December 2000

www.chemicalprocessing.com
!
Valves and
the CE Mark
Training:
Safety
W eighing the Options
Y
ou see it on toys, voltmeters and
guitars. It seems the CE mark is
on everything.
And the mark soon will be on some control valves
as well. After May 29, 2002, all pressure equipment
within the scope of the Pressure Equipment Directive
(PED)
1
will be required to have a CE mark to freely
enter the European Economic Area (EEA).
2
The PED
will add some out-of-pocket expenditures for both
EEA and non-EEA manufacturers.
But what does this mean for valve customers in the
United States?Will they get a different valve than what
is shipped to Europe? Does the CE mark signify a
higher quality product?Does it signify a safer product?
Not since ISO has a simple acronym caused so much
confusion. This article explains what the CE mark does
and does not mean.
A brief history
In 1957, a group of
European countries, called
member states, signed the
Treaty of Rome to achieve
a single European market.
The treaty created what
became known as the
Four Freedoms, whi ch
established a system where
people, finances, services
and goods could move
freely across borders.
Following ratification of
the treaty, the ability to trade goods freely still did not
exist because the laws of each member state differed. A
manufacturer was required to have its products tested
and approved in several member states, which truly
caused a trade barrier. Imagine not being able to ship
from Iowa to Wisconsin because of different technical
codes and standards!
Directives became the mechanisms to overcome
these trade barriers. Besides creating an open market
for product movement, directives remove technical
barriers by harmonizing standards and imposing con-
sistent requirements for safety. Failure to meet a direc-
tive is a criminal offense that can result in fines,
impounding of product or imprisonment.
After acceptance by the European Commission
and Parli ament, a di rective i s publi shed i n the
Official Journal of theEuropean Community(OJEC).
A directive becomes mandatory five years after its
publication.
3
There are many directives low-volt-
age (LVD), electromagnetic compatibility (EMC)
and explosive atmospheres (ATEX), to name a few
but the one that has most valve manufacturers con-
cerned and end users confused is the PED. The direc-
tive was adopted on May 29, 1997, which means
pressure equipment must be in compliance by May
29, 2002.
Explaining the CE mark
The CE acronym stands for Conformit Europenne,
which is French for European Conformity. It repre-
sents a unified Europe in the Four Freedoms, one of
which calls for the free movement of goods. The CE
mark allows product access and free movement of
goods throughout the EEA. It is not a certification or
approval mark. It is not a quality mark, and it is not
intended to be used as a tool for promotion. Instead, it
indicates the product conforms to the essential
requirements of the applicable directive(s). For the
PED, the CE mark implies that the manufacturer of the
pressure equipment has taken into account all hazards
resulting from pressure and has met the safety require-
ments outlined in the directive.
Reprinted from Chemical Processing, December 2000
VALVES
Understandingthe
CE Mark
and
Europes
Pressure Equipment Directive
Whats all
the fuss?
By Michael C. Headley, P.E.
1. Directive 97/23/EC of the European Parliament.
2. IncludesAustria, Belgium, Denmark, Finland,
France, Germany, Great Britain, Greece, Iceland,
Ireland, Italy, Liechtenstein, Luxembourg,
Netherlands, Norway, Portugal, Spain and Sweden.
3. After publication, directivesallow manufacturers
a two-and-one-half-year transition period to gear
up. During thistime, no manufacturer can place a
CE mark on their product. After thistime period,
manufacturerscan place the CE mark on their
productsvoluntarily. For the PED, the two-and-one-
half-year date wasNov. 30, 1999.
Inside the PED
There are 21 articles and six annexes in the PED. They
cover areas that affect how a manufacturer designs;
qualifies suppliers, weld and NDE personnel and pro-
cedures; sources and orders material; manufactures
product; ensures traceabi li ty; provi des operati ng
instructions; and documents the process. Although it
has similarities to ISO, the PED is much more com-
prehensive. Like ISO 9001, Annex I of the PED deals
with both product design and the manufacturing
process. Specifically, Annex I of the PED outlines the
essential safety requirements (ESRs) that cover the
products design, construction materials and manu-
facturing methods.
