Technical Service Bulletin New Legal Framework Pressure ... - HSB … · 2015-11-05 · HSB Global...

Hartford Steam Boiler UK Limited

Crosby Court 28 George Street Birmingham, B3 1QG United Kingdom Notified Body Number 2561

Registered Address: Baker Tilly Marlborough House Victoria Road South Chelmsford Essex CM1 1LN England Registration Number: 02708264

HSB Global Standards

Technical Service Bulletin

New Legal Framework Pressure Equipment Directive

(PED 2014/68/EU) Synopsis

August 2015

HSB Global Standards Pressure Equipment Directive





Foreword

2014/68/EU was published on June 27, 2014 in the European Union (EU) Official Journal approved by

the European Parliament and of the Council of May 15, 2014 as a part of a larger initiative by the EU to

bring nine European Commission (EC) “New Approach” Directives, such as 97/23/EC, into alignment

with the “New Legal Framework” (NLF) which was adopted in 2008. The prime objective of the NLF

Pressure Equipment Directive 2014/68/EU is alignment, to ensure a pattern of consistency is followed

that is evident between this and all other directives. The essential safety requirements remain virtually

unchanged with the exception of the addition of risk analysis which will be discussed in the synopsis.

In an effort to avoid confusion between the two Pressure Equipment Directives, this synopsis will refer to

the outgoing “New Approach” PED 97/23/EC as 97/23/EC and the “New Legal Framework” Pressure

Equipment Directive 2014/68/EU as 2014/68/EU.

Compared to 97/23/EC, the 2014/68/EU has grown in size by almost 60% to 96 pages, it now has seven

Chapters containing 52 Articles and a further six Annexes. Although there are extensive additions, a

number of deletions and changes to the document, the impact on manufacturers is less than might be

imagined. The majority of the additions concern the Notification of Conformity Assessment Bodies and

EU legal aspects. This document will assist manufacturers in identifying the areas that need to be

addressed for future compliance. There were several editorial changes made between the two directives

that will not be covered within this document, but all significant changes applicable for the manufacturer

will be addressed.

2014/68/EU will be implemented in two parts. The first part became mandatory on June 1, 2015, and is

in relation to Article 13, Classification of pressure equipment. The second part, the replacement of the

97/23/EC becomes effective July 19, 2016. This implementation is discussed in detail below.

Obligations of Economic Operators (Chapter 2)

97/23/EC only identified manufacturers, and manufacturer’s representatives, as being the entities to

place equipment on the market, and bear the associated responsibilities of the Directive. 2014/68/EU

expands greatly on this and now includes defined obligations of importers and distributers. These are

described as being responsible for ensuring that the pressure equipment manufacturer has drawn up the

necessary technical documentation, that the equipment bears the CE marking and is accompanied by

the appropriate operating instructions.






Importers and distributers have defined responsibilities when they have reason to believe the equipment

is not in conformity to the Directive. This includes informing the market surveillance authorities where

this presents a safety risk.

Article 10, NLF PED contains important information for importers and distributers. It states when they

place the equipment on the market under their own name or trademark that they shall be considered as

a manufacturer (and thus bear the associated responsibilities of the manufacturer, as described in the

Directive). This requirement is not intended to apply to such organizations who place the equipment on

the market under the original manufacturers name, for example valve stockists who hold catalogues of

valves where the manufacturer is clearly identified.

Article 10 also details firm rules when an importer or distributer modifies the equipment in such a way

that compliance with the Directive may be affected. If they make such modifications before placing on

the market then they are to be considered a manufacturer.

Generally the responsibilities of the manufacturer, or authorized representatives, remain the same in

2014/68/EU.

Fluid Classification Change (Article 13)

The Dangerous Substances Directive (Directive 67/548/EEC) has been repealed as of June 1, 2015 and

replaced by the European Regulation (EC) No 1272/2008 on classification, labeling and packaging of

substances and mixtures. It is known by its abbreviated form, ‘the CLP Regulation’ or just plain ‘CLP’.

