Weinstein Associates

safety assurance from concept to marketplace

Frequently Asked Questions

Warning Labels

Can multiple product warning labels protect a manufacturer of poorly designed products from liability?

No! Both the European Union and the United States have the same hierarchy for reducing risks: Whenever possible, the hazard must be eliminated in the design. When this is not possible, the risk of harm must be reduced through guarding or other protective devices. Only after these means have been exhausted should residual risks be addressed through warning and/or informing users of special training, procedures or protective equipment that must be used to avoid harm.

When does a manufacturer have a legal "duty" to warn?

Manufacturers have a legal duty to provide adequate instructions in all cases and to warn of any dangers that would not be apparent to the average user. Some courts have imposed a duty to warn even with respect to open and obvious dangers. The duty to warn extends to all known dangers, as well as to all the dangers that ought to be known to the manufacturer on the basis of existing state-of-the-art technology. A few courts have even held manufacturers liable for failure to warn of product dangers that were not knowable at the time, but this rigid form of strict liability has generally been limited to incidents of asbestos exposure.

The duty to warn continues throughout the useful safe life of the product. Manufacturers must notify buyers of any hazard posed by a defect discovered in design or manufacture, as well as of any safety devices that may be developed; in such cases, retrofit or recall of the product may also be mandated. This duty can be especially problematic for manufacturers of long-lived products, such as heavy industrial machinery. Extensive, accurate recordkeeping is a must if the manufacturer is to fulfill this ongoing duty.

Are product warning label requirements the same under U.S. law and E.U. law?

There are similarities between E.U. standards and U.S. case law in the realm of warnings. As stated earlier, both the United States and European Union have the same hierarchy in addressing hazards: they should be designed out of the product if possible, and guarded against if not. Only when neither of these options are effective should warnings be the means of protecting the user from a hazard. Neither would find simply the word "Warning!" or "Danger!" appropriate. Further, standards and case law require that the warnings be readily understandable, that they inform the user of the risk and what to do to avoid the risk, and that they last the life of the machine.

However, the method used to accomplish this end differs between the two markets. According to the Machinery Directive, "warnings should preferably use readily understandable pictograms and/or be drawn up in one of the languages of the country in which the machinery is to be used, accompanied, on request by the languages understood by the operators." Specific guidance is provided in E.U. standards such as EN 292-2, General Principles for Design, Technical Principles and Specifications, and ISO 3864, Safety Colours and Safety Signs.

The key to meeting the U.S. legal requirements is the ambiguous requirement that warnings must be "adequate." However, the courts have not provided specific guidance on what constitutes adequacy, only general guidelines. The U.S. standard for safety labels is the ANSI Z535 series, Safety Signs and Colors. The safety label that meets the ANSI standard comprises a panel with the safety alert symbol and appropriate signal word (danger, warning, or caution) over a message panel that conveys the hazard, the consequences of encountering the hazard, and what to do to avoid the hazard. When one or more of these elements is obvious or self-explanatory, it can be omitted (e.g. the result of encountering an electrocution hazard is death by electrocution). The standard also prescribes the colors, fonts, relative sizes, etc., for these components; which signal word is appropriate; and the layout of these components.

A symbol or pictorial is optional in the ANSI standard; it can be used to supplement or replace the word message. This is in contrast to the European Union, where the symbol is usually the entire label. The pictorial can represent the hazard, a hazardous situation, the result of not avoiding the hazard, or some combination thereof (e.g., the "lightening bolt" may represent an electrical hazard while a hand being mangled may represent the consequence of not avoiding a nip-point hazard.) In other words, the symbol used in the E.U. conveys exactly what the ANSI standard requires of the message panel, so in theory, the E.U. symbol of a given hazard, with the addition of the safety alert symbol, signal word and color requirements of ANSI, would "translate" into an acceptable domestic symbol.

When are warning labels considered "legally adequate" in the United States?

