Ia Study Alignment CLP - en

Impact Assessment Study
on the Alignment of the

Pressure Equipment Directive
to the CLP Regulation
(Contract: 30-CE-0502728/00-73)
Final Report
prepared for
DG Enterprise and Industry
February 2013
Impact Assessment Study on the
Alignment of the Pressure Equipment
Directive to the CLP Regulation
Final Report – February 2013
prepared for
DG Enterprise & Industry
by
Risk & Policy Analysts Limited,

Farthing Green House, 1 Beccles Road, Loddon, Norfolk, NR14 6LT, United Kingdom
Tel: +44 1508 528465 Fax: +44 1508 520758
Email: post@rpaltd.co.uk
RPA REPORT – ASSURED QUALITY
Project: Ref/Title J796 PED-CLP

Approach: In accordance with contract and earlier study reports
Report Status: Final Report (Revised)
Report Prepared by: Pete Floyd, Director
Meg Postle, Director
Nigel Tuffnell, Senior Consultant
Scott Marshall, Researcher
Gill Pagliuca, Denehurst Chemicals
Terry Egginton, HPI Verification Services
Report approved for issue by: Pete Floyd, Director
Date: 27th February 2013
If produced by RPA, this proposal is printed on 100% recycled, chlorine-free paper

Disclaimer
The contents of this Report (and its Annexes) do not necessarily

reflect the opinion or the position of the European Commission or any
other organisation mentioned in the Report, but they are those of Risk
& Policy Analysts Limited. Access to these documents is restricted
and conditional to the fact that the results obtained in executing this
study are owned solely by the European Commission.
Risk & Policy Analysts
EXECUTIVE SUMMARY
Article 9 of the Pressure Equipment Directive (PED) separates ‘fluids’ into two
groups based on their hazard classification under the Dangerous Substances
Directive 67/548/EEC (DSD). Group 1 comprises ‘dangerous fluids’, as classified by
the DSD, whilst a Group 2 fluid is any other fluid. To take account of the hazards
associated with dangerous fluids, the requirements for the conformity assessment for
compliance with the PED are generally more extensive for pressure equipment
containing Group 1 fluids than for Group 2 fluids.
The Classification, Labelling and Packaging Regulation (CLP) was introduced to

implement the Globally Harmonised System (GHS) of Classification and Labelling of
Chemicals. The CLP will replace the DSD over a transitional period that will end on
31 May 2015. All downstream legislation that incorporates the DSD including the
PED will need to be aligned to the CLP.
In relation to the PED, as the classification of hazardous substances for the CLP is
different from that used for the DSD, it will be necessary to redefine what constitutes
a ‘dangerous fluid’ in terms of the CLP classification in order to align the PED with
the CLP.
The transition from the DSD to the CLP for physical hazards should be reasonably
smooth. Whilst there will be a change in the terminology and codes used to identify
the hazards, only a small number of fluids will change from one Group to another.
The transition from the DSD to the CLP for health hazards will not be as smooth as
for the physical hazards. Under the CLP, there will be a greater number of hazard
classes and categories and the boundaries do not often align with those of the DSD.
Consequently, it is inevitable that a number of substances will need to change
grouping under the PED.
There is consensus from stakeholders that there is no requirement to change the PED
conformity assessment procedures in respect of ‘dangerous fluids’. Rather the
problem is that in some ‘boundary areas’, the classification of some substances under
CLP may lead to some substances previously categorised as Group 2 fluids becoming
Group 1 fluids and vice-versa. The overwhelming view from stakeholders is that the
alignment needs to be as simple and as close to the current situation as possible.
With this in mind, it is proposed that the wording of Article 9 para 2.1 (which defines
Group 1 fluids) is amended to refer to the Hazard Statements associated with the
various hazardous properties defined in the CLP. The current wording is presented
overleaf with the suggested revision shown below.
Page i
Alignment of the PED to the CLP Regulation
Article 9 of the PED – Current Definition of Group 1 Fluids

2.1. Group 1 comprises dangerous fluids. A dangerous fluid is a substance or preparation covered by
the definitions in Article 2 (2) of Council Directive 67/548/EEC of 27 June 1967 on the
approximation of the laws, regulations and administrative provisions relating to the classification,
packaging and labelling of dangerous substances (1).
Group 1 comprises fluids defined as: explosive, extremely flammable, highly flammable,
flammable (where the maximum allowable temperature is above flashpoint), very toxic, toxic,
oxidizing.
(1) OJ No 196, 16. 8. 1967, p. 1. Directive as last amended by Commission Directive 94/69/EC (OJ No
L 381, 31. 12. 1994, p. 1).
Revised Article 9 for PED – Future Definition of Group 1 Fluids

2.1. Group 1 comprises dangerous fluids. A dangerous fluid is a substance or mixture covered by the
definitions in Article 3 of Regulation (EC) No 1272/2008 of the European Parliament and of the
Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures
(1),
Group 1 comprises fluids defined as:
- explosive with Hazard Statements H200, H201, H202, H203, H204 and H205,
- organic peroxides or self-reactive with Hazard Statements H240, H241 and H242,
- flammable gas with Hazard Statements H220 and H221,
- flammable liquids with Hazard Statements H224 and H225 and, where the maximum allowable
temperature is above flashpoint, H226,
- flammable solids with Hazard Statement H228,
- pyrophoric liquids and solids with Hazard Statement H250,
- contact with water emits flammable gases with Hazard Statements H260 and H261,
- oxidising with Hazard Statements H270, H271 and H272,
- acute toxicity – oral with Hazard Statement H300,
- acute toxicity – dermal with Hazard Statement H310 (Option 1 only)
- acute toxicity – dermal with Hazard Statements H310 and H311 (Option 2 only)
- acute toxicity – inhalation with Hazard Statements H330 and H331,
- specific target organ toxicity with Hazard Statement H370.
(1) OJ L 353, 31.12.2008, p. 1.
The key differences between the current situation and future options are summarised
in the table below.
Summary of Changes in Alignments for Options 1 and 2

Hazard Class Hazard Statement Comment
Some substances with Flash Points from 21
H225: Highly flammable
Flammable Liquids to 23oC will now be automatically
liquid and vapour
categorised as Group 1 fluids
Self-Reactive Theoretically, it is possible that some
Substances and Mixtures H242: Heating may cause flammable substances (R10) may be
and a fire reclassified as a self-reactive substance with
Organic Peroxides the Hazard Statement H242
Acute Toxicity* Exclusion of H301 leads to some substances

H301: Toxic if swallowed previously categorised as Group 1 being
(oral) reclassified as Group 2 fluids
Page ii
Summary of Changes in Alignments for Options 1 and 2

Exclusion of H311 leads to some substances
H311: Toxic in contact
previously categorised as Group 1 being
with skin (Option 1 only)
Acute Toxicity* reclassified as Group 2 fluids
(dermal) Inclusion of H311 leads to some substances
reclassified as Group 1 fluids
Inclusion of H331 leads to some vapours
Acute Toxicity*
H331: Toxic if inhaled previously categorised as Group 2 being
(inhalation)
Inclusion of H370 leads to some substances
Acute Toxicity (specific H370: Causes damage to
target organ toxicity) organs
* Note: It is important to stress that, in relation Acute Toxicity, most substances will be unaffected. In
other words, most substances which are currently categorised as ‘very toxic’ and ‘toxic’ under the
DSD will remain Group 1 fluids but will be classified as Acute Toxicity Categories 1 and 2 under the
CLP. Similarly, most substances which are currently categorised as ‘harmful’ will remain Group 2
fluids but will be classified as Acute Toxicity Category 4. As such, the area of interest concerns those
substances which will be classified as Acute Toxicity Category 3 under the CLP with the associated
Hazard Statements H301, H311 and H331.
The most significant impacts (in terms of numbers of substances affected) are likely to
be associated with the Hazard Statements H301, H311 and H331.
The costs of complying with the PED depend not only on the relevant Hazard
Category for the equipment but also the compliance module(s) selected. Although
there are few robust data available, it is estimated that the current annual compliance
costs are probably of the order of €250m. These costs relate to pressure equipment
placed on the EU market which was manufactured in the EU or imported into the EU.
In some cases, the compliance costs will increase after alignment with the CLP
Regulation due to some substances being re-categorised as Group 1 fluids. Of
course, compliance costs may decrease if a substance is re-categorised as a Group 2
fluid. In both instances where there is a change of fluid group, the equipment remains
the same but the cost of the conformity assessment procedure is liable to change. In
other words, the pressure equipment will still need to meet the same fundamental
standards of design and construction. The only potential change will be the level of
conformity assessment procedure (modules) and the extent of notified body
involvement. These changes and their associated costs are considered to be the most
significant impacts to industry resulting from the alignment of the PED with the CLP.
The costs of additional conformity assessments as a result of the PED aligning to the
CLP have been estimated to be around €8.5 million per annum. Since Option 2 will
involve some substances with Hazard Statement H311 (toxic in contact with skin)
moving from Group 2 to Group 1, the associated compliance costs will be higher than
for Option 1 in which some substances with Hazard Statement H311 will move from
Group 1 to Group 2. The additional costs of aligning the PED to the CLP have been
Page iii
estimated to be around €7.5 million per annum for Option 1 and €9.5 million per
annum for Option 2.
In comparing the options, it is considered that both Options 1 and 2 are effective in
meeting the requirement to align the PED with CLP in a simple manner, as far as is
possible.
Given the rare occurrence of pressure equipment failures and the low level of risk
associated with transient exposures to substances which are dermally toxic, it
appears very unlikely that the additional costs of Option 2 will outweigh the marginal
reduction in risks to those in the vicinity of pressure equipment. As such, Option 1 is
considered to be more efficient than Option 2.
Clearly, since the fundamental objectives of the PED will remain unchanged then
there is no reason to suggest that the coherence with other legislation will be
challenged. With this in mind, it is considered that both Options 1 and 2 may be
considered coherent in relation to other EU policy objectives.
From the brief analysis presented above, it is clear that there is little to choose
between the two Options as both are effective and coherent. However, Option 2 will
result in slightly more costs than Option 1 with only marginal benefits (in terms of a
reduced risk associated with exposure to substances which are toxic to the skin). As
such, Option 1 is the preferred option on the grounds that it appears to be more
efficient than Option 2.
Page iv
TABLE OF CONTENTS
1. INTRODUCTION 1
1.1 Background 1
1.2 Study Aims 1
1.3 Structure of Report 2
2. PED AND CLP 3
2.1 Pressure Equipment Directive 3
2.2 The CLP Regulation 11
2.3 PED and CLP 12
3. TRANSLATION OF PHYSICAL HAZARDS 15
3.1 Introduction 15
3.2 Explosives 15
3.3 Flammable Substances 16
3.4 Oxidising Substances 20
3.5 Physical Hazards According to CLP 21
4. TRANSLATION OF HEALTH HAZARDS 23
4.1 Introduction 23
4.2 Acute Toxicity – Overview 23
4.3 Specific Target Organ Toxicity 27
4.4 Summary 30
5. PROBLEM IDENTIFICATION & POLICY OPTIONS 31
5.1 Evaluation of PED 31
5.2 Consultation with Stakeholders 32
5.3 Responses from Stakeholders 33
5.4 Problem Identification 36
5.5 Development of Policy Options 37
6. IMPACT ASSESSMENT 45
6.1 Introduction 45
6.2 Numbers of Substances 46
7. COSTS OF ALIGNMENT 57
7.1 Costs by Module 57
7.2 Compliance Costs to Industry 61
7.3 Costs of Alignment with the CLP Regulation 65
8. COMPARING THE OPTIONS 69
8.1 The IA Guidelines 69
8.2 Effectiveness 69
8.3 Efficiency 70
8.4 Coherence 71
8.5 Preferred Option 72
ANNEX 1: CORRELATION ON OF DSD AND CLP CLASSIFICATIONS

ANNEX 2: BOUNDARY TOXIC SUBSTANCES
ANNEX 3: AN APPROACH TO IDENTIFICATION OF BOUNDARY SUBSTANCES
Page v
Glossary
CEN European Committee for Standardization

CLP Regulation (EC) No 1272/2008 on the classification, labelling and packaging
of substances and mixtures
DPD Dangerous Preparations Directive 1999/45/EC
DSD Dangerous Substances Directive 67/548/EEC
EEA European Economic Area
GHS United Nations’ Globally Harmonised System of Classification and Labelling
of Chemicals
IA Impact Assessment
(M)SDS (Material) Safety Data Sheet
NLF New Legislative Framework
PED Pressure Equipment Directive 97/23/EC
REACH Regulation (EC) No 1907/2006 concerning the Registration, Evaluation,
Authorisation and Restriction of Chemicals
SEP Sound Engineering Practice (under PED)
Seveso II Council Directive 96/82/EC on the control of major-accident hazards
involving dangerous substances
Seveso III Directive 2012/18/EU on the control of major-accident hazards involving
dangerous substances
Page vi
1. INTRODUCTION
1.1 Background
Article 9 of the Pressure Equipment Directive (PED1) separates ‘fluids’ into two
groups based on their hazard classification under the Dangerous Substances Directive
67/548/EEC (DSD2). Group 1 comprises ‘dangerous fluids’, as classified by the
DSD, whilst a Group 2 fluid is any other fluid. To take account of the hazards
associated with dangerous fluids, the requirements for compliance with PED are
generally more extensive for Group 1 fluids than for Group 2 fluids
The DSD is now being replaced by the Classification, Labelling and Packaging
Regulation (CLP3) over a transitional period that will end on 31 May 2015. As the
classification of hazardous properties for CLP is different from that used for DSD, it
will be necessary to redefine what constitutes a ‘dangerous fluid’ in terms of CLP
classification in order to align the PED with CLP.
Under a framework contract with DG Enterprise and Industry, Risk & Policy Analysts
Ltd. (RPA) has been commissioned to undertake a study to assess the impacts of
redefining ‘dangerous fluids’ for PED.
1.2 Study Aims

The primary objective of the present study is to support the European Commission to
carry out an impact assessment which will accompany a proposal on the alignment of
the PED to both the New Legislative Framework (NLF) and the CLP Regulation.
Since NLF alignment has already been considered in an earlier assessment4, this study
will focus on just the alignment of the PED to the CLP Regulation.
To fulfil the task specifications and prepare a robust impact assessment, it is necessary
to examine the impact of the changes in classification of substances based on the CLP
Regulation, compared to the current classification based on the DSD (only the hazard
1
Directive 97/23/EC of the European Parliament and of the Council of 29 May 1997 on the
Approximation of the Laws of the Member States concerning Pressure Equipment (OJ L 181,
9.7.1997, pp1-58), hereafter referred to as the Pressure Equipment Directive or PED.
2
Council Directive 67/548/EEC of 27 June 1967 on the Approximation of Laws, Regulations and
Administrative Provisions relating to the Classification, Packaging and Labelling of Dangerous
Substances (OJ 196, 16.8.1967, p1-98), hereafter referred to as the Dangerous Substances Directive or
DSD.
3
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December
2008 on Classification, Labelling and Packaging of Substances and Mixtures, Amending and
Repealing Directives 67/548/EEC and 1999/45/EC, and Amending Regulation (EC) No 1907/2006,
(OJ L 353, 31.12.08, pp1-1335), hereafter referred to as the Classification, Labelling and Packaging
Regulation, the CLP Regulation or CLP.
4
Commission Staff Working Paper: Impact Assessment Accompanying Document to the 10
Proposals to Align Product Harmonisation Directives to Decision No 768/2008/EC, SEC(2011)
1376 final, dated 21.11.11.
Page 1
categories listed for Group 1 fluids under the PED). It concerns, in particular, the
physical and health related hazard classes and categories.
Against this background, RPA is expected to undertake analysis of the:
 current situation with regard to classification of substances under the PED; and
 the different options for aligning the PED to the CLP Regulation and
their associated impacts.
1.3 Structure of Report
In order to provide the context for the study, Section 2 provides an introductory
overview of the PED and the CLP Regulation. Sections 3 and 4 provide a detailed
account of the correlation between the hazard categories under the PED and the CLP
Regulation.
Thereafter the approach to the impact assessment elaborated by this study closely
follows the European Commission’s Impact Assessment Guidelines5. The key steps,
therefore, in carrying out the assessment are:
 Impact Assessment (IA) Step 1: Identification of existing problems and

objectives of legislative intervention;
 IA Step 2: Defining the policy options;
 IA Step 3: Identification of impacts that are relevant and key stakeholders that
might be affected;
 IA Step 4: Initial assessment of the importance of these impacts based on their
expected magnitude and on the likelihood of them occurring;
 IA Step 5: In-depth analysis of the most significant impacts;
 IA Step 6: Comparison of the policy options; and
 IA Step 7: Identification of the preferred policy option.
Section 5 of this report highlights the key problem areas associated with the planned
alignment of the PED with the CLP Regulation and the possible policy options (IA
Steps 2 and 3). This section takes account of targeted consultation which was
undertaken for this study.
Section 6 provides an outline of the potential impacts and while Section 7 provides a
detailed account of the costs of different options (to cover IA Steps 4 and 5). These
sections take account of a stakeholder workshop to discuss this study held in
November 2012. The final IA Steps 6 and 7 are presented in Section 8, which
summarises the analysis with a recommendation for the preferred option.
5
European Commission (2009): Impact Assessment Guidelines, SEC(2009) 92, dated 15 January
2009.
Page 2
2. PED AND CLP

2.1 Pressure Equipment Directive
2.1.1 Purpose and Scope of Pressure Equipment Directive (97/23/EC)
The Pressure Equipment Directive (97/23/EC) has two main objectives. Firstly, it
seeks to enable the free trade of pressure equipment and assemblies within the
European Economic Area (EEA). This is achieved through the harmonisation of
national systems with regards to hazards due to pressure for the design, manufacture,
testing and conformity assessment of such products throughout the EEA. As a
general rule, the manufacturer or his authorized representative will affix the CE mark
to pressure equipment to demonstrate that it has complied with the provisions of the
Directive.
The provisions of the PED do not prescribe specific technical solutions to problems to
which designers and manufacturers must conform. Rather, within the provisions and
Annexes are essential safety requirements that have been tailored for the range of
pressure equipment that falls within the scope of the Directive. This approach allows
designers and manufacturers to innovate and develop new pressure equipment. Not
only does this approach encourage competition, it also ensures the second objective of
the PED is met, namely, a high level of safety for pressure equipment.
As outlined under Article 1, the scope of the PED extends to pressure equipment
(vessels, piping, safety accessories and pressure accessories) and assemblies with a
maximum allowable pressure greater than 0.5 bar6. The PED therefore affects a wide
range of equipment, including storage containers, water boilers, industrial pipe
work, pressure safety devices, reaction vessels, and even domestic pressure
cookers and fire extinguishers. The PED does not however cover the continued use
of pressure equipment (subject to national in-service regulations) nor does it cover the
wide range of pressure equipment listed below (Article 1(3))7
1. Pipelines comprising piping or a system of piping designed for the conveyance of

any fluid or substance to or from an installation (onshore or offshore). However,
it does apply to standard pressure equipment (e.g. in pressure reduction stations
or compression stations).
2. Networks for the supply, distribution and discharge of water and associated
equipment and headraces.
3. Simple pressure vessel equipment which is covered by Directive 87/404/EC;
4. Aerosol dispensers which are covered by Directive 75/324/EEC.
5. Equipment for the functioning of vehicles which is covered by Directives
70/156/EEC, 74/150/EEC or 92/61/EEC.
6. Equipment classified as no higher than category I under Article 9 of the PED
including:
6
Note that 1 bar = atmospheric pressure = 100,000 Pa (N/m2) = 14.7 psi
7
Text in italics are an exact quotation from the PED and other text summarises provisions of
the Directive.
Page 3
 new machinery covered by Directive 2006/42/EC (formerly Directive

89/392/EEC);
 lifts covered by Directive 95/16/EC;
 electrical equipment covered by Directive 2006/95/EC (formerly Directive
73/23/EEC);
 medical devices covered by Directive 93/42/EEC;
 appliances burning gaseous fuels covered by Directive 2009/142/EC
(previously Directive 90/396/EEC);
 equipment and protective systems intended for use in potentially explosive
atmospheres covered by Directive 94/9/EC.
7. Military equipment covered by Article 223 of the Treaty of Rome.
8. Items specifically designed for nuclear use, failure of which may cause an
emission of radioactivity.
9. Well-control equipment used in the petroleum, gas or geothermal exploration and
extraction industry and in underground storage which is intended to contain
and/or control well pressure.
10. Equipment comprising casings or machinery where ... pressure is not a
significant design factor.
11. Blast furnaces including the furnace cooling system, hot-blast recuperators, dust
extractors and blast-furnace exhaust-gas scrubbers and direct reducing cupolas,
including the furnace cooling, gas converters and pans for melting, re-melting,
de-gassing and casting of steel and non-ferrous metals.
12. Enclosures for high-voltage electrical equipment.
13. Pressurized pipes for the containment of transmission systems.
14. Ships, rockets, aircraft and mobile off-shore units, as well as equipment
specifically intended for installation on board or the propulsion thereof.
15. Pressure equipment consisting of a flexible casing.
16. Exhaust and inlet silencers.
17. Bottles or cans for carbonated drinks for final consumption.
18. Vessels designed for the transport and distribution of drinks having a PS·V of not
more than 500 bar·L and a maximum allowable pressure not exceeding 7 bar.
19. Equipment covered by transport regulations (ADR, RID, IMDG and the ICAO
Convention).
20. Radiators and pipes in warm water heating systems.
21. Vessels designed to contain liquids with a gas pressure above the liquid of not
more than 0,5 bar.
In addition to the PED, the Commission has published formal guidance to ensure the
coherent application of the PED8 - hereafter referred to as the PED Guidelines. The
PED Guidelines are developed and agreed by the Commission’s Working Group
“Pressure”, which is composed of representatives of Member States, European
federations, the Notified Bodies Forum and CEN.
8
Guidelines related to the Pressure Equipment Directive 97/23/EC (PED), available from
(http://ec.europa.eu/enterprise/sectors/pressure-and-gas/files/ped/ped-guidelines_en.pdf).
Page 4
2.1.2 Classification of Pressure Equipment
To ensure that pressure equipment within the scope of the PED is safe when placed on
the market and put into service, it must comply with the PED’s Essential Safety
Requirements. Compliance with these requirements is realised by subjecting the
design and manufacture of pressure equipment to the appropriate conformity
assessment procedure. The breadth of the conformity assessment procedure itself is
dependent on the classification of the pressure equipment.
Equipment is classified under the PED using one of the nine tables (which,
confusingly, are actually graphs) listed under Annex II. The correct table is
determined by the type of equipment, state of contents (liquid or gas) and finally,
where there are two conformity assessment tables to choose from, the grouping of the
fluid (Group 1 or 2). Figure 2.1 and Table 2.1 provide an overview as to how the
correct table is selected under the PED.
Figure 2.1: Classification of equipment under the PED9
9
PED Guideline 2/13
Page 5
Table 2.1: Determination of Applicable Category

Equipment Classification Group 1 Fluid Group 2 Fluid
gaseous Table 1 Table 2
Vessels
liquid Table 3 Table 4
gaseous Table 6 Table 7
Piping
liquid Table 8 Table 9
volume According to Tables 1 to 4
Pressure Accessories
DN According to Tables 6 to 9
general Category IV
Safety Accessories
specific Category of respective equipment
Assemblies According to highest element (except safety accessories)
Fired or otherwise heated pressure equipment with the risk of overheating
Table 5
intended for generation of steam or super-heated water
Source: Commission presentation, February 2012
The correct Conformity Assessment Table must be selected because the threshold
values (allowable pressure and volume or nominal size) used to determine the
category classification of the pressure equipment are markedly lower within the tables
for Group 1 fluids as compared to the tables for Group 2 fluids. This can be
illustrated with reference to Tables 3 and 4 for vessels containing liquids which have
been reproduced as Figures 2.2 and 2.3
Figure 2.2: Conformity Assessment Table 3 for Vessels (Liquid, Group 1)
Page 6
Figure 2.3: Conformity Assessment Table 4 for Vessels (Liquid, Group 2)
By comparing Figure 2.2 (PED Conformity Assessment Table 3) and Figure 2.3 (PED
Conformity Assessment Table 4), the potential impact of a substance moving Groups
can be demonstrated. For example, Table 4 should be used to ascertain the hazard
classification for a vessel that uses a Group 2 liquid fluid. By interpreting the table, it
is clear that pressure equipment with a maximum allowable pressure of 450 bar and a
volume of 10,000 litres, would need to fulfil the requirements of Hazard Category I.
Following the alignment of the PED to the CLP, if the substance were to move from
Group 2 to Group 1, the vessel would now need to use Table 3 (see Figure 2.2) to
ascertain the applicable hazard category. Due to the lower hazard thresholds of Table
3, the vessel operating at 450 bar and with a volume of 10,000 litres would now need
to fulfil the requirements of Hazard Category II. As this category requires the
involvement of a notified body, this would increase the cost of complying with the
PED.
In the above example, a substance moving from Group 2 to Group 1 would result in
the associated equipment moving into a higher hazard category bracket. However, it
Page 7
must be stressed that the changing of fluid group under the PED as a result of
alignment to the CLP will not always result in a change of hazard category. Indeed,
whilst a substance may change group, it is possible that it will not change hazard
class. For example, a comparison of Tables 3 and 4 indicates that a vessel with a
volume of 1 litre and operating at 100 bar will need to fulfil the requirements of
Sound Engineering Practice, irrespective of whether the fluid it uses is Group 1 or 2.
If such equipment used a fluid that changed group under the PED, there would be no
impact of the alignment to the CLP, as the PED compliance costs would remain the
same.
More generally, pressure equipment using any of the Tables for Group 1 fluids is
more likely to fall within a higher threshold bracket and thus have a higher category
classification. The more demanding and more expensive conformity assessment
procedure associated with a high category classification (discussed below)
underscores the importance of ensuring fluids are assigned to the correct group.
2.1.3 Conformity Assessment Procedure
Thorough interpretation of the appropriate Conformity Assessment Table will classify

the pressure equipment as belonging to one of five categories, with increasing levels
of hazard associated with a higher category number. As outlined below, for each
category, the PED sets out modules which, in combination, provide the route to
conformity (PED assessment modules in brackets). Manufacturers may choose the
module(s) which allows conformity to the PED and best suits them. For example, a
manufacturer from Category III may elect to undertake B + E in combination, whilst
another manufacturer would select modules B1 + D.
1. SEP (Sound Engineering Practice – no PED modules).