The CLP Regulation adopts the United Nations’ Globally Harmonised System on the classification and

labeling of chemicals (GHS) across all European Union countries.

The CLP re-classifies certain substances from the Dangerous Substances Directive. The European

Commission conducted an assessment regarding the effects of the re-classifications and concluded that

only a small number of substances/mixtures would be affected and that the impact on manufacturers

would be minimal.

Article 9 of 97/23/EC outlines the provisions for dangerous fluids (substances) and classifies them in

Group 1, all other fluids not referenced were placed in Group 2. Article 13 of 2014/68/EU classifies

substances and mixtures as hazardous and places them in Group 1, all other substances and mixtures

fall into Group 2. The hazardous substances and mixtures are now broken down into 17 different

physical and health classes in accordance with Parts 2 and 3 of Annex I in the CLP Regulation.






What this means for manufacturers is that all equipment CE marked after June 1, 2015 must have its

fluid group determined by the new regulation. This applies even to existing designs already certified on a

B (EC-Type Examination), B1 (EC Design Examination) certificate and those also approved under the

module H1 design examination certificates. All pressure equipment manufacturers are encouraged to

review the fluid groups based on the equipment’s contents. Should the fluid group change from Group 2

to Group 1 when performing this against the CLP Regulation, then the category of the equipment should

also be re-checked. If this results in a change in the category of the equipment, then this will require

revision or possible invalidation of the certificate if it results in a higher category than the module may be

applied to. Manufacturers are encouraged to contact the Notified Body should this occur. As mentioned

before – the EC has stated that these will affect only a very small number of substances, but it is

essential the check is performed.

The labels associated with the substances and mixtures have also been changed to coincide with the

CLP, manufacturers are also encouraged to review these.

Hazard and Risk Analysis (Annex I)

Annex I, paragraph 3 was revised. In 97/23/EC this paragraph stated that the manufacturer was

responsible for performing a hazard analysis in order to identify those which apply to the equipment on

account of pressure, and then take these into account in the design of the equipment. The revision has

introduced only two words – “and risks”. 2014/68/EU now requires the manufacturer to analyze the

hazards and risks as they apply to the equipment. Although a minimal amount of text has been added,

the impact of these two words, and how the manufacturer is to address this adequately, is still being

discussed in the Conformity Assessment Body forums.

Whilst a hazard analysis considers such common and less common factors as overpressure, fatigue,

brittle fracture, wind, earthquake, fire, explosion and so on, it’s implied that a risk analysis would take this

a step further, most likely considering the probability and the magnitude of a failure. It’s understandable

that this presents a problem for the majority of manufacturers, such finite details regarding the location

and nature of the installation is usually unknown and often the final user will not readily release such

information.

Our Design Check List template (DCL, form QP10.3-F.002) has always addressed risk evaluation at a

fundamental level and was compiled following the results of discussions at the EU Conformity

Assessment Body Forum in Brussels at the onset of the 97/23/EC. We know from these discussions that






there was always an underlying belief that the hazard analysis should include the consideration of risk

otherwise the use of Annex I 1.2 bullet points could not be technically justified. We continue to be

involved in CABF meetings at national and European level that include discussions regarding the

resulting expectations from the addition of “and risks” and hope that the outcome will be no more

onerous in the future than it is now for our manufacturers completing our DCL.

Conformity Assessment Module Changes (Article 14/Annex III)

In order to coincide with the NLF, the conformity assessment modules have changed slightly as follows:

Modules A1, C1, B1 and B have all been

replaced with new ones as shown. The

replaced modules are not used in the NLF.

Although there are differences in the structure

of the text, in principle the requirements are

the same.

.

This means in the future when selecting modules for 2014/68/EU the following selection options will

apply. It continues to be acceptable to choose to apply a module for a higher category equipment to any

equipment which has a lower category.

