 (professional and amateur products respectively)

(d) For professional products, an optional Company Advisory Information at the discretion of
the authorisation holder in line with the guidance at this Labelling Handbook Volume
2/ Section 8.

1.5 Responsibilities of a user following the label

1.5.1 Professional products

The whole product label other than Company Advisory Information has a legal basis and
all label instructions in those sections must be followed by the user. The
authorisation will highlight specific conditions of use which cannot be varied or
disregarded in any circumstances (for example crops to be treated, maximum dose
rates, numbers of treatments, latest time of application, personal protective equipment
and various environmental and other restrictions). Copies of authorisations are available
on our website). Some Directions for Use may possibly be varied by the user by virtue
of advice given in the Code of Practice for Using Plant Protection Products:

• Water volume used for the application of products

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• Use of tank-mixtures
• Use of product on crops in accordance with the requirements of an Extension of
Authorisation for Minor Use (previously called the Specific Off-Label Approvals
Scheme).

1.5.2 Amateur products

The whole product label has a legal basis and all label instructions must be followed
by the user.

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2. PROCEDURES FOR AUTHORISATION OF A LABEL

2.1 Stage 1 - Applicant submits a draft label

2.1.1 For most applications you must provide a copy of a draft label which will be considered
during the evaluation of your application. This includes:
(a) Applications for a commercial level of authorisation of a new product.

(b) Applications for changes to an existing authorised product where changes are
required to the label text, for example for authorisation on new crops; for claims to
control new pests, diseases or weeds.

2.1.2 The draft label text must include the proposed text set out in;
• The general requirements specified in Volume 1 (all products )
• Volumes 2 (professional products) or 3 (amateur products) of this Handbook.

2.1.3 All standard text required in this guidance must appear. You must ensure that all the
proposed claims/recommendations can be justified by the supporting safety and efficacy
data package. It is however not necessary at this stage to reflect all the formatting
requirements set out in Volume 1 (meaning legibility, fonts, final artwork and colours).

Important Notes

A draft label is not required for the following types of applications:

- applications where there are no changes to the authorised label. For example those
addressing confirmatory data requirements or those for minor changes to the formulation

- applications for new products submitted via the Administrative Stream where the
Authorisation/Permit will simply make reference to using the authorised label for the ‘parent’
or ‘reference product’ with an amendment to the tradename/ MAPP no./
Authorisation/Permit holder*. For such products you must still follow all the guidance in this
Handbook on formatting, legibility, acceptable text changes, etc.

* Parallel Trade Permits also require labelling in line with the ‘reference product’. However
you are still required to submit a draft label with any such application but it will not be
checked unless you specifically request this service - see our website guidance.

- applications for a Permit for Trial Purposes (you must label the product in line with the
conditions set out in the Permit and the requirements of Volume 4 of this Handbook).

Where you do not submit a draft label for a commercial authorisation (other than Parallel Trade
Permits), you must provide a suitable reference to the previously authorised label (including
COP number under which the product label was submitted and the HSE reference for that label
as specified on the current authorisation).

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2.2 Stage 2 - HSE considers the draft label as part of an application

We will check the draft label during the processing of your application to ensure that it
complies with the legal requirements and that the contents of the label are supported by
relevant data and the safety/efficacy assessment. A fee is applied to the checking of a
new draft label.

2.3 Stage 3 – HSE issues authorisation with label amendments to the draft
label

2.3.1 If appropriate, we will issue an authorisation for the product which will include a
reference to the submitted draft label and a list of amendments included in the letter
accompanying the authorisation. It is your responsibility to ensure that these
amendments are incorporated into the final printed label and that it complies with all the
formatting requirements set out in this Handbook.

2.3.2 There is no requirement for the routine submission of the final printed label. However,
you may be asked to submit the final label as part of our rolling programme of label
checks required under Article 68 of Regulation (EC) No 1107/2009.

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3. INFORMATION THAT MUST APPEAR ON THE LABEL


A PPP label will include 2 types of information which are known as ‘authorised text’ and
‘other’ text. There is also other information (on classification) which are required under
separate legislation.

3.1 ‘Authorised Text’

3.1.1 ‘’Authorised Text’ is information relating to the safe, efficacious and humane use of the
product, which falls within the remit of the PPP legislation and supported by safety and
efficacy data. Meaning the sections headed Important Information, Safety Precautions,
Directions for Use, Extensions of Use, plus all the information on the Identity of the
product. This is the part of the label that we check and to which we may require
amendments.

3.1.2 ‘Authorised Text’ is applicable to professional products (Volume 2), amateur products
(Volume 3) and Experimental Authorisations (Volume 4) although the requirements differ
between each. It is important that you refer to the correct section of the Labelling
Handbook when considering the ‘Authorised Text’ for your PPP label.

(a) Professional Products

Authorised text for a Professional Product Label consists of the following:

Product Identity See Volume 2/ Section 2


Important Information See Volume 2/ Section 3
Safety Precautions See Volume 2/ Section 5
Medical Advice See Volume 2/ Section 6
Directions for Use See Volume 2/ Section 7

(b) Amateur Products

Authorised text for an Amateur Product Label consists of the following:

Product Identity See Volume 3/ Section 2


Safety Instructions See Volume 3/ Section 4
Medical Advice See Volume 3/ Section 5
Instructions for Use See Volume 3/ Section 6

3.1.3 The ’Authorised Text’ may usually only be substantively amended by submission of an
application for change in authorisation. However, the Labelling Handbook allows a
degree of flexibility in approach to formatting (see Volume 1/ Section 5).or changes to
wording that can be made without applying for authorisation (see Volume 1/ Section 7).

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3.2 ‘Other Text’

3.2.1 ‘Other Text’ is either:

(a) Information that has to appear by virtue of other legislation, for example,
classification and labelling under CLP. We do not check this section although the
Notice of Authorisation will include either our assessed classification or, if we have
not assessed it, the applicant’s proposal. See section 3.3. below and Volume 2/
Section 3 (professional products) and Volume 3/ Section 2 (amateur products)
for full guidance.