2. Category I (A).
3. Category II (A1, D1 and E1).
4. Category III (B1 + D, B1 + F, B + E, B + C1, H).
5. Category IV (B + D, B + F, G, H1).
The modules vary in the level of conformity assessment, ranging from Module A,
which only details a process of self-certification, to Module H, which details full
quality assurance, inspection and surveillance by a third party independently verified
assessor (Notified Body) as summarised in Table 2.2 (overleaf). Evidently, the high
category equipment conformity assessment procedure is comparably more extensive
and thus financially more expensive than equipment deemed to pose less of a hazard.
However, it is important to note that irrespective as to the category (SEP and I to IV),
the pressure equipment itself will remain the same, as will the Essential Safety
Requirements. In other words, the pressure equipment will still need to meet the same
fundamental standards of design and construction. The only potential change will be
the level of conformity assessment procedure (modules) and the extent of notified
body involvement. Clearly, the change of fluid grouping (from Group 2 to 1 or vice
versa) could result in such changes.
Page 8
Table 2.2: Modules Requirements under the PED

Module Design Production
A Technical documentation Internal production control
Internal production control with monitoring of the final
A1 Technical documentation
assessment
B Type examination
B1 Design examination
C1 Monitoring of final assessment
D Quality assurance for production, final inspection and test
D1 Technical documentation Quality assurance for production, final inspection and test
E Quality assurance for final inspection and test
E1 Technical documentation Quality assurance for final inspection and test
F Product verification
G Unit verification Unit verification
H Quality assurance for design, manufacture, final inspection and test
Quality assurance for design, manufacture, final inspection and test with design
H1
examination and monitoring of final assessment
DTI, Pressure Equipment, Guidance Notes on the UK Regulations – URN 05/1074 (April 2005)
In addition to the Modules set out in the PED itself, Member States have agreed
harmonised standards that set out the technical details needed to be sure of complying
with the PED. These standards are not mandatory, but if they are not followed then a
manufacturer shall have to demonstrate compliance with the essential safety
requirements (ESR) of the PED. Pressure equipment in Categories I to IV must
possess a CE mark, whilst equipment subject to Sound Engineering Practice is not
allowed to possess a CE mark.
2.1.4 Grouping of Fluids
Article 9 of the PED separates ‘fluids’ into two groups based on their hazard
classification under the Dangerous Substances Directive 67/548/EEC (DSD). For the
purposes of the PED, a fluid is defined as:
gases, liquids and vapours in pure phase as well as mixtures thereof. A fluid
may contain a suspension of solids10.
Thus, gas containing pieces of solids or drops of liquid will also be considered a
fluid11.
Group 1 comprises ‘dangerous fluids’, as classified by the DSD, whilst a Group 2

fluid is any other fluid. A fluid is only a Group 1 ‘dangerous fluid’ if it possesses the
10
PED Article 1 (2.7)
11
PED Guideline 1/24.
Page 9
properties cited in Article 9, paragraph 2 (2) of the PED. More specifically,

dangerous fluids will have one or more of the risk phrases listed in Table 2.3.
Table 2.3: Hazard Class and R-Phrases

Hazard Class Risk Phrase
R2 - Risk of explosion by shock, friction, fire or other sources of
Explosive ignition
R3 - Extreme risk of explosion by shock, friction, fire or other
sources of ignition
Extremely Flammable R12 - Extremely flammable
R11 - Highly flammable
Highly Flammable R15 - Contact with water liberates extremely flammable gases
R17 - Spontaneously flammable in air
Flammable R10 - Flammable (only if the intended maximum allowable
temperature is above its flashpoint) 12
R7 - May cause fire
O; Oxidising R8 - Contact with combustible material may cause fire
R9 - Explosive when mixed with combustible material
R26 - Very toxic by inhalation
T+; Very Toxic R27 - Very toxic in contact with skin
R28 - Very toxic if swallowed
R39 - Danger of very serious irreversible effects
R23 - Toxic by inhalation
R24 - Toxic in contact with skin
T; Toxic R25 - Toxic if swallowed
R39 - Danger of very serious irreversible effects
R48 - Danger of serious damage to health by prolonged exposure
It is noted that the PED makes no explicit reference to the Dangerous Preparations
Directive 99/45/EC (DPD). However, the PED Guidelines13 make it clear that where
a DPD classification for a mixture exists, this classification should be used to
determine the grouping of that mixture.
Due to the financial implications of assigning a fluid to the correct group (discussed
above), a number of PED Guidelines further clarify whether fluids in particular states
are Group 1 or Group 2.
If a solid is suspended in the fluid, its classification should take into account the group
of the fluid, the group of the solid and, if known, the group of the mixture. If the
mixture as a whole is classified as dangerous under the DPD, this should be used to
determine its grouping. Otherwise, the classification (and grouping) should be that of
the most dangerous solid or liquid14. It is therefore necessary to consider how the
hazard classification of some solids may change in the transition from the PED to
CLP.
12
PED Guideline 2/20 - The ‘flash point’ is the lowest temperature at which the vapour of a liquid can be
made to ignite momentarily in air.
13
PED Guideline 2/24
14
PED Guideline 2/30
Page 10
Conversely, if a non-suspended solid is blanketed by a Group 2 gas, or if the solid

particles are big enough that they would not be expected to be released in the case of a
pressure accident, classification will be undertaken with reference to Table 2
contained within the Annex of the PED15. Since the classification of a fluid may be
influenced by the presence of a solid, this report must also consider how the
introduction of CLP will impact the classification of such substances and mixtures.
If a chemical or physical reaction is likely to take place within the pressure

equipment, the fluid which has the highest category will determine the classification
of the final fluid. This will take account of starting, intermediate and final fluids and
take into account all reasonably foreseeable conditions16.
2.2 The CLP Regulation

The underlying objectives and purpose of The United Nations’ Globally Harmonised
System of Classification and Labelling of Chemicals (GHS)17 within the European
Union is outlined under Chapter 1:
a) enhance the protection of human health and the environment by providing an

internationally comprehensible system for hazard communication;
b) provide a recognized framework for those countries without an existing system;
c) reduce the need for testing and evaluation of chemicals; and
d) facilitate international trade in chemicals whose hazards have been properly
assessed and identified on an international basis18.
The CLP Regulation was specifically introduced to implement the GHS and thus the
overarching aim of the classification and labelling approach, as noted in the recital
and Article 1 of CLP, is to:
“ensure a high level of protection of human health and the environment as well
as the free movement of substances, mixtures and articles…”.
This objective is fulfilled by harmonising the criteria for the classification of

substances and mixtures according to health, environmental and physical hazards.
Accordingly, the hazard communication element, which includes requirements for
labelling and safety data sheets, is also harmonised. By identifying and
communicating harmonised hazard criteria, the appropriate safety procedures and
protective measures for health and the environment can be taken during handling,
transport and use of chemicals.
15
PED Guideline 2/26
16
PED Guideline 2/27
17
GHS is intended to provide a global basis for a harmonised information provision system for hazardous
substances and mixtures and a Plan of Implementation was adopted at the World Summit on
Sustainable Development (WSSD) in Johannesburg in 2002; the first edition was approved by the
Committee of Experts in December 2002 and published in 2003.
18
Chapter 1.1, 1.1.1.4
Page 11
CLP will replace both the DSD and DPD over a transitional period that will end on 31
May 2015 (summarised in Figure 2.2 below).
Figure 2.2: Summary of CLP Transitional Timetable
2.3 PED and CLP

From the discussion above, it can be seen that the objectives of the PED and CLP are
different. The PED is concerned with the safety and functioning of the internal
market in respect of pressure equipment whilst the CLP seeks to protect human health
and the environment through identification of harmful substances and mixture.
Article 9 of the PED currently uses the DSD/DPD to classify substances and assign
them to either Group 1 or Group 2. Since the DSD/DPD is to be repealed by CLP on
1 June 2015, the hazard categories currently employed by Article 9 must be replaced
by the corresponding hazard classes, categories, and hazard statements of the CLP
Regulation. However, a question remains as to the best way to align the PED to the
CLP.
When aligning the PED to the CLP, it is important to ensure that the fundamental
objectives of the PED (safety and functioning of the market) are not undermined.
Furthermore, to ensure that the financial impact of the alignment is limited, where
possible, the alignment should be simple and straightforward. This should ensure that
all members of the pressure equipment industry, whether that is a large pressure
equipment manufacturer or an SME that has only limited knowledge of the CLP, can
understand and comply with the newly aligned PED. Fortunately, due to the
similarities between the DSD and the CLP, the transition from the former to the latter
should be relatively smooth. The relevant hazard classes for the DSD and CLP have
been outlined in Table 2.4 (next page).
With regard to the physical hazards, the classification criteria for physical hazards
under CLP have been aligned to GHS as have those of the UN Transport of
Dangerous Goods Model Recommendations, which are then taken up through the
Page 12
various modal transport regulations such as ADR19, RID20, ADNR21, IMDG22, ICAO23
and the EU Inland Transport Directive. It is expected that users will be familiar with
the new ways that physical hazards may be described and that data from classification
for the transport regulations will facilitate translation of classifications from
DSD/DPD to CLP.
Table 2.4: Overview of Physical and Health Hazards translation from DSD to CLP
Physical Hazards
DSD Hazard Classes CLP Hazard Classes
Explosives
Oxidising gases
Explosive
Oxidising liquids
Oxidising solids
Oxidising
Flammable gases
Flammable liquids
Extremely Flammable
Flammable solids
Pyrophoric liquids
Highly Flammable
Pyrophoric solids
Substances and mixtures which, in contact with
Flammable*
water, emit flammable gases
Self-reactive substances and mixtures
Self-heating substances and mixtures
*A Flammable Fluid is only classified as a Group 1 Fluid if the intended maximum allowable
temperature is above its flashpoint.
Human Health Hazards
DSD Hazard Classes CLP Hazard Classes
Very Toxic Acute Toxicity
STOT – Single Exposure
Toxic STOT – Repeated Exposure
Following alignment with the CLP, there will still be a small number of physical
hazard substances that will move from Group 2 to Group 1..
For the human health hazard (Acute Toxicity), the division of this hazard class into
several hazard classes and changes in the cut off values used to differentiate
hazardous substances and mixtures within the hazard class, means that aligning the
PED with CLP is not as simple or direct. It is important to note that this change will
not result in a substance falling out of the scope of the PED, for the substances will
continue to be classified as either a Group 1 or Group 2 fluid. However, a number of
substances will change Group under the PED.
19
The European Agreement concerning the International Carriage of Dangerous Goods by Road
20
Regulations Concerning the International Carriage of Dangerous Goods by Rail
21
Regulations for the Carriage of Dangerous Substances on the Rhine
22
International Maritime Dangerous Goods Code
23
International Civil Aviation Organisation Technical Instructions
Page 13
Page 14
3. TRANSLATION OF PHYSICAL HAZARDS

3.1 Introduction
The transition from the DSD to CLP for physical hazards should be reasonably
smooth. Whilst there will be a change in the terminology and codes used to identify
the hazards, only a small number of fluids will change from one Group to another.
The following tables provide a simplified and comprehensible overview of the
translation from the DSD to CLP for the physical hazards. Consequently, they have
not been drawn to scale and are figurative only. A more detailed description of the
translation from the DSD to CLP for physical hazards can be found in Annex 1.
It should also be noted that the word ‘substance’ in the following discussion is used to
mean any substance, mixture or explosive article that falls within the scope of the
DSD, DPD or CLP Regulation.
3.2 Explosives
Table 3.1: Translation from the DSD to CLP (Explosive)

E; Explosive E; Explosive
DSD
R3 R2
PED Classified as ‘Group 1’ fluid under PED
Explosive
CLP Unstable Div 1.1 Div 1.2 Div 1.3 Div 1.4 Div 1.5 Div 1.6
H203:
H201: H202: H205:
Explosive; H204:
H200: Explosive; Explosive; May
fire, blast Fire or
HS Unstable mass severe mass N/A
or projection
Explosive explosion projection explode
projection hazard
hazard hazard in fire
hazard
Substances (and mixtures) classified as explosive under the DSD will now be
classified as unstable or within one of the five divisions (listed under Table 3.1). In
addition, under CLP, there are Division 1.6 Explosives which are extremely
insensitive articles that have a low probability of initiation and have been designed to
avoid accidental detonation during storage and transportation (for example,
warheads). Division 1.6 properties are tested for using Test series 7, and include tests
such as the bullet impact test, as outlined in section 17 of the UN Manual of Tests and
Criteria.
Since these articles will not be found in pressure equipment, it is proposed that these
should not be classified as a Group 1 fluid under the PED. This approach benefits
Page 15
from simplicity and will assist industry with a smooth transition from the DSD to
CLP.
Table 3.2: Translation from the DSD to CLP (Explosive)

E; Explosive
DSD
R2 / R3
PED Classified as ‘Group 1’ under PED
Organic Peroxide Self-reactive

CLP
Type A Type B Type C & D Type A Type B Type C & D
H240: H241: H240: H241:

H242: H242:
Heating Heating Heating Heating
Heating Heating
HS may cause may cause a may cause may cause a
may cause a may cause a
an fire or an an fire or an
fire fire
explosion explosion explosion explosion
Some substances that were previously classified as E; Explosive (R2 / R3) according
to the DSD will change hazard class according to CLP. The possible changes have
been outlined above in Table 3.2. Type E and F have not been included in Table 3.2
because it is unlikely that substances previously classified as explosive under the DSD
will be given either of these classifications under the CLP. This is because Type E
substances will neither detonate nor deflagrate and show low or no effect when heated
under confinement, whilst Type F is equally non-reactive, in addition to having low or
no explosive power. It must however be stressed that substances which are classified
as H242 Type E or F will be Group 1 fluids under the PED (see Table 3.5 and Table
3.10 below).
3.3 Flammable Substances
Table 3.3: Translation from the DSD to CLP (Extremely Flammable (gas))
F +; Extremely Flammable
DSD
R12
Flammable Gas
CLP Category 1 Category 2
HS H220: Extremely flammable gas H221: Flammable gas
Table 3.3 demonstrates that fluids previously classified as F +; Extremely Flammable

(R12) will continue to be classified as a Group 1 fluid.
Page 16
Table 3.4: Translation from the DSD to CLP (Flammable (Liquids))

F +;
F; Highly
Extremely F; Flammable
DSD Flammable
Flammable R10*
R11
R12
* Substances classified as F; Flammable (R10) will be Group 1 if the intended maximum allowable
Classified as ‘Group 1’ fluid

PED
under PED
FP °C ≤0 0 - 21 21 - 23 23 - 55 55 - 60
Flammable Liquids*
CLP
Category 1 Category 2 Category 3**
* As discussed further in Annex 1, the demarcation between Category 1 and 2 flammable liquids
also takes account of the boiling point. Nevertheless, extremely flammable liquids (R12) under DSD
will generally become Category 1 flammable liquids under CLP
** Substances classified as a Flammable Liquid, Category 3 will be a Group 1 fluid if the intended
maximum allowable temperature is above its flashpoint.
H224:
Extremely
HS flammable H226: Flammable liquid and vapour
liquid and vapour
liquid and
vapour
Table 3.4 shows that the most direct and simple translation from the DSD to CLP will
be to classify only Categories 1 and 2 as a Group 1 fluid under the PED. The cut of
values for a Group 1 fluid will thus increase from a flashpoint of 21°C to 23°C.
Substances previously classified as F; Flammable (R10) under the DSD and have a
flashpoint between 21 and 23°C will now be a Group 1 fluid, either Category 1 or 2.
This will result in a small increase in the number of substances classified as dangerous
fluids for the purposes of the PED (unless those substances were used in pressure
equipment where the maximum allowable temperature was above their flashpoint).
To ensure congruity between the DSD and CLP, as occurred with substances
classified as F; flammable (R10), substances with the Hazard Statement H226: Flam
Liq. 3 will be classified as a Group 1 fluid if the intended maximum allowable
Page 17
Table 3.5: Translation from the DSD to CLP (Flammable)

F +; Extremely Flammable F; Highly Flammable F; Flammable
DSD
R12 R11 R10*
* Substances classified as F; Flammable (R10) will be Group 1 if the intended maximum allowable
Self – reactive
CLP
Type C Type D Type E Type F Type G
HS H242: Heating may cause a fire N/A
Some substances that are classified as flammable according to the DSD will move
into the ‘self-reactive’ hazard class according to the CLP (see Table 3.5 above).
Those previously classified as F+; Extremely Flammable (R12) and F; Highly
Flammable (R11) will clearly remain within Group 1. In addition, a small number of
substances classified as F; Flammable (R10) under the DSD will under CLP be
classified as a Group 1 fluid. Whereas previously substances in this hazard class
would only be classified as Group 1 if the maximum allowable temperature was
above the flashpoint, those substances that move to Self-reactive Type F will by
default be classified as dangerous fluids. For the less hazardous substances classified
as Type G, there is no corresponding Hazard Pictogram, Signal Word or Hazard
Statement. It is proposed not to include these in Group 1.
Type A and Type B substances have not been included in Table 3.5, as it is unlikely
that a substance previously classified as Flammable under the DSD will fall within
these classes. In other words, a substance classified as a Type A (or Type B)
substance under CLP would have previously been classified as an ‘explosive’ under
DSD (as opposed to being an ‘extremely flammable’ substance for example).
Page 18
Table 3.6: Translation from the DSD to CLP (Highly Flammable (Solid))
F; Highly Flammable
DSD
R11
Flammable Solids
HS H228: Flammable solid
Substances that are classified as F; Highly Flammable (R11) (solid) under the DSD
and fulfil the definition of a fluid under CLP will continue to be classified as a Group
1 fluid.
Table 3.7: Translation from the DSD to CLP (Highly Flammable)

F; Highly Flammable F; Highly Flammable
DSD
R17 (liquid) R17 (solid)
Pyrophoric Liquid Pyrophoric Solid

CLP
Category 1 Category 1
H250: Catches fire spontaneously if H250: Catches fire spontaneously if

HS exposed to air exposed to air
Substances that were previously classified as F; highly flammable (R17) according to

the DSD are given a separate pyrophoric hazard class under CLP, with solids and
liquids transferring accordingly. The scope of CLP is the same as DSD and these
substances and mixtures that move hazard class will continue to be classified as a
Group 1 fluid under the PED.
Page 19
Table 3.8: Translation from the DSD to CLP (Highly flammable)

F; Highly Flammable
DSD
R15
Contact with Water Emits Flammable Gases

CLP
Category 1 Category 2 Category 3
H260: In contact with

water releases flammable
HS H261: In contact with water releases flammable gases
gases which may ignite
spontaneously
Substances previously classified as F; Highly Flammable (R15) according to the DSD

will be classified under CLP as a water reactive substance, as the overall scope of this
hazard class is the same. Although CLP has sub-divided this class into three
categories, all substances that qualify for this hazard class will continue to be
classified as a Group 1 fluid for the purposes of the PED.
3.4 Oxidising Substances

Table 3.9: Translation from the DSD to CLP (Oxidising)
O; Oxidising O; Oxidising O; Oxidising O; Oxidising
DSD
R8 (gas) R9 (liquid) R9 (solid) R8 (liquid / solid)
Oxidising (gas/liquid/solid)
Ox. liq. /
CLP
Ox. gas. Ox liq. Ox sol. sol. Ox. liq / sol Ox. liq / sol
Category 1 Category 1 Category 1 Category Category 2 Category 3
1
H270: May
cause or
H271: May cause fire or explosion; H272: May intensify fire;
HS intensify
strong oxidiser oxidiser
fire;
oxidiser
Those substances that are classified as O; Oxidising (R8 / R9) according to the DSD
will be re-classified as displayed in Table 3.9 above. Although oxidisers are divided
differently according to CLP, when compared to DSD, the overall scope of the hazard
classes is the same under both systems (for gases and liquids they are identical, for
solids the differences are very small). No issues have been identified with regard to
the transition from the DSD to CLP.
Page 20
Table 3.10: Translation from the DSD to CLP (Oxidising)

O; Oxidising
DSD
R7
Organic Peroxide
CLP
Type C Type D Type E Type F
HS H242: Heating may cause a fire
Organic peroxides that were previously classified as O; Oxidising (R7) are also given
a separate hazard class under CLP. Those substances will also continue to be
classified as Group 1 fluids for the purposes of the PED. Since it is unlikely that a
substance previously classified as an oxidising substance (R7) under the DSD would
be classified as a Type A or Type B organic peroxide, these have not been included in
Table 3.7 (as they are included in Table 3.2).
3.5 Physical Hazards According to CLP

The preceding tables and discussion suggest that the impact of aligning the PED with
CLP will be minimal and the transition should be smooth for physical hazards. In all
but a few cases, substances that are classified according to the DSD as E; Explosive,
F+; Extremely Flammable, F; Highly Flammable and O; Oxidising may change
hazard class or category but will not change group under the PED.
Substances that were previously classified as F; Flammable (R10) under the DSD
were not classified as dangerous fluids, unless the intended maximum allowable
temperature was above its flashpoint. The transition from the DSD to CLP will result
in some substances moving to higher categories as a result of the shift in the
temperature parameters. In these instances, substances will now be automatically
classified as dangerous fluids under the PED by default, irrespective of their
maximum operating temperature.
Page 21
Page 22
4. TRANSLATION OF HEALTH HAZARDS

4.1 Introduction
The transition from DSD to CLP for health hazards – with particular reference to
acute toxicity - will not be as smooth as for the physical hazards. As can be seen from
Table 4.1 below, this hazard class is split into a greater number of hazard classes and
categories and as will be explored in greater detail below, the parameters of these
boundaries do not often align with those of the DSD. Consequently, it is inevitable
that a number of substances will change grouping under the PED.
Table 4.1: Overview of Translation from DSD to CLP for Human Health Hazards
PED Group 1 fluid under DSD Possible Group 1 fluid categories under CLP
R26 - Very toxic by inhalation;
R27 - Very toxic in contact with skin;
T+;
R28 - Very toxic if swallowed; and
Very Acute Toxicity – Oral, Categories 1/2/3/4
Toxic R39 - Danger of very serious
irreversible effects. Acute Toxicity – Dermal, Categories 1/2/3/4
R23 - Toxic by inhalation; Acute Toxicity – Inhalation, Categories 1/2/3/4
R24 - Toxic in contact with skin; STOT – Single exposure (SE)
R25 - Toxic if swallowed; STOT – Repeated exposure (RE)
R39 - Danger of very serious
T;
irreversible effects; and
Toxic
R48 - Danger of serious damage to
health by prolonged exposure.
4.2 Acute Toxicity – Overview
4.2.1 Overview
As noted under Annex I, 3.1.1.2 of the CLP, the hazard class ‘Acute Toxicity’
differentiates substances according to route of exposure (Oral, Dermal and Inhalation)
as well as severity of hazard. Due to the different physical forms that inhaled
substances may take and the variable impact that each form has on toxicity, ‘Acute
Toxicity - Inhalation’ is further defined so as to differentiate between ‘Gas’ ‘Vapours’
and ‘Dusts and Mists’, as outlined in Table 4.2 below.
Table 4.2: Acute Toxicity Categories and Acute Toxicity Estimates (ATE)
Exposure Route Category 1 Category 2 Category 3 Category 4
Oral (mg/kg
ATE ≤ 5 5 < ATE ≤ 50 50 < ATE ≤ 300 300 < ATE ≤ 2000
body-weight)
Dermal (mg/kg
ATE ≤ 50 50 < ATE ≤ 200 200 < ATE≤ 1000 1 000 < ATE ≤ 2000
bodyweight)
Gases (ppmV*) ATE ≤ 100 100 < ATE≤ 500 500 < ATE ≤ 2500 2 500 < ATE ≤20000
Vapours (mg/l) ATE ≤ 0.5 0.5 < ATE ≤ 2.0 2.0 < ATE ≤ 10.0 10.0 < ATE ≤ 20.0
Dusts and Mists
ATE ≤ 0.05 0.05 < ATE ≤ 0.5 0.5 < ATE≤ 1.0 1.0 < ATE ≤ 5.0
(mg/l)
Note: * Gas concentrations are expressed in parts per million per volume (ppmV).
Page 23
Substances are classified using the values listed in Table 4.2 above, with each route of
exposure considered. If the substance falls into multiple hazard categories, the most
severe category will be used for the overall determination of label elements such as
pictograms, signal words, etc.24.
The transition from the DSD to CLP for the hazard class Acute Toxicity will not be
smooth, for the DSD splits this hazard class into three categories (very toxic, toxic
and harmful) whereas the CLP splits it into four categories (acute toxic 1,2,3 and 4),
each subdivided into five exposure routes (oral, dermal, inhalation vapour, inhalation
gas and inhalation dust and mist). These have been arranged in tables below which
indicate the relative differences between each system using LD50 25 and LC50 26 values.
4.2.2 Acute Toxicity – Oral
Table 4.3: Translation from the DSD to CLP (Acute Toxicity - Oral)
DSD T+; Very Toxic T; Toxic Xn; Harmful
R28 R25 R22
LD50 ≤5 5 – 25 25 – 50 50 – 200 200 – 300 300 - 2000
Acute Toxicity – Oral

CLP
Category 1 Category 2 Category 3 Category 4
H302: Harmful
HS H300: Fatal if swallowed H301: Toxic if swallowed
if swallowed
Table 4.3 figuratively demarcates the Category boundaries of the DSD and CLP. As
can be clearly seen, the boundary between toxic and harmful and the cut-off point for
assigning a substance as a group 1 or group 2 fluid does not match the boundaries in
CLP. A decision must be made whether to include or exclude Category 3 substances
as Group 1 fluids under the PED.
To draw the boundary so as to include only Categories 1 and 2 would reduce the
number of fluids deemed to be dangerous (Group 1 fluid) for the purposes of the PED.
Conversely, if the boundary were to be drawn so as to include Categories 1, 2 and 3,
additional substances would be captured and classified as a Group 1 fluid that were
24
ECHA (November 2012) Guidance on the Application of CLP Criteria Available from
http://echa.europa.eu/documents/10162/13562/clp_en.pdf
25
Lethal dose - the amount of material, given all at once or over a short period of time, which causes the
death of 50% of a group of test animals (expressed as mg/kg bodyweight).
26
Lethal concentration - concentration of the chemical that, in the air, will kill 50% of test animals in a
given time (usually expressed as parts per million by volume (ppmV) or mg/litre).
Page 24
previously deemed Xn; Harmful (R22) and‘ Group 2’ according to the DSD. There is
no justification for extending the scope so as to include Category 4.
4.2.3 Acute Toxicity – Dermal
Table 4.4: Translation from the DSD to CLP (Acute Toxicity – Dermal)
T+; Very Toxic T; Toxic Xn; Harmful
DSD
R27 R24 R21
LD50 ≤ 50 50 - 200 200 - 400 400 - 1000 1000 - 2000
Acute Toxicity – Dermal

CLP Category 1 Category 2 Category 3 Category 4
H310: Fatal in contact with H311: Toxic in contact H312: Harmful in