Like ISO 9002, Annex III of the PED deals with the
process and conformity assessment procedures (see the
figure). But unlike ISO, the PED ensures products are
produced at a consistent level of safety, not quality.
The PED applies to the design, manufacture and
conformity assessment of pressure equipment having a
maximum allowable pressure greater than 0.5 bar (7.25
psig). The directive defines four types of pressure
equipment: vessels, piping, safety accessories and pres-
sure accessories. Control valves, for instance, fall under
pressure accessories because they have a pressure-
bearing housing and operational function.
Depending on its type, size
4
and the type of fluid,
5
the equipment is placed into a category that defines the
degree of hazard resulting from pressure. The higher
the category number, the higher the risk and level of
required conformity assessment (see the table).
Annex II includes conformity assessment proce-
dures. These are modules
6
levels of conformity
assessment that detail what quality assessment (QA)
criteria are required and classify auditing and inspec-
tion criteria.
Equipment that is not seen as a significant risk
because of pressure falls into the Sound Engineering
Practice (SEP) category. Pressure equipment in the
SEP category which is a function of the size and
application must be designed and manufactured
using recognized codes and standards. SEP products
do not and cannot bear the CE mark.
Notified bodies are responsible for assessing a
manufacturers conformity. They are appointed by a
member states government to act as independent third
parties to ensure the design and manufacture of pres-
sure equipment are safe. The notified bodies are the
final authorities on interpretation of the PED and
assessment. Their involvement varies, according to the
category and chosen assessment module. Examples of
notified bodies are Lloyds Register and TV.
CE and the end user
Both valve manufacturers and notified bodies are
learning how to comply with the PED. Because the
PED is now in the transitional period, manufacturers
can comply voluntarily, but are not obligated to do so
until the May 29, 2002, deadline.
If the product falls into the SEP category, the prod-
uct cannot bear the CE mark. For all practical purposes,
a valve of 1 inch or smaller, regardless of pressure and
application fluid, falls into the SEP category.
Although customers may perceive it as such, the CE
mark is not a certification, approval or mark of quality.
While indirectly related to quality, the CE mark is prima-
rily associated with safety.
For the PED, it is associ-
ated with safety regarding
pressure-related hazards.
The CE mark is not to be
used as a marketing tool
to enhance sales.
The PED is a man-
date for products enter-
ing the EEA, but what
VALVES
Reprinted from Chemical Processing, December 2000
PED
I SO 9001
I SO 9002
A
n
n
e
x

I
A
n
n
e
x

I
I
I
Pr oduc t
- desi gn
- manuf ac t ur e
- mat er i al s
Pr oc ess
- c onf or mi t y
assessment
The PED enc ompasses mor e t han I SO c ompl i anc e r equi r ement s.
PRESSURE EQUI PMENT DI RECTI VE
4. If volume is more a factor than DN size, as in an
actuator, then volume isused.
5. The PED defines two fluid groups: Group 1 as
dangerous (toxic, flammable, etc.) and Group 2 as
not dangerous.
6. Definesthe quality requirementsneeded to satisfy
the category level.
about other countries? Can a non-EEA customer
request it?It is possible, but because part of the goal of
the directive is to harmonize technical standards for
free trade across EEA borders, it makes no sense for
non-EEA countries to require it. The CE mark should
not become a boilerplate specification that is added
because customers perceive they are getting a better-
quality product. Non-EEA customers should not feel
they are getting an inferior
product if the product does
not display the CE mark.
Unfortunately, achiev-
ing compliance is not easy.
Manufacturers have only
two ways to comply: They
can meet the Harmonized
European Standards
7
or
follow the PED. Although
CEN, the European stan-
dards-making body, has a
mandate from the European Commission to prepare
Harmonized European Standards, not all of them will
be issued before the May 29, 2002, deadline. So in real-
ity, manufacturers of pressure equipment have only
one option: to satisfy the ESRs outlined in Annex I of
the PED.
Multiple directives may apply to the same item. For
example, an industrial process (I/P) transducer would
need to comply with both the EMC and ATEX
directives.
