December 2000

!Valves and
the CE Mark

www.chemicalprocessing.com

Safety Training:
Weighing the Options

VA LV E S

Understanding the

CE Mark
By Michael C. Headley, P.E.

and Europes

Pressure Equipment Directive Whats all the fuss?

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.
1. Directive 97/23/EC of the European Parliament. 2. Includes Austria, Belgium, Denmark, Finland, France, Germany, Great Britain, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Netherlands, Norway, Portugal, Spain and Sweden. 3. After publication, directives allow manufacturers a two-and-one-half-year transition period to gear up. During this time, no manufacturer can place a CE mark on their product. After this time period, manufacturers can place the CE mark on their products voluntarily. For the PED, the two-and-onehalf-year date was Nov. 30, 1999.

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 consistent requirements for safety. Failure to meet a directive is a criminal offense that can result in fines, impounding of product or imprisonment. After acceptance by the European Commission and Parliament, a directive is published in the Official Journal of the European Community (OJEC). A directive becomes mandatory five years after its publication.3 There are many directives low-voltage (LVD), electromagnetic compatibility (EMC) and explosive atmospheres (ATEX), to name a few but the one that has most valve manufacturers concerned and end users confused is the PED. The directive was adopted on May 29, 1997, which means pressure equipment must be in compliance by May 29, 2002.

Explaining the CE mark 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, which established a system where people, finances, services and goods could move freely across borders. Following ratification of The CE acronym stands for Conformit Europenne, which is French for European Conformity. It represents 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 requirements outlined in the directive.

Reprinted from Chemical Processing, December 2000

VA LV E S

PRESSURE EQUIPMENT DIRECTIVE

Product
-design -manufacture -materials
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 procedures; sources and orders material; manufactures product; ensures traceability; provides operating instructions; and documents the process. Although it has similarities to ISO, the PED is much more comprehensive. 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 manufacturing 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 pressure accessories. Control valves, for instance, fall under pressure accessories because they have a pressurebearing housing and operational function. Depending on its type, size4 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 procedures. These are modules6 levels of conformity assessment that detail what quality assessment (QA) criteria are required and classify auditing and inspection 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

Process

PED
ISO 9001

-conformity assessment

Ann

ex I

ISO 9002 III x e n n A

The PED encompasses more than ISO compliance requirements.

parties to ensure the design and manufacture of pressure 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 product 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 primarily associated with safety. For the PED, it is associ4. If volume is more a factor than DN size, as in an ated with safety regarding actuator, then volume is used. pressure-related hazards. The CE mark is not to be 5. The PED defines two fluid groups: Group 1 as used as a marketing tool dangerous (toxic, flammable, etc.) and Group 2 as to enhance sales. not dangerous. The PED is a man6. Defines the quality requirements needed to satisfy date for products enterthe category level. ing the EEA, but what

Reprinted from Chemical Processing, December 2000

VA LV E S

Pressure-Related Hazard Categories

Level of hazard resulting from pressure SEP Explanation
Products with the lowest hazard resulting from pressure. Manufacturers simply must use good engineering practices with recognized codes and standards. The product must not bear the CE mark. Allows the manufacturer to self-certify, but it must keep a technical file and deliver a conformity certification. No notified body involvement. The product must bear the CE mark. Quality assurance (QA) approval or surveillance by a notified body. Requires the manufacturer to ensure the quality of the product by using a certified production QA system audited by a notified body. The product must bear the CE mark. Type examination or design examination and surveillance by a notified body or QA approval. Requires the manufacturer to have a QA system along with certification of the product design by a notified body. Having a full QA design and production system (ISO 9001) that has been audited by a notified body also can satisfy this level. The product must bear the CE mark. Type examination and verification by a notified body meet this requirement. This category poses the greatest pressure-related hazard. Safety relief valves automatically are placed into this category. The requirements are similar to those of Category III, with the addition of surveillance by a notified body and certified type tests.

Category I

Category II

Category III

Category IV

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 reality, 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 material 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 vehicle in place, and by using European-appointed independent third parties to review the manufacturers design, manufacturing processes, materials and suppliers, the CE mark should help minimize the risk of hazards resulting from pressure.

Additional Guidance
More information about the CE mark and the PED can be found in the following resources:
q

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 betterquality product. Non-EEA customers should not feel they are getting an inferior product if the product does 7. Published in the OJEC, they are a special subset not display the CE mark. of European standards that begin with the preface Unfortunately, achievEN, for European Norm. The EN standards ing compliance is not easy. have particular relevance to the ESRs. The use of a Manufacturers have only published harmonized standard (EN) in the design two ways to comply: They and manufacture of a product will give the precan meet the Harmonized sumption of conformity to those ESRs listed in European Standards7 or Annex ZA of the particular harmonized standard. follow the PED. Although If a harmonized standard exists, it may be used to CEN, the European standards-making body, has a comply with the PED.
D350812X012

q q

The Web site for ORGALIME, a European federation of national industry associations representing the mechanical, electrical, electronic and metals industries, www.orgalime.org. The PED Information Resources Centre, http://ped. eurodyn.com. The European Unions Web site, www.europa.eu.int. Valve Purchasers Guide to the European Pressure Equipment Directive, Engineering Equipment and Materials Users Association (EEMUA), Publication No. 196,1999. Official Journal of the European Communities, Directive 97/23/EC, 181, Vol. 40, July 9, 1997.

Headley is a senior engineer for Fisher Controls International Inc., Marshalltown, Iowa. He can be contacted by e-mail at michael.headley@frco.com.

Reprinted from Chemical Processing, December 2000