HS
skin with skin contact with skin
Determining where the boundary will be drawn for the dermal exposure route will
again be determined by a decision to either increase or decrease the fluids classified as
‘Group 1’ fluids under the PED. As is made clear in Table 4.4, the DSD classification
T; Toxic (R24) intersects Category 3 (H311). Thus a decision must be made to either
include Category 3 and potentially increase the fluids listed under ‘Group 1’, or
exclude the Category and potentially decrease the number of fluids that are listed
under Group 1.
4.2.4 Acute Toxicity – Inhalation (Dusts and Mists and Vapours)
Table 4.5: Translation from the DSD to CLP (Acute Toxicity – Dusts and Mists)
DSD
R26 R23 R20
LC50 ≤ 0.05 0.05 – 0.25 0.25 – 0.5 0.5 - 1 1-5
Acute Toxicity – Dusts and Mists

CLP
H331: Toxic
HS H330: Fatal if inhaled H332: Harmful if inhaled
if inhaled
Page 25
With regard to the exposure route ‘Acute Toxicity – Dusts and Mists’, alignment is
simple and direct, with Category 3 (H331) aligning perfectly with the T; Toxic (R23)
according to the DSD. Equally, Table 4.6 below demonstrates that Category 2 (H330)
‘Acute Toxicity - Vapours’ aligns perfectly with the T; Toxic (R23) according to the
DSD.
Table 4.6: Translation from the DSD to CLP (Acute Toxicity – Vapours)
T+;Very Toxic T; Toxic Xn; Harmful
DSD
R26 R23 R20
LC50 ≤ 0.5 0.5 – 2 2 - 10 10 -20
Acute Toxicity – Vapours

CLP
H332:
H331: Toxic if
HS H330: Fatal if inhaled Harmful if
inhaled
inhaled
4.2.5 Acute Toxicity – Gas
Table 4.7: Classification for Gases under CLP

LC50 (gases)
≤ 100 100 - 500 500 - 2500 2500 - 20000
(ppm V*)
CLP Category 1 Category 2 Category 3 Category 4
H331: Toxic if H332: Harmful if

HS H330: Fatal if inhaled
inhaled inhaled
Note: *For a ‘typical’ gas with a molecular weight of 50 then concentrations of 100, 500 and 2500
ppmV would equate to around 0.2, 1.0 and 5.0 mg/l respectively.
It is not possible to produce an accurate comparison table for the hazard class ‘Acute
Gas Toxicity’ because the criteria used to measure and classify substances are
different according to the DSD and CLP. The DSD classification of a substance or
mixture for the hazard class Acute Inhalation Toxicity is derived from the mass (mg/l)
inhaled in a given volume. On the other hand, CLP classifies substances and mixtures
using the volume concentrations (ppmV)27.
27
For the differences between gas concentrations by weight and volume, see, for example,
http://www.epa.gov/apti/bces/module2/concentrate/concentrate.htm#major
Page 26
4.3 Specific Target Organ Toxicity
Within CLP, substances which cause specific target organ toxicity (STOT) effects at
doses lower than those causing acute lethal effects may be classified as STOT-SE
(Single exposure) or in the case of chronic toxicity testing, STOT-RE (Repeated
exposure). This report will not consider STOT-RE (equivalent to T; R48 and Xn; R48
under the DSD/DPD), as the release of dangerous fluid from pressure equipment
following an accident will in all probability only occur once. Substances with this
classification should therefore be listed as a Group 2 fluid by default.
Although STOT-SE is a new term in CLP, it is not a new concept since it was covered
under the DSD. CLP defines this hazard class under Annex 1: 3.8.1.1 as “specific,
non-lethal target organ toxicity arising from a single exposure to a substance or
mixture”. It includes all “significant health effects that can impair function, both
reversible and irreversible, immediate and/or delayed…”28. Where the criteria for
STOT-SE and another hazard class are fulfilled, only the most appropriate hazard
class may be assigned, thereby avoiding “double classification”29. This hazard class is
applicable to any exposure route that is relevant for humans, although this will
principally be oral, dermal or inhalation30.
Substances that fall within the STOT-SE are classified using guidance value ranges
outlined under Annex I, Table 3.8.2 of CLP. This approach is different to the strict
threshold limits which are outlined elsewhere for the hazard class Acute Toxicity.
Suppliers may vary their classification according to their expert judgement, provided
there are valid scientific grounds for doing so.
Substances will be classified in either Category 1 or 2 for STOT-SE, depending on the

nature and severity of the effect(s) observed. The hazard category STOT-SE 3, which
is used to classify for the transient effects of respiratory irritation (R38) and narcotic
effects (R67) has not been included below, as these were not previously considered
under the PED and do not present an increased risk to justify inclusion within the
aligned PED.
The following tables compare the classification of STOT-SE according to the DSD
and CLP. As with the previous tables, they are primarily designed to highlight the
different parameters and boundaries of the DSD and CLP. They are therefore not to
scale and should not be used as an indicative guide to the number of substances
contained within the various Categories.
There are three possible exposure routes, Oral Dermal and Inhalation (which is further
divided to provide criteria for Gases, Vapours, and Dusts and Mists). For Gases it is
not possible to produce an accurate translation table because the criteria used to
measure and classify substances are different according to the DSD and CLP. The
DSD classification of a substance or mixture for the hazard class ‘Acute Toxicity –
28
CLP Annex I, 3.8.1.1
29
ECHA (November 2012) Guidance on the Application of CLP Criteria Available from
http://echa.europa.eu/documents/10162/13562/clp_en.pdf
30
CLP, Annex I, 3.8.1.5
Page 27
Inhalation’ is derived from the mass (mg/l) inhaled in a given volume. On the other
hand, CLP classifies substances and mixtures for the STOT-SE gas exposure route
using the volume concentration (ppmV)31.
Table 4.8: Translation from the DSD to CLP (STOT-SE Oral)

DSD
R39/28 R39/25 R68/22
Guidance
Values
≤ 25 25 – 200 200 – 300 300 - 2000
(mg/kg-
bw)
STOT-SE Oral
CLP
H371: May cause damage to organs

H370: Causes damage to organs (or state all
(or state all organs affected, if known)
organs affected if known) (state route of
HS (state route of exposure if it is
exposure if it is conclusively proven that no
conclusively proven that no other
other routes of exposure cause the hazard)
routes of exposure cause the hazard)
Table 4.9: Translation from the DSD to CLP (STOT-SE Dermal)

DSD
R39/27 R39/24 R68/21
Guidance
Values
≤ 50 50-400 400-1000 1000 - 2000
(mg/kg-
bw)
STOT-SE Dermal
CLP
H371: May cause damage to organs

H370: Causes damage to organs (or state all
(or state all organs affected, if known)
organs affected if known) (state route of
HS (state route of exposure if it is
exposure if it is conclusively proven that no
conclusively proven that no other
other routes of exposure cause the hazard)
routes of exposure cause the hazard)
31
For the differences between gas concentrations by weight and volume, see, for example,
http://www.epa.gov/apti/bces/module2/concentrate/concentrate.htm#major
Page 28
Table 4.10: Translation from the DSD to CLP (STOT-SE Dusts and mists)
T+; Very
T; Toxic Xn; Harmful
DSD Toxic
R39/23 R68/20
R39/26
Guidance
Values ≤ 0.25 0.25 -1.0 1.0 – 5.0
mg/l/4hr
CLP STOT – SE Dusts and Mists
H370: Causes damage to organs (or H371: May cause damage to organs (or
state all organs affected if known) state all organs affected, if known) (state
HS (state route of exposure if it is route of exposure if it is conclusively proven
conclusively proven that no other that no other routes of exposure cause the
routes of exposure cause the hazard) hazard)
Table 4.11: Translation from the DSD to CLP (STOT-SE Vapours)

T+; Very
T; Toxic Xn; Harmful
DSD Toxic
R39/23 R68/20
R39/26
Guidance
Values ≤ 0.5 0.25 -2.0 2.0 – 10.0 10.0 – 20.0
mg/l/4hr
STOT – SE Vapours
H371: May cause damage to

H370: Causes damage to organs (or state all organs (or state all organs
organs affected if known) (state route of exposure affected, if known) (state route of
HS
if it is conclusively proven that no other routes of exposure if it is conclusively
exposure cause the hazard) proven that no other routes of
exposure cause the hazard)
Page 29
Table 4.12: CLP Guidance Value Ranges for STOT-SE Gas

Guidance Values
≤ 2500 2500 > 20000
ppmV/4h
STOT–SE Gas
CLP
H370: Causes damage to organs (or H371: May cause damage to organs
state all organs affected if known) (or state all organs affected, if known)
HS (state route of exposure if it is (state route of exposure if it is
conclusively proven that no other conclusively proven that no other
routes of exposure cause the hazard) routes of exposure cause the hazard)
Note: *For a ‘typical’ gas with a molecular weight of 50 then concentrations of 2500 and 20,000
ppmV would equate to around 5.0 and 40 mg/l respectively.
Collectively assessing the five tables (Tables 4.8 to 4.12 above), it is apparent that the
classification of a Group 1 fluid must not include substances captured by STOT-SE
Category 2 (H371). To do so would unnecessarily increase the number of substances
classified as a Group 1 fluid. Thus for STOT-SE, only Category 1 fluids (H370) will,
for the purposes of the PED, be classified as Group 1 fluids.
4.4 Summary
It has been demonstrated that the transition from the DSD to CLP will be relatively
smooth for the physical hazards, with only a small number of substances changing
fluid group. However, the alignment is not as smooth for the human health hazards
and a decision will need to be made as to which categories under the Acute Toxicity
hazard class will designate a substance as being a dangerous fluid in the context of the
PED.
These ‘boundary areas’ will form the focus of this Impact Assessment.
Page 30
5. PROBLEM IDENTIFICATION & POLICY OPTIONS
5.1 Evaluation of PED

The PED has been the subject of a recently completed evaluation32 which concluded,
inter alia, that the PED:
 has been highly relevant for the improved functioning of the Internal Market;
 has led to a greatly improved and much more consistent regulatory framework for
facilitating the free movement of pressure equipment;
 has opened up intra-EU trading opportunities; and, of particular relevance to this
study
 has successfully combined market integration with maintaining the high levels of
safety that Europe was already accustomed to.
The evaluation did not identify any past problems associated with the classification of
fluids as Group 1 or Group 2 based on the DSD classifications cited in Article 9.
However, it was noted that, in some cases, manufacturers may err on the side of
caution and some small firms may find the compliance procedures complex (see Box
5.1).
Box 5.1: Experience of Group 1 Fluids

Where required compliance with the PED is carried out by the manufacturer of the pressure
equipment (in certain cases users may have the capacity to perform this role), he has therefore to
make certain assumptions, usually in dialogue with the user, but in cases where no agreement is
reached the manufacturer has to presume that the fluid is ‘hazardous’ and the pressure equipment
classified accordingly within Fluid Group 1. It may be the case that more stringent conformity
assessment modules have had to be applied unnecessarily and costs increased.
It was mentioned that small firms may have particular difficulties in dealing with the framework,
simply because procedures are relatively complex for products where there is the greatest hazard.
However, it was generally felt that all pressure equipment had to be assessed based on common rules
and aligned to common safety categories regardless of the size of the manufacturer.
Source: Quoted from CSES (2012): Evaluation of the Pressure Equipment Directive
As regards the future, the evaluation notes that there are some concerns over the
alignment with CLP due to the changing classification but that the intention with the
alignment is to stay as close as possible to the current classification (Article 9 based
on the Dangerous Substances Directive).
32
CSES (2012): Evaluation of the Pressure Equipment Directive, Final Report prepared for DG
Enterprise, dated October 2012.
Page 31
5.2 Consultation with Stakeholders
RPA undertook direct communications during September/October 2012 with a range

of stakeholders which included:
1. Public authorities (policy and market surveillance);

2. Equipment manufacturers;
3. Equipment users;
4. Service providers (design offices, consultancies and system integrators);
5. Conformity assessment bodies (notified bodies and user inspectorates); and
6. Standardisation bodies.
A brief questionnaire was sent to over 340 relevant stakeholders with a reminder
circulated to those who had not responded. Further assistance was also welcomed
from the UK Department for Business, Innovation and Skills, which responded to the
questionnaire and also forwarded it on behalf of RPA to additional stakeholders.
With a view to engaging with the widest possible audience, particularly SMEs that
may have otherwise been overlooked, RPA contacted relevant pressure equipment
groups within Linked-In33. Where appropriate, we also contacted industry via the
telephone to further increase the number of participants in this study. A more detailed
questionnaire was sent to those stakeholders who expressed an interest in the study
and a willingness to answer further questions, as summarised in Table 5.1.
Table 5.1: Stakeholder Response to Questionnaire

No. of
Stakeholder Respondents
Responses
German Engineering Federation
The Expansion Joint Manufacturers Association
The Swiss Mechanical and Electrical Engineering Industries
Industry Association 7 The European Industrial Gases Association
European Federation of Chemical Engineering
UIC (French Chemical Association)
Tank Storage Association
Member State
Austria, Belgium, Bulgaria, Cyprus, Czech Republic,
Authorities, EU
Finland, France, Germany, Ireland, Italy, Latvia,
Technical Associations 28
Luxembourg, Netherlands, Norway, Poland, Slovakia,
and other State
Slovenia, Spain, Switzerland and United Kingdom
Authorities
Private Companies 2 Italy, United Kingdom
Although the response rate was lower than anticipated, this may reflect the limited
impact that aligning the PED with CLP will have. As has been noted, the alignment
is relatively smooth for the physical hazards, with only a small number of substances
changing Group. It should also be noted that manufacturers often by default design
and manufacture equipment to comply with the more stringent modules. As one
33
These included the groups Pressure Equipment Engineers and Pressure Vessel Association, both of
which have other 2,000 members via http://www.linkedin.com.
Page 32
stakeholder noted, many UK manufactures use Module F or G irrespective of the

category of the pressure equipment.
Another factor that will reduce the potential impact of the alignment is the industry
practice of designing equipment as suitable for Group 1 fluids by default so as to
appeal to the widest possible market which corresponds to the finding from the
evaluation study reported Box 5.1.
A workshop was also arranged by the Commission in November 2012 to engage with
stakeholders and allow the dissemination of potential problems associated with the
alignment of the PED to CLP. Following the workshop, it became apparent that the
low response rate may be attributed to the difficulty of stakeholders being able to
accurately predict the impact of the alignment of the PED to CLP. By way of
example, a user will specify which fluid(s) will be used in pressure equipment and
will then provide the manufacture with the appropriate specifications.
If, for some reason, one or more fluids had become reclassified as a Group 1 fluid, the
user may be faced with additional costs. However, it may be possible to avoid these
costs by reducing the maximum allowable pressure or volume of the equipment used.
Put differently, a manufacturer may adjust the design and operating parameters of
pressure equipment so as to ensure that when the appropriate Conformity Assessment
Table is applied, the conformity assessment procedures available to the manufacturer
remain the same.
5.3 Responses from Stakeholders
5.3.1 Understanding of the DSD/DPD and Differences between the DSD and CLP
Industry associations and private companies were asked to express an opinion on their
understanding of the current classification scheme (DSD/DPD) and the differences
between CLP and the DSD. The results are displayed in Tables 5.2 and 5.3 (next
page).
Table 5.2: Understanding of DSD/DPD

Not
Stakeholder Very Good Good Moderate Poor Very Poor
Applicable
Industry
2 4 1
Association
Private
1
Company34
These results would suggest that the current regime used to classify fluids as a group
1 fluid under the (DSD/DPD) is well understood by industry. The responses were
also accompanied by comments. The respondent who noted this question was not
applicable commented that their members did not need to understand the DSD/DPD
34
One of the private companies failed to complete this part of the questionnaire.
Page 33
as users would provide them with the appropriate specifications, having already
ascertained which Category of equipment they required. This view was also echoed
by other respondent’s as well industrial association attendees at the Commission
workshop, who nevertheless noted they had a good understanding of the DSD.
Table 5.3: Understanding the Differences Between the DSD and CLP
Not
Stakeholder Very Good Good Moderate Poor Very Poor
Applicable
Industry
4 1 1 1
Association
Private
51 1
Company
The responses suggest that whilst much of the industry is aware that the DSD will be
replaced by CLP, efforts should still be made to widely communicate the upcoming
changes. As with above, one of the respondents noted that their manufacturers will
not need to be aware of the changes, as users will provide the appropriate
specifications. Again, this view was echoed during the workshop held by the
Commission on the alignment of the PED with CLP. Interestingly, the respondent
who noted their members’ knowledge of CLP was poor commented that it was
possible that CLP could be introduced and manufacturers would not be aware of the
change. This is because they would continue to manufacture goods as specified by
users, without any knowledge that their users would be categorising equipment using
CLP.
5.3.2 Concerns with regard to the Alignment of the PED with CLP
The responses outlined in Table 5.4 below reveal a relatively even split in respect of
those concerned by the alignment of the PED with CLP. The subsequent table gives
an overview of the specific comments made in respect of the proposed alignment. It
should be noted that some respondents commented on interlinking aspects, meaning
that they may be represented in multiple columns. For example, a respondent may
have commented that they were concerned with a substance changing category
classification and the resulting impact this would have on the cost of compliance.
Table 5.4: Do you have any concerns with regard to the alignment of the PED with CLP
Stakeholder Yes No No clear position
Industry Association 3 3 1
Member State Authorities, EU Technical Associations and
11 15 2
other State Authorities
Private Companies 2
Considering the responses above, there is a relatively even split in respect of the
concern expressed about the alignment of the PED with CLP. Most interestingly, it
was difficult to ascertain a clear position from the private companies who responded
to the questionnaire. This perhaps further reinforces the notion that information about
CLP has yet to be fully communicated to downstream users.
Page 34
5.3.3 Comments regarding the alignment of the PED to CLP
Table 5.5 below summarises the specific concerns expressed by stakeholders with
regard to the alignment of the PED to CLP. Comments from the Commission
workshop have also been included within the discussion below where appropriate.
Table 5.5: Outline of comments from those concerned with the alignment of the PED with CLP
Align PED
Change in Increased
Increased cost promptly Simple
category administrative Safety
of compliance provide clear alignment
classification effort
guidelines
7 4 4 3 2 2
Increased Costs of Compliance & Change in Category Classification
The biggest concern that emerged from the consultation was the potential for
increased cost of compliance as a result of substances moving from ‘Group 2’ to
‘Group 1’. One industry association objected to the possibility of increased costs on
the basis of what they perceive to be a formal alignment, particularly given that no
safety concerns have been expressed with regard to the categorisation of pressure
equipment under the PED. Both the responses to the questionnaire and the recent
evaluation of the PED (see Section 5.1) concur that there are few safety concerns
related to the PED.
However, one respondent noted unease with Module A1, which requires notified body
involvement only for the final assessment by means of unexpected visits. Thus it is
possible for Category II equipment that contains a very toxic fluid to be PED
compliant, with no involvement of a notified body during the design phase and
without the need for the notified body to perform any inspections during manufacture.
Indeed, it is also possible that pressure equipment containing very toxic fluids could
be categorised under the PED as SEP, which permits the manufacturer to ensure
compliance with the PED without the need for any notified body involvement.
As well as the immediate costs associated with certifying pressure equipment,

stakeholders commented that they were concerned about the increased costs of ‘In
Service Periodic Inspections’ as a result of change in the Grouping of a fluid (it is
more expensive to periodically inspect pressure equipment in higher categories). Of
course, the change in classification may result in a substance moving to a lower
category, thus decreasing the cost of compliance. Interestingly, the concern about
increased costs of ‘In Service Periodic Inspection’ costs also arose at the Commission
workshop.
With regard to the increase of these costs, it is important to understand that the PED
has harmonised the requirements for the ‘first placing on the market’ and the initial
‘putting in to service’ of pressure equipment. Regulating only these matters, it does
not harmonise the ‘periodic inspections’ of pressure equipment, which is left to the
discretion of Member States. Despite this, stakeholders have reported that the
Page 35
requirements for their ‘periodic inspections’ are based on the PED Conformity
Assessment Tables in Annex II. Thus a change in the grouping of a fluid may well
influence the costs of such periodic inspections. However, as this change is a result of
national legislation that is not directly governed by the PED, any subsequent impacts
are secondary and must not influence the final selection of the options.
Administrative effort
Stakeholders were also concerned about an increase in administrative effort that

would be required following the alignment of the PED with CLP. Examples of
additional activities include training teams to understand the new vocabulary and
pictograms of CLP, as well as undertaking the necessary changes to their computer
databases.
Simple Alignment and Guidelines
There was a preference for simple alignment from the responses to the questionnaire,
a view echoed by almost all attendees to the workshop. A simple alignment should
help to ensure full and complete comprehension following the transition from the
DSD to CLP. Related to this point, notified bodies emphasised the importance of
providing prompt Guidance Notes, as manufacturers will seek advice from notified
bodies to ensure that they have complied with the amended PED.
Alignment of PED to CLP
With regard to specific comments on how the PED should be aligned, one stakeholder
noted they were concerned that the PED would be aligned to CLP so as the parameter
for Acute Toxicity would be set at Category 3 for all exposure routes (Oral, Dermal
and Inhalation). The stakeholder disapproved of such an extension in scope as it
would result in more of the equipment they operate using Group 1 fluids. However,
the biggest impact of adopting this route of exposure for this particular stakeholder
would arise from the ‘In Service Periodic Inspections’. Whilst such concerns are
valid, as has been explained above, such impacts must not influence the selection of
options.
Another stakeholder suggested that the alignment of the PED for Acute Toxicity
should mirror that adopted under Seveso III. If the PED were to adopt the same
approach as Seveso III, this will be because it is the option that best aligns the PED to
CLP. The current boundary delineations of Seveso III will not influence the final
option selected for the PED.
5.4 Problem Identification
As outlined above, there is a general consensus that PED and the use of Group 1 and
Group 2 fluids based on DSD classifications has not presented undue problems. The
DSD is now being replaced by the CLP Regulation and will be fully repealed by 1st
June 2015. As such, the PED has to be aligned to the CLP Regulation by that date.
Page 36
There is consensus that there is no requirement to change the PED in respect of

‘dangerous fluids’. Rather the problem is that in some ‘boundary areas’, the
classification of some substances under CLP may lead to some substances previously
categorised as Group 2 fluids becoming Group 1 fluids and vice-versa. The
overwhelming view from stakeholders is that the alignment needs to be as simple and
as close to the current situation as possible.
5.5 Development of Policy Options
5.5.1 Baseline
The baseline is the current situation based on Article 9 of the PED (see Box 5.2).
Box 5.2: Article 9 of the PED - Classification of Pressure Equipment

1. Pressure equipment referred to in Article 3 (1) shall be classified by category in accordance with
Annex II, according to ascending level of hazard.
For the purposes of such classification fluids shall be divided into two groups in accordance with 2.1
and 2.2.
2.1. Group 1 comprises dangerous fluids. A dangerous fluid is a substance or preparation covered by
the definitions in Article 2 (2) of Council Directive 67/548/EEC of 27 June 1967 on the
approximation of the laws, regulations and administrative provisions relating to the classification,
packaging and labelling of dangerous substances (1).
- explosive,
- extremely flammable,
- highly flammable,
- flammable (where the maximum allowable temperature is above flashpoint),
- very toxic,
- toxic,
- oxidizing.
2.2. Group 2 comprises all other fluids not referred to in 2.1.
3. Where a vessel is composed of a number of chambers, it shall be classified in the highest category
applicable to the individual chambers. Where a chamber contains several fluids, classification shall
be on the basis of the fluid which requires the highest category.
(1) OJ No 196, 16. 8. 1967, p. 1. Directive as last amended by Commission Directive 94/69/EC (OJ No
L 381, 31. 12. 1994, p. 1).
Since the scope and intent is to be retained largely unchanged, paragraphs 1, 2.2 and 3
from Article 9 will remain unchanged. As discussed in Sections 3 and 4, the CLP
Regulation has new hazard categories which require slightly more definition. In order
to ensure simplicity, it is proposed that the categories are supplemented with relevant
hazard statements as this will provide a clear guide to relevant stakeholders as to
which precise categories would lead to a fluid being included in Group 1 or Group 2.
Page 37
5.5.2 Option 1
The first option provides for a simple re-alignment from DSD to CLP – as shown in
Box 5.3. As indicated above, paragraphs 1, 2.2 and 3 will remain unchanged from the
current Article 9 of the PED. The relevant hazard statements for the ‘boundary areas’
are summarised in Table 5.6. From this, it will be seen that some substances will
move from Group 2 to Group 1 and, in two cases, vice-versa.
Box 5.3: Revised Article 9 for PED – Option 1 (new text is underlined)
and 2.2.
(1),
- acute toxicity – dermal with Hazard Statement H310,
- specific target organ toxicity with Hazard Statement H370,
(1) OJ L 353, 31.12.2008, p. 1.
Table 5.6: Summary of Boundary Areas for Option 1

liquid and vapour
Substances and Mixtures H242: Heating may cause flammable substances (R10) may be
and a fire reclassified as a self-reactive substance with
Organic Peroxides the Hazard Statement H242 (see Table 3.5)
Acute Toxicity Exclusion of H301 leads to some substances

Page 38


(dermal) with skin
Acute Toxicity
(inhalation)
5.5.3 Option 2
The second option again provides for a simple re-alignment from DSD to CLP – as
shown in Box 5.4. The only change from Option 1 is the inclusion of Hazard
Statement H311. As before, the relevant hazard statements for the ‘boundary areas’
are summarised in Table 5.7. From this, it will be seen that some substances will
move from Group 2 to Group 1 and, in just one case, vice-versa.
Box 5.4: Revised Article 9 for PED – Option 2 (change from Option 1 is underlined)
and 2.2.
(1),
- acute toxicity – dermal with Hazard Statements H310 and H311,
- specific target organ toxicity with Hazard Statement H370,
(1) OJ L 353, 31.12.2008, p. 1.
Page 39

liquid and vapour
Self-Reactive Substances Theoretically, it is possible that some

and Mixtures and H242: Heating may cause flammable substances (R10) may be
a fire reclassified as a self-reactive substance with
Organic Peroxides the Hazard Statement H242 (see Table 3.5)