New Approach PED 97-23-EC NLF PED 2014-68-EU

Category I Module A Module A

Category II Module A1 Module A2

Module D1 Module D1

Module E1 Module E1

Category III Modules B1 + D Modules B (design type) + D

Modules B1 + F Modules B (design type) + F

Modules B + E Modules B (production type) + E

Modules B1 + C1 Modules B (production type) + C2

Module H Module H

Category IV Modules B + D Modules B (production type) + D

Modules B + F Modules B (production type) + F

Module G Module G

Module H1 Module H1






The names of some of the modules have also changed as detailed in the table below, these new names

more accurately summarize the manufacturers and notified bodies’ duties, particularly with regard to the

required unexpected visits. These are now clearly indicated as supervised pressure equipment checks at

random intervals.

The terms “EC Type-Examination” and “EC Design-Examination'” have also been replaced with the term

"EU-Type Examination".

New Approach PED 97-23-EC NLF PED 2014-68-EU

Module A Internal production control Internal production control

Module A2 (was A1) Internal manufacturing checks with monitoring of final assessment

Internal production control plus supervised pressure equipment checks at random intervals

Module B (production)

EC Type examination EU-Type examination – production type

Module B (design)

(was B1) EC design examination EU-Type examination – design type

C2 (was C1) conformity to type

Conformity to type based on internal production control plus supervised pressure equipment checks at random intervals

D Production quality assurance Conformity to type based on quality assurance of the production process

D1 Production quality assurance Quality assurance of the production process

E Product quality assurance Conformity to type based on pressure equipment quality assurance

E1 Product quality assurance Quality Assurance of the final pressure equipment inspection and testing

F Product verification Conformity to type based on pressure equipment verification

G EC unit verification Conformity based on unit verification

H Full quality assurance Conformity based on full quality assurance

H1 Full quality assurance with design examination and special surveillance of the final assessment

Conformity based on full quality assurance plus design examination

Annex III still addresses the conformity assessment procedures. Although there are changes in some of

the layout and text descriptions, the module requirements remain the same in principal. Generally the

text has been expanded in each module description for clarification, and revised in its layout and

formatting. It has also removed many of the cross references between modules that is present in

97/23/EC, 2014/68/EU now lists each module’s responsibilities and requirements in full under each

module heading. There is guidance provided within each module description for CE marking and EU






declaration of conformity, where applicable to the module. There is also a section added to each module

to detail the responsibilities of an Authorised representative, when used.

Article 48

Although there no transition period as described above, there is a paragraph written into Article 48 that

will greatly assist manufacturers, and Notified Bodies, to cope with this immediate transition.

Article 48 states that “certificates and decisions issued by conformity assessment bodies under Directive

97/23/EC shall be valid under this directive”.

What this means is that all certificates issued under 97/23/EC, and this includes Quality System

Certificates, EC-Type and EC-Examination certificates, remain valid without need for revision following

the implementation of 2014/68/EU on July 19 2016.

For example:

A valid module B1 certificate issued referencing 97/23/EC, remains valid as an EU-Type

examination certificate for Module B (Design).

A valid Quality System Certificate for Module H1, including associated design certificates, remain

valid without revision under 2014/68/EU.

In addition to certificates, the Article also states that decisions under 97/23/EC remain valid. What

this means is for equipment that is applied under module G for example, if the design part of the

conformity assessment is completed and accepted by the Notified Body, before July 19, 2016,

then the decision to accept the design remains valid once 2014/68/EU becomes effective.

HSB GS will provide more information in due course with details about how certificates may be

revised to reference 2014/68/EU if requested by the manufacturer, or when certificates are

renewed.

Transition from the 97/23/EC to 2014/68/EU

Article 49 gives details on the implementation of 2014/68/EU:

On June 1, 2015 only Article 13 of 2014/68/EU becomes effective (Fluid classification change as

described earlier).






On the July 19 2016 2014/68/EU has full implementation, and 97/23/EC is withdrawn.

With 97/23/EC, there was a transition phase from the original application on November 29 1999,

until the May 29 2002, where use of the PED was optional (becoming mandatory only after May

29, 2002), there is no such luxury with the implementation of 2014/68/EU.

There is essentially no transition phase between the withdrawal of the 97/23/EC and the full

implementation of 2014/68/EU. The key stage for manufacturers to consider is the signing date of

the declaration of conformity for the equipment. This is the day that the manufacturer declares it

complies with the applicable regulation.