(b) Additional advice that may be supplied on, or with the product label and which is not
within the remit of the Regulations. It includes additional useful advice on:

• the handling and use of the product at the discretion of the authorisation holder
(for example Company Advisory Information for professional products - see
Volume 2/ Section 7)

• information which is required by other legislation (for example Material Safety


Data Sheets (MSDS) required under REACH regulations. A requirement of
the REACH Regulation is that all products must be supplied with MSDS. They
may appear on the label if using the following phrase:

‘This Safety Data Sheet does not form part of the label authorised under
Regulation (EC) 1107/2009.

• information that relates to non-pesticidal uses which are not controlled under
Regulation (EC) 1107/2009, for example uses as a fertiliser/crop nutrient or
general disinfectant uses. A label may carry such recommendations as long as
they are clearly separated from those for PPP uses and a statement must appear
explaining that these uses are not part of the text as controlled under the
Regulation (EC) 1107/2009.

• website URLs or QR codes which provide links to other useful information for the
user. We have no specific restrictions as to their use on labels as long as:
- their size and location does not restrict label information required under the
product authorisation; and
-- the information linked to is in line with the authorisation or other regulatory
requirements

We do not check these aspects of the label and it is your responsibility to comply
with the relevant requirements.

3.3 CLP requirements

3.3.1 Since 31 July 2004 all PPPs in the UK have been included under the scope of the
Chemicals (Hazard Information and Packaging for Supply) Regulations 2002 (CHIP).

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CHIP implemented Directives 67/548/EEC (the ‘Dangerous Substances Directive’ -


DSD) and 1999/45/EC (the ‘Dangerous Preparations Directive’ - DPD), which required
that those responsible for the marketing of the product must classify and label the
product with respect to physico-chemical properties, human health and environmental
effects. The product must be classified using either the ‘conventional’ method of
calculation (based on the components of the formulation) or by using specific formulation
data (or via a combination of both). CHIP required certain symbols (and associated
wording for example ‘Dangerous for the environment’), Risk (R) phrases to reflect the
classification, and safety (S) phrases to ensure safe use.

3.3.2 On 20 January 2009 the above Directives were replaced by a new EU Regulation
1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures (the
CLP Regulation) which will implement the United Nations’ Globally Harmonised System
(GHS) for classification and labelling in all EU Member States. The CLP Regulation
introduced new classification criteria, hazard pictograms and labelling phrases (hazard
statements and precautionary statements). Further background on the GHS can be
found on the HSE website.

3.3.3 CHIP 4 introduced transitional arrangements to allow a gradual migration from the
existing DSD/DPD classification system (CHIP 3) to the CLP system. CHIP 4 applied to
the classification of substances from 1 December 2010 and to the classification of
mixtures from 1 June 2015. Substances and mixtures which are already in the supply
chain before 1 December 2010 (substances) and 1 June 2015 (mixtures) may be
postponed until 1 December 2012 and 1 June 2017 respectively. The additional two
years are granted in order to avoid unnecessary burdens of re-labelling and re-
packaging on enterprises reclassifying their substances and mixtures according to CLP.

3.3.4 Regulation 1272/2008 is now part of UK legislation. See the CLP Guidance
Document for full guidance on authorisation holders’ responsibilities for CLP labelling
and how such labelling impinges on PPP authorisation and labelling.

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4. LABELLING DIFFERENT PARTS OF THE PACKAGING

4.1 Components of a label

4.1.1 The label is defined as the written, or graphic matter on, or attached to, or accompanying
the plant protection product. It may take the form of:

• a label printed on or attached directly to the container


• a fold-out leaflet attached to that label or a separate or detachable leaflet
• additional outer packaging (for example cardboard outers) or separate inner packs
(for example sachets within a cardboard outer).

4.1.2 As it is important to convey certain important information to the user at when the product
is first handled, we have defined the type of information that should appear on different
parts of the container label for each of the above.

4.2 Physical requirements of a label

4.2.1 The label must be strong, durable and attached securely, and remain so during all
conditions under which the container is likely to be transported, stored and used. It
should be resistant to both the contents of the container and of other substances with
which it might be expected to come into contact.

4.2.2 It must be in a prominent position on the container and for ‘dangerous’ products
(classified in accordance with CLP) the label must be placed so that it can be read
horizontally when the container is in its upright position.

4.2.3 The label must be the largest size allowed by the design of the pack but at least:

Container capacity Dimensions of label


* 3 litres or less * not less than 52 x 74 mm
exceeding 3 litres but less than 50 litres not less than 74 x 104 mm
exceeding 50 litres but less than 500 litres not less than 105 x 148 mm
exceeding 500 litres not less than 148 x 210 mm

If it is impracticable to comply with the dimensions for this pack size, the label should be
as large as possible. Please contact us for advice in this instance.

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4.3 Labels directly affixed to container

Ideally all of the ‘Authorised Text’ plus the CLP information should appear on the label
written directly onto or adhered to the container. For clarity, we suggest that this type of
label be arranged in two or more areas such as a Main Area and a Subsidiary Area.
(meaning a ‘front’ panel and ‘back’ panel respectively).

The Main Area of the label (for example the front panel) should preferably contain at
least:
• product tradename
• product registration number
• formulation type
• amount and name of the active substance
• the anticholinesterase warning phrase (if appropriate)
• biological use phrase
• CLP information.

The Subsidiary Area (for example the back panel) should contain the remainder of the
‘Authorised Text’ if it does not already appear on the front panel.

However, if space constraints dictate, other options are acceptable providing that
all the information is visible to a user upon first handling the pack.

4.4 Use of a separate leaflet for certain label text

4.4.1 Where (due to space constraints) it is impossible to include all of the ‘Authorised Text’ on
the label fixed to the container, then you may include a separate leaflet or similar with
the Directions for Use (professional products) or Instructions for Use (amateur products).
This may be:

• directly fixed to the container label (for example a fold-out leaflet);or


• a booklet supplied separately with the product.

4.4.2 The label affixed to the container must contain all of the ’Authorised Text’ on safe
handling of the product (meaning everything except the ‘Directions for Use/’Instructions
for Use). It must include a phrase ‘signposting’ the user to where this information can be
found. For example:

‘See attached leaflet/ separate booklet for ‘Directions for Use’/’Instructions for
Use’

4.4.3 As well as the Directions for Use/ Instructions for Use the leaflet must contain all of the
’Authorised Text’. It must also contain the following phrase:

‘This leaflet/booklet is part of the authorised Product Label’.