Acute Toxicity Inclusion of H311 leads to some substances

(dermal) with skin
Acute Toxicity
(inhalation)
5.5.4 Discussion
Other Options
As previously indicated, the overwhelming view from stakeholders is that the

alignment of PED to the CLP Regulation needs to be as simple and as close to the
current situation as possible. Nevertheless, consideration was given to more novel
ways in which this alignment could be achieved. For example, it was suggested at the
workshop (held in November 2012) that the distinction of fluids (i.e. between Group 1
and Group 2 fluids) could be removed from the PED. If this were to be adopted, a
decision would need to be made as to which conformity assessment tables under
Annex II of the PED would be used to determine the category classification of
pressure equipment.
Given that one of the primary objectives of the PED is to ensure a high level of safety
for pressure equipment across the EU, one option would be that the tables for Group 1
fluids would be used to classify all pressure equipment. Alternatively, the tables
could be merged, with the category cut-off values somewhere between those currently
used for Group 1 and Group 2 fluids.
Such changes could have significant impacts and the results of the consultation and
discussions during the workshop made it clear that stakeholders wanted the PED to be
aligned to the CLP Regulation as simply and directly as possible. This approach
would minimise the number of substances that would change fluid group and allow
them to quickly adapt and comply with any changes made. With industry needing to
Page 40
comprehend and adapt to CLP, any proposed further changes such as the removal of
the fluid grouping from the PED should be considered at a later date.
Inclusion/Exclusion of Toxic Substances
Nevertheless, there remain some ‘boundary areas’ where decisions need to be made -
with particular regard to the inclusion/exclusion of substances with Hazard Statements
H301, H311 and H331. Above all, the inclusion/exclusion of substances into Group 1
will be determined by the potential health hazards they pose to users in the event of a
pressure equipment malfunction. This will ensure that the primary objective of the
PED, the safety of pressure equipment, is respected and maintained. The financial
implications of any changes on industry will therefore be a secondary consideration.
Acute Toxicity – Inhalation: Broad Approach
It will be recalled that Acute Toxicity – Inhalation, comprises of three exposure routes
(dusts and mists, vapours, gas). A simple overview of how the CLP aligns to the
DSD for this hazard class and three exposure routes has been provided below (for
further detail see Section 4.2 above). If the sub-divided exposure routes are
considered in isolation, then direct alignment is possible, with Group 1 fluids
comprising of H331: toxic if inhaled for ‘dusts and mists’ (category 3) and H330:
fatal if inhaled (category 2). Aligning the PED in this way is precise and would not
result in any substances from these hazard classes changing fluid group. As
previously noted, it is not possible to compare the DSD and CLP for Acute Toxicity –
gas, because the criteria used to measure and clarify substances are different
according to the DSD and CLP.
Table 5.8: Translation from the DSD to CLP (Acute Toxicity – Inhalation sub-divisions)
DSD T+; Very Toxic T; Toxic Xn; Harmful

Acute Toxicity – Dusts and Mists
CLP
H331: Toxic if
HS H330: Fatal if inhaled H332: Harmful if inhaled
inhaled
Acute Toxicity – Vapours

CLP
H331: Toxic H332: Harmful if

if inhaled inhaled
Acute Toxicity – Gas
CLP
H331: Toxic if H332: Harmful if

inhaled inhaled
Note: For further details on the category threshold limits, please see Tables 4.5, 4.6 and 4.7 for
dusts & mists, vapours and gas respectively.
Page 41
Whilst this approach for ‘dusts and mists’ and ‘vapours’ is direct, because the Hazard
Statements are the same for the sub-divided exposure routes, the pressure equipment
users/manufacturers would need to know which exposure route was being referred to.
By way of example, the substance would be a Group 1 fluid if it had been classified as
H331 for dusts and mists, but would be a Group 2 fluid if it had been classified as
H331 for the vapour exposure route.
Pressure equipment users and manufacturers ascertain information on a substance

from safety data sheets. These contain Hazard Statements and pictograms to convey
the relevant information to the reader. Crucially, they will typically not provide any
further information such as the sub-division of exposure routes for which it was
classified. Thus without undertaking further work, a pressure equipment
user/manufacture will only be able to determine from the safety data sheet that a
substance has been designated as H331. It will not be known whether this was for the
exposure route of dusts and mists or of vapours or of gas.
To prevent the transition from the DSD becoming overly complex and burdensome
for manufacturers, the precise alignment has not been considered in the options.
Rather, the same Hazard Statement (and, hence, category number) for classifying a
substance as a Group 1 fluid will be assigned to all of the sub-divided inhalation
exposure routes. Although this ‘broad’ approach is not as direct and some substances
will change fluid group, it represents a practical solution designed to make the
transition from DSD to the CLP less burdensome for industry.
Acute Toxicity – Inhalation: Inclusion/Exclusion of H331
Having ascertained that the ‘broad’ approach must be adopted, the decision as to
whether substances classified as H331 should be a Group 1 fluid must be made. To
include H331 will result in an increase in substances (Vapours in Category 3) whilst
to exclude H331 will reduce the number of substances classified as a group 1 fluid
(Dusts and Mists in Category 3). In essence, this decision hinges upon the inherent
dangers presented by substances classified with this hazard statement and the
potential for harm should there be a pressure equipment failure.
It is apparent that following a pressure equipment failure, substances classified

as Acute Toxicity – Inhalation may pose a threat to those within the vicinity. For
instance, pressure equipment could have an undetected minor leak that exposes
workers to the substance. Equally, in the event of a catastrophic failure, a fluid
may be rapidly dispersed and inhaled by those near to the operating pressure
equipment. Taking these risks into consideration, there is a strong argument
that H331 substances should be classified as Group 1 fluids.
Acute Toxicity – Oral (H301)
In the context of a pressure equipment failure, the dangers presented by

substances which are toxic if swallowed (H301) are minimal. In the event of an
undetected minor pressure equipment failure and a catastrophic incident, an
individual is unlikely to orally ingest a significant quantity of these particular
fluids.
Page 42
For substances which are toxic if swallowed (H301), the threshold is an LD50 of 50
mg/kg of bodyweight (see Table 4.3). For a typical EU adult of 70 kg, this equates to
3.5 grams which is equivalent to a teaspoon. In the event of an incident involving
pressure equipment, it is very unlikely that someone nearby would ingest such
quantities of fluid. For this reason, it is not considered that substances classified as
H301 present a significant hazard. As such, these substances have been excluded
from the alignment under both Options 1 and 2.
Acute Toxicity – Dermal (H311)
In the context of a pressure equipment failure, the potential dangers presented by

substances which are toxic in contact with skin (H311) are linked with the volume of
substance to which an individual is exposed. . For such substances, the threshold is
an LD50 of 200 mg/kg of bodyweight (see Table 4.4). For a typical EU adult of 70
kg, this equates to 14 grams which is equivalent to a tablespoon.
In the event of an incident (whether small or catastrophic), it is possible (but not

inevitable) that someone nearby would be sprayed or splashed with a potentially
harmful quantity of fluid. Of course, there are any number of factors (the wearing of
personal protective equipment (PPE), the individual’s proximity to the pressure
equipment, the safety response measures in the event of an exposure) that make it
very difficult to generalise as to the risks posed by H311 substances in the event of a
pressure equipment failure. With this in mind, it is acknowledged that a decision will
need to be made as to whether to include or exclude such substances from Group 1.
This explains the distinction between the PED alignment under Option 1 and PED
alignment under Option 2.
It should be noted that substances with higher dermal toxicities and the associated
Hazard Statement H310 will continue to be categorised as Group 1 fluids under
Options 1 and 2.
Page 43
Page 44
6. IMPACT ASSESSMENT
6.1 Introduction
6.1.1 The C&L Inventory
Given that the purpose of this report is to assess the impact of aligning the PED with
CLP, efforts must be made to determine the number of substances used in pressure
equipment that may move from one Group to another. The volume and prevalence of
these substances will influence the resultant impacts with particular regard to the
potential additional costs associated which could result from the application of more
stringent compliance procedures.
The CLP Regulation established a classification and labelling inventory of substances

which is maintained by the European Chemicals Agency (ECHA). The inventory is
in the form of database which may be accessed online and currently has over 100,000
substances35.
6.1.2 Harmonised Classifications
The inventory includes substances that are both harmonised and not harmonised. The
distinction between the two classifications is important for the purposes of this report,
as it is only a ‘harmonised classification’ and its assigned hazard statement that has
been approved by regulators. Other classifications on the C&L Inventory have been
self-assigned by industry and there is widespread acknowledgement that these self-
classifications vary greatly in reliability. Unfortunately, only around 4,000 substances
have been harmonised and therefore have reliable classifications on which to base
further analysis. To ensure this report is based on robust data and not subject to
challenge, this impact assessment must draw conclusions from the limited data that
are currently harmonised.
The harmonised classifications can be found in two ways. Annex VI to the CLP
Regulation can be consulted, making sure to check the 1st ATP 36, 2nd ATP37 and 3rd
ATP38 to CLP. A search using the appropriate CAS number, EC number or substance
name will help to identify the relevant substance. Alternatively, harmonised
classifications (as listed in Annex VI to the CLP Regulation) can be found and
downloaded in Excel format from the Institute for Health and Consumer Protection
(JRC-IHCP)39. RPA elected to utilise the Excel database, as substances could be
searched and filtered using the hazard statements relevant for this study40.
35
http://echa.europa.eu/information-on-chemicals/cl-inventory-database
36
http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:235:0001:0439:en:PDF
37
http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:083:FULL:en:PDF
38
http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:179:0003:0010:EN:PDF
39
http://esis.jrc.ec.europa.eu/clp/ghs/doc/Annex6_Table3-1.zip
40
It is accepted that the number of substances with harmonised classification has increased from 4,136 in
the original Annex VI (and as listed in the Excel table) to 4,472 at the time of writing.
Page 45
It should be noted that for some of the harmonised classifications, classes of

compound and their salts have been registered under the harmonised classification
database as a single entity (e.g. sodium, potassium and ammonia alkali
fluorosilicates). For the purposes of counting the number of substances that may
change fluid group, this report has considered such single entities a single substance.
6.2 Numbers of Substances
6.2.1 Overview
An initial indication of the prevalence of substances which have properties in the

‘boundary areas’ can be derived from the number of entries with these codes on the
C&L Inventory database, as shown in Table 6.1. It will be seen that the percentage
figures for those substances with harmonised classifications are similar to those for
substances which have been self-classified.
Table 6.1: Number of Substances on ECHA’s C&L Inventory with Hazard Statements in the
‘Boundary Areas’ (as of 5 November 2012)
All Substances Harmonised Classification
Hazard Statement Number of Number of
% Total % Total
Entries1 Entries1
H225 Highly
flammable liquid and 2,276 2.1% 132 3.2%
vapour
H242 Heating may
204 0.2% 35 0.8%
cause a fire
H301 Toxic if
8,430 7.7% 321 7.8%
swallowed
H311 Toxic in
3,080 2.8% 187 4.5%
contact with skin
H331 Toxic if
3,142 2.9% 202 4.9%
inhaled
H370 Causes damage
480 0.4% 8 0.2%
to organs
All Substances 109,120 4,136
Notes:
1) Substances may have more than one of these code or, indeed, other codes.
Based on Table 6.1, it would be expected that the greatest impact will be related to
substances classified as Acute Toxicity, Category 3 with associated Hazard
Statements H301, H311 and H331.
Page 46
6.2.2 Identifying Boundary Substances
To identify those substances that may change group, the individual hazard statements
of the boundary substances (H310, H311, H331, H225, H242, H370) were entered
into the database. The results of this search are displayed in Table 6.1 under column
‘Harmonised Classification’. Summing the numbers for each of these hazard
statements might, at first sight, suggest that there are 885 boundary substances (Table
6.2). In fact some substances appear more than once under different hazard
statements. By way of example, methanol appeared in entries with five different
hazard statements H225, H331, H311, H301, H370 and, as such, appears five times in
Table 6.2.
The substances were then checked to ensure they were not classified as a Group 1
fluid because of another inherent hazard. For example, potassium bromate (CAS No.
7758-01-2) has the Hazard Statements H301 (Acute ‘Oral’ Tox. 3), H350 (Carc. 1B)
and H271 (Ox. Sol. 1). To consider only the Hazard Statement H301 would make
Potassium Bromate a ‘boundary’ substance. However, for the purposes of the PED,
the Hazard Statement H271 (Ox. Sol. 1) identifies potassium bromate as a substance
that should be classified as a dangerous fluid in any event. Thus, the grouping of this
fluid will not be impacted as a result of the PED aligning with CLP, as irrespective of
the inclusion/exclusion of H301 (Acute ‘Oral’ Tox. 3), this substance will remain a
Group 1 fluid. The number of substances that continue to be classified as border
substances has been listed in numerical form in Table 6.2.
Table 6.2: Number of Substances that may be Included/Excluded as a Dangerous Fluid under
Article 9 of the PED
Number of entries excluding
Hazard Statement (HS) Number of Entries1 those with a Group 1
Hazard Statement
H225 Highly flammable liquid and
132 119
vapour
H242 Heating may cause a fire 35 33
H301 Toxic if swallowed 321 255
H311 Toxic in contact with skin 187 128
H331 Toxic if inhaled 202 169
H370 Causes damage to organs 8 6
Total 885 710
Notes:
1. From Table 6.1.
The number of boundary substances is then further reduced when those substances
with the Hazard Statement H331 – Acute Toxic Inhalation are removed (Table 6.3
below). As has been discussed above, there is a strong argument that H331
substances should be classified as Group 1 fluids because of the inherent dangers they
pose in the context of pressure equipment.
Page 47
Table 6.3: Number of Substances that may be Included/Excluded as a Dangerous Fluid under
Number of entries
Number of entries also
Hazard Statement (HS) excluding those with a
excluding H331
Group 1 Hazard Statement
H225 Highly flammable liquid
119 109
and vapour
H242 Heating may cause a fire 33 30
H301 Toxic if swallowed 255 133
H311 Toxic in contact with skin 128 40
H331 Toxic if inhaled 169 169
H370 Causes damage to organs 6 6
Total 710 487
It was possible to further reduce the number of substances that will be impacted by
the alignment of the PED to the CLP by virtue of flashpoints (Hazard Statement
H225) and specific hazard classifications (H242 Type F).
H225 – Highly Flammable Liquid and Vapour
The flashpoints of the 109 substances with the Hazard Statement H225 were then
examined to identify those substances with flashpoints that fell within the parameters
of 21°C to 23°C. This was done by reviewing the MSDSs within the Sigma-Aldrich
website41, a major chemical supplier. Only three substances42 listed in Table 6.4, will
be classified as Group 1 fluids as a result of the PED aligning with the CLP. It is
noted that the UK Department for Business Innovation and Skills has previously
identified 12 substances43 that fall within these parameters. However, many of these
have not yet received a harmonised classification.
Table 6.4: Boundary Substances with the Hazard statement H225

Substance CAS No Flashpoint °C
tert-butyl propionate 20487-40-5 21
propan-1-ol; n-propanol 71-23-8 22
1,2-diethoxyethane 629-14-1 22
41
http://www.sigmaaldrich.com/united-kingdom.html
42
Out of the 109 listed with a harmonised H225 classification and not otherwise categorised as Group 1
43
UK Department for Business Innovation & Skills (2010): Adaptation of Art. 9 of the PED to CLP-
Regulation with regard to physical hazards, available from:
http://www.bis.gov.uk/assets/biscore/business-sectors/docs/p/proposal-adaptation-article-9-ped-to-clp-
regulation.doc
Page 48
H242 – Heating May Cause Fire
It will be recalled that the Hazard Statement H242 encompasses substances that are
within the hazard class Self-reacting substances and Organic peroxides Type C, D, E
and F. It is theoretically possible that substances may move from the DSD hazard
class Flammable (R10) to Self-reacting Type F under the CLP. Of the potential 30
boundary substances, none fall within this boundary zone.
H301 - Toxic if Swallowed, H311 Toxic in Contact with Skin, H331 Toxic if
Inhaled and H370 Causes Damage to Organs
Consultation of Tables 4.3, 4.4 and 4.8 through to 4.12 clearly show that the
thresholds of the DSD intersect the CLP categories. Whilst it is possible to identify
the substances that fall within the CLP categories that are intersected by the DSD
thresholds, it is not possible to determine with certainty how many substances fall on
each side of the intersection. It can only be acknowledged that within the total
number of ‘boundary’ substances with ‘boundary’ hazard statements, a number would
have previously been classified as a dangerous fluid under the PED and likewise, a
number would not.
Equally, it must be acknowledged that the number of ‘boundary’ substances presented

below assumes that all of these substances will be used within pressure equipment.
To ensure this report is objective and is beyond challenge, it has been assumed that
this is indeed the case. These numbers are therefore very conservative in terms of the
number of ‘boundary’ substances that may change fluid group as discussed further in
Annex 3.
Summary
Table 6.5 below provides a summary of the boundary substances as a result of the
alignment of the PED to the CLP. To reiterate, this reflects the impact of aligning the
PED with CLP for those substances that have a harmonised classification.
Table 6.5: Numbers of Entries that may be Included/Excluded as a Dangerous Fluid under
Hazard Statement (HS) Number of ‘boundary’ Entries
H225 Highly flammable liquid and vapour 3
H242 Heating may cause a fire 0
H301 Toxic if swallowed 133
H311 Toxic in contact with skin 40
H331 Toxic if inhaled 169
H370 Causes damage to organs 6
Total 351
Page 49
6.2.3 Substances Affected by Policy Options
The discussion of the options below considers only those contentious issues where a
decision must be made as to whether include or exclude substances with a particular
hazard statement. In other words, the inclusion of Categories 1 and 2 for all exposure
routes within the Acute Toxicity hazard class44 and Category 3 for Acute Toxicity –
Inhalation45 will not be discussed further.
Option 1
As outlined in Section 5.5.2, Option 1 leads to the removal of some substances which
are toxic if swallowed (H301) and which are toxic in contact with the skin (H311)
from being classified as Group 1 fluids. However, by including the Hazard Statement
H331, additional substances will be classified as a Group 1 fluid. A numerical
summary as to whether the identified boundary substances are a Group 1 or Group 2
fluid under Option 1 has been provided in Table 6.6 below. A full listing of the 316
substances with harmonised classifications H301, H311 and H331 is presented in
Annex 2.
Table 6.6: Option 1 – Impact of Aligning PED with CLP

Substances Classified as a Substances Classified as a
Hazard Statement (HS)
Group 1 fluid Group 2 fluid
Exclude H301 Toxic if
0 133
swallowed
Exclude H311 Toxic in
0 40
contact with skin
Include H331 Toxic if
169 0
inhaled
Option 2
As outlined in Section 5.5.3, Option 2 leads to the removal of some substances which
are toxic if swallowed (H301) from being classified as Group 1 fluids. However,
Option 2 includes as Group 1 fluids those substances which are toxic in contact with
the skin (H311) in addition to those that are toxic if inhaled (H331). A numerical
summary as to whether the identified boundary substances are a Group 1 or Group 2
fluid under Option 1 has been provided in Table 6.7 below.
44
Acute Toxicity – Oral (H300), Acute Toxicity - Dermal (H310) and Acute Toxicity – Inhalation
(H330) and
45
Acute Toxicity – Inhalation (H331)
Page 50
Table 6.7: Option 2 – Impact of aligning PED with CLP

Substances classified as a Substances classified as a
Hazard Statement (HS)
Group 1 fluid Group 2 fluid
0 107
swallowed
Include H311 Toxic in
40 0
contact with skin
169 0
inhaled
It is noted that there are now only 107 substances with the Hazard Statement H301
that will be classified as a Group 2 fluid. This is because 26 of the 40 substances with
the Hazard Statement H311 also have the Hazard Statement H301.
6.2.4 Nature of Impacts
The aim here is to establish the types of impacts that can be expected to occur and the
stakeholders affected. This is achieved by reviewing the comprehensive checklist of
potential economic, environmental and social impacts set out in Tables 1 to 3 of the
Commission’s Impact Assessment Guidelines and identifying any additional impacts.
Both direct and indirect impacts are considered.
Based on the information collected, as a preliminary guide, the types of impacts that
might be the most relevant to the alignment of PED to the CLP Regulation have been
identified (see Table 6.8).
Table 6.8: Pre-screening of the Relevance of the Impacts

Impact type Relevant?
Economic Impacts
Functioning of the internal market and competition Not relevant
Competitiveness, trade and investment flows Potentially relevant
Operating costs and conduct of business/SMEs Potentially relevant
Administrative burdens on businesses Potentially relevant
Public authorities Potentially relevant
Property rights Not relevant
Innovation and research Not relevant
Consumers and households Not relevant
Specific regions and sectors Potentially relevant
Third countries and international relations Potentially relevant
Macroeconomic environment Not relevant
Social Impacts
Employment and labour markets Not relevant
Standards and rights related to job quality Not relevant
Social inclusion and protection of particular groups Not relevant
Gender equality, equality treatment and opportunities, non-discrimination Not relevant
Individuals, private and family life, personal data Not relevant
Page 51
Table 6.8: Pre-screening of the Relevance of the Impacts

Impact type Relevant?
Governance, participation, good administration, access to justice, media and Not relevant
ethics
Public health and safety Potentially relevant
Crime, Terrorism and Security Not relevant
Access to and effects on social protection, health and educational systems Not relevant
Culture Not relevant
Social impacts in third countries Not relevant
Environmental Impacts
The climate Not relevant
Transport and the use of energy Not relevant
Air quality Not relevant*
Biodiversity, flora, fauna and landscapes Not relevant*
Water quality and resources Not relevant*
Soil quality or resources Not relevant*
Land use Not relevant
Renewable or non-renewable resources Not relevant
The environmental consequences of firms and consumers Not relevant
Waste production/generation/recycling Not relevant
The likelihood or scale of environmental risks Potentially relevant
Animal welfare Not relevant
International environmental impacts Not relevant
* Note that although some incidents may result in environmental impacts, this will not be directly
affected by the alignment of PED to CLP as discussed further below.
As can be seen from Table 6.8, the impacts of the planned alignment will be primarily
economic as outlined further below.
Impact on the Internal Market and Competition
Since the scope and intent of the PED remains essentially unchanged, there should be
no significant impact on the internal market or competition.
Impact on Competitiveness, Trade and Investment Flows
Although the overall impact on trade should be minimal, it is conceivable that some
specialist sectors might be impacted. For example, a particular specialist sector may
rely on the use of a particular substance which is a Group 2 fluid which, after
alignment with CLP, is reclassified as a Group 1 fluid with an associated increase in
compliance costs which affects the competitiveness of that sector. It must be stressed
that such sectors have not been identified in consultation with stakeholders.
Operating Costs and Conduct of Business/SMEs
The reclassification of some substances (and mixtures) may lead to additional

compliance costs. While this would provide additional income to notified bodies, the
Page 52
cost would be borne by the manufacturers and installers of pressure equipment and
their customers. Although there appear to be no reliable data on companies involved
with pressure equipment, the recent evaluation report46 notes that there are many
SMEs within the sector. Although it is anticipated that the overall impact will be
small, it is possible that some individual SMEs may be significantly impacted if their
business is reliant on a substance which moves from Group 2 to Group 1 with
significant additional costs (see Box 6.1).
Box 6.1: Change in Operating Costs & Conduct of Business

It could be argued that the greatest potential impact on individual businesses would occur when the
exiting business was based entirely on a Group 2 fluid used in equipment covered by Sound
Engineering Practice (SEP) for which there is no involvement of Notified Bodies or use of CE
marking – such as vessels of 100l in volume under 20 bars pressure. Should the substance be moved
to Group 1, this would place the same equipment under Hazard Category II necessitating additional
compliance procedures, involvement of a Notified Body and affixing a CE mark with a potentially
significant increase in costs. Of course, in response the company could also adapt by changing the
operating pressure, the volume or the substance to keep within the SEP Hazard Category.
Although the Commission is, of course, committed to minimising the impacts of

regulation on SMEs and micro-businesses in particular47, there has been no suggestion
that PED and/or the CLP Regulation should be relaxed in any way in respect of
micro/small businesses. Similarly, while it is possible that some individual
companies or, conceivably, specialist sectors could be impacted, the overall impact on
trade and competitiveness is not expected to be significant. As such, it is not
considered necessary to undertake a more rigorous analysis of the sectoral
competitiveness48.
Administrative Burdens on Businesses
Changes would require that companies (including notified bodies) familiarise

themselves with the new requirements and adapt their procedures. Of course, such
familiarisation would be required in any event in order to understand the CLP
Regulation. However, the functioning of PED in terms of its procedures would
remain unchanged.
Public Authorities
Public authorities would incur costs of transposing any changes to the PED into
national legislation and may incur an increased administrative burden due to the need
46
CSES (2012): Evaluation of the Pressure Equipment Directive, Final Report prepared for DG
Enterprise, dated October 2012.
47
See, for example, European Commission (2011): Minimizing Regulatory Burden for SMEs
Adapting EU Regulation to the Needs of Micro-Enterprises, COM(2011) 803 final dated
23.11.2011.
48
With reference to European Commission (2012): Operational Guidance for Assessing Impacts on
Sectoral Competitiveness within the Commission Impact Assessment System - A
"Competitiveness Proofing" Toolkit, SEC(2012) 91 final, dated 27.1.2012.
Page 53
to provide advice – although this may already be covered through the implementation
of the CLP Regulation.
Property Rights
It is not anticipated that alignment of the PED to the CLP Regulation would have any
impacts on property rights.
Innovation and Research
significant impacts on innovation and research.
Consumers and Households
significant impacts on consumers and households.
Specific Regions and Sectors
It is very unlikely that specific regions will be impacted by the planned alignment of
PED with the CLP Regulation. However, as indicated above, it is conceivable that
some specialist sectors could be impacted – but none have been identified.
Third Countries and International Relations
Although the overall impact on third countries and international relations should be
small, any companies exporting from third countries into the EU will need to
familiarise themselves with the new requirements for ‘dangerous fluids’ in the revised
PED. As for businesses within the EU, it is possible that some individual companies
may be significantly impacted if it is reliant on a substance which moves from Group
2 to Group 1.
Macroeconomic Environment
significant impact on the overall macroeconomic environment.
Social and Environmental Impacts
In general, it is not anticipated that alignment of the PED to the CLP Regulation
would have any significant social or environmental impacts (see Table 6.8). Clearly,
the PED does affect two of the listed areas:
 Public Health and Safety; and