On the date of July 18 2016, the declaration of conformity needs to be signed with reference to

97/23/EC.

On the next day, July 19 2016, the declaration of conformity needs to be signed with reference to

2014/68/EU

Although there are no technical changes to the essential safety requirements (other than adding

risk), manufacturers need to bear these dates in mind for future pressure equipment construction,

taking into account the expected date of signing the declaration of conformity.

Guidelines

There is an ongoing effort to transfer all of the applicable old guidelines to 2014/68/EU. As there are no

real technical changes to the PED, the work is in changing the references to text and paragraphs that

appear in all the guidelines. This task has proved more time consuming then first expected, and there is

expected to be a significant delay in the completion of this guideline transfer. However, as there is no

real technical change in the guidelines, they can continue to be used once 2014/68/EU comes into

effect, provided consideration is given for the paragraph references.

2014/68/EU will also have new guidelines. At the time of this publication, two of new guidelines have just

been published along with two transposed guidelines from 97/23/EC. These new guidelines will also be

numbered differently – with a prefix A-01, A-02, B-01, etc depending on their classification grouping.

Further information on this grouping will appear on 2014/68/EU website in due course:

(http://ec.europa.eu/growth/sectors/pressure-gas/index_en.htm).

http://ec.europa.eu/growth/sectors/pressure-gas/index_en.htm






Correlation Table

Following is a correlation table, which is in Annex VI of 2014/68/EU, along with the newly introduced

Chapters, general comments giving descriptions on the contents of new or amended Articles and

Annexes.

CORRELATION TABLE

Directive 97/23/EC

Directive 2014/68/EU Comments

~~~ Chapter 1 General provisions, Articles 1 to 5

~~~ Chapter 2 Obligations of economic operators, Articles 6 to 11

~~~ Chapter 3 Conformity and classification of pressure equipment and assemblies, Articles 12 to 19

~~~ Chapter 4 Notification of conformity assessment bodies, Articles 20 to 38

~~~ Chapter 5 Union market surveillance, control of pressure equipment and assemblies entering the Union market, and Union safeguard procedure, Articles 39 to 43

~~~ Chapter 6 Committee procedure and delegated acts, Articles 43 to 46

~~~ Chapter 7 Transition and final provisions, Articles 46 to 52

Article 1(1) Article 1(1) Definitions have been moved to Article 2. The Article has been revised editorially, but there is no technical change in the scope of the new PED.

Article 1(2) Article 2(1) to (14) Includes all the definitions from the old PED, and expands this list significantly. New definitions are in sections (17) through (32) and include definitions for putting into service, economic operators etc…

Article 1(3) Article 1(2) See Article 1 above

~~~ Article 2(15) to (32) See Article 2 above

Article 2 Article 3 Title changed from Market Surveillance to Making Available on the Market and Putting Into Service. Editorially revised also.

Article 3 Article 4 Numbering and editorial revision only.

Article 4(1) Article 5(1) Added a paragraph on free movement for equipment assessed by user inspectorate.

Article 4(2) Article 5(3) See Article 5 above.

~~~ Article 6 New Article. It correlates several major responsibilities of the manufacturer that were previously found scattered throughout the old PED, and lists these obligations in one article.

~~~ Article 7 New Article. Gives the responsibilities of authorized representatives, when one is appointed by a manufacturer.

~~~ Article 8 New Article. Gives the responsibilities for importers.

~~~ Article 9 New Article. Gives the responsibilities for distributers.

~~~ Article 10 New Article. Important Article highlighting that when importers or distributers place equipment on the market under their own name or trademark, or modify equipment already on the market, that they shall be considered as a manufacturer for the purpose of the Directive.