Safety labels exist to warn users of hazards and the risks of injury which they may be unaware of, and to provide them with the information necessary to avoid those hazards. Prior to developing an effective safety label, there are three basic elements that must be described, understood and analyzed:

The label itself must, in some fashion, convey three pieces of information to the user:

This information may be conveyed through words, or through a pictorial, which can depict one or two of these elements, or through a combination of the two. For example, to address severe hazards, we have found that in developing labels for certain industrial equipment, the best results were obtained when the pictorial conveys the hazard and the nature of the injury, while an accompanying word message explains all three elements. For workers who may be illiterate or who cannot read the languages of the word message, our objective was to ensure that the pictorial conveys the message that there is a serious injury associated with the use of the equipment, such that they are prompted to ask for verbal guidance from a co-worker or supervisor in communicating the proper action to take. ANSI Z535.3, Criteria for Safety Symbols, provides a procedure for evaluating safety symbol effectiveness: a sample of 50 people who are representative of the product user population(s) are asked the symbol's meaning; at least 85% must understand the meaning, and no more than 5% can think the symbol means the opposite of what it intended to convey. The ANSI Z535 standard series sets no requirements for testing a complete label. However, if an injury does occur, it is a virtual certainty that any resulting products liability litigation will allege, among other things, that the warnings are inadequate. To defend against this allegation, the manufacturer must prove that the warnings were understandable to the user population. A comprehensive label testing program is the basis for such proof.

CE Marking

When can I self-assess my product's compliance with CE Marking requirements, and when must I have a test laboratory certify my products?

In most cases, the manufacturer can self-assess conformity of his/her product and place the CE Mark on the product without third party certification. However, if the product falls into a high risk category of equipment (see Annex IV of the Machinery Directive), the product will have to be tested and/or certified by a third party assessor (referred to as a Notified Body). Additionally, specific types of regulated equipment, such as pressure vessels, telecommunications equipment and certain medical devices and equipment also require Notified Body evaluation. Refer to the E.U. Directives which apply to your specific product.

What steps are necessary for CE Marking Conformity self-assessment?

  1. Identify the E.U. Directives applicable to your product.

    Read the Machinery Directive (MD) and determine if your product falls within the E.U. definition of "machine." Determine if your product is subject to other E.U. Directives. Review the EMC, Low Voltage, Pressure Vessel, Gas Appliance, Telecommunications Equipment, Personal Protective Equipment, Toy, Lift and Construction Products, and Medical Devices Directives for applicability.

  2. Identify the E.U. standards applicable to your product.

    Review all E.U. standards which might affect your machine. The Directives identified in Step 1 state the legal requirements; the E.U. standards identified and reviewed in this step explain how to comply with the Directives. More than 1000 standards exist.

  3. Examine the Essential Health & Safety Requirements (EHSR's) of the applicable Directives.

    For example, Annex I of the Machinery Directive contains the EHSR's for most electro-mechanical equipment. It includes specific safety requirements addressing e.g., controls, mechanical hazards, guards and protection devices, electrical and material hazards, noise, vibration, emissions, maintenance, and instructions and warnings.

    As part of the EHSR examination, a thorough Hazard Identification and Risk Assessment must be performed on the subject equipment. Using the data from this Risk Assessment, the manufacturer must apply the following principles, in the order given:

  1. Eliminate or reduce risks as far as possible;
  2. Take the necessary protection measures in relation to risks that cannot be eliminated; and
  3. Inform users of residual risks due to any shortcomings of the protections measures adopted, indicate whether any particular training is required, and specify any need to provide personal protection equipment.
  1. Compile the "Information for Use."

    Prepare the information which will accompany the product, as well as the documentation which will be retained in the Technical File. This includes technical and operation manuals, warning labels and devices, equipment markings, and data produced during the Risk Assessment and EHSR examination.

  2. Generate a Technical File.

    A Technical File is required regardless of whether a manufacturer is able to self-assess, or whether Notified Body testing and/or certification is necessary.

  3. Determine the Need for Notified Body Involvement.

    Manufacturers of equipment listed in Annex IV of the Machinery Directive will be required to submit either the Technical File or a sample machine to an E.U. Notified Body. If necessary, the Notified Body will perform type-examination. Additionally, manufacturers of certain types of telecommunications equipment will be required to submit a sample machine to an E.U.-approved laboratory for EMC testing and verification. Finally, regulated products, such as pressure vessels and certain medical devices and equipment require Notified Body evaluation.

  4. Affix CE Marking and Prepare the Declaration of Conformity.

    The manufacturer is responsible for preparing the Declaration of Conformity, and affixing the CE Marking to the product. Only one Marking is affixed, representing compliance with