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4.4.4 The leaflet must be of sufficient quality and durability for the purpose.

4.4.5 Where affixed labels are too small to even include all of the information on safe handling,
then it may be possible to further reduce the requirements for the label text. You should
contact us for advice in such cases.

4.5 Labelling outer packs

4.5.1 Some containers are sold to the user in outer packaging. This outer packaging (for
example often a cardboard carton) must also contain the ’Authorised Text’ (as for the
label fixed to the container), although where space is limited it is acceptable to refer the
Directions/Instruction for Use to the actual product container or a leaflet as under para.
4.4 above.

4.5.2 This only applies to outer packaging which is supplied directly to the user. There are
specific labelling requirements relating to packaging used only for the transport of
products covered under separate legislation. Guidance can be found on the HSE
website. You must ensure that packaging used purely for transport comply with the
appropriate legislation.

4.6 Labelling inner containers

4.6.1 Where an inner liner is not intended to be removed from a container (for example a
polyethylene liner in a cardboard outer for solid formulations), a statement warning
against removal from the container must appear on the label (for example DO NOT
REMOVE INNER LINER) in the Safety Precautions or Safety Instructions sections as
appropriate (see Volumes 2 or 3 for details). As a further precaution, such inner liners
may be labelled with essential information on safe handling (meaning all text except
Directions for Use (professional products) and Instructions for Use (amateur products)).

4.6.2 Where an outer pack contains one or more inner containers (for example sachets; water
soluble bags) intended to be removed from the outer pack during use, the inner(s) must
also be labelled with essential information for the user on safe handling. Advice on the
labelling of certain types of inner containers such as sachets and water soluble packs
where space is limited is detailed below. Applicants wishing to label such containers in
any other way should discuss the issue with us.

4.7 Labelling water soluble bags

4.7.1 A water soluble bag or sachets should carry all the information required for the safe
handling of the product (everything except Directions for Use for professional products
and Instructions for Use for amateur products). However, due to the potential size of
such packs and impracticality of printing large amounts of information on PVA a reduced
level of labelling may be acceptable.

4.7.2 The vital consideration in dealing with such packs is reducing the likelihood of a user
removing unlabelled packets from labelled containers long before use and then
forgetting what they are. It is not permissible to package a quantity of unlabelled soluble

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packets in an outer container where they could be separated from the accompanying
labelling. Each packet must include identifying labelling on the PVA itself. If this is not
feasible, the applicant should contact us to discuss the issue.

4.7.3 The following minimum information has been considered acceptable for the water
soluble bag itself. Any application for such labelling will be considered on a case-by-case
basis.

(a) product tradename


(b) product registration number
(c) the formulation type and name and amount of the active substance
(e) phrases such as:
DO NOT TOUCH [WITH WET HANDS OR GLOVES]
DO NOT STORE
USE IMMEDIATELY
ENSURE ALL OTHER LABEL INSTRUCTIONS ARE FOLLOWED

4.7.4 Additional Safety Precautions are also usually required on any outer container in which
the water soluble bag is supplied to alert the operator to the hazards of touching the bag.

DO NOT TOUCH WATER SOLUBLE BAG [WITH WET HANDS OR GLOVES]


PLACE WHOLE BAG DIRECTLY INTO THE SPRAY TANK

4.7.5 Outer packaging should carry all the ’Authorised Text’. If the applicant wishes to label
outer packs in any other way, it is essential that draft text is submitted to us for
consideration. Any novel packaging type will be dealt with on a case-by-case basis and
applicants should contact us for advice. Possible scenarios include:

• Single bag in protective outer – for example tear-open foil envelope containing
each soluble packet. The foil will require labelling but reduced labelling may be
acceptable depending on the size of the foil pack and whether it is itself packaged in
an outer container. (This foil envelope method has the added benefit of protecting
the soluble packet from moisture which could cause shelf-life problems).

• Multiple bags in protective outer - for example ‘egg-box’ type of package where
each packet is enclosed in a depression with a tear-off top that seals each
depression. The tear-off top may possibly carry required labelling.

4.8 Labelling different authorised products in one outer pack

4.8.1 Where you intend to sell two or more separate authorised products packaged within the
same outer pack (for example ‘Agronomy packs’/’Box sets’ or similar sold as a
promotion), the outer pack offered for sale or supply to the user must comply with the full
label requirements for the container label for each of the products.

4.8.2 Note that this is not a ‘twin-pack’ (which is covered by para. 4.9 below) meaning the
‘box-set’ is not identified as a single product with specific claims/recommendations for

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use of the 2 or more components together Such packs do not need a separate
authorisation, tradename or MAPP number unlike ‘twin-packs.

4.9 Labelling a single product containing two or more separate components


(for example twin-pack)

4.9.1 ‘Guidelines on the Provision of Pesticide Mixing Services and Sale of Pesticide Twin
Packs and Kits’ can be found in the Applicant Guide .

Where two or more PPP formulations are packaged and sold together specifically for use
as a tank-mix, the ‘combination’ constitutes a single product with a single tradename and
MAPP no. Such products may be supplied as two or more separate packs within a
single outer container, as a single container with two or more separate compartments, or
any other acceptable system of packaging. The specific labelling requirements will be
considered on a case-by case basis depending on the packaging but the following gives
the general principles when you are drafting your label for submission with an
application.

4.9.2 In all cases, any outer pack label must fully explain the nature of the product as a whole
and its separate components (meaning specifically for each component, the formulation
type, active substance content and pack size) and give full information on handling and
use of both the individual components and the mixture.

4.9.3 Where the product comprises an outer pack containing a number of separate inner
packs each component container must:

(a) carry both the tradename and MAPP number of the product and, less
prominently, the identity of the individual components (name, formulation type,
active substance content, pack size and batch number) (note: if an individual
component is authorised separately as a product in its own right, that MAPP
number must not appear as well).

(b) carry all other information on Product Identity, Important Information, Safety
Precautions and Directions/Instructions for Use for the product as a whole (rather
than information specific to the individual components):

(i) the Important Information will include the rates required for each
component plus any other requirements for each individual component
(there will only be a single maximum number of treatments, latest timing
etc for the use of the mixture on any one crop/situation).