 The Likelihood or Scale of Environmental Risks.
Page 54
It is, of course, acknowledged that a major incident involving a pressure equipment

failure could impact upon the neighbouring environmental compartments (air, water,
soil, etc.). However, the alignment of the PED to the CLP Regulation does not
directly impact upon the likelihood or consequences of such incidents. This is
because the alignment does not directly impact the engineering codes used for the
design and construction of pressure equipment but will impact (in some cases) upon
the associated procedures for verifying that the correct engineering codes have been
applied. Of course, it may be argued that a more rigorous compliance regime should
reduce the chances of sub-standard pressure equipment being placed on the market
which, in turn, should reduce the chances of an incident which could adversely affect
human health or the environment.
Under the Seveso Directive, operators across the EU are required to report major
accidents (and ‘near misses’) and the (anonymised) reports are available to the public
on eMARS49. Inspection of these reports suggests that 10 to 40 incidents are reported
per year and that they cover a wide range of incidents. It is, however, immediately
apparent that failures of pressure equipment are rare.
A recent detailed analysis50 of UK and Dutch data (including eMARS data) explores
the causes of incidents involving pressure equipment. The report finds that most
incidents are caused by problems with design (for example, wrong materials), faulty
operation (including human error), material/equipment degradation (through corrosion
and/or poor maintenance), etc. There is no suggestion that the underlying compliance
regime of PED is failing to deliver pressure equipment which is safe when designed,
operated and maintained in the correct manner.
This view is one of the main findings of the PED evaluation report in which it is
stated that:
On the whole, it is unlikely that any of the infrequent pressure equipment

related accidents that have occurred in Europe could be linked to a failing of
the PED. If an accident had occurred it was more likely to be associated with
poor maintenance of equipment or a failure to apply the regulations.
With these points in mind, any impacts on public health and safety or environmental
risks resulting from alignment of the PED to the CLP Regulation are likely to be
insignificant.
The potential costs of the alignment are considered in more detail in Section 7.
49
e-Major Accidents Reporting System hosted by JRC at: https://emars.jrc.ec.europa.eu/
50
HSL/RIVM (2012): The Major Accident Failure Rates Project, Research Report RR915 prepared
for the UK Health & Safety Executive.
Page 55
Page 56
7. COSTS OF ALIGNMENT
7.1 Costs by Module
7.1.1 Overview
The five Hazard Categories used in PED and their associated modules for
demonstrating compliance are set out below. For some categories, there are multiple
routes of compliance. Manufacturers can select the option that best reflects their scale
of production and the extent of notified body involvement demanded by their
customers. For example, a large chemical company may insist that an item of
pressure equipment designated as Category III under the PED, complies with the
Directive through adherence to the requirements listed under Module H.
Alternatively, a SME may prefer that the same item of equipment conforms to the
PED by fulfilling the requirements of Modules B and E.
It should be stressed that the prices below are indicative and represent an average
across the Community. Thus for very complex equipment the fees are likely to be
higher and for simple equipment the fees lower. With regard to the quoted fees, they
reflect the direct cost of fulfilling the requirements of the relevant module and
compliance with the PED.
The costs for sound engineering practice have been set at €0 so as to serve as a
baseline against which other modules can be compared. It is acknowledged that, in
practice, manufacturers would incur some costs when fulfilling these requirements.
7.1.2 Sound Engineering Practice
Pressure equipment and assemblies that are designed and manufactured in accordance
with the principles of sound engineering practice need not comply with any of the
internal PED modules and must not bear a CE mark. They do however need to be
accompanied with adequate instructions for use and must bear markings that identify
the manufacturer or his authorised representative established within the Community51.
The manufacturer is responsible for the application of sound engineering practice and
ensuring it is used safely during its intended life, when used in foreseeable or
reasonably foreseeable conditions52.
Table 7.1: Cost of Complying with PED Module (Sound Engineering Practice)
Estimated cost in Euros (€) per annum, per
Module
manufacturer
N/A €0
51
PED Article 3.3
52
PED Guideline 9/1
Page 57
7.1.3 Category I
Module A (internal production control): This is a core module, the requirements of

which also appear in subsequent modules. To assist with the comprehension of the
modules below, these compliance measures have not been listed again for subsequent
categories – although the associated costs of compliance have been included within
the estimated costs. For an item of pressure equipment to comply with Category I, the
manufacturer or his authorized representative must:
 prepare technical documentation (that addresses the Essential Safety

Requirements (ESR) of the PED);
 ensure the item of pressure equipment conforms with the Essential Safety
Requirements;
 ensure pressure equipment is CE marked;
 draw up a declaration of conformity; and
 retain all documents for 10 years
Table 7.2: Cost of Complying with PED Category I

Module
product group, per manufacturer
A €75
The costs of fulfilling the requirements listed under Category I will depend on the
competence and knowledge of the manufacturer. Some manufacturers may be able to
fulfil all of the requirements in-house without the need for a notified body (applying
module A). The additional cost of compliance for these manufacturers will be
relatively small. Conversely, manufacturers will contract a notified body to assess the
technical documentation and confirm their products compliance with the ESR. For
these manufacturers, the cost of compliance will be larger. The estimated figure
represents the average cost of compliance, taking into consideration those who
manufacturers who seek the assistance of notified bodies and those who perform in
house compliance checks.
7.1.4 Category II
Module A1 (internal manufacturing checks with monitoring of the final assessment):

This requires that:
 a notified body monitor the final assessment by means of unexpected visits.
Module D1 (production quality assurance): A notified body must assess quality

assurance for production, final inspection and test. This comprises:
 of an assessment of the quality system of the manufacturer; and

 the manufacturer be subject to surveillance.
Page 58
Module E1 (product quality assurance): A notified body must assess the quality
assurance for final inspection and test, which requires:
 an assessment of the quality system; and

 the manufacturer be subject to surveillance.
Table 7.3: Cost of Complying with PED Module Category II

Module
manufacturer across the Community
A1 €500
D1 €1000
E1 €1000
7.1.5 Category III
Module B1 (EC design-examination) and Module B (EC type-examination): Module

B1 is concerned with technical documentation only, while Module B also requires
that a Notified Body checks the manufacture of a sample production (representative
example). The former is likely to be used for bespoke pressure equipment, the latter
for serially produced pressure equipment. As is evident in Table 7.4 below, they must
be used in conjunction with another module. Each module requires that:
 a notified body attests that the design of an item meets the applicable provisions of
the PED (Module B1);
 a notified body attests that a representative example of production in question
meets the applicable provisions of the PED (Module B). In this way, several
versions of the pressure equipment can be covered, provided the differences
between the versions do not affect the level of safety; and
 for both modules B and B1, the notified body must also check the technical
documentation and assess the materials used, approve the joining of pressure
equipment parts, verify the personnel undertaking welding and non-destructive
tests.
Module C1 (conformity to type): As noted in Table 7.4 below, this Module can only
be used with Module B (EC type-examination) which as discussed above, is used for
serially produced items. Designed to monitor the final assessment, Module C1 is
similar to A1, with the exception that this module is also used to verify that the
representative example approved under Module B is tested in accordance with the
PED.
Module D (production quality assurance): Module D must be used with Module B1

for Category III pressure equipment (Table 7.4) or Module B for Category IV
pressure equipment (Table 7.5). Module D1 is similar to A1, establishing
requirements for quality assurance for production, final inspection and test. Thus it
requires a notified body to:
Page 59
 assess the quality system of the manufacturer; and

 subject the manufacturer to surveillance.
Module E (product quality assurance): This module establishes requirements for

quality assurance for final inspection and test. A notified body must:
 assess the quality system of the manufacturer; and

 subject the manufacturer to surveillance.
Module F (product verification): As with C1, this module must be used with either
Module B1 for Category III pressure equipment (Table 7.4) or Module B for Category
IV pressure equipment (Table 7.5), with module selection determined by the
manufacturer. The manufacturer will take into consideration the number of units
intended to be manufactured, whether serial production is envisaged and whether he
has an approved quality assessment system. In addition to the requirements listed
under Module A1, a notified body must also:
 verify the personal undertaking the permanent joining of parts and performing the
non-destructive tests;
 verify the material certificates;
 review and approve non-destructive test reports;
 inspect the item during manufacture; and
 witness final inspection and examine any safety devices.
Module H (full quality assurance): This module has extensive notified body
involvement, with the notified body tasks comprising the basic components of
Module A as well as:
 quality assurance for design;

 quality assurance for manufacture; and
 final inspection and test.
Table 7.4: Cost of Complying with PED Category III

Module
B1 + D €1500 for B1 and €700 for D
B+E €2000 for B, and €700 for E
H €2000 for initial compliance, then €1200
Module
item/per batch, per manufacturer
B1 + F €1500 for B1 and €700 per item for F
B + C1 €2000 for B and €700 per batch for C
Page 60
7.1.6 Category IV
Module G (EC unit verification): This module is typically used for bespoke pressure
equipment that is not serially produced. It is similar to B1 + F (Table 7.4), with the
exception that a notified body must:
 examine the equipment during manufacture and perform the necessary tests where
appropriate.
Module H1 (full quality assurance with design examination and special surveillance
of the final assessment): In addition to the full assessment carried out under Module
H, a notified body will undertake design assessment, additional surveillance and final
assessment of the pressure equipment under Module H1.
Table 7.5: Cost of Complying with PED Module (Category IV)

Module
B+D €2000 for B and €1000 for D
Module
item/per batch, per manufacturer
G €2000 per item
H1 €1500 per design, and €300 per batch
B+F €2000 for B and €1000 for F, per item or batch
7.2 Compliance Costs to Industry
7.2.1 Estimated Number of Manufacturers Impacted
There are few reliable data on the pressure equipment industry sector. Indeed, a
recent Commission Impact Assessment report53 states:
Market data on these sectors is almost impossible to obtain. Information

sources are restricted, as there is no single EU professional association
representing the whole pressure equipment sector. Official statistical
classification systems only reference a limited number of relevant products.
Several attempts undertaken in the past to quantify the market for pressure
equipment in Europe have failed.
In the absence of robust data, some estimates have been made on the basis of
available Eurostat data for 2009 and 2010 (2011 data are not yet available). The
estimates were based on the following NACE (Rev 2) codes:
53
Commission Staff Working Paper Impact Assessment - Accompanying Document to the 10
Proposals to Align Product Harmonisation Directives to Decision No 768/2008/EC, SEC(2011)
1376 final, dated 21.11.2011.
Page 61
 24.2 Manufacture of tubes, pipes, hollow profiles and related fittings, of steel;
 25.2 Manufacture of tanks, reservoirs and containers of metal;
 25.3 Manufacture of steam generators, except central heating hot water boilers;
 28.12 Manufacture of fluid power equipment;
 28.13 Manufacture of other pumps and compressors; and
 28.14 Manufacture of other taps and valves.
The available statistics for these codes suggests an industry of around 15,000
enterprises across the EU as shown in Table 7.6. The associated ‘production value’ is
about €100 bn per annum.
Table 7.6: Numbers of Enterprises in the EU-27

NACE Code 2009 2010
24.2 Manufacture of tubes, pipes, hollow profiles and
1,756 1,977
related fittings, of steel
25.2 Manufacture of tanks, reservoirs and containers of
5,550 5,650
metal
25.3 Manufacture of steam generators, except central
970 1,014
heating hot water boilers
28.12 Manufacture of fluid power equipment 1,661 1,757
28.13 Manufacture of other pumps and compressors 2,551 2,523
28.14 Manufacture of other taps and valves 2,686 2,812
Totals 15,174 15,733
Source: Eurostat SBS Annual detailed enterprise statistics for industry (NACE Rev.2 B-E)
[sbs_na_ind_r2]
7.2.2 Imported Pressure Equipment
In addition to EU manufacturers, there will be companies exporting pressure

equipment into the EU. For this analysis, two example product groups were taken
from each of the above NACE codes in order to derive a ratio between the imported
and produced quantities and values. The selected product groups are shown in Table
7.7.
Table 7.7: Example Product Groups

Product Code Description
24201310 Tubes and pipes, of circular cross-section, seamless, of stainless steel (excluding
line pipe of a kind used for oil or gas pipelines and casing, tubing and drill pipe
used for oil or gas drilling)
24202300 Tubes and pipes, welded, of an external diameter > 406,4 mm, of steel (excluding
line pipe of a kind used for oil or gas pipelines and casing used for oil or gas
drilling)
25291110 Iron or steel reservoirs, tanks, vats and similar containers for gases, of a capacity >
300 litres (excluding compressed or liquefied gas, fitted with mechanical or thermal
equipment)
25291200 Containers for compressed or liquefied gas, of metal
Page 62
Table 7.7: Example Product Groups

Product Code Description
25301150 Vapour generating boilers (including hybrid boilers) (excluding central heating hot
water boilers capable of producing low pressure steam, watertube boilers)
25301170 Super-heated water boilers (excluding central heating hot water boilers capable of
producing low pressure steam)
28121130 Hydraulic cylinders
28121450 Valves for the control of oleohydraulic power transmission for pipes, boiler shells,
tanks, vats and the like
28132300 Compressors for refrigeration equipment
28133100 Parts of pumps for liquids and for liquid elevators
28141120 Pressure-reducing valves of cast iron or steel, for pipes, boiler shells, tanks, vats
and the like (excluding those combined with lubricators or filters)
28141315 Process control valves for pipes, boiler shells, tanks etc excluding valves for
pressure-reducing or oleohydraulic/pneumatic power transmissions, check,
safety/relief valves, temp. regulators
The associated import and production values are shown in Table 7.8.
Table 7.8: Quantities (x1000) and Values (€m) of Imports and Production by Product Group
Product Year IMPQNT IMPVAL PRODQNT PRODVAL Ratio Q Ratio V
2009 34704 248 375445 1681 9% 15%
24201310
2010 40238 238 331577 1603 12% 15%
2009 150589 122 467174 480 32% 25%
24202300
2010 102514 83 487040 522 21% 16%
2009 1326 6 112296 521 1% 1%
25291110
2010 1459 10 103090 481 1% 2%
2009 52244 124 388363 1460 13% 9%
25291200
2010 52295 133 367665 1358 14% 10%
2009 no data 67 27 576 no data 12%
25301150
2010 no data 12 28 564 no data 2%
2009 no data 2 2 111 no data 1%
25301170
2010 no data 1 3 118 no data 1%
2009 no data 87 4508 1317 no data 7%
28121130
2010 no data 113 5547 1301 no data 9%
2009 8063 263 79586 1984 10% 13%
28121450
2010 10352 317 92411 2727 11% 12%
2009 11576 710 33089 2086 35% 34%
28132300
2010 15526 997 38370 2512 40% 40%
2009 0 815 no data 2541 no data 32%
28133100
2010 0 1039 no data 2924 no data 36%
2009 1526 26 12719 226 12% 11%
28141120
2010 1620 30 11000 228 15% 13%
2009 6440 156 150000 1600 4% 10%
28141315
2010 7145 174 100000 2100 7% 8%
Source: Eurostat SBS - Statistics on the production of manufactured goods (prom)
Page 63
As might be expected, the ratios vary from product group to product group but an
overall estimate of around 15% seems to of the right order. On this basis it will be
assumed that in addition to the 15,000 EU manufacturers, there will be a further 2,250
importers.
7.2.3 Estimated Manufacturers by Category
To determine the impact of any changes of aligning the PED to CLP, the distribution
of pressure equipment manufactured within each of the five categories must be
estimated. The estimates presented in Table 7.9 are centred on the overall number of
manufacturers which has been estimated as 17,250. To facilitate the subsequent
analysis, the estimates have been further divided into the choice of modules where
appropriate. Clearly, these figures are uncertain but, nevertheless, provide a basis on
which to derive some indicative costs.
Table 7.9: Number of Manufacturers that Construct Pressure Equipment

Hazard Estimates of the Numbers of Manufacturers
PED Module
Category Low Medium High
SEP N/A 12000 17250 22500
I A 4500 5200 6000
II A1, D1, E1 3500 4600 5750
(B1 +F) (B + C1) 2200 3350 4500
III (B1 + D) (B + E) 400 600 850
H 100 200 300
(B + D) 1000 2500 4000
(G) 100 200 300
IV
H1 100 300 400
B+F 100 300 400
7.2.4 Baseline Costs
By combining the numbers of manufacturers by category/module with the costs

associated with each module (as derived in Section 7.1 above), it was possible to
estimate the baseline costs of compliance with PED.
In order to derive these estimates, it was necessary to make some further assumptions:
 on average, each manufacturer has 40 product groups per category/module;

 limited runs are 500 items while bespoke runs are 15 items/year; and
 ‘initial compliance costs’ are spread over 5 years.
As can be seen from table 7.10 (next page), the total compliance costs of PED are
estimated to be in the range €120m to €350m with a mid-estimate of €236m. As
would be expected, the compliance costs increase with increasing hazard and the
‘average’ costs by Hazard Category are presented in Table 7.11 (next page).
Page 64
Table 7.10: PED Compliance Costs (€m) by Hazard Category and PED Module
Hazard
PED Module Low Medium High
Category
SEP N/A 0.0 0.0 0.0
I A 13.5 15.6 18.0
II A1, D1, E1 13.4 17.6 22.0
(B1 +F) (B + C1) 3.7 5.4 7.1
III (B1 + D) (B + E) 11.9 17.9 25.3
H 4.8 9.7 14.5
(B + D) 42.0 105.0 168.0
(G) 30.0 60.0 90.0
IV
H1 1.4 4.1 5.4
B+F 0.7 1.1 1.3
Totals (€m) 121.4 236.3 351.6
Table 7.11: PED Compliance Costs (€m) by Hazard Category

Hazard Category Mid Estimate
SEP 0.0
I 15.6
II 17.6
III 32.9
IV 170.2
7.3 Costs of Alignment with the CLP Regulation
As discussed in Sections 3, 4, 5 and 6 most Group 1 fluids, as currently categorised

according to the DSD classification, will remain Group 1 fluids when the PED is
aligned to the CLP Regulation. There are, however, a number of substances in
‘boundary areas’ where changes in the group classification may occur. As explored in
Section 6, the number of such substances will be less than 10% of the total54. It
should be recalled that the number of boundary substances reflects a very
conservative estimate. Indeed, it is likely that the number of boundary substances that
are in fact used in pressure equipment is much lower (see Annex 3).
The proportion of manufacturers which will be making equipment affected by such

potential changes is difficult to estimate because of a lack of market data. Of course,
many manufacturers will focus entirely on Group 2 fluids such as water/steam
equipment manufacturers while others may manufacture equipment for a diverse
range of fluids (such as a vessel or valve manufacturer).
Using the ‘best available knowledge’, it has been cautiously estimated that 20% of
manufacturers may be affected, although the true figure may indeed be less.
However, of the 20% of manufacturers that are impacted, industry practice, the types
54
Less than 400 of the 4136 substances with harmonised classification could potentially move fluid
groups on alignment with CLP (see Tables 6.5, 6.6 and 6.7 for further detail).
Page 65
of pressure equipment manufactured and the percentage of fluids that are Group 1 and
Group 2 will mitigate any impacts of the PED aligning itself to the CLP.
It is common practice for pressure equipment to be designed and certified so as to be

compatible with Group 1 fluids. This is especially prevalent for pressure equipment
that is small and serially produced, particularly Category II equipment, as it ensures
equipment will appeal to the widest possible market. Very expensive bespoke
equipment will also be over engineered and designed and tested to be compatible with
a Group 1 fluid to ensure that it can be used for any fluid during its entire life span (30
years is not exceptional). Taking this into account, of the manufacturers that supply
pressure equipment that use substances that may change group, it has been estimated
that 50% of pressure equipment will be compatible with Group 1.
Similarly, users of pressure equipment will often specify to manufacturers that they
want an item of pressure equipment to be designed and manufactured to be
compatible with a Group 1 fluid. This request will be submitted irrespective of
whether the fluid to be used with the equipment is Group 1 or 2, with any difference
in the cost of compliance absorbed in preference for adopting higher standards of
safety. It has been estimated that around 25% of the manufacturers adopt this
practice.
In summary, 20% of manufacturers use ‘boundary’ substances of which 50% already

use Group 1 design by default and 25% are requested to design to Group 1 standards
in any event. In other words, the potential changes may affect 25% of the 20% of
manufacturers using ‘boundary’ substances which equates to 5% of all manufacturers.
To provide a basis for further analysis, it has been assumed that the associated
compliance costs would be 5% of the total. In other words, the compliance costs
associated with those manufacturers handling ‘boundary’ substances form 5% of the
total estimated costs for each PED Hazard Category.
If it is further assumed that the extra costs are associated with moving from one
hazard category to the next (due to a substance moving from Group 2 to Group 155),
the costs of alignment can be estimated as shown in Table 7.12.
Table 7.12: PED Compliance Costs (€m) by Hazard Category

5% of Current Costs of Moving up
Hazard Category Mid Estimate (€m)
Costs (€m) from Lower Category
SEP 0.0 0.00 n/a
I 15.6 0.78 0.78 (from SEP to I)
II 17.6 0.88 0.10 (from I to II)
III 32.9 1.65 0.77 (from II to III)
IV 170.2 8.51 6.87 (from III to IV)
Alignment Costs €8.5m*
* The range can be estimated to be from €2.7m to €13.3m by carrying forward the figures from Table
7.10.
55
Of course, in some cases, a change in group will lead to no change in the hazard category and, in a few
cases, it is possible that there would be a change of two, or conceivably, three categories.
Page 66
Of course, there will be no additional costs for equipment which is already considered
Hazard Category IV.
Since the difference between Options 1 and 2 appears to be small, with very
conservative results suggesting up to 40 substances from the harmonised classification
(compare Tables 6.6 and 6.7) changing fluid group, the associated costs will be
similar.
It has been assumed that Option 2 (inclusion of H311 substances) will have an
associated cost of €9.5m while the costs of Option 1 (exclusion of H311 substances)
will be lower at around €7.5m. This 20% cost differential is intended to reflect the
proportion of substances which will be affected under each Option.
In summary, the costs of aligning the PED to the CLP Regulation are estimated
to be of the order of €8.5m per annum. Given the small number of ‘boundary’
substances that present physical hazards, the cost of alignment is largely
influenced by the alignment of the health hazards, specifically Acute Toxicity.
Where some fluids move from Group 1 to Group 2, compliance costs may be
reduced and where some fluids move from Group 2 to Group 1, compliance costs
may increase. Of course, this figure could be further mitigated should
manufacturers using a Group 1 fluid choose to change the operating parameters
(volume of pressure equipment or maximum allowable pressure) so as to ensure
the pressure equipment is categorised in the same way.
Page 67
Page 68
8. COMPARING THE OPTIONS

8.1 The IA Guidelines
The Impact Assessment Guidelines suggest that the options should be considered
against the criteria of:
 Effectiveness: the extent to which options achieve the objectives of the

proposal;
 Efficiency: the extent to which objectives can be achieved for a given level of
resources at least cost (cost-effectiveness); and
 Coherence: the extent to which options are coherent with the overarching
objectives of EU policy, and the extent to which they are likely to limit trade-
offs across the economic, social, and environmental domain.
In this section, consideration is given to these criteria for Options 1 and 2.
8.2 Effectiveness
The PED must be aligned with the CLP Regulation. This will require a revision to
Article 9 of the PED which currently categorises fluids according to the DSD
classification. The categorisation of fluids according to the CLP Regulation
classification will, in the vast majority of cases, remain unchanged. However, there
are some boundary areas in which substances may change fluid groups – depending
on the precise alignment adopted.
Following consultation with stakeholders, it became clear that there was a lack of
understanding amongst industry as to the consequences of aligning the PED to the
CLP. To ensure a smooth transition, it was agreed that the prime aim of the alignment
is to maintain the current regime of the PED, whilst ensuring that any changes are
kept as simple as possible. With this in mind, we recommend that reliance be placed
on the use of the new ‘hazard statements’.
The key differences between the current situation and future options are summarised
in Table 8.1.
Table 8.1: Summary of Changes in Alignments for Options 1 and 2

liquid and vapour
Substances and H242: Heating may cause flammable substances (R10) may be
Mixtures and a fire reclassified as a self-reactive substance with
Organic Peroxides the Hazard Statement H242
Page 69
Table 8.1: Summary of Changes in Alignments for Options 1 and 2