Although there is some overlap, the PED goes into
greater depth than ISO about how the manufacturer
designs and qualifies suppliers, procedures, welders
and NDE personnel. It also covers such items as mate-
rial traceability, labeling and operating instructions.
The general public and end users alike want to be
free from fears related to pressure equipment failure. It
is up to the manufacturer of such equipment to design
and produce products that will not endanger others.
The PED is the most comprehensive compliance vehi-
cle in place, and by using European-appointed inde-
pendent third parties to review the manufacturers
design, manufacturing processes, materials and suppli-
ers, the CE mark should help minimize the risk of haz-
ards resulting from pressure.
Headley is a senior engineer for Fisher Controls
International Inc., Marshalltown, Iowa. Hecan becon-
tacted by e-mail at michael.headley@frco.com.
VALVES
SEP
Cat egory I
Cat egory II
Cat egory III
Cat egory IV
Product s wi t h t he l owest hazard resul t i ng f rom pres-
sure. Manuf act urers si mpl y must use good engi neer-
i ng pract i ces wi t h recogni zed codes and st andards.
The product must not bear t he CE mark.
Al l ows t he manuf act urer t o sel f - cert i f y, but i t must
keep a t echni cal f i l e and del i ver a conf ormi t y cert i f i -
cat i on. No not i f i ed body i nvol vement . The product
must bear t he CE mark.
Qual i t y assurance (QA) approval or survei l l ance by a
not i f i ed body. Requi res t he manuf act urer t o ensure
t he qual i t y of t he product by usi ng a cert i f i ed pro-
duct i on QA syst em audi t ed by a not i f i ed body. The
product must bear t he CE mark.
Type exami nat i on or desi gn exami nat i on and survei l -
l ance by a not i f i ed body or QA approval . Requi res t he
manuf act urer t o have a QA syst em al ong wi t h cert i f i -
cat i on of t he product desi gn by a not i f i ed body. Havi ng
a f ul l QA desi gn and product i on syst em (ISO 9001)
t hat has been audi t ed by a not i f i ed body al so can sat -
i sf y t hi s l evel . The product must bear t he CE mark.
Type exami nat i on and veri f i cat i on by a not i f i ed body
meet t hi s requi rement . Thi s cat egory poses t he
great est pressure- rel at ed hazard. Saf et y rel i ef val ves
aut omat i cal l y are pl aced i nt o t hi s cat egory. The
requi rement s are si mi l ar t o t hose of Cat egory III, wi t h
t he addi t i on of survei l l ance by a not i f i ed body and
cert i f i ed t ype t est s.
Pr essur e- Rel at ed Hazar d Cat egor i es
Expl anat i on
Level of hazar d
r esul t i ng f r om pr essur e
More i nf ormat i on about t he CE mark and t he PED can be f ound
i n t he f ol l owi ng resources:
G
The Web si t e f or ORGALIME, a European f ederat i on of nat i on-
al i ndust ry associ at i ons represent i ng t he mechani cal , el ect ri -
cal , el ect roni c and met al s i ndust ri es, www.orgal i me.org.
G
The PED I nf or mat i on Resour ces Cent r e, ht t p: / / ped.
eurodyn.com.
G
The European Uni ons Web si t e, www.europa.eu.i nt .
G
Val ve Purchasers Gui de t o t he European Pressure Equi pment
Di r ect i ve, Engi neer i ng Equi pment and Mat er i al s User s
Associ at i on (EEMUA), Publ i cat i on No. 196,1999.
G
Of f i ci al Journal of t he European Communi t i es, Di rect i ve
97/ 23/ EC, 181, Vol . 40, Jul y 9, 1997.
Addi t i onal Gui danc e
7. Published in theOJEC, they area special subset
of European standardsthat begin with thepreface
EN, for European Norm. The EN standards
haveparticular relevanceto theESRs. Theuseof a
published harmonized standard (EN) in thedesign
and manufacture of a product will give the pre-
sumption of conformity to those ESRs listed in
Annex ZA of theparticular harmonized standard.
If a harmonized standard exists, it may beused to
comply with thePED.
D350812X012 Reprinted from Chemical Processing, December 2000