(ii) the Safety Precautions must include all the relevant phrases for each
component Where each component would separately be labelled with a
different Safety Precautions phrase addressing the same risk area, the
‘worst-case’ must be specified.

(iii) the Directions For Use must give the appropriate information for handling
the components and using them in mixture. Note that the same option for
use of a separate Leaflet applies.

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4.9.4 Where the individual components are supplied in a multi-compartment container (with or
without an outer pack):

(a) it must be clear in which compartment each named component is in and the
Container Label must clearly identify which information applies to which
component.

(b) it must carry all the other information as listed above for separate containers but
the information obviously need appear only once on the multi compartment
container.

4.9.5 Where a product consists of one (or more) PPPs and is sold with a separately packaged
non-PPP (for example an adjuvant, dye, carrier) to be mixed prior to application of the
product, the same labelling guidelines apply. The labelling required will depend on the
nature of the non-pesticide (for example adjuvant, solvent, dye). Applicants should
contact us for specific advice in such cases.

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5. LEGIBILITY OF INFORMATION

5.1 Language

Labels must be in English. It is unusual to have multi-lingual labels in the UK although


there is nothing in the UK legislation to prevent you from doing so. For example
translating the UK authorised label into other languages for non-English speaking users
in the UK.

5.2. Font and font size

As well as the restrictions on label size, the whole label should be prepared so that it is
clear and legible to the user. The largest possible typeface should be used in relation to
the label size. Small font sizes cause significant difficulties for those users who are
visually impaired. Where appropriate, other Volumes in this guidance set further
requirements for the printing of certain text with respect to size, bold-highlighting and
capitalisation such that it stands out on the label.

5.3 Text and background colours

Colours of the label background and text are at your discretion. However, to ensure
maximum impact, there must be adequate colour contrast of the print to the background,
for example black print on white background. Other combinations which would make the
text difficult to read should not be used (for example red on black).

5.4 Hazard symbol size

The hazard symbol must appear in line with the CLP Regulation.

5.5 Legibility of Product Label for refillable containers

You must check the condition and legibility of labels for refillable containers each time
the packs are re-filled. Where necessary new labels must be attached to the container.

5.6 Graphics and artwork

5.6.1 Use of graphics as part of the label is at your discretion. If graphics are used as part of
the label background upon which text is superimposed, it should not be of a colour or of
such complexity to render illegible the overlying text. Use of graphics should not take up
excessive space so as to make the label text illegible or difficult to read.

5.6.2 It is acceptable to include artwork or graphics on the final printed label which did not
appear on the draft label submitted to us. Artwork may appear for various reasons
especially in association with the Directions For Use section (for example to clarify the
text) or as a marketing tool (for example product logos). We encourage their use if they
improve the clarity of the label text. Graphics and symbols are acceptable as long as

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they do not obscure or crowd required label text or misrepresent the product. Nor should
they be used instead of ’Authorised Text’.

5.6.3 Examples of acceptable graphics and symbols include:

• diagrams of how to open product containers


• pictures depicting authorised personal protective equipment (professional products
only)
• pictures illustrating proper use
• pictures to aid identification of target pests
• company and product logos.

5.6.4 Examples of unacceptable graphics and symbols include those which are:

unrelated to the authorised use


• an unauthorised crop/situation
• pictures of people using a product without the required personal protective
equipment
• pictures of a pest or weed not claimed to be controlled by the product); or

misleading to the user


• symbols implying safety or non-toxicity, such as a red cross or a medical seal of
authorisation,
• pictures of hedgehogs, birds or other wildlife
• pictures implying home garden use of a commercial/industrial product) or
• a ‘child/pet logo’ on a metaldehyde containing product or any other product
for which this has not specifically been agreed with HSE- see para 5.7. below
for full details of the ‘Child/Pet Logo’ requirements

5.7 Use of ‘Child/Pet Logo’

5.7.1 Full details are in Regulatory Update 03/2010. For any authorised products (and
especially those authorised for amateur/home garden use), logos implying ‘child/pet
friendly/safe’ must not be used with the exception that you may include the following
‘Industry Standard' logo for home garden lawn treatments:

Links to images for label printing can be found on the HSE website.

5.7.2 This logo must be accompanied by a relevant imperative label phrase such as:

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‘Keep children and pets away from treated area [until granules have been
watered in]’

This phrase replaces the former passive version (‘Children and pets need not be
excluded from the treated area’) which is no longer allowed. We will decide on the
precise phrase depending on the nature of the product. No other logos may be used

5.7.3 Some non-lawn products have previously been assessed where non-standard logos
and passive forms of phrase (such as ’children and pets need not be excluded from the
treated area’) were agreed by HSE. When the requirements for the above logo came
into force these had to be amended to the above logo and the phrase changed to the
imperative form by 28 January 2012.

However, the standard logo and imperative phrase cannot be added to products where
the non-standard forms have not already been agreed and approved by HSE.

The appropriate form of logo/phrase for new or re-registered products will be


considered as part of the risk assessment conducted by HSE.

5.7.4 There are a very small number of low risk products such as ferric phosphate slug
pellets where this imperative labelling would be inappropriate (given that the pellets
need to remain intact to be effective). Ferric phosphate product labels should therefore
contain the following phrase alongside the ‘children and pets’ logo if it is used:

‘Use as directed to protect children and pets’.

If using the above phrase the additional phrase ‘Keep children and pets away from
spillages’ must be added to the ‘Safety Instructions’

5.7.5 The logo may not be used on metaldehyde and methiocarb slug pellets and other
bait-based products of equivalent toxicity.

Important Note

If in doubt as to whether your required artwork falls within the acceptable criteria, you
should contact us for advice before going to print.

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6. AVOIDING FALSE OR MISLEADING INFORMATION

6.1 What is ‘false and misleading information?

6.1.1 When preparing the draft and final label you must ensure that no false or misleading
claims are included. Examples are given below. If you are unsure whether a claim or
statement is false or misleading, you should consult us for advice.