~~~ Article 11 New Article. Economic operators responsibilities regarding requests from Market Surveillance Authorities

Article 5 ~~~ Deleted, included in Article 12, see below






Article 6 ~~~ Deleted, now obsolete

~~~ Article 12(1) New Article. Presumption of Conformity, includes intent of Article 5 97/23/EC

Article 7(1) Article 45 Part of Chapter 6. Committee procedure and delegated acts Delegated power, expands on empowerment of the Commission to take actions for safety reasons

Article 7(2) Article 44(1) Part of Chapter 6. Requirements for the Committee on Pressure Equipment according to the addressed Regulation

Article 7(3) ~~~ Deleted, now obsolete

Article 7(4) Article 44(5), second subparagraph

Part of Chapter 6. Change of wording, same intent, addressed Regulation number

Article 8 ~~~ Deleted, requirements expanded, see Chapter 5, Articles 39 to 43 below

Article 9(1) Article 13(1), introductory sentence

Identical

Article 9(2) point 1

~~~ Deleted, obsolete

~~~ Article 13(1)(a) Group 1 substances and mixtures, references CLP Regulation

Article 9(2) point 2

Article 13(1)(b) Group 2 substances and mixtures

Article 9(3) Article 13(2) Identical

Article 10 Article 14 Editorial changes, deletion of paragraph 1.1, text references the module changes


Article 11(2) Article 15(2) Editorial changes only



~~~ Article 15(4) New paragraph, Commission shall publish approval of EAM that meet Annex in the OJ


~~~ Article 15(6) New paragraph, withdrawal of EAM from the OJ

Article 12 ~~~ Revised and included under Article 24

Article 13 ~~~ Revised and included under Article 24



Article 14(3) to (8)

Article 16(2) to (7) Editorial changes only

Article 14(9) and (10)

~~~ Intent included in Article 32

~~~ Article 17 New Article References DOC requirements

~~~ Article 18 References the Regulation regarding the principles of CE Marking

Article 15(1) ~~~ Deleted, obsolete, information contained in Article 18



Article 15(4) and (5)

~~~ Deleted

~~~ Article 19(3) to (6) New paragraphs regarding CE Marking, Reinforcement of requirements previously in modules or not addressed






~~~ Article 20 Chapter 4 of the Directive. Notification of Conformity Assessment Bodies New Articles. Rules and requirements for Notification Authorities and Conformity Assessment Bodies. Includes information from parts of previous PED

~~~ Article 21

~~~ Article 22

~~~ Article 23

~~~ Article 24

~~~ Article 25

~~~ Article 26

~~~ Article 27

~~~ Article 28

~~~ Article 29

~~~ Article 30

~~~ Article 31

~~~ Article 32

~~~ Article 33

~~~ Article 34

~~~ Article 35

~~~ Article 36

~~~ Article 37

~~~ Article 38

Article 16 ~~~ Deleted, the intent is included in Chapter 5, see below

Article 17 ~~~ Deleted

Article 18 ~~~ Deleted, the intent is included in Chapter 5, see below

~~~ Article 39 Chapter 5, Union market surveillance, control of pressure equipment and assemblies entering the Union market, and Union safeguard procedure. New Articles address non-complying equipment, including reference to new Regulations

~~~ Article 40

~~~ Article 41

~~~ Article 42

~~~ Article 43

~~~ Article 44(2) to (4) New paragraphs, addresses the Committee on Pressure Equipment applicable Regulations ~~~ Article 44(5), first

subparagraph

~~~ Article 46 New Article under Chapter 6. Addresses the Commissions power to adopt delegated acts for a set period and further extensions

~~~ Article 47 Part of Chapter 7. Transitional and final provisions New Article, Penalties, addresses penalties on economic operators regarding infringements of national laws (the Directive)

Article 19 ~~~ Deleted, obsolete

Article 20(1) to (2)

~~~ Deleted, obsolete

Article 20(3) Article 48(1) Editorial changes

~~~ Article 48(2) and (3) New paragraphs address equipment put into service prior to 1 June 2015 and validity of certificates and decisions made under 97/23/EC

~~~ Article 49 Part of Chapter 7 New Article, Transposition. Adoption in Law and the effective date of implementation






~~~ Article 50 Part of Chapter 7 New Article, Repeal. Deletion of Article 9 from 97/23/EC from 1 June 2015, repeal of 97/23/EC from 19 July 2016

~~~ Article 51 Part of Chapter 7 New Article, Entry into force and application of 2014/68/EU from 19 July 2016

Article 21 Article 52 Editorial changes only

Annex I Annex I Essential Safety Requirements. Generally minor editorial changes only. Preliminary observation 3 was revised to add in the word “risk”, when describing the manufacturers’ responsibilities with regards to performing a hazard and risk analysis.