Acute Toxicity* Exclusion of H301 leads to some substances

Exclusion of H311 leads to some substances
Acute Toxicity* reclassified as Group 2 fluids
(dermal) Inclusion of H311 leads to some substances
Acute Toxicity*
(inhalation)
Acute Toxicity Inclusion of H370 leads to some substances
H370: Causes damage to
(specific target organ previously categorised as Group 2 being
organs
toxicity) reclassified as Group 1 fluids
* Note: It is important to stress that, in relation Acute Toxicity, most substances will be unaffected.
In other words, most substances which are currently categorised as ‘very toxic’ and ‘toxic’ under the
DSD will remain Group 1 fluids but will be classified as Acute Toxicity Categories 1 and 2 under the
CLP. Similarly, most substances which are currently categorised as ‘harmful’ will remain Group 2
fluids but will be classified as Acute Toxicity Category 4. As such, the area of interest concerns those
substances which will be classified as Acute Toxicity Category 3 under the CLP with the associated
Hazard Statements H301, H311 and H331.
It is considered that both Options 1 and 2 are effective in meeting the requirement to
align the PED with CLP in a simple manner, as far as is possible.
8.3 Efficiency
The most significant direct impacts (in terms of numbers of substances affected) are
likely to be associated with the Hazard Statements H301, H311 and H331. It has
proven difficult to provide an accurate assessment as to the exact number of
substances that will change fluid group following alignment to the CLP. To ensure
the analysis was robust, only the harmonised classifications were assessed (4,000 of a
possible 100,000 substances). Of the 4,000 harmonised substances, no more than 300
(i.e. 7%) substances would change fluid group Unfortunately, due to the way in
which substances are classified using thresholds, it is not possible to provide a more
accurate assessment that is not subject to challenge56.
Interestingly, an indirect impact of changes in the PED relates to in-service

inspections which are undertaken at national level and represent recurring costs
throughout the lifetime of the equipment. These impacts are beyond the scope of this
study, with associated increased costs not taken into account.
56
As discussed further in Annex 3.
Page 70
In some cases, where a substance is re-categorised as a Group 1 fluid, the compliance

costs will increase after alignment with the CLP Regulation. The costs of complying
with PED depend not only on the relevant Hazard Category for the equipment but also
the compliance module(s) selected. Although there are few robust data available, it is
estimated that the current annual compliance costs are probably of the order of
€250m.
The additional costs of aligning the PED to the CLP have been estimated to be around
€8.5 million per annum, with no significant benefits beyond regulatory alignment.
Since Option 2 will involve some substances with Hazard Statement H311 (toxic in
contact with skin) moving from Group 2 to Group 1, the associated compliance costs
will be higher than for Option 1 in which some substances with Hazard Statement
H311 will move from Group 1 to Group 2. The additional costs of aligning the PED
to the CLP have been estimated to be around €7.5 million per annum for Option 1 and
€9.5 million per annum for Option 2.
Given the rare occurrence of pressure equipment failures and the low level of risk
associated with transient exposures to substances which are dermally toxic, it appears
very unlikely that the additional costs of Option 2 will outweigh the marginal
reduction in risks to those in the vicinity of pressure equipment. As such, Option 1 is
considered to be more efficient than Option 2.
8.4 Coherence
Currently the PED co-exists with a wide range of legislation relating not only to the
health and safety of workers, public safety and to the protection of the environment
but also to the safe manufacture, transport and storage of oil and gas, chemicals and
explosives.
Alignment of the PED to CLP is not intended to change the fundamental objectives of
the Directive to ensure the free trade of pressure equipment and assemblies within the
European Economic Area (EEA) while ensuring high levels of safety.
Clearly, since the fundamental objectives of the PED will remain unchanged then
there is no reason to suggest that the coherence with other legislation will be
challenged. By way of example, whether or not a particular category of substances is
included or excluded from being classified as a dangerous fluid should have no
influence on how such categories of substanecs should be classified under different
legislation with different objectives.
With this in mind, it is considered that both Options 1 and 2 may be considered
coherent in relation to other EU policy objectives.
Page 71
8.5 Preferred Option
From the brief analysis presented above, it is clear that there is little to choose
between the two Options as both are effective and coherent. However, Option 2 will
result in slightly more costs than Option 1 with only marginal benefits (in terms of a
reduced risk associated with exposure to substances which are toxic to the skin). As
such, Option 1 is the preferred option on the grounds that it appears to be more
efficient than Option 2.
Page 72
ANNEX 1:
CORRELATION OF DSD
AND CLP CLASSIFICATIONS
Page A1-1
Page A1-2
Annex 1.1: Translation Between Classification in Accordance with the DSD and CLP for Physical Hazards (Explosives)
Current reference in Art. 9 and R-phrase Possible Group Hazard Classification under Article 9, PED after Explanatory Comments
according to PED Guideline 2/7 alignment with CLP
E; R2 Risk of explosion by shock, friction, Annex I, 2.1.1.1 and 2.1.1.2 of CLP outline and define the relevant terms for Substances and mixtures that are currently classified as E; R2
fire or other sources of ignition substances, mixtures and articles that fall within the Explosive hazard class. or E; R3 according to the DSD are expected to be classified
E; R3 Extreme risk of explosion by shock, Explosive substances, mixtures and articles that are not classified as unstable as explosive under CLP.
friction, fire or other sources of ignition will be assigned to the appropriate division below, as determined by the
(liquid) hazard they present However because CLP divides physcial hazards into a greater
number of hazard classes than DSD/DPD some substances
may move from this hazard class and be classified under CLP
The Explosive Divisions under CLP hazard classes for organic peroxides or self-reactives (see
Division Type of Hazard relevant category below for more discussion).
Unstable explosives
CLP also classifies as explosive substances or mixtures that
1.1 Mass Explosion have been manufactured to produce an explosive or
1.2 Projection pyrotechnic effect, irrespective of how it may otherwise have
1.3 Fire or minor blast/projection been classified. Thus a small number of these ‘intentional
explosives’ will be classified under CLP as explosive, which
1.4 No significant hazard, only a small hazard in the event of was not the case under the DSD.
ignition or initiation
1.5 Insensitive substances or mixtures that have a mass explosion
hazard
1.6 Extremely insensitive articles which do not have a mass
explosion hazard
CLP Annex I, 2.1.2.1
Page A1-1
Annex 1.2: Translation Between Classification in Accordance with the DSD and CLP for Physical Hazards (Testing and Screening for Explosives)
Regulation (EC) No. 440/2008 (Tests The screening procedure identifies whether a substance or mixture Under the DSD, if any of the tests undertaken for the purpose of
Methods Regulation): possesses reactive groups that have the potential for rapid energy release identifying explosive properties (test method A.14) show a
and thus whether or not a substance mixture may be ‘explosive’ or positive result, the substance/mixture will be classified as
New substances that are suspected of ‘unstable explosive’. This is outlined under: explosive.
possessing explosive qualities may be  CLP Annex I, 2.1.4.1;
subsequently classified as explosive  Appendix 6 (Part 3) of the UN Manual of Tests and Criteria57 Whereas the DSD classification system only takes into account the
according to the results of test method A.14 identifies the substance/mixture as potentially having explosive intrinsic properties of a substance or mixture, CLP scheme also
(explosive properties) found under effects will the test be necessary; and considers the packaged state of the substance or mixture. This
Regulation (EC) No. 440/2008 (former  Technical Guidance Document on the Information Requirements for change of approach could mean that some substances or mixtures
Annex V to DSD). Three tests are REACH. 58 that were previously classified as explosive according to the DSD,
undertaken to determine whether a will no longer be classified as explosive under CLP if they are
substance or mixture possesses explosive Thus there is a series of tests which have been divided into groups. By packaged in such a way that they do not meet CLP criteria.
properties: conducting Test series 1 – 4, it is possible to assess whether a However, this is not an entirely new concept to CLP, as Note T to
substance/mixture has possible explosive effects. These tests may be Annex I of the DSD includes a similar provision.
 thermal sensitivity test (Koenen test); undertaken in any order and indeed, for the safety of experimenters, it
 mechanical sensitivity to impact may be prudent to conduct test series 3 first59. In broad terms, Test series Notably, the questions under Test series 3 for mechanical
(Fallhammer); and 1-4 assesses: sensitivity differ slightly from the mechanical test undertaken for
 mechanical sensitivity to friction  thermal sensitivity; the purposes of the DSD and the criteria are also different.
(Friction apparatus)  detonation behaviour; Specifically, the outcome of tests 3 (a) and 3 (b) determine
 deflagration behaviour; whether a substance or mixture is too sensitive to mechanical
 mechanical sensitivity; stimuli, for which lower limits are stated. Conversely, upper
 thermal stability; and limits were used in the A.14 test to determine whether a substance
 response to fire. or mixture presented an explosive hazard60.
57
Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria Fifth revised edition United Nations: New York and Geneva, 2009 (ST/SG/AC.10/11/Rev.5)
58
Technical Guidance Document on the Information Requirements for REACH, Part 2 EWG 1-7, REACH Implementation Project (RIP) 3.3 Phase 2, chapter 7.1.11.3
59
This is because test series 3 uses relatively small sample sizes compared to other tests, thus reducing the risk to test personnel.
60
ECHA (November 2012) Guidance on the Application of CLP Criteria Available from http://echa.europa.eu/documents/10162/13562/clp_en.pdf
Page A1-2
Annex 1.3: Translation Between Classification in Accordance with the DSD and CLP for Physical Hazards (Flammable Gas)
F+; R12 Extremely flammable (gas). For the purposes of CLP classification, ‘Flammable’ gases are defined as As the DSD has only one category for flammable gases, a direct
“a gas or gas mixture having a flammable range with air at 20°C and a translation to CLP is not possible. However, alignment is
Flammable gases are defined in DSD as standard pressure of 101,3 kPA”61 (i.e. at atmospheric pressure). relatively simple as the breadth of the hazard class flammable
“gaseous substances and preparations which gases under CLP remains the same as that of F+; R12 under the
are flammable in contact with air at ambient Gases qualifying as flammable will then be sub-divided into one of two DSD. Substances or mixtures previously classified under the
temperature and pressure.” hazard categories as follows: DSD as F+; R12 will simply be re-classified as either Category 1
or Category 2 flammable gases.
F+; R12 may also be used for liquids (see
later discussion) The exception to the classification procedure is Ammonia, which
Criteria for Flammable Gases is currently classified as F; R10 according to the DSD. Under
Category Criteria CLP, this will be classified as Flammable Gas Category 2.
1 a) are ignitable when in a mixture of 13% or less by
volume in air; or
b) have a flammable range with air of at least 12
percentage points regardless of the lower flammable
limit.
2 Gases, other than those of Category 1, which, at 20°C and
a saturated pressure of 101,3 kPa, have a flammable range
while mixed in the air.
CLP Annex I, Table 2.2.1
61
CLP Annex I, 2.2.1.
Page A1-3
Annex 1.4: Translation Between Classification in Accordance with the DSD and CLP for Physical Hazards (Flammable Liquids)
F+; R12 Extremely flammable (liquid); For the purposes of CLP, ‘Flammable’ liquids are liquids “having a flash A small number of additional substances and mixtures may be
F; R11 Highly flammable (liquid); and point of not more than 60°C”63. Such liquids are then further subdivided captured by CLP where their flashpoint falls between 55°C (the
F; R10 Flammable (where it is intended to into three categories as outlined below: cut-off under DSD) and 60°C (the cut-off under CLP).
be used at maximum allowable temperature
that exceeds its flashpoint). DSD Classification CLP Classification
60
The PED guidance confirms that flammable
means any fluid “intended to be used at a Flash 55
maximum allowable temperature TS above point
its flashpoint”62. in °C
R10 Cat. 3
The current classification according to the 23
DSD is up to a flash point of 55 °C. Label Elements for Flammable Liquids 21
Category Criteria R11 Cat. 1 Cat. 2
1 Flash point < 23 °C and initial boiling point ≤ 35 °C 0 R12
2 Flash Point < 23 °C and initial boiling point > 35 °C ≤ 35 > 35 ≤ 35 > 35
3 Flash point ≥ 23 °C and ≤ 60°C*
Boiling Point / Initial Boiling Point
* It should be noted that flammable liquids of category 4 of the GHS are
not implemented in the EU-CLP Regulation. However, CLP, gas oils, in °C
diesel and light heating oils that have a flash point between ≥ 55 °C and Comparison of Flashpoint / (Initial) Boiling Point64 according
≤ 75 °C are to be regarded as Category 3. to DSD and CLP65
62
PED Guideline 2/20
63
CLP Annex I 2.6.1.
64
The boiling point of a substance is the temperature at which the vapour pressure of the liquid equals environmental pressure (101, 325 kPa) surrounding the liquid
65
Page A1-4
Annex 1.5: Translation Between Classification in Accordance with the DSD and CLP for Physical Hazards (Flammable Solids)
F; R11 – Highly Flammable As noted above, the grouping of a solid will influence the hazard Most solids and mixtures classified as ‘F; R11’ according to the
classification of a mixture, where the fluid contains a suspension of a DSD will translate into a flammable solid according to CLP.
solid. This necessitates discussion of this hazard class. However, there may be some cases where substances or mixtures
are better classified as self-reactive or possibly even, explosive
Flammable solids and mixtures are classified according to their burning according to CLP67. These will however, remain as Group 1
behaviour and are defined under Annex I, 2.7.1.1. Since flammability is fluids.
an intrinsic hazard within this hazard class, substances and mixtures
classified as explosive, an organic peroxide, self-reactive, pyrophoric or A conservative approach is adopted when it comes to classifying
oxidising solid should not be considered for classification as a flammable substances as Category 1 or Category 2, with Category 2 assigned
solid66. only when the decision can be reasonably justified68.
Flammable solids will be classified as either Category 1 or Category 2

depending on the results of the burning test outlined below:
Category 1: Substances and mixtures other than metal powders:
(a) wetted zone does not stop fire and
(b) burning time < 45 seconds or burning rate > 2.2 mm/s
Metal powders: burning time ≤ 5 minutes
Category 2: Substances and mixtures other than metal powders:
(a) wetted zone stops the fire for at least 4 minutes and
(b) burning time < 45 seconds or burning rate > 2.2 mm/s
Metal powders: burning time > 5 minutes and ≤ 10 minutes
66
67
Ibid
68
Ibid
Page A1-5
Annex 1.6: Translation Between Classification in Accordance with the DSD and CLP for Physical Hazards (Pyrophoric Liquids)
F; R17 – Spontaneously flammable in air. Pyrophoric Liquids are defined under Annex I, 2.9.1. The tests used to classify a substance or mixture as F; R17; and
those used to determine whether a mixture or substance is a
There is only one Category (Category 1) for pyrophoric liquids as pyrophoric liquid are identical69.
outlined below:
Equally, in a similar fashion to F; R17; CLP hazard class
pyrophoric liquids contains only one Category. Furthermore, the
Criteria for Pyrophoric Liquids classification criteria are also identical. The transition from the
Category Criteria DSD to CLP in respect of these hazard classes is direct and
1 The liquid ignites within 5 min when added to an inert simple.
carrier and exposed to air, or it ignites or chars a filter
paper on contact with air within 5 min
69
The DSD uses A.13 test in EC-Regulation 440/2008 whilst CLP methods N.3 as described in Part 3 Section 33 of the United Nations Manual of Tests and Criteria.
Page A1-6
Annex 1.7: Translation Between Classification in Accordance with the DSD and CLP for Physical Hazards (Pyrophoric Solids)
F; R17 – Spontaneously flammable in air Pyrophoric Solids are defined under Annex I, 2.10.1, where it is noted The tests used to classify a substance or mixture as F; R17; and
that mixtures fall within this hazard class. As has already been noted, the those used to determine whether a mixture or substance is a
grouping of a solid will influence the hazard classification of a mixture, pyrophoric solid are identical70.
where the fluid contains a suspension of a solid. This necessitates
discussion of this hazard class. Equally, in a similar fashion to F; R17; CLP hazard class
pyrophoric solids contains only one Category. Furthermore, the
There is only one Category (Category 1) for pyrophoric solids as outlined classification criteria are also identical. The transition from the
below: DSD to CLP in respect of these hazard classes is direct and
simple.
Criteria for Pyrophoric Solids

Category Criteria
1 The solid ignites within 5 minutes of coming into contact
with air.
70
The DSD uses A.13 test in EC-Regulation 440/2008 whilst CLP methods N.3 as described in Part 3 Section 33 of the United Nations Manual of Tests and Criteria.
Page A1-7
Annex 1.8: Translation Between Classification in Accordance with the DSD and CLP for Physical Hazards (Contact with water emits flammable gases)
F; R15; Contact with water liberates CLP defines substances or mixtures which, in contact with water emit All substances and mixtures that are classified as F; R15
extremely flammable gases. flammable gases under CLP Annex I, 2.12.1. These substances or according to the DSD will be classified under CLP as a substance
mixtures will be classified in one of three categories: or mixture which, in contact with water emits flammable gases.
Category 1: Any substance or mixture which reacts vigorously with Although under CLP the hazard class has been sub-divided into
water at ambient temperatures and demonstrates generally a tendency three categories, the breadth is comparable to the classification
for the gas produced to ignite spontaneously, or which reacts readily under the DSD. Consequently, this should be a straightforward
with water at ambient temperatures such that the rate of evolution of alignment.
flammable gas is equal to or greater than 10 litres per kilogram of
substance over any one minute. CLP may however have an impact on pyrophoric substances or
Category 2: Any substance or mixture which reacts readily with water at mixtures. As noted in CLP guidance document, if a substance or
ambient temperatures such that the maximum rate of evolution of mixture was classified as F; R17 under the DSD, no additional
flammable gas is equal to or greater than 20 litres per kilogram of classification in respect of F; R15; was required71. This is no
substance per hour, and which does not meet the criteria for Category 1. longer the case under CLP, which mandates a UN N5. Test under
Category 3: Any substance or mixture which reacts slowly with water at nitrogen atmosphere for substances already classified as F; R17.
ambient temperatures such that the maximum rate of evolution of
flammable gas is equal to or greater than 1 litre per kilogram of
substance per hour, and which does not meet the criteria for Categories 1
and 2.
71
Page A1-8
Annex 1.9: Translation Between Classification in Accordance with the DSD and CLP for Physical Hazards (Oxidising Gases)
O; R8 - Contact with combustible material CLP defines an oxidising gas under Annex I, 2.4.1. There is only one All oxidising gases classified according to the DSD as O; R-8 will
may cause fire (gas) Category under CLP, which is outlined below: be classified as a Category 1 Oxidising gas under CLP (Ox. Gas
1). Alignment is relatively simple.
Criteria for Oxidising Gases The only slight difference is that under the DSD, a gas was
classified as having oxidising potential O; R8 if it had an
Category Criteria oxidising potential of at least 21%. Whereas under CLP, the
oxidizing potential must be at least 23.5%. CLP also takes into
1 Any gas which may, generally by providing oxygen, cause account the fact that other gases in a mixture may have an
or contribute to the combustion of other material more than inertising effect different from nitrogen72.
air does.
72
UK Department for Business Innovation & Skills (2010): Adaptation of Art. 9 of the PED to CLP-Regulation with regard to physical hazards, available from:
http://www.bis.gov.uk/assets/biscore/business-sectors/docs/p/proposal-adaptation-article-9-ped-to-clp-regulation.doc
Page A1-9
Annex 1.10: Translation Between Classification in Accordance with the DSD and CLP for Physical Hazards (Oxidising Liquid)
O; R8 Contact with combustible material The definition for Oxidising liquids can be found under Annex I, 2.13.1. Liquids that have been classified as O; R8 and O; R9 according to
may cause fire (liquid); An oxidising liquid will be classified into one of three Categories of this the DSD can be re-classified under CLP. Although CLP sub-
O; R9 Explosive when mixed with class in accordance with test method O.2 in Part III, sub section 34.4.2 of divides the hazard class into three categories, its total coverage as
combustible material (liquid) the UN – Manual of tests and Criteria73 as outlined below: defined by the cut-off limits corresponds to the previous
Category 1: Any substance or mixture which, in the 1:1 mixture, by classification under the DSD. Due to these similarities, transition
mass, of substance (or mixture) and cellulose tested, spontaneously from the DSD to CLP should be smooth in respect of substances
ignites; or the mean pressure rise time of a 1:1 mixture, by mass, of in this hazard class74.
substance (or mixture) and cellulose is less than that of a 1:1 mixture, by
mass, of 50 % perchloric acid and cellulose
Category 2: Any substance or mixture which, in the 1:1 mixture, by
mass, of substance (or mixture) and cellulose tested, exhibits a mean
pressure rise time less than or equal to the mean pressure rise time of a
1:1 mixture, by mass, of 40 % aqueous sodium chlorate solution and
cellulose; and the criteria for Category 1 are not met
Category 3: Any substance or mixture which, in the 1:1 mixture, by
mass, of substance (or mixture) and cellulose tested, exhibits a mean
pressure rise time less than or equal to the mean pressure rise time of a
1:1 mixture, by mass, of 65 % aqueous nitric acid and cellulose; and the
criteria for Category 1 and 2 are not met.
73
74
Page A1-10
Annex 1.11: Translation Between Classification in Accordance with the DSD and CLP for Physical Hazards (Oxidising Solid)
Current reference in Art. 9 and R- Possible Group Hazard Classification under Article 9, PED after Explanatory Comments
phrase according to PED Guideline 2/7 alignment with CLP
O; R8 Contact with combustible material The definition for Oxidising solids can be found under CLP Annex I, Solids that have been classified as O; R8 and O; R9 according to
may cause fire (solid); and 2.14.1. It is necessary to consider this hazard class because the grouping the DSD can be re-classified under CLP. Although CLP sub-
O; R9 Explosive when mixed with of a solid will influence the hazard classification of mixture, where the divides the hazard class into three categories, its total coverage as
combustible material (solid) fluid contains a suspension of a solid. defined by the cut-off limits corresponds to the previous
classification under the DSD. The testing procedure under CLP is
slightly different to that under the DSD but is expected to cover
An oxidising solid will be classified into one of three Categories of this
the same substances and mixtures. Due to these similarities,
class in accordance with test method O.1 in Part III, sub section 34.4.2 of
transition from the DSD to CLP should be smooth in respect of
the UN – Manual of tests and Criteria75 . The three categories are
substances in this hazard class76 .
outlined below:
Criteria for Oxidising Solids
Category Criteria
1 Any substance or mixture which, in the 4:1 or 1:1 sample-to-

cellulose ratio (by mass) tested, exhibits a mean burning time
less than the mean burning time of a 3:2 mixture, by mass, of
potassium bromate and cellulose
equal to or less than the mean burning time of a 2:3 mixture
(by mass) of potassium bromate and the criteria for Category
1 are not met.
equal to are less than the mean burning time of a 3:7 mixture
(by mass) of potassium bromate and cellulose and the
criteria for Categories 1 and 2 are not met.
75
76
Page A1-11
Annex 1.12: Translation Between Classification in Accordance with the DSD and CLP for Physical Hazards (Self-Reactive)
E; R2 Risk of explosion by shock, friction, The definition for ‘Self-reactive’ substances or mixtures can be found The ‘Self-reactive’ substances and mixtures hazard class under
fire or other sources of ignition; under Annex I, 2.8.11 of CLP. CLP does not directly correspond to any of the hazard classes
E; R3 Extreme risk of explosion by shock, under the DSD. Thus it is a novel class, which will capture
friction, fire or other sources of ignition; These substances shall be classified in one of types for this class substances and mixtures that have previously been classified under
F+; R12 for Extremely flammable; according to the results of Test Series A to G: other hazard classes according to the DSD. These hazard classes
have typically been listed under Article 9 of the PED, meaning
F; R11 Highly flammable  Test series A: determine if there is propagation of detonation; that substances and mixtures that will now be classified as ‘Self-
 Test series B: determine if there is detonation in the package; reactive’ were previously classified as dangerous fluids under the
 Test series C: determine if there is propagation of deflagration; PED
 Test series D: determine if there is rapid deflagration in the package;
 Test series E: determine the effect of heating under confinement;
For example, substances or mixtures that would qualify as ‘Self-
 Test series F: determine the explosive power;
reactive’ Test series A, B and in part C according to CLP, have
 Test series G: determines the effect of a thermal explosion of a been classified according to the DSD as Explosive (E; R2 or E;
substance as packaged for transport R3).
Whilst substances or mixtures that would qualify as Test Series C
As outlined under Annex I, 2.8.2.1, this procedure need not be applied if: to F have been classified according to the DSD as flammable (F+;
 the mixture of substance does not contain any chemical groups with R12, F; R11 and in some cases F; R10) .
explosive or self-reactive properties; or
for a single organic substance or homogenous mixture of organic
Specific examples of this include:
substances, the self–accelerating decomposition temperature is greater
than 75 °C for a 50 Kg package or the heat decomposition is less than
300 J/g. • 3-Azidosulfonylbenzoic acid (currently E; R-2)
• 2,2'-dimethyl-2,2'-azodipropiononitrile; ADZN (currently E;
R2); and
•Ammonium bis(1-(3,5-dinitro-2-oxidophenylazo)-3-(N phenyl
carbamoyl)-2-naphtholato)chromate(1-) (currently F; R11)
Page A1-12
ANNEX 2:
BOUNDARY TOXIC SUBSTANCES

H301 – Toxic if H311 - Toxic in H331 – Toxic if

Index Number International chemical identification
swallowed contact with skin inhaled
006-010-00-1 5,5-Dimethyl-3-oxocyclohex-1-enyl dimethylcarbamate; 5,5-Dimethyldihydroresorcinol dimethylcarbamate; Dimetan 1
006-016-00-4 Propoxur (ISO); 2-Isopropyloxyphenyl N-methylcarbamate; 2-Isopropoxyphenyl methylcarbamate 1
006-018-00-5 Aminocarb (ISO); 4-Dimethylamino-3-tolyl methylcarbamate 1 1
006-022-00-7 Decarbofuran (ISO); 2,3-Dihydro-2-methylbenzofuran-7-yl methylcarbamate 1 1 1
006-023-00-2 Mercaptodimethur (ISO); Methiocarb (ISO); 3,5-Dimethyl-4-methylthiophenyl N-methylcarbamate 1
006-028-00-X Dinobuton (ISO); 2-(1-methylpropyl)-4,6-dinitrophenyl isopropyl carbonate 1
006-029-00-5 Dioxacarb (ISO); 2-(1,3-Dioxolan-2-yl)phenyl N-methylcarbamate 1
006-035-00-8 Pirimicarb (ISO); 5,6-Dimethyl-2-dimethylamino-pyrimidin-4-yl N,N-dimethylcarbamate 1
006-037-00-9 Promecarb (ISO); 3-Isopropyl-5-methylphenyl N-methylcarbamate 1
006-040-00-5 3-methylpyrazol-5-yl-dimethylcarbamate; Monometilan 1 1 1
006-041-00-0 Dimethylcarbamoyl chloride 1
006-046-00-8 Bendiocarb (ISO); 2,2-Dimethyl-1,3-benzodioxol-4-yl N-methylcarbamate 1 1
Bufencarb (ISO); Reaction mass of 3-(1-methylbutyl)phenyl N-methylcarbamate and 3-(1-ethylpropyl)phenyl N- 1 1
006-047-00-3
methylcarbamate
006-083-00-X Butocarboxim (ISO); 3-(Methylthio)-2-butanone O-[(methylamino)carbonyl]oxime 1 1 1
Benfuracarb (ISO); Ethyl N-[2,3-dihydro-2,2-dimethylbenzofuran-7-yloxycarbonyl(methyl)aminothio]-N-isopropyl- β- 1
006-088-00-7
alaninate
007-008-00-3 Hydrazine 1 1 1
007-013-00-0 1,2-Dimethylhydrazine 1 1 1
007-014-00-6 Salts of hydrazine 1 1 1
007-025-00-6 (4-Hydrazinophenyl)-N-methylmethanesulfonamide hydrochloride 1
009-004-00-7 Sodium fluoride 1
009-005-00-2 Potassium fluoride 1 1 1
009-006-00-8 Ammonium fluoride 1 1 1
009-007-00-3 Sodium bifluoride; Sodium hydrogen difluoride 1
009-008-00-9 Potassium bifluoride; Potassium hydrogen difluoride 1
009-009-00-4 Ammonium bifluoride; Ammonium hydrogen difluoride 1
009-012-00-0 Alkali fluorosilicates(Na); [1] Alkali fluorosilicates(K); [2] Alkali fluorosilicates(NH4) [3] 1 1 1
009-015-00-7 Sulphuryl difluoride 1
009-018-00-3 Magnesium hexafluorosilicate 1
015-030-00-X Demeton-O-methyl (ISO); O-2-Ethylthioethyl O,O-dimethyl phosphorothioate 1
015-031-00-5 Demeton-S-methyl (ISO); S-2-Ethylthioethyl dimethyl phosphorothioate 1 1
Page A2-1