(a) a false or misleading statement concerning the composition of the product

(b) a false or misleading statement concerning the effectiveness of the product as a


pesticide

(c) a false or misleading statement about the use of the product for purposes other than
as a pesticide

(d) a false or misleading comparison with other pesticides

(e) any statement directly or indirectly implying that the pesticide is recommended or
endorsed by HSE, any Government Department, other than the factual phrase ‘This
product is authorised under The Control of Pesticides Regulation/The Plant
Protection Product Regulations/ EU Regulation 1107/2009’

(f) a false or misleading statement that the product is endorsed by another organisation

(g) a true statement worded in such a way as to give a false or misleading impression to
the purchaser

(h) general claims as to the safety of the pesticide or its ingredients. This includes
statements such as ‘safe,’ ‘non-poisonous’, ‘harmless’ or ‘non-toxic to humans and
pets’ (irrespective of whether a qualifying phrase such as ‘when used as directed’
also appears)

(i) comparative statements on the safety of the product, such as ’Contains all natural
ingredients’, ‘Among the least toxic chemicals known’, and ‘Safer than chemical
pesticides’

6.1.2 However, specific claims which do not fall within the above categories and which are
demonstrably true (meaning supported by our safety and efficacy assessment) may be
acceptable for example ’Children and pets may play on treated turf once dry’.

6.1.3 We note that there may be authorised products on the market which have
phrases/claims that may now be unacceptable and these will be addressed when the
next suitable application is evaluated, for example at re-registration. This includes
products with the specific phrases discussed in sections 6.2. and 6.3 below.

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6.2 Claims for a ‘biodegradable’ product

6.2.1 The claim ‘biodegradable’ is not acceptable. However, the following phrases may be
used on product labels if supported by suitable evidence:

PROFESSIONAL PRODUCTS:
• ‘Upon soil adsorption the herbicidal properties of {product} are lost, it is degraded by
micro-organisms/microbes in the soil. Following crops may be drilled 48 hours after
application.’

HOME GARDEN PRODUCTS:


• ‘[Product] is degraded by micro-organisms/microbes in the soil’; or
• ‘[Product] is broken down naturally in the soil.’ or similar

Note that it is also not appropriate to incorporate words such as 'fully' or ‘totally’ into
these phrases.

6.2.2 You must note that these phrases will not be applied where an active substance is
simply unavailable in the soil rather than having actually been degraded.

6.3. Claims of ‘eco-friendly’/‘natural’/‘organic’

6.3.1 There are an increasing number of requests for products that make reference to
‘Organic’, Natural’ or ‘Eco-friendly’ in the tradename or elsewhere on the label. These
descriptions imply safety to the environment.

6.3.2 ’Natural’, ‘Eco-friendly’ or similar phrases are unacceptable in all cases whether in a
tradename or as a label claim.

6.3.3 ‘Organic’ may not appear in the tradename but only be used as a claim on the label if it
can be justified as part of an application (based on the formulation composition). Such
consideration would normally require technical input and so the Administrative route is
not appropriate (but see 6.3.5 below for an exception for professional products).

It may be possible to allow a statement of fact on the labelfor example:

‘This product is recognised/registered with the [reference to an appropriate organic


association]...’

Such a statement must be supported or confirmed to be true by the authorisation holder


as part of an application. You may find it helpful to refer to the Defra publication
'Compendium of UK Organic Standards'’ Sept 2006 when considering the use of the
term ‘organic’.

6.3.4 Any text such ‘suitable for organic gardening’ is unacceptable.

6.3.5 Professional products may include factual statements of acceptance in organic schemes
in the ‘Company Advisory Section’ without the need for an application to change the

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label. Such a section does not exist on amateur labels and therefore any such claim
must be considered by HSE as explained above in para. 6.3.3.

6.4 Misleading tradenames

You should note that the product name is considered as part of the product label and
must not include false or misleading terms (see Section 6.3. above for our policy on the
use of phases such as eco-friendly’/‘natural’/‘organic’). These mostly apply to home
garden products but some will also apply to professional products. Appendix 1 clarifies
what is acceptable to HSE, to allow applicants and authorisation holders to make
informed choices when developing tradenames.

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7. MAKING ACCEPTABLE CHANGES TO ‘AUTHORISED TEXT’


7.1 Amending text

In some cases you may be able to make changes to the ‘’Authorised Text’’, which do not
require a change to the authorisation and which therefore may be made without a formal
application to us. These changes must not alter the meaning of the ’Authorised Text’,
but simply present the same information in a different way. For example text may be
tabulated, or bulleted, or text may be rewritten so that it means the same as the
authorised statement. We have produced some examples to help you decide what type
of changes can be made to text and these are in Appendix 2 to this Volume.

7.2. Removal of text

7.2.1 You may delete all claims and recommendations for a particular use of a product (ie
crop/situation) where the deleted text is specific only to that use. However, you should
consider applying for commercial withdrawal of such uses so that the authorisation is
amended (see the HSE website for further information).

7.2.2. You should note that the position regarding liability for the consequences of product
failure set out in the Consumer Protection Act 1987 applies in these cases. Unless a use
is formally withdrawn by means of an application to alter the statutory conditions, the
authorisation holder remains liable for any crop damage which may arise so long as the
product has been used in accordance with the authorised conditions of use (including
during the period of any phased revocation). This applies regardless of whether the use
appears on the label.

7.3 Changes to ‘convenience tank-mix’ recommendations

You may delete or add ‘convenience’ tank mix recommendations, as long as you have
the necessary supporting data (see’ tank-mix section’ of the ‘The Applicant Guide’ which
also includes guidance on how to include tank-mix information on the label.).

7.4 ‘Other Text’ and ‘Company Advisory Information’

7.4.1 Certain information may appear within the body of the ‘’Authorised Text’’ which are not
subject to the Regulation and changes may be made to these without a change in
authorisation, such as Company disclaimer statements, trademark information.

7.4.2 For professional products, there is scope for amending information that is not supported
by data and not covered by the Regulations. Such text which is considered to be
‘advisory’ may be removed from the ‘’Authorised Text’’ sections to be included in a
separate ‘Company Advisory Information’ section (see Volume 2 for details).

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7.5 Dual UK/Irish labelling

Where appropriate clearance has been obtained from the PCS, you may make the
necessary changes to a UK authorised label for the production of a dual UK/Irish label.
As HSE and the PCS have slightly different arrangements for authorisation of labels
there are different ways in which a dual label may be authorised. Full details of the
authorisation procedure and the labelling requirements (which differ for amateur and
professional products) can be found in Appendix 3 to this Volume.