Annex II Annex II Changes to the Module names. A1 is now A2, C1 is now C2, B1 is now B (design type). The conformity assessment tables themselves remain unchanged.

Annex III, introductory wording

Annex III, introductory wording

Identical

Annex III, point 1, Module A

Annex III, point 1, Module A

Editorial changes only. Added paragraph on CE Marking and the Declaration of Conformity by the manufacturer. Added paragraph on Authorised Representative responsibilities, when used (these paragraphs have been added to all modules).

Annex III, point 2, Module A1

Annex III, point 2, Module A2

Changed Module from A1 to A2 and module name changed. The text has been expanded for clarification in places, and also revised to remove the need for several cross references to other modules when describing requirements.

Annex III, Module B

Annex III, point 3.1, Module B, EU-type examination - Production type

Changed Module name EU-Type examination – production type. Other minor editorial changes.

Annex III, Module B1

Annex III, point 3.2, Module B, EU-type examination - design type

Changed Module name EU-Type examination – design type. Other minor editorial changes.

Annex III, Module C1

Annex III, point 4, Module C2

Changed Module from C1 to C2 and module name change. The text has been expanded for clarification

Annex III, Module D

Annex III, point 5, Module D

Changed Module name. Other minor editorial changes

Annex III, Module D1

Annex III, point 6, Module D1


Annex III, Module E

Annex III, point 7, Module E


Annex III, Module E1

Annex III, point 8, Module E1


Annex III, Module F

Annex III, point 9, Module F


Annex III, Module G

Annex III, point 10, Module G


Annex III, Module H

Annex III, point 11, Module H


Annex III, Module H1

Annex III, point 12, Module H1

Changed Module name. Other minor editorial changes and text expanded instead of cross references






Annex IV ~~~ Deleted. Information contained within chapter 4 now

Annex VII ~~~ Deleted. Information contained within chapter 4 now

Annex VII ~~~ Deleted

Annex VII Annex IV EC Declaration of Conformity has been renamed to EU Declaration of Conformity. There have been small changes to the options for content of the declaration, as well adding a format for particulars of the signatory authorized to sign, where appropriate.

~~~ Annex V Gives the formal repeal of directive 97/23/EC

~~~ Annex VI Correlation table. Follows the format of this table and gives the correlation between Articles and Annexes

For more information pertaining to the new Directive please see the following links:

New Pressure Equipment Directive (PED) Website

Archived Pressure Equipment Directive (PED): Overview – European Commission Website

PED EC 2014/68/EU – Full text Regulation (EC) No 1272/2008 – Full Text

Classification and Labeling (CLP/GHS)

EU Blue Guide

This Synopsis was prepared by the HSB Global Standards Notified Body Staff to provide insights into the intent of these changes, and their potential impact on PED users.

We hope you find this information helpful. Any questions or comments on this document may be directed to:

Gavin Edley Technical Manager [email protected]

Lee Moffatt Quality Manager [email protected]

http://ec.europa.eu/growth/sectors/pressure-gas/index_en.htm

http://ec.europa.eu/enterprise/sectors/pressure-and-gas/documents/ped/index_en.htm

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L:2014:189:FULL&from=EN%20#page=166

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02008R1272-20131201

http://ec.europa.eu/growth/sectors/chemicals/classification-labelling/index_en.htm

http://ec.europa.eu/DocsRoom/documents/4942/attachments/1/translations/en/renditions/pdf&rct=j&frm=1&q=&esrc=s&sa=U&ei=1KoSVMvOOuW_ygP72oGACw&ved=0CBQQFjAA&usg=AFQjCNFv6CrL_2tjt7roAM3oXocj1tmh_w

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