015-037-00-8 Phenkapton (ISO); S-(2,5-Dichlorophenylthiomethyl) O,O-diethyl phosphorodithioate 1 1 1
015-044-00-6 Carbophenothion (ISO); 4-Chlorophenylthiomethyl O,O-diethyl phosphorodithioate 1 1
015-045-00-1 Mecarbam (ISO); N-Ethoxycarbonyl-N-methylcarbamoylmethyl O,O-diethyl phosphorodithioate 1 1
015-046-00-7 Oxydemeton-methyl; S-2-(Ethylsulphinyl)ethyl O,O-dimethyl phosphorothioate 1 1
015-047-00-2 Ethion (ISO); O,O,O',O'-Tetraethyl S,S'-methylenedi (phosphorodithioate); Diethion 1
015-048-00-8 Fenthion (ISO); O,O-Dimethyl-O-(4-methylthion-m-tolyl) phosphorothioate 1
015-049-00-3 Endothion (ISO); S-5-Methoxy-4-oxopyran-2-ylmethyl dimethyl phosphorothioate 1 1
015-050-00-9 Thiometon (ISO); S-2-Ethylthioethyl O,O-dimethyl phosphorodithioate 1
015-058-00-2 Morphothion (ISO); O,O-Dimethyl-S-(morpholinocarbonylmethyl) phosphorodithioate 1 1 1
015-059-00-8 Vamidothion (ISO); O,O-Dimethyl S-2-(1-methylcarbamoylethylthio) ethyl phosphorothioate 1
015-064-00-5 Bromophos-ethyl (ISO); O-4-Bromo-2,5-dichlorophenyl O,O-diethyl phosphorothioate 1
015-066-00-6 Omethoate (ISO); O,O-Dimethyl S-methylcarbamoylmethyl phosphorothioate 1
015-067-00-1 Phosalone (ISO); S-(6-Chloro-2-oxobenzoxazolin-3-ylmethyl) O,O-diethyl phosphorodithioate 1
015-075-00-5 S-[2-(Isopropylsulphinyl)ethyl] O,O-dimethyl phosphorothioate 1 1 1
015-077-00-6 2,2-Dichlorovinyl 2-ethylsulphinylethyl methyl phosphate 1 1 1
015-078-00-1 Demeton-S-methylsulphon (ISO); S-2-Ethylsulphonylethyl dimethyl phosphorothioate 1
015-084-00-4 Chlorpyrifos (ISO); O,O-Diethyl O-3,5,6-trichloro-2-pyridyl phosphorothioate 1
015-085-00-X Chlorphonium chloride (ISO); Tributyl (2,4-dichlorobenzyl) phosphonium chloride 1
015-086-00-5 Coumithoate (ISO); O,O-Diethyl O-,8,9,10-tetrahydro-6-oxo-benzo(c)chromen-3-yl phosphorothioate 1
015-099-00-6 Pirimiphos-ethyl (ISO); O,O-Diethyl O-2-diethylamino-6-methylpyrimidin-4-yl phosphorothioate 1
015-109-00-9 Crotoxyphos (ISO); 1-Phenylethyl 3-(dimethoxyphosphinyloxy) isocrotonate 1 1
015-121-00-4 Edifenphos (ISO); O-Ethyl S,S-diphenyl phosphorodithioate 1 1
015-126-00-1 Heptenophos (ISO); 7-Chlorobicyclo(3.2.0)hepta-2,6-dien-6-yl dimethyl phosphate 1
015-129-00-8 Isofenphos (ISO); O-Ethyl O-2-isopropoxycarbonylphenyl-isopropylphosphoramidothioate 1 1
015-130-00-3 Isothioate (ISO); S-2-Isopropylthioethyl O,O-dimethyl phosphorodithioate 1 1
015-131-00-9 Isoxathion (ISO); O,O-Diethyl O-5-phenylisoxazol-3-ylphosphorothioate 1 1
015-132-00-4 S-(chlorophenylthiomethyl) O,O-dimethylphosphorodithioate; Methylcarbophenothione 1 1
Trans-isopropyl-3-[[(ethylamino)methoxyfosfinothioyl]oxy]crotonate; isopropyl 3- 1
015-136-00-6
[[(ethylamino)methoxyphosphinothioyl]oxy]isocrotonate; Propetamphos (ISO)
015-138-00-7 Quinalphos (ISO); O,O-Diethyl-O-quinoxalin-2-yl phosphorothioate 1
015-140-00-8 Triazophos (ISO); O,O-Diethyl-O-1-phenyl-1H-1,2,4-triazol-3-yl phosphorothioate 1 1
015-168-00-0 Fosthiazate (ISO); (RS)-S-sec-Butyl-O-ethyl-2-oxo-1,3-thiazolidin-3-ylphosphonothioate 1 1
Page A2-2

015-174-00-3 1-Chloro-N,N-diethyl-1,1-diphenyl-1-(phenylmethyl)phosphoramine 1
015-175-00-9 Tert-butyl (triphenylphosphoranylidene) acetate 1
015-193-00-7 Triphenyl(phenylmethyl)phosphonium 1,1,2,2,3,3,4,4,4-nonafluoro-N-methyl-1-butanesulfonamide (1:1) 1
015-197-00-9 Bis(2,4,4-trimethylpentyl)dithiophosphonic acid 1
016-009-00-8 Disodium sulfide; Sodium sulfide 1
016-010-00-3 Sodium polysulphides 1
016-011-00-9 Sulphur dioxide 1
016-012-00-4 Disulphur dichloride; Sulfur monochloride 1
016-054-00-3 Sodium 4-(2,4,4-trimethylpentylcarbonyloxy)benzenesulfonate 1
017-001-00-7 Chlorine 1
017-002-00-2 Hydrogen chloride 1
017-026-01-0 Chlorine dioxide ... % 1
028-011-00-6 Nickel dichloride 1 1
033-001-00-X Arsenic 1 1
033-002-00-5 Arsenic compounds, with the exception of those specified elsewhere in this Annex 1 1
033-004-00-6 Diarsenic pentaoxide; Arsenic pentoxide; Arsenic oxide 1 1
033-005-00-1 Arsenic acid and its salts with the exception of those specified elsewhere in this Annex 1 1
034-001-00-2 Selenium 1 1
034-002-00-8 Selenium compounds with the exception of cadmium sulphoselenide and those specified elsewhere in this Annex 1 1
042-002-00-4 Tetrakis(dimethylditetradecylammonium) hexa-μ-oxotetra-μ3-oxodi-μ5-oxotetradecaoxooctamolybdate(4-) 1
048-003-00-6 Cadmium diformate; Cadmiumformate 1 1
048-005-00-7 Cadmiumhexafluorosilicate(2-); Cadmium fluorosilica 1 1
048-007-00-8 Cadmium iodide 1 1
050-007-00-8 Tripropyltin compounds, with the exception of those specified elsewhere in this Annex 1 1 1
050-008-00-3 Tributyltin compounds, with the exception of those specified elsewhere in this Annex 1
050-011-00-X Triphenyltin compounds, with the exception of those specified elsewhere in this Annex 1 1 1
050-021-00-4 Dichlorodioctyl stannane 1
051-004-00-4 Antimony trifluoride 1 1 1
056-004-00-8 Barium chloride 1
078-001-00-0 Tetrachloroplatinates with the exception of those specified elsewhere in this Annex 1
078-002-00-6 Diammonium tetrachloroplatinate 1
078-003-00-1 Disodium tetrachloroplatinate 1
Page A2-3

078-004-00-7 Dipotassium tetrachloroplatinate 1
078-005-00-2 Hexachloroplatinates with the exception of those specified elsewhere in this Annex 1
078-006-00-8 Disodium hexachloroplatinate 1
078-007-00-3 Dipotassium hexachloroplatinate 1
078-008-00-9 Diammonium hexachloroplatinate 1
078-009-00-4 Hexachloroplatinic acid 1
080-008-00-9 Phenylmercury nitrate; [1] Phenylmercury hydroxide; [2] Basic phenylmercury nitrate [3] 1
080-009-00-4 2-Methoxyethylmercury chloride 1
080-011-00-5 Phenylmercury acetate 1
082-011-00-0 Lead hydrogen arsenate 1 1
601-067-00-4 Triethyl arsenate 1 1
602-002-00-2 Bromomethane; Methylbromide 1 1
602-005-00-9 Methyl iodide; Iodomethane 1 1
602-007-00-X Bromoform; Tribromomethane 1
602-008-00-5 Carbon tetrachloride; Tetrachloromethane 1 1 1
602-010-00-6 1,2-Dibromoethane 1 1 1
602-021-00-6 1,2-Dibromo-3-chloropropane 1
602-030-00-5 1,3-Dichloropropene; [1] (Z)-1,3-Dichloropropene [2] 1 1
602-037-00-3 Α-Chlorotoluene; Benzyl chloride 1
602-038-00-9 Α,α,α-trichlorotoluene; Benzotrichloride 1
602-042-00-0 1,2,3,4,5,6-hexachlorcyclohexanes with the exception of those specified elsewhere in this Annex 1
602-043-00-6 Lindane (ISO); γ-HCH or γ-BHC; γ-1,2,3,4,5,6-hexachlorocyclohexane 1
602-044-00-1 Camphechlor (ISO); Toxaphene 1
DDT (ISO); Clofenotane (INN); Dicophane; 1,1,1-Trichloro-2,2-bis(4-chlorophenyl)ethane; 1
602-045-00-7
Dichlorodiphenyltrichloroethane
602-046-00-2 Heptachlor (ISO); 1,4,5,6,7,8,8-Heptachloro-3a,4,7,7a-tetrahydro-4,7-methanoindene 1 1
602-048-00-3 Aldrin (ISO) 1 1
602-058-00-8 Α,α-Dichlorotoluene; Benzylidene chloride; Benzal chloride 1
602-063-00-5 Heptachlor epoxide; 2,3-Epoxy-1,4,5,6,7,8,8-heptachloro-3a,4,7,7a-tetrahydro-4,7-methanoindane 1
602-064-00-0 1,3-Dichloro-2-propanol 1
602-076-00-6 2,3,4-Trichlorobut-1-ene 1
602-088-00-1 2,3-Dibromopropan-1-ol; 2,3-Dibromo-1-propanol 1
Page A2-4

603-018-00-2 Furfuryl alcohol 1
603-026-00-6 1-Chloro-2,3-epoxypropane; Epichlorhydrin 1 1 1
603-063-00-8 2,3-Epoxypropan-1-ol; Glycidol; Oxiranemethanol 1
603-066-00-4 1,2-Epoxy-4-epoxyethylcyclohexane; 4-Vinylcyclohexene diepoxide 1 1 1
603-076-00-9 But-2-yne-1,4-diol; 2-Butyne-1,4-diol 1 1
603-078-00-X Prop-2-yn-1-ol; Propargyl alcohol 1 1 1
603-166-00-8 R-1-Chloro-2,3-epoxypropane 1 1 1
603-185-00-1 2,4-Dichloro-3-ethyl-6-nitrophenol 1
604-001-00-2 Phenol; Carbolic acid; Monohydroxybenzene; Phenylalcohol 1 1 1
604-004-00-9 M-Cresol; [1] o-Cresol; [2] p-Cresol; [3] mix-Cresol [4] 1 1
604-006-00-X 3,4-Xylenol; [1] 2,5-Xylenol; [2] 2,4-Xylenol; [3] 2,3-Xylenol; [4] 2,6-Xylenol; [5] Xylenol; [6] 2,4(or 2,5)-Xylenol [7] 1 1
604-011-00-7 2,4-Dichlorophenol 1
604-012-00-2 4-Chloro-o-cresol; 4-Chloro-2-methyl phenol 1
604-013-00-8 2,3,4,6-Tetrachlorophenol 1
604-015-00-9 2,2'-Methylenebis-(3,4,6-trichlorophenol); Hexachlorophene 1 1
604-037-00-9 3,5-Xylenol; 3,5-Dimethylphenol 1 1
605-001-00-5 Formaldehyde … % 1 1 1
605-010-00-4 2-Furaldehyde 1 1
605-014-00-6 Chloral hydrate; 2,2,2-Trichloroethane-1,1-diol 1
605-022-00-X Glutaral; Glutaraldehyde; 1,5-Pentanedial 1 1
606-013-00-3 P-benzoquinone; Quinone 1 1
606-016-00-X Pindone (ISO); 2-Pivaloylindan-1,3-dione 1
Chlordecone (ISO); Perchloropentacyclo[5,3,0,02,6,03,9,04,8]decan-5-one; 1 1
606-019-00-6
Decachloropentacyclo[5,2,1,02,6,03,9,05,8]decan-4-one
606-107-00-4 8-Azaspiro[4.5]decane-7,9-dione 1
607-003-00-1 Chloroacetic acid 1 1 1
607-055-00-5 Endothal-sodium (ISO); Disodium 7-oxabicyclo(2,2,1)heptane-2,3-dicarboxylate 1
Coumafuryl (ISO); Fumarin; (RS)-3-(1-(2-Furyl)-3-oxobutyl)4-hydroxycoumarin; 4-Hydroxy-3-[3-oxo-1-(2-furyl) 1
607-058-00-1
butyl]coumarin
607-065-00-X Bromoacetic acid 1 1 1
607-068-00-6 Iodoacetic acid 1
607-070-00-7 Ethyl chloroacetate 1 1 1
Page A2-5

607-072-00-8 2-Hydroxyethyl acrylate 1
Kelevan (ISO); Ethyl 5-(perchloro-5-hydroxypentacyclo[5,3,0,02,6,03,9,04,8]decan-5-yl)-4-oxopentanoate; Ethyl 5- 1
607-079-00-6
(1,2,3,5,6,7,8,9,10,10-decachloro-4-hydroxypentacyclo(5,2,1,02,6,03,9,05,8)dec-4-yl)-4-oxovalerate
607-080-00-1 Chloroacetyl chloride 1 1 1
607-090-00-6 Thioglycolic acid 1 1 1
607-108-00-2 2-Hydroxy-1-methylethylacrylate; [1] 2-Hydroxypropylacrylate; [2] Acrylic acid, monoester with propane-1,2-diol [3] 1 1 1
607-112-00-4 2,2-Dimethyltrimethylene diacrylate; neopentyl glycol diacrylate 1
607-117-00-1 2,3-Epoxypropyl acrylate; Glycidyl acrylate 1 1 1
607-120-00-8 2,2'-oxydiethyl diacrylate; Diethylene glycol diacrylate 1
607-138-00-6 Butyl chloroformate; Chloroformic acid butyl ester 1
607-150-00-1 Endothal (ISO); 7-Oxabicyclo(2,2,1)heptane-2,3-dicarboxylic acid 1
607-151-00-7 Propargite (ISO); 2-(4-tert-Butylphenoxy) cyclohexyl prop-2-ynyl sulphite 1
607-158-00-5 Sodium salt of chloroacetic acid; Sodium chloroacetate 1
607-166-00-9 Medinoterb acetate (ISO); 6-tert-Butyl-3-methyl-2,4-dinitrophenyl acetate 1
607-168-00-X Dipropyl 6,7-methylenedioxy-1,2,3,4-tetrahydro-3-methylnaphthalene-1,2-dicarboxylate; Propylisome 1
607-181-00-0 3,5-Dichloro-2,4-difluorobenzoyl fluoride 1
607-201-00-8 Thiocarbonyl chloride 1
607-205-00-X Methyl chloroacetate 1 1
607-206-00-5 Isopropyl chloroacetate 1
607-214-00-9 N,N-hydrazinodiacetic acid 1
607-246-00-3 Allyl methacrylate; 2-Methyl-2-propenoic acid 2-propenyl ester 1
607-256-00-8 Azoxystrobin (ISO); Methyl (E)-2-{}{2-[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl}}-3-methoxyacrylate 1
607-319-00-X Deltamethrin (ISO); (S)-α-Cyano-3-phenoxybenzyl (1R, 3R)-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropanecarboxylate 1 1
607-332-00-0 Cyclopentyl chloroformate 1
607-368-00-7 1-(N,N-Dimethylcarbamoyl)-3-tert-butyl-5-carbethoxymethylthio-1H-1,2,4-triazole 1 1
607-417-00-2 3-Chloropropyl chloroformiate 1
Α-Cypermethrin (ISO); Racemate comprising (R)-α-cyano-3-phenoxybenzyl (1S,3S)-3-(2,2-dichlorovinyl)-2,2- 1
607-422-00-X dimethylcyclopropanecarboxylate; (S)-α-Cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dichlorovinyl)-2,2-
dimethylcyclopropanecarboxylate
Prallethrin (ISO); ETOC; 2-Methyl-4-oxo-3-(prop-2-ynyl)cyclopent-2-en-1-yl 2,2-dimethyl-3-(2-methylprop-1- 1
607-431-00-9
enyl)cyclopropanecarboxylate
607-478-00-5 Tetramethylammonium hydrogen phthalate 1
Page A2-6

607-504-00-5 Diammonium 1-hydroxy-2-(4-(4-carboxyphenylazo)-2,5-dimethoxyphenylazo)-7-amino-3-naphthalenesulfonate 1
607-534-00-9 Ethyl 2-(3-benzoylphenyl)propanoate 1
607-537-00-5 Isopropylammonium 2-(3-benzoylphenyl)propionate 1
607-565-00-8 3-Ethyl 5-methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate 1
Reaction product of thioglycerol and mercaptoacetic acid consisting mainly of 3-mercapto-1,2- 1
607-615-00-9
bismercaptoacetoxypropane and oligomers of this substance
608-002-00-9 Trichloroacetonitrile 1 1 1
608-007-00-6 Ioxynil (ISO); 4-Hydroxy-3,5-diiodobenzonitrile 1 1
608-008-00-1 Chloroacetonitrile 1 1 1
608-009-00-7 Malononitrile 1 1 1
608-017-00-0 Bromoxynil octanoate (ISO); 2,6-Dibromo-4-cyanophenyl octanoate 1
608-018-00-6 Ioxynil octanoate (ISO); 4-Cyano-2,6-diiodophenyl octanoate 1
608-034-00-3 Chlorfenapyr (ISO); 4-Bromo-2-(4-chlorophenyl)-1-ethoxymethyl-5-trifluoromethylpyrrole-3-carbonitrile 1
608-043-00-2 3-(cis-3-Hexenyloxy)propanenitril 1
Fipronil (ISO); 5-Amino-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-4-[(trifluoromethyl)sulfinyl]-1H-pyrazole-3- 1 1 1
608-055-00-8
carbonitrile
608-058-00-4 Esfenvalerate (ISO); (S)-α-Cyano-3-phenoxybenzyl-(S)-2-(4-chlorophenyl)-3-methylbutyrate 1 1
608-063-00-1 (S)-α-Hydroxy-3-phenoxy-benzeneacetonitrile 1
608-066-00-8 Salts of ioxynil with the exception of those specified elsewhere in this Annex 1 1
609-003-00-7 Nitrobenzene 1 1 1
609-006-00-3 4-Nitrotoluene 1 1 1
609-007-00-9 2,4-Dinitrotoluene; [1] Dinitrotoluene [2] 1 1 1
609-016-00-8 Dinitrophenol (reaction mass of isomers); [1] 2,4(or 2,6)-Dinitrophenol [2] 1 1 1
609-021-00-5 Sodium salt of DNOC; Sodium 4,6-dinitro-o-cresolate; [1] Potassium salt of DNOC; Potassium 4,6-dinitro-o-cresolate [2] 1 1 1
609-025-00-7 Dinoseb (ISO); 6-sec-Butyl-2,4-dinitrophenol 1 1
609-026-00-2 Salts and esters of dinoseb, with the exception of those specified elsewhere in this Annex 1 1
609-028-00-3 Dinex (ISO); 2-Cyclohexyl-4,6-dinitrophenol 1 1 1
609-029-00-9 Salts and esters of dinex 1 1 1
609-033-00-0 Dinosam (ISO); 2-(1-Methylbutyl)-4,6-dinitrophenol 1 1 1
609-034-00-6 Salts and esters of dinosam 1 1 1
609-041-00-4 2,4-Dinitrophenol 1 1 1
609-049-00-8 2,6-Dinitrotoluene 1 1 1
Page A2-7

609-050-00-3 2,3-Dinitrotoluene 1 1 1
609-051-00-9 3,4-Dinitrotoluene 1 1 1
609-052-00-4 3,5-Dinitrotoluene 1 1 1
609-054-00-5 2,3-Dinitrophenol; [1] 2,5-Dinitrophenol; [2] 2,6-Dinitrophenol; [3] 3,4-Dinitrophenol; [4] Salts of dinitrophenol [5] 1 1 1
609-055-00-0 2,5-Dinitrotoluene 1 1 1
609-062-00-9 2-Bromo-2-nitropropanol 1
610-002-00-9 1,1-Dichloro-1-nitroethane 1 1 1
610-003-00-4 Chlorodinitrobenzene 1 1 1
610-005-00-5 1-Chloro-4-nitrobenzene 1 1 1
610-008-00-1 2,6-Dichloro-4-nitroanisole 1
611-003-00-7 Fenaminosulf (ISO); Sodium 4-dimethylaminobenzenediazosulphonate 1
Tetrakis(tetramethylammonium) 6-amino-4-hydroxy-3-(7-sulfonato-4-(4-sulfonatophenylazo)-1- 1
611-020-00-X
naphthylazo)naphthalene-2,7-disulfonate
611-046-00-1 4,4'-Diamino-2-methylazobenzene 1
611-071-00-8 Tris(tetramethylammonium) 5-hydroxy-1-(4-sulphonatophenyl)-4-(4-sulphonatophenylazo)pyrazole-3-carboxylate 1
Tetrakis(tetramethylammonium)3,3'-(6-(2-hydroxyethylamino)1,3,5-triazine-2,4-diylbisimino(2-methyl-4,1- 1
611-098-00-5
phenyleneazo))bisnaphthalene-1,5-disulfonate
612-008-00-7 Aniline 1 1 1
612-009-00-2 Salts of aniline 1 1 1
612-010-00-8 Chloroanilines, with exception of those specified elsewhere in this Annex 1 1 1
612-012-00-9 O-nitroaniline; [1] m-Nitroaniline; [2] p-Nitroaniline [3] 1 1 1
612-015-00-5 N-methylaniline 1 1 1
612-016-00-0 N,N-Dimethylaniline 1 1 1
Phenylhydrazine; [1] Phenylhydrazinium chloride; [2] Phenylhydrazine hydrochloride; [3] Phenylhydrazinium sulphate 1 1 1
612-023-00-9
(2:1) [4]
612-024-00-4 M-toluidine; 3-Aminotoluene 1 1 1
612-025-00-X Nitrotoluidines, with the exception of those specified elsewhere in this Annex 1 1 1
612-026-00-5 Diphenylamine 1 1 1
Xylidines with the exception of those specified elsewhere in this Annex; Dimethyl anilines with the exception of those 1 1 1
612-027-00-0
specified elsewhere in this Annex
612-028-00-6 P-Phenylenediamine 1 1 1
612-029-00-1 Benzene-1,4-diamine dihydrochloride; P-Phenylenediamine dihydrochloride 1 1 1
Page A2-8

612-030-00-7 2-Methyl-p-phenylenediamine sulphate [1] 1
612-031-00-2 N,N-Dimethylbenzene-1,3-diamine; [1] 4-Amino-N,N-dimethylaniline; 3-Amino-N,N'-dimethylaniline [2] 1 1 1
612-035-00-4 2-Methoxyaniline; O-Anisidine 1 1 1
612-039-00-6 2-Ethoxyaniline; O-Phenetidine 1 1 1
612-053-00-2 N-Ethylaniline 1 1 1
612-054-00-8 N,N-Diethylaniline 1 1 1
612-055-00-3 N-methyl-o-toluidine; [1] N-methyl-m-toluidine; [2] N-methyl-p-toluidine [3] 1 1 1
612-056-00-9 N,N-Dimethyl-p-toluidine; [1] N,N-Dimethyl-m-toluidine; [2] N,N-Dimethyl-o-toluidine [3] 1 1 1
612-080-00-X 4-Amino-N,N-diethylaniline; N,N-Diethyl-p-phenylendiamine 1
612-091-00-X O-toluidine; 2-Aminotoluene 1 1
612-099-00-3 4-Methyl-m-phenylenediamine; 2,4-Toluenediamine 1
612-102-00-8 N,N-bis(3-Aminopropyl)methylamine 1 1
612-109-00-6 Bis(2-Dimethylaminoethyl)(methyl)amine 1
612-110-00-1 2,2'-Dimethyl-4,4'-methylenebis(cyclohexylamine) 1 1
612-116-00-4 C8-18Alkylbis(2-hydroxyethyl)ammonium bis(2-ethylhexyl)phosphate 1
612-124-00-8 N,N,N-Trimethylanilinium chloride 1 1
612-125-00-3 2-Methyl-p-phenylenediamine; 2,5-Toluenediamine 1
612-126-00-9 Toluene-2,4-diammonium sulphate; 4-Methyl-m-phenylenediamine sulfate 1
(4-Ammonio-m-tolyl)ethyl(2-hydroxyethyl)ammonium sulphate; 4-(N-Ethyl-N-2-hydroxyethyl)-2- 1
612-133-00-7
methylphenylenediamine sulphate
612-137-00-9 4-Chloroaniline 1 1 1
612-143-00-1 N5,N5-Diethyltoluene-2,5-diamine monohydrochloride; 4-Diethylamino-2-methylaniline monohydrochloride 1
612-145-00-2 O-Phenylenediamine 1
612-146-00-8 O-Phenylenediamine dihydrochloride 1
612-147-00-3 M-Phenylenediamine 1 1 1
612-148-00-9 M-Phenylenediamine dihydrochloride 1 1 1
Methyl-phenylene diamine; Diaminotoluene; [technical product – reaction mass of 4-methyl-m-phenylene diamine (EC 1
612-151-00-5
No 202-453-1) and 2-methyl-m-phenylene diamine (EC No 212-513-9)]
612-160-00-4 P-toluidine; 4-Aminotoluene; [1] Toluidinium chloride; [2] Toluidine sulphate (1:1) [3] 1 1 1
612-196-00-0 4-Chloro-o-toluidine; [1] 4-Chloro-o-toluidine hydrochloride [2] 1 1 1
612-197-00-6 2,4,5-Trimethylaniline; [1] 2,4,5-Trimethylaniline hydrochloride [2] 1 1 1
612-199-00-7 4,4'-Oxydianiline and its salts; P-Aminophenyl ether 1 1 1
Page A2-9