7.6 Unacceptable changes to ‘Authorised Text’

7.6.1 You must not make any changes to the standard headings, sub-headings and other
phrases defined in Volumes 2 & 3 relating to Important Information, Safety
Precautions/Information and Directions/Instructions For Use.

7.6.2 You must not change any information on the Product Identity which is specified on the
Notice of Authorisation and where such a change requires an amendment to the
authorisation (such as tradename, authorisation holder/marketing company, MAPP no,
formulation type, active substance and content).

7.6.3 You must not make changes to the meaning of the text.

7.6.4 You must not add any text which was not considered by HSE during evaluation of
application(s) for authorisation, and for which assessment of supporting safety and/or
efficacy data is required.

7.6.5 You must not delete any text which is supported by safety and/or efficacy
data/information and is required for the safe and efficacious use of the product.

Important Note

Any changes to the text must also follow the criteria for the ‘avoidance of false and
misleading information’. If in doubt as to whether your required changes fall within the
acceptable criteria, you should contact us for advice before going to print.

Version 1 May 2014


Version 2 September 2014
Version 3 November 2020

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Appendix 1: Requirements for product tradenames

There are a number of different issues surrounding product tradenames that are of
potential concern to HSE. The following advice on our position on tradenames was
published in an Information Update: 07/2008 (14 February 2008). Please note that for
existing products that carried tradenames with the types of claims discussed as
potentially unacceptable, we will make a reassessment of those tradenames during
re-registration of those products.

1. Market branding and unclear tradenames

1.1 In many instances, companies use market branding, often in terms of a recognisable
‘trading family name’. This is often situated close to the agreed tradename, which makes
it difficult for the user to distinguish what the product is called. In addition, different font
sizes and colours are used to highlight different elements of the product name, for
example:

‘ROBERTS PATENT weedkiller for garden paths’ which is actually registered as ‘Weedkiller
for Garden Paths’ with Roberts Ltd. as the authorisation holder.

1.2. We allow the use of such branding, both as text or pictorial representations, but the
product name must be formatted such that it is clear to the user what the full tradename
is. Whilst the use of different sized fonts and colours for different parts of the tradename
is acceptable, applicants should ensure that this would not confuse a user. Clearly in
the example above the actual authorised tradename is ambiguous.

1.3 Whilst it is necessary to maintain flexibility in label layout, proposed product names
should be notified to take account of market branding (if it is to be used in close proximity
to the name). For example ‘Roberts Patent Weedkiller For Garden Paths’ rather than
‘Weedkiller For Garden Paths’

2. Market branding and insufficient distinction between tradenames

2.1 Some products are most recognisable via the market branding (which are registered as
part of the tradename) and the remainder of the name is very similar within a product
range, for example ‘ROBERTS WEEDKILLER 1’ and ‘ROBERTS WEEDKILLER 2’.
These products may have different formulations, uses and even active substances.

2.2 This type of differentiation between product names may be insufficient to enable users to
clearly distinguish the products, potentially causing incidents through mistaken use (such
as a total weedkiller being used on lawns).

2.3 We consider that where there is a potential safety concern, tradenames must be more
distinctive than the above. Where applicants require various products with similar
names, we will consider the composition of the products before a decision is made on

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the acceptability of the name. This will also apply to changes made via the
Administrative route.

3. Duplicate/Historical tradenames

Whilst we do not consider trademark or copyright issues with respect to tradenames, we do


check if the name has been used previously for another product. You may then be required to
change the name (depending on the nature of the historical product and when/if it ceased to be
marketed).

4. Inappropriate tradenames

4.1 Tradenames must not mislead users. We do not allow:

• claims for superlative action, expressed or implied (such as ‘BEST EVER


weedkiller’)
• claims for increased activity where none has been demonstrated by the data
provided (such as ‘IMPROVED ACTION bug killer’)
• claims for misrepresentations about the content of the product (such as
‘CHEMFREE weedkiller’, NATURAL insecticide)
• claims such as ‘ORGANIC’ even if the product may have been approved by a
particular organic association and such a claim has been allowed on the label-
see Volume 1/section 6.3.

4.2 In light of the above, all requests for new tradenames will be scrutinised to determine
whether the names are appropriate. If the proposed name is not acceptable, we will
contact the applicant(s) to explain the basis for our decision and ask for an alternative
name.

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Appendix 2: Examples of acceptable alternatives to ‘’Authorised


Text’’

1. Contents statement

‘Authorised Text’ Acceptable alternatives

An emulsifiable concentrate formulation • [active 1] (100g/l) and [active 2] (50 g/l)


containing 100g/l [active 1] and 50 g/l [active 2] formulated as emulsifiable concentrate
in xylene (also contains xylene)

• Formulation type: emulsifiable concentrate


Active substances: 100g/l [active 1] and 50
g/l [active 2]
Contains xylene

2. Biological use phrases

‘Authorised Text’ Acceptable alternatives

For the control of annual grasses and a wide • A contact and residual herbicide for control
range of broad leaved weeds in winter wheat of annual grasses and broad leaved weeds
and winter barley, and certain varieties of in listed cereals
winter rye and triticale
• For control of a range of weeds in listed
cereals

A fast acting aphicide for use in a range of • An insecticide for control of aphids in sugar
crops beet, potatoes, cereals, peas, beans,
brassicas and other crops

• An aphicide for use in listed crops

A broad-spectrum insecticide controlling many • An insecticide for use against a number of


pests of agricultural, horticultural and forestry pests in a range of crops, including leather
crops jackets in pasture

• A broad-spectrum insecticide for the


control of a number of insect pests in
cereals, pasture and various fruit and
vegetable crops

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‘Authorised Text’ Acceptable alternatives

A protectant fungicide for the control of potato • A fungicide for use against certain
blight, downy mildew in winter oilseed rape diseases in potato, oilseed rape and
and cereal diseases cereals


A protectant fungicide for the control of
potato blight, downy mildew in winter
oilseed rape and leaf spot, brown rust,
yellow rust, sooty mould, leaf blotch and
net blotch in listed cereals
Note: Where the biological use phrase is expanded (as shown above), this is acceptable only
where the claims made are as detailed elsewhere in the Directions For Use.

