4. Q & A on the EC Directives

Q 1. What is CE marking?

A1	CE marking is a mark indicating that a manufacturer certifies his products as conforming to the EC Directives.(It is necessary to meet essential requirements of all the EC Directives applied.) For reference, "CE" stands for "Commuaute Europeenne" or "European Community" in English.

Q 2. What are the EC Directive and EN (Europe Norms)?

Each member Nation of the EU has, in the past guaranteed the quality and safety of its products according to their own standards and criteria. Today, common standards and criteria apply to the entire member Nations to allow free distribution of goods within the EU. These are known as EC Directives. ("EC Directive" is a general term for Mandatory requirements issued by the European Community Council.)
EN is a common standard set by CEN and CENELEC, European standardization bodies. Harmonized EN standards are utilized as a complement to EC Directives.

Q 3. What happens to machines and components not carrying a CE mark?

A3	Machines and components to be exported (or distributed) from Japan to member Nations of the EU must conform to the EC Directives. Thus, if they are not marked with CE showing conformity, distribution will not be permitted within the EU.

Q 4. What is the correlation between CE marking and the responsibility of the manufacturer ?

Since CE marking is a mark indicating that a Manufacturer certifies that his products conform to the EC Directives, the Manufacturer is responsible for applying the mark. (Self-Declaration).
If machines and components carrying a CE mark infringe safety or non-conformity with a directive, member Nations can take Legal countermeasures. In other words, free transfer of such products can be excluded from the market, and bans on future shipment, operation and use will be imposed.

Q 5. What is the requirement of a Manufacturer exporting products to member nations of EU?

A5	In order to avoid risks mentioned in A 4 above, more and more Manufacturers are asking a third party, such as an EC notified body to carry out inspection and test, and provide a Certificate of Conformity (only Notified Bodies are authorized to certify conformity with standards).

Q 6. What are the contents of the EC Directives?

Typical directive contents are shown below. Machines and components marked with CE should meet all the directives applied.

Directive	Typical directive no.	Subject example
Machinery	89/392/EEC	Machine tools, Construction equipment, Wood working machines, Insertion machines, Inspection machines, Textile machinery
Electromagnetic Compatibility (EMC)	89/336/EEC	Equipment with electric / electronic devices, Household appliances, Office appliances, Telephones, Motors
Low Voltage	93/68/EEC	Machines operated above 50V AC 50 to 1000VAC V & 75V DC to 1500 VDC
Medical Device	93/42/EEC	Diagnostic and treatment equipment
Simple Pressure Vessels	93/68/EEC	Gas pressure vessels, Pneumatic vessels
Remote Communication Terminal	93/97/EEC	Fax machines, Modems, ISDN
Toy Safety	88/378/EEC	Dolls, Puzzles, ChildrenÕs bicycles
Gas Combustion Apparatus	90/396/EEC	Gas heater, Gas boiler
Marking	93/68/EEC	Uniform indication for CE marking

Q 7. What is the Machinery Directive?

The Machinery Directive contains essential health and safety requirements for machinery, as applied to industrial machines e.g. machine tools, injection molding machines and automatic machines. Pneumatic equipment is not specified in Machinery Directive. However, the use of SMC products that are certified as conforming to EN Standards, allows customers to simplify preparation work of the Technical Construction File required for a Declaration of Conformity.

Q 8. What is the Low Voltage Directive?

A8	This directive is applied to products, which operate above 50VAC to 1000VAC and 75VDC to 1500VDC operating voltage, and require electrical safety measures to be introduced.

Q 9. What is the Electromagnetic Compatibility (EMC) Directive?

A9	The EMC Directive specifies electromagnetic compatibility. Equipment which may generate electromagnetic interference or whose function may be compromised by electromagnetic interference is required to be immune to electromagnetic affects (EMS / immunity) without emitting excessive electromagnetic affects (EMI / emission). The following example shows the testing carried out on SMC digital flow switches (PFA/PFW).

	Products are considered to conform with the EMC directives when they are individually tested and satisfy all the essential requirements. SMC ensures that each product is certified as conforming to the EMC Directives, for safety, when a customer applies for a Certificate of Conformity for an entire machine. This is designed to ensure that ÒnoiseÓ will not cause failure.

Q 10. What is the Simple Pressure Vessels Directive?

A10	This directive is applied to welded vessels whose maximum operating pressure (PS) and volume of vessel (V) exceed 50 bar/L. Such vessels require EC type examination and then CE marking.

Q 11. Which directive is relevant to SMC products? Which SMC products require CE marking?

A11

Directives relevant to SMC products are EMC, Low Voltage and Simple Pressure Vessels Directive. For pneumatic equipment comprising electric / electronic parts, either the EMC or Low Voltage Directive, or both directives are applied. In such cases, CE marking is required.
Therefore, pneumatic equipment without electric / electronic parts is not subjected to CE marking.
The Simple Pressure Vessels Directive is applicable to SMC air tanks (series AT) and tanks for booster valves (series VBAT). However, neither of the products conform to these directives (are not CE marked) and, therefore, cannot be exported to Europe.

Q 12. What is the difference between a CE-marked product and a certified product?

A12

As mentioned in ÒIssue of Declaration of Conformity by the manufacturer & CE markingÓ and ÒEC Directives & ENÓ above, a certified product is a product certified by a Notified Body stating it conforms to both EN and EC Directives. On the other hand, a CE-marked product is a product that the manufacturer, SMC in this case, declares conforms to the relevant EC Directives in accordance with the Declaration of Conformity issued by a Notified Body. Products themselves have no difference.

Q 13. What about specials (- X) under EC Directives?Q

A13

Since special part numbers are not registered in the Certificate of Compliance for standard products, specials cannot be considered as conformable products with standards.
However, if items, to which any standards are not applied, (e.g. Different lead wire length) are specified for specials, a Certificate of Compliance for a standard product can be issued defining the commonalities and differences between the standard and special products (with the use of an assembly drawing, dimensional drawing, etc.).

Q 14. What about spare parts (for maintenance) ?

A14	Since the conformity of spare parts for CE-marked machines (components) have been confirmed, as a unit, it is unnecessary to carry out further conformity testing.

Q 15. What does the Technical Construction File (TCF) contain?

A15

Technical construction file is required to evaluate and establish conformity of products with Directives. It describes how essential requirements are satisfied and measures are taken and, at the same time, consists of Technical information such as specifications and wiring diagrams required for a better understanding of the product.
This is an example, but the Technical Construction File should contain the following information.

1) General description of the product (e.g.. Instruction and Maintenance Manual)
2) System block diagram, Wiring diagram
3) The necessary explanation / description in order to understand the operation
4) List of applied standards together with an explanation of safety precautions required to meet the essential requirements of directives
5) Content of the Inspection/Test carried out
6) Test report
7) Operation manual (Specifications)

The Manufacturer is required to keep these documents, together with a written Declaration of Conformity, for 10 years following the end of the productÕs production. It is also necessary to submit the Technical Construction File, by specific date, if a control authority requests it.

Q 16. What does Self-Declaration (Declaration of Conformity) contain?

A16

A written Declaration of Conformity by the manufacturer is a document declaring that a product conforms to the required essential requirements of each directive. It should contain the following.

1) Name of the manufacturer
2) Location
3) Description & model number of the product
4) Applied directives & harmonized standards
5) Name & address of a proxy resident in the EU
6) Signature of the responsible person Declaring.

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