612-202-00-1 3,4-Dichloroaniline 1 1 1
612-210-00-5 5-Nitro-o-toluidine; [1] 5-Nitro-o-toluidine hydrochloride [2] 1 1 1
613-037-00-8 4-Methylpyridine; 4-Picoline 1
613-044-00-6 Captan (ISO); 1,2,3,6-Tetrahydro-N-(trichloromethylthio)phthalimide 1
613-047-00-2 1-Dimethylcarbamoyl-5-methylpyrazol-3-yl dimethylcarbamate; Dimetilan (ISO) 1
613-074-00-X 3-(3-Methylpent-3-yl)isoxazol-5-ylamine 1 1
613-092-00-8 1,10-Phenanthroline 1
Hexakis(tetramethylammonium) 4,4'-vinylenebis((3-sulfonato-4,1-phenylene)imino(6-morpholino-1,3,5-triazine-4,2- 1
613-105-00-7
diyl)imino)bis(5-hydroxy-6-phenylazonaphthalene-2,7-disulfonate)
613-112-00-5 Octhilinone (ISO); 2-octyl-2H-isothiazol-3-one 1 1
613-133-00-X Etridiazole (ISO); 5-Ethoxy-3-trichloromethyl-1,2,4-thiadiazole 1
613-149-00-7 Pyridaben (ISO); 2-Tert-butyl-5-(4-tert-butylbenzylthio)-4-chloropyridazin-3(2H)-one 1 1
613-159-00-1 Fenazaquin (ISO); 4-[2-[4-(1,1-Dimethylethyl)phenyl]-ethoxy]quinazoline 1
Reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7]; And 2-methyl-2H -isothiazol-3-one [EC 1 1 1
613-167-00-5 no. 220-239-6] (3:1); Reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7]; And 2-methyl-4-
isothiazolin-3-one [EC no. 220-239-6] (3:1)
613-173-00-8 Fluquinconazole (ISO); 3-(2,4-Dichlorophenyl)-6-fluoro-2-(1H-1,2,4-triazol-1-yl)quinazolin-4-(3H)-one 1 1
613-185-00-3 2,3,5,6-Tetrahydro-2-methyl-2H-cyclopenta[d]-1,2-thiazol-3-one 1
613-209-00-2 Cis-1-(3-Chloropropyl)-2,6-dimethyl-piperidin hydrochloride 1
613-232-00-8 3-(Benzo[b]thien-2-yl)-5,6-dihydro-1,4,2-oxathiazine-4-oxide 1
613-236-00-X 2-Chloro-3-trifluoromethylpyridine 1 1
613-266-00-3 2-Chloro-5-chloromethylthiazole 1
613-272-00-6 Pyraclostrobin (ISO); Methyl N-{2-[1-(4-chlorophenyl)-1H-pyrazol-3-yloxymethyl]phenyl}(N-methoxy)carbamate 1
613-275-00-2 3-(2-Chloroethyl)-6,7,8,9-tetra-hydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one monohydrochloride 1
Ketoconazole; 1-[4-[4-[[(2SR,4RS)-2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4- 1
613-283-00-6
yl]methoxy]phenyl]piperazin-1-yl]ethanone
614-022-00-9 Digitoxin 1 1
614-025-00-5 Ouabain 1 1
614-026-00-0 Strophantin-K 1 1
615-002-00-2 Methyl isothiocyanate 1 1
615-008-00-5 3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate; Isophorone di-isocyanate 1
615-009-00-0 4,4'-Methylenedi(cyclohexyl isocyanate); Dicyclohexylmethane-4,4'-di-isocyanate 1
Page A2-10

615-010-00-6 2,2,4-Trimethylhexamethylene-1,6-di-isocyanate; [1] 2,4,4-Trimethylhexamethylene-1,6-di-isocyanate [2] 1
615-011-00-1 Hexamethylene-di-isocyanate 1
615-013-00-2 Cyanamide; Carbanonitril 1
615-018-00-X 2-(2-butoxyethoxy)ethyl thiocyanate 1 1
615-019-00-5 Dicyclohexylcarbodiimide 1
615-021-00-6 1,3,5-Tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione; TGIC 1 1
615-024-00-2 2-Phenylethylisocyanate 1
616-003-00-0 Acrylamide; Prop-2-enamide 1
616-013-00-5 Butyraldehyde oxime 1
616-033-00-4 Cyprofuram (ISO); N-(3-Chlorophenyl)-N-(tetrahydro-2-oxo-3-furyl)cyclopropanecarboxamide 1
616-036-00-0 2-Chloracetamide 1
616-063-00-8 3-Dodecyl-(1-(1,2,2,6,6-pentamethyl-4-piperidin)-yl)-2,5-pyrrolidindione 1
616-090-00-5 1-(1,4-Benzodioxan-2-ylcarbonyl)piperazine hydrochloride 1 1 1
616-091-00-0 1,3,5-Tris-[(2S and 2R)-2,3-epoxypropyl]-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione 1
616-124-00-9 Lithium bis(trifluoromethylsulfonyl)imide 1 1
(2R,6as,12as)-1,2,6,6a,12,12a-Hexahydro-2-isopropenyl-8,9-dimethoxychromeno[3,4-b]furo[2,3-h]chromen-6-one; 1
650-005-00-2
Rotenone
650-006-00-8 Benquinox (ISO); P-Benzoquinone 1-benzoylhydrazone 4-oxime 1
650-008-00-9 Drazoxolon (ISO); 4-(2-Chlorophenylhydrazone)-3-methyl-5-isoxazolone 1
Page A2-11
Page A2-12
ANNEX 3
AN APPROACH TO
IDENTIFICATION OF
BOUNDARY SUBSTANCES
A3.1 Overview
To provide an accurate assessment of the impact of aligning the PED to the CLP,
those substances that are used in pressure equipment and are liable to move from one
fluid group to another must be identified. From the outset, it was hoped that the
consultation process would assist with the gathering of this information. Despite
extensive desk-based research, a widely circulated questionnaire and a workshop with
industry, this information was not forthcoming.
To overcome the lack of information, an objective methodology, as outlined in the

report, was adopted. Whilst this identified those substances that may potentially
change fluid group, it is apparent that not all of these substances are likely to be used
in pressure equipment. The final impacts presented in the report are therefore
conservative and the financial impact of aligning the PED to the CLP will probably be
significantly lower.
In an attempt to provide an estimate as to the ‘true’ financial impact of aligning the

PED to the CLP, the harmonised ‘boundary’ substances were examined by the study
team. Comprising of a pressure equipment specialist with many years of experience
within the industry and a number of chemical experts, the team compiled a list of
harmonised ‘boundary’ substances that are likely to be used in pressure equipment.
This process notably reduced the number of potential boundary substances.
Although this approach provides a better reflection of the likely impact of aligning the
PED to the CLP, it was ultimately rejected for the purposes of the report because the
view of the expert study team may be subject to challenge at a later date.
Nevertheless, the results of this process have been summarised below for the Acute
Toxicity hazard class. It must be reiterated that the information presented is based on
the best available knowledge of the expert study team.
A3.2 Alternative Approach
Introduction
To identify the substances that may change fluid group as a result of alignment of the
PED to the CLP, the ‘boundary’ harmonised substances were listed (see Annex 2) and
screened using the hazard statements as outlined in the report. This base number of
‘boundary’ substances was then subject to examination by the expert study team,
resulting in an initial list of ‘boundary’ harmonised substances that may be used in
pressure equipment.
These substances were then screened for a second time to ensure they were not
classified as a Group 1 fluid by virtue of another hazard class. A numerical overview
of the results has been presented in Table A3.1 below, followed by tables which list
examples of the ‘boundary’ substances and their respective hazard statements.
Page A3-1
Table A3.1: Numbers of Substances that may be Included/Excluded as a Dangerous Fluid

under Article 9 of the PED
Number listed under
Number listed under
HS and used in PE
Hazard Statement Numbers of Entries HS and used in
and not otherwise
(HS) listed under HS* Pressure Equipment
classified as a Group
(PE)
1 Fluid
H301 Toxic if
321 42 28
swallowed
H311 Toxic in contact
187 23 12
with skin
H331 Toxic if inhaled 202 37 26
Total 710 102 66
* Note that these entries are the same as presented in Table 6.2 of the main report
Acute Toxicity (H301)
Table A3.2 lists some examples of the 28 potential ‘boundary substances’ with
Hazard Statement H301 (Toxic if swallowed) that were considered likely to be used
in pressure equipment (and not otherwise classified as a Group 1 fluid).
Table A3.2: Example Boundary Substances for Hazard Statement H301 (Toxic if swallowed)
Hazard Hazard
No. Name of Substance CAS No.
Classification Statement
1 Hydrazine 302-01-2 Flam. Liq. 3 H226
Carc. 1B H350
Acute Tox. 3 H331
Acute Tox. 3 H311
Acute Tox. 3 H301
Skin Corr. 1B H314
Skin Sens. 1 H317
Aquatic Acute 1 H400
Aquatic Chronic H410
1
2 1,2- 540-73-8 Carc. 1B H350
Dimethylhydrazine Acute Tox. 3 H331
Acute Tox. 3 H311
Acute Tox. 3 H301
2
3 Sodium fluoride 7681-49-4 Acute Tox. 3 H301
Eye Irrit. 2 H319
Skin Irrit. 2 H315
4 Potassium fluoride 7789-23-3 Acute Tox. 3 H331
Acute Tox. 3 H311
Acute Tox. 3 H301
5 Ammonium fluoride 12125-01-8 Acute Tox. 3 H331
Acute Tox. 3 H311
Acute Tox. 3 H301
Page A3-2
Table A3.3 lists some examples of the 12 potential ‘boundary substances’ with
Hazard Statement H311 (Toxic in contact with skin) that were considered likely to be
used in pressure equipment (and not otherwise classified as a Group 1 fluid).
Table A3.3: Example Boundary Substances for Hazard Statement H311 (Toxic in contact with
skin)
Hazard Hazard
Carc. 1B H350
Acute Tox. 3 H331
Acute Tox. 3 H311
Acute Tox. 3 H301
Skin Corr. 1B H314
Skin Sens. 1 H317
1
2 1,2-Dimethylhydrazine 540-73-8 Carc. 1B H350
Acute Tox. 3 H331
Acute Tox. 3 H311
Acute Tox. 3 H301
2
Acute Tox. 3 H311
Acute Tox. 3 H301
Acute Tox. 3 H311
Acute Tox. 3 H301
5 Alkali 16893-85-9 [1] Acute Tox. 3 H331
fluorosilicates(Na) [1]; 16871-90-2 [2] Acute Tox. 3 H311
Alkali 16919-19-0 [3] Acute Tox. 3 H301
fluorosilicates(K); [2]
Alkali
fluorosilicates(NH4) [3]
Table A3.4 lists some examples of substances classified with the Hazard Statement
H331 (Toxic if inhaled) that were considered likely to be used in pressure equipment
(and not otherwise classified as a Group 1 fluid).
Table A3.4: Example Boundary Substances for Hazard Statement H331 (Toxic if inhaled)
Hazard Hazard
1 Dimethylcarbamoyl 79-44-7 Carc. 1B H350
chloride Acute Tox. 3 H331
Acute Tox. 4 H302
Eye Irrit. 2 H319
STOT SE 3 H335
Skin Irrit. 2 H315
Page A3-3
Table A3.4: Example Boundary Substances for Hazard Statement H331 (Toxic if inhaled)
Hazard Hazard
Carc. 1B H350
Acute Tox. 3 H331
Acute Tox. 3 H311
Acute Tox. 3 H301
Skin Corr. 1B H314
Skin Sens. 1 H317
1
3 1,2- 540-73-8 Carc. 1B H350
Dimethylhydrazine Acute Tox. 3 H331
Acute Tox. 3 H311
Acute Tox. 3 H301
2
Acute Tox. 3 H311
Acute Tox. 3 H301
Acute Tox. 3 H311
Acute Tox. 3 H301
A3.3 Substances affected by Policy Options
Option 1
As has been outlined in the report, Option 1 leads to the removal from Group 1 some
substances which are toxic if swallowed (H301) and which are toxic in contact with
the skin (H311). Those substances which are toxic if inhaled (H331) will however be
classified as Group 1 fluids.
An overview of the number of substances that will be classified as a Group 1 and

Group 2 fluid respectively is provided in Table A3.5. There are noticeably fewer
substances with the Hazard Statements H301 and H311 l because many substances
also have the Hazard Statement H331 (such as hydrazine and potassium fluoride for
example). In other words, it makes no difference whether some substances have the
Hazard Statement H301 and H311 as the Hazard Statement H331 will determine that
the substance is a Group 1 fluid.
Table A3.5: Option 1 – Impact of aligning PED with CLP

Hazard Statement (HS) Substances with HS in Group 1 Substances with HS in Group 2
0 8
swallowed
Exclude H311 Toxic in
0 1
contact with skin
26 0
inhaled
Page A3-4
Option 2
As detailed in the report, Option 2 leads to the removal from Group1 those substances
which are toxic if swallowed (H301). However, Option 2 includes some substances
which are toxic in contact with the skin (H311) or toxic if inhaled (H331) as being
classified as Group 1 fluids. A numerical overview of the impact of this option is
provided in Table A3.6 below. Again, there are fewer substances because some
substances with the Hazard Statements H301 and H311 also have the Hazard
Statement H331.
Table A3.6: Option 2 – Impact of aligning PED with CLP

Hazard Statement (HS) Substances with HS in Group 1 Substances with HS in Group 2
0 8
swallowed
Include H311 Toxic in
1 0
contact with skin
26 0
inhaled
Final Boundary Substances
Table A3.7 provides a list of boundary substances that were considered likely to be
used in pressure equipment and may change group as a result of the PED aligning
with the CLP. The impact of including substances with the Hazard Statement H331
has been taken into account and explains the reduced number of boundary substances
with the Hazard Statement H301 and H311.
Table A3.7 ‘Boundary’ Substances H301, H311, H331

H311 - Toxic in contact
No. H301 - Toxic if swallowed H331 - Toxic if inhaled
with skin
Disodium sulfide;
1 Sodium fluoride Dimethylcarbamoyl chloride
Sodium sulfide
Sodium bifluoride;
2 Hydrazine
Sodium Hydrogen difluoride
Potassium bifluoride;
3 Potassium Hydrogen 1,2-Dimethylhydrazine
difluoride
Ammonium bifluoride;
4 Ammonium Hydrogen Potassium fluoride
difluoride
5 Sodium polysulphides Ammonium fluoride
Alkali fluorosilicates(Na)
[1];
Disulphur dichloride;
6 Alkali fluorosilicates(K) [2];
Sulfur monochloride
Alkali fluorosilicates(NH4)
[3]
7 Chlorine dioxide ... % Sulphur dioxide
8 Barium chloride Chlorine
9 Hydrogen chloride
10 Arsenic
Page A3-5
Table A3.7 ‘Boundary’ Substances H301, H311, H331

H311 - Toxic in contact
No. H301 - Toxic if swallowed H331 - Toxic if inhaled
with skin
Arsenic compounds, with the
11 exception of those specified
elsewhere in this annex
Bromomethane;
12
Methylbromide
Methyl iodide;
13
Iodomethane
Bromoform;
14
Tribromomethane
Carbon tetrachloride;
15
Tetrachloromethane
16 1,2-Dibromoethane
Α,Α-Dichlorotoluene;
17 Benzylidene chloride;
Benzal chloride
But-2-yne-1,4-diol;
18
2-butyne-1,4-diol
Phenol;
Carbolic acid;
19
Monohydroxybenzene;
Phenylalcohol
20 Formaldehyde … %
21 Chloroacetic acid
22 Nitrobenzene
23 4-Nitrotoluene
2,4-Dinitrotoluene;
24
Dinitrotoluene
25 Aniline
26 Salts of aniline
A3.4 Impact of Options
Overview
Clearly, the actual impacts will depend not only on the numbers of substances
affected but also the extent (and importance) of their usage within pressure
equipment. Indeed, if the industry is heavily dependent on a particular fluid and it is
used in high volumes, the impact of changing the grouping of that fluid will be
significant. By consulting Regulation (EC) No 1907/2006 concerning the
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
registration database, it can be determined whether a substance is used above
particular thresholds within Europe. It must be stressed that this substance could be
used for any purpose and may not be intended for use within pressure equipment.
However, if a substance is not registered under REACH, it can be cautiously inferred
that this substance is not widely used in pressure equipment. Thus if it were to
change group following the alignment of the PED to CLP, the impact of such a
change would be minimal.
Page A3-6
Registration under REACH
REACH is concerned with the production and the use of chemical substances,
specifically those that have the potential to impact human health or the environment.
Manufacturers, importers and downstream users are deemed to be responsible when
they manufacture, place on the market or use substances. Substances within the scope
of REACH must be registered with ECHA before they can be manufactured, imported
or placed on the market. For ‘phase-in’77 substances, this is a tiered process, with
substances used in high volumes or with specific hazard classifications registered first
(Table 3.8 below). The highest tonnage per year (the average of the three preceding
years or per calendar year) manufactured or imported after 1 June 2007 is used to
determine the deadline for registration78.
Table A3.8: Overview of REACH Compliance Timetable

Deadline to submit
Registration Dossier Criteria for substances
to ECHA
Phase 1: Phase-in substances manufactured in the EU or imported in
30 November 2010 quantities of 1000 tonnes or more per year per manufacturer or per
importer, at least once after 1 June 2007.
Phase 1: Phase-in substances classified as carcinogenic, mutagenic or
toxic to reproduction, category 1 or 2, in accordance with the DSD and
30 November 2010
manufactured in the Community or imported in quantities reaching 1 tonne
or more per year per manufacturer or per importer, at least once after 1
June 2007.
Phase 1: Phase-in substances classified as very toxic to aquatic
organisms which may cause long-term adverse effects in the aquatic
30 November 2010 environment (R50/53) in accordance with the DSD and manufactured in
the Community or imported in quantities reaching 100 tonne or more per
year per manufacturer or per importer at least once after 1 June 2007.
Phase 2: Phase-in substances manufactured or imported in quantities of
31 May 2013 100 tonnes or more per year per manufacturer in the Community or per
importer at least once after 1 June 2007.
Phase 3: Phase-in substances manufactured in the Community or
31 May 2018 imported in quantities of 1 tonne or more per year per manufacturer or per
importer at least once after 1 June 2007.
* ECHA (May 2012) Guidance on Registration, Version 2.0 (Guidance for the implementation of
REACH) downloaded from: http://echa.europa.eu/documents/10162/13632/registration_en.pdf
77
A substance is considered to be a ‘phase-in’ substance if it meets at least one of the following criteria:
1. It is listed in the European Inventory of Existing Commercial Chemical Substances;
2. The substance was manufactured in any current EU Member State after 31 May 1992; and/or
3. The substance was placed on the market on the market of a current EU Member State before 1
June 2007 by the manufacturer or importer and is a ‘no-longer polymer’.
Substances that do not meet these criteria are considered to be ‘non-phase in’ substances. Non-phase in
substances do not benefit from the tiered approach and need to be registered before they can
manufactured, imported or placed on the market in the EU.
78
ECHA (May 2012) Guidance on Registration, Version 2.0 (Guidance for the implementation of
Page A3-7
This is graphically represented in Figure A3.1 below.
Figure A3.1: REACH registration dates79
The number of ‘boundary’ substances that are registered under REACH has been
summarised in Table A3.9 (a full list of the substances and REACH registration dates
is provided under Table A3.10 below).
Table A3.9: Number of Boundary Substances Registered Under REACH

REACH Registration Date Number of Substances
31/05/2018 1
30/11/2010 29
Not Registered 3
N/A* 2
*Salts of aniline and Arsenic Compounds are not a specified entity.
Of the 35 substances, only three have not been registered with REACH. As has been
noted, a single registration for the purposes of the C & L harmonised classifications
has been treated as a single substance. Thus, the three substances, which will be
Group 1 fluids as they are classified under H331 (Toxic if inhaled) that have not been
registered are:
 1,2-Dimethylhydrazine;
 2,4-Dinitrotoluene; Dinitrotoluene and
 Alkali fluorosilicates (Na) [1]; Alkali fluorosilicates (K) [2]; Alkali
fluorosilicates (NH4) [3].
79
ECHA (May 2012) Guidance on Registration, Version 2.0 (Guidance for the implementation of
Page A3-8
Since these substances have not yet been registered under REACH and are not due to
be registered on 31/05/2018, it is reasonable to assume that these substances have not
been used in the Community or manufactured or imported in quantities of 1 tonne or
more per year per manufacturer or importer. It can therefore be inferred that these
three substances are not used in high volumes within pressure equipment, meaning the
alignment of the PED to CLP for these substances will have a marginal impact.
Similarly, 1,2-Dibromoethane, which will be a Group 1 fluid as it has been classified

as Acute Toxicity – Inhalation (H331), will not be registered under REACH until
31/05/2018. This registration date means that it has been manufactured or imported in
quantities between 1 and 100 tonne per year. Given that this usage accounts for all of
Europe in all applications, which may or may not include pressure equipment, it can
be cautiously stated that the changing in fluid group of this substance will only have a
marginal impact on the pressure equipment industry.
Of the 29 substances that were registered under REACH on 30/11/2010, 18 of them

qualify as a CMR or very toxic to the aquatic environment. As noted in the Table 3.8
and Figure 3.1 above, these properties mean that a substance may be registered under
REACH at lower quantities. However, an understanding of the properties of the
chemicals and their typical use within industry suggests that they have been registered
on 30/11/2010 because they are manufactured or imported in quantities over 10,000
tonnes across the Europe. Unfortunately, this means that for all the 29 chemicals
listed on this date, it is not possible to draw any conclusions as to the volume that is
used in pressure equipment.
REACH Registration date of Boundary substances
Table A3.10 lists the Boundary substances for both Options 1 and 2 (which are the
same) as well as their REACH registration date. For those substances with no
registration date, it can be presumed that they are not used in high volumes in pressure
equipment.
Table A3.10 Registration Date of ‘Boundary’ Substances that may Change Fluid Group
Date registered with
No. Substance
REACH
Acute Toxicity - Oral (H301)
1 Sodium Fluoride 30/11/2010
Sodium Bifluoride;
2 30/11/2010
Sodium Hydrogen Difluoride
Potassium Bifluoride;
3 30/11/2010
Potassium Hydrogen Difluoride
Ammonium Bifluoride;
4 30/11/2010
Ammonium Hydrogen Difluoride
5 Sodium Polysulphides 30/11/2010
Disulphur Dichloride;
6 30/11/2010
Sulfur Monochloride
7 Chlorine Dioxide ... % 30/11/2010
8 Barium Chloride 30/11/2010
Page A3-9
Table A3.10 Registration Date of ‘Boundary’ Substances that may Change Fluid Group
Date registered with
No. Substance
REACH
Acute Toxicity - Dermal (H311)
Disodium Sulfide;
9 30/11/2010
Sodium Sulfide
Acute Toxicity – Inhalation (H331)
10 Dimethylcarbamoyl chloride 30/11/2010
11 Hydrazine 30/11/2010
12 1,2-Dimethylhydrazine Not Registered
13 Potassium fluoride 30/11/2010
14 Ammonium fluoride 30/11/2010
Alkali fluorosilicates(Na) [1];
15 Alkali fluorosilicates(K) [2]; Not Registered
Alkali fluorosilicates(NH4) [3]
16 Sulphur dioxide
17 Chlorine 30/11/2010
18 Hydrogen chloride 30/11/2010
19 Arsenic 30/11/2010
Arsenic compounds, with the exception of those specified
20 N/A
elsewhere in this annex
Bromomethane;
21 30/11/2010
Methylbromide
Methyl iodide;
22 30/11/2010
Iodomethane
Bromoform;
23 30/11/2010
Tribromomethane
Carbon tetrachloride;
24 30/11/2010
Tetrachloromethane
25 1,2-Dibromoethane 31/05/2018
Α,Α-Dichlorotoluene;
26 Benzylidene chloride; 30/11/2010
Benzal chloride
But-2-yne-1,4-diol;
27 30/11/2010
2-butyne-1,4-diol
Phenol;
Carbolic acid;
28 30/11/2010
Monohydroxybenzene;
Phenylalcohol
29 Formaldehyde … % 30/11/2010
30 Chloroacetic acid 30/11/2010
31 Nitrobenzene 30/11/2010
32 4-Nitrotoluene 30/11/2010
2,4-Dinitrotoluene;
33 Not Registered
Dinitrotoluene
34 Aniline 30/11/2010
35 Salts of aniline N/A
Page A3-10
A3.5 Summary
This annex presents the impact of the PED alignment to the CLP as adopted in the
final report. However, it has also screened and removed those substances that are not
likely to be used in pressure equipment. This results in a significantly smaller number
of substances (35 substances) that may change fluid group following PED alignment.
Furthermore, it can be cautiously inferred from REACH registration information that
3 of these 35 substances are not used in significant quantities in pressure equipment,
negating any potential impact of the PED aligning with the CLP.
Page A3-11
Page A3-12

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Impact Assessment Study

on the Alignment of the

Final Report – February 2013

DG Enterprise & Industry

Risk & Policy Analysts Limited,

RPA REPORT – ASSURED QUALITY

Project: Ref/Title J796 PED-CLP

Report approved for issue by: Pete Floyd, Director

Date: 27th February 2013

If produced by RPA, this proposal is printed on 100% recycled, chlorine-free paper

The contents of this Report (and its Annexes) do not necessarily

The Classification, Labelling and Packaging Regulation (CLP) was introduced to

Article 9 of the PED – Current Definition of Group 1 Fluids

Revised Article 9 for PED – Future Definition of Group 1 Fluids

Summary of Changes in Alignments for Options 1 and 2

Acute Toxicity* Exclusion of H301 leads to some substances

Summary of Changes in Alignments for Options 1 and 2

ANNEX 1: CORRELATION ON OF DSD AND CLP CLASSIFICATIONS

CEN European Committee for Standardization

1.2 Study Aims

Against this background, RPA is expected to undertake analysis of the:

1.3 Structure of Report

 Impact Assessment (IA) Step 1: Identification of existing problems and

2. PED AND CLP

2.1.1 Purpose and Scope of Pressure Equipment Directive (97/23/EC)

1. Pipelines comprising piping or a system of piping designed for the conveyance of

 new machinery covered by Directive 2006/42/EC (formerly Directive

2.1.2 Classification of Pressure Equipment

Figure 2.1: Classification of equipment under the PED9

Table 2.1: Determination of Applicable Category

Figure 2.2: Conformity Assessment Table 3 for Vessels (Liquid, Group 1)

Figure 2.3: Conformity Assessment Table 4 for Vessels (Liquid, Group 2)

2.1.3 Conformity Assessment Procedure

Thorough interpretation of the appropriate Conformity Assessment Table will classify

1. SEP (Sound Engineering Practice – no PED modules).

Table 2.2: Modules Requirements under the PED

2.1.4 Grouping of Fluids

Group 1 comprises ‘dangerous fluids’, as classified by the DSD, whilst a Group 2

properties cited in Article 9, paragraph 2 (2) of the PED. More specifically,

Table 2.3: Hazard Class and R-Phrases

Conversely, if a non-suspended solid is blanketed by a Group 2 gas, or if the solid

If a chemical or physical reaction is likely to take place within the pressure

2.2 The CLP Regulation

a) enhance the protection of human health and the environment by providing an

This objective is fulfilled by harmonising the criteria for the classification of

Figure 2.2: Summary of CLP Transitional Timetable

2.3 PED and CLP

3. TRANSLATION OF PHYSICAL HAZARDS

Table 3.1: Translation from the DSD to CLP (Explosive)

PED Classified as ‘Group 1’ fluid under PED

Table 3.2: Translation from the DSD to CLP (Explosive)

PED Classified as ‘Group 1’ under PED

Organic Peroxide Self-reactive

H240: H241: H240: H241:

3.3 Flammable Substances

PED Classified as ‘Group 1’ fluid under PED

CLP Category 1 Category 2

HS H220: Extremely flammable gas H221: Flammable gas

Table 3.3 demonstrates that fluids previously classified as F +; Extremely Flammable