3. Pest control claims, application doses and timings

‘Authorised Text’ Acceptable alternatives

Pest controlled: cutworms. Dose per hectare: • Cutworms will be controlled by the
2.0 litres application of 2.0 litres of product per
hectare

• For control of cutworm, apply 2.0 l/ha


product

For the reduction of downy mildew • Disease: downy mildew (reduction of).
(Peronospora parasitica) [product] should be Application rate: 1.7 kg product in 200 –
applied at 1.7 kg in 200 – 1000 litres of water 1000 l/ha water
per hectare
• Apply 1.7 kg product in 200 – 1000 litres of
water per hectare for the reduction of
downy mildew (Peronospora parasitica

Annual weeds will be controlled if spraying is • For control of annual weeds, apply
done while the majority of weeds are seedlings [Product] when the majority of weeds are
seedlings

• Control of annual weeds will only be


achieved if application takes place when
the majority of weeds are at the seedling
stage

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‘Authorised Text’ Acceptable alternatives

Apply post-crop emergence, when susceptible • Apply [product] before the susceptible
weeds have not passed the stage shown in the weeds have passed their recommended
following tables and before the crop reaches growth stage (see table, below).
the second node detectable stage (Zadoks 32) Applications may be made from crop
emergence up to second node detectable
stage (Zadoks 32)

• Application timing: After crop emergence


until the second node detectable stage
(Zadoks 32). Susceptible weeds will only
be controlled up to the growth stages
described in the table below

Leaf blotch: spray when disease is seen, • For the control of leaf blotch
before the second node detectable stage of (Rhynchosporium secalis), apply [product]
the crop at the first sign of disease. The latest
timing of application is the second node
detectable stage of the crop (Zadoks 32)

• Apply [product] at the onset of disease


symptoms for the control of leaf blotch.
Application must be made prior to the
second node detectable stage of the crop

4. Application method, water volume and spray quality

‘Authorised Text’ Acceptable alternatives

Apply [product] in 200-450 litres of water per • Use an application volume in the range
hectare. 200 – 450 l/ha

• Apply in 200 – 450 litres of water per


hectare

• Water volume: 200 – 450 litres of water per


hectare

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‘Authorised Text’ Acceptable alternatives

Apply as a medium quality spray (as defined • Spray quality: medium spray (BCPC
by BCPC). A spray pressure of 2 – 3 bar is classification), using 2 – 3 bars
recommended.
• A spray pressure of 2 – 3 bars is
recommended to give a medium quality
spray, as defined by BCPC

• Spray quality: BCPC medium spray

Thoroughly mix the pellets with the seed when • Mix pellets with the seed when filling the
filling the drill hopper, ensuring that they are drill. Ensure an even distribution through
evenly distributed throughout the seed the seed by mixing thoroughly

• It is important to achieve an even


distribution with the seed when applying
[product] by admixture at drilling.
Thoroughly mix the pellets and seed when
filling the hopper

Mixing – Half fill the spray tank with water, add • Spray tank mixing instructions: Half fill the
the required amount of [product] and agitate tank with water. Add the recommended
during completion of filling amount of [product] and commence
agitation. Top up tank to required level and
continue agitation

• Mixing instructions: Half fill the spray tank


before adding the required quantity of
product. Commence agitation before
completion of filling.

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5. Tank cleaning instructions

‘Authorised Text’ Acceptable alternatives

Wash equipment thoroughly with water and • Following use of the product, immediately
liquid detergent immediately after use. Finally wash out the spray tank with water and
wash out twice with water and drain liquid detergent. Then wash twice more
with water, and drain the tank

• The spray tank should be washed as soon


as possible after use. Thoroughly wash the
tank with a mixture of liquid detergent and
water. Carry out a further two washes with
water and drain.

Wash out the sprayer thoroughly after use of • Use a wetting agent or proprietary tank
[product], using a wetting agent or proprietary cleaner to thoroughly clean the sprayer
tank cleaner after use

• The spray equipment must be properly


cleaned after application of the product.
Use a wetting agent or a recommended
proprietary tank cleaner (eg [product]).

6. Restrictions and warnings

‘Authorised Text’ Acceptable alternatives

Do not treat broadcast crops as uncovered • To avoid damage to uncovered seed, DO


seed may be damaged NOT treat broadcast crops

• This product is not suitable for use on


broadcast crops, due to the risk of damage
to uncovered seed

Do not treat on crops grown for seed • Not for use on seed crops

• Do not use on crops being grown for seed

In common with many soil-applied PPPs the • Activity may be reduced in organic soils
activity of [product] may be reduced in organic
soils • The activity of this product may be reduced
in soils containing more than 10% organic
matter

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‘Authorised Text’ Acceptable alternatives

Do not apply when the crop is wet or rain is • Do not apply to crops with wet foliage, or if
imminent rain is expected

• Do not apply is rain is expected or if the


crop is already wet

Do not roll or harrow within a week of spraying • Do not roll or harrow for seven days before
or after spraying

• Do not carry out cultivations (rolling,


harrowing) +/- 7 days of spraying

7. Agronomic advice/general recommendations for use

‘Authorised Text’ Acceptable alternatives

The purpose of spraying is to delay the 75% • Treatment is carried out to delay the
foliage blight development stage until after the development of foliar blight until the end of
full weight of tubers has been formed. With bulking. With main crop varieties the full
main crop varieties, bulking comes to an end weight of tubers will have been formed by
in late September, so there is no point in late-September; there is no point in
preserving the haulm after this stage continuing treatment after this stage

• For main crop varieties, bulking will be


complete by late-September and there is
no point in preserving the haulm after this
stage

Phoma leaf spot is spread by rainsplash and • Phoma can be found from October
can be found from October onwards onwards, and is spread by rainsplash

• Rainsplash is the principal mechanism by


which Phoma leaf spot is spread through
the crop, and it is usually found from
October onwards

8. Positive and convenience tank mixtures

‘Authorised Text’ Acceptable alternatives

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‘Authorised Text’ Acceptable alternatives

For improved control of [x] and residual • Low dose post-emergence programme:
activity, [product 2] may be added to [product] Tank-mix with [product] 2 for improved
applications in a low dose post-emergence control of [x] and residual activity
programme
• When using [product] in a post-emergence
low dose programme, addition of [product
2] will enhance control of [x] and give
residual activity

Compatibility: The following mixtures for use • The following products are compatible with
on cereals only are compatible provided they [product] when used in cereals. Note that
are sprayed at the dose and timing for each each product must be applied within the
component recommended doses and timings.

• Compatibility, cereals. The table below


gives compatibility recommendations for
[product]. All products must be applied
within their authorised recommendation for
use

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Appendix 3: Dual UK/Irish labelling

1. Authorisation procedure

1.1 If it is known at the outset that a dual label is required for a new product, then you must
apply to both HSE and PCS (the Irish Regulatory Authority), with labels drafted in
accordance with the guidance below following the usual application procedure/
requirements for each Regulatory Authority.

1.2 Alternatively, you may first seek authorisation in the UK, and then subsequently apply for
authorisation in Ireland via the PCS. In this case you may follow the guidance below and
make the necessary changes to the UK authorised label without further recourse to HSE.
However, a copy of the updated (joint) label must be submitted once authorisation has
been issued by the PCS.

1.3 If you first seek authorisation in the Republic of Ireland, then subsequently apply for
authorisation in the UK then a further application must be made to the PCS to secure
authorisation for a joint labelled product.

1.4 Where required HSE and the PCS will liaise on any specific issues, which arise, for
example if requests are not covered by the guidance.

1.5 Any changes to the label which would affect its dual status (for example changes to label
claims, new crops/situations) must be supported by applications, and accepted by both
regulatory authorities before a dual label can be authorised.

2. Joint labelling requirements

The following requirements have been agreed between the PCS and HSE. In general if the
labelling requirements between the regulatory authorities differ the more stringent statements
(and geographical restrictions) must be used.

2.1 Professional Products

2.1.1 A ‘DPD’ (risk and safety) text box must appear on the front panel of the product label
(the same panel as the product name) with the heading ‘Risk and Safety information’.
This box must contain the relevant symbols and phrases required under the Dangerous
Preparations Directive or the CLP Regulation (in full), should be in a prominent position
and hold a significant proportion of the front panel area.

2.1.2 Risk phrases should be in bold and each on a separate line of the ‘DPD’ (risk and safety)
box and be in sentence case (not capitalised). The safety phrases should be in normal
font, under the risk phrases and each on a separate line, of the ‘risk and safety’ box.
Where space restrictions apply some flexibility may be given to the layout of these
phrases.

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Chemicals Regulation Division
Labelling Handbook
Volume 1- Requirements for all Products

2.1.3 The DPD required phrase ‘To avoid risk to man and the environment, comply with the
instructions for use’ must be included in the ‘DPD’ (risk and safety) box.

Ireland use this P501 phrase: 'Dispose of contents/container to a licensed hazardous


waste disposal contractor or collection site except for triple rinsed empty containers
which can be disposed of as non-hazardous waste'.

2.1.4 Additional UK-safety information (for example LERAPs, PPE, disposal phrases) must be
included outside the ‘DPD’ (risk and safety) box, on the main or subsidiary area of the
label (front, side or back). This information must appear under the heading ‘SAFETY
PRECAUTIONS’ and phrases marked ‘UK only’ where appropriate.

2.1.5 The UK-specific phrases relating to COSHH and the CPA voluntary Initiative must be
moved near to the Safety Precautions’ section of the label, and must be highlighted as
applying in the UK only (for example ‘The (COSHH) Control of Substances Hazardous to
Health Regulations may apply to the use of this product at work – UK only’).

2.1.6 PCS and MAPP numbers must be included beside each other in the bottom right hand
corner of the ‘DPD’ (risk and safety) box and also in close proximity to the product name.

2.1.7 The GAP information must be in a text box with the heading Important Information on a
main panel (front, side or back) of the container or label. Where it is not possible to
include all the required detail in the text box it may be signposted to a separate leaflet
supplied with the product. The phrase ‘Read the label before use. Using this product
in a manner that is inconsistent with the label may be an offence. Follow the code
of practice for using plant protection products’ must be included in the text box.
This phrase should also appear on any separate or detachable leaflet and any additional
outer packaging or separate inner packs.

2.1.8 Additional instructions for use should be clearly outlined.

2.2 Amateur Products

2.2.1 Where a product is classified and attracts a hazard symbol in accordance with the
Dangerous Preparations Directive or CLP Regulation, a ‘DPD’ (risk and safety) box must
be included on the front panel of the label using the same format as professional
products. If the product is not classified (meaning it does not attract a hazard symbol)
the information may be included on another panel of the label.

2.2.2 Risk phrases should be in bold and each on a separate line of the ‘DPD’ (risk and safety)
box. The safety phrases should be in normal font, under the risk phrases and each on a
separate line, of the ‘DPD’ (risk and safety) box. Where space restrictions apply some
flexibility may be given to the layout of these phrases.

2.2.3 The phrase ‘To avoid risk to man and the environment, comply with the instructions for
use’ must be included in the ‘DPD’ (risk and safety) box.

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November 2020
Chemicals Regulation Division
Labelling Handbook
Volume 1- Requirements for all Products

2.2.4 Additional safety information (for example disposal phrases) must be included outside
the ‘DPD’ (risk and safety) box, on the main or subsidiary area of the label (front, side or
back), under the heading Safety INSTRUCTIONS’ and phrases marked ‘UK only’ or
‘Ireland-only’ where appropriate.

2.2.5 The following disposal phrases may, if required, be included on a dual label in the ‘DPD’
(risk and safety) box:

• Do not empty into drains (S29)


• Do not contaminate water with the product or its container (SP1)

Additional disposal phrases may be required and where appropriate marked ‘UK-only’ or
‘Ireland-only’. See Volume 3 for further UK guidance and the PCS will advise on any
necessary ‘Ireland-only’ phrases.

2.2.6 Pictures or graphics portraying the product as ‘Harmless’ or ‘safe’ to children or pets
cannot be included. A phrase indicating re-entry period for humans and animals may be
allowed if appropriate.

2.2.7 PCS and MAPP numbers must be included beside each other in the bottom right hand
corner of the ‘risk and safety’ box and also in close proximately to the product name.

2.2.8 Additional instructions for use should be clearly outlined.

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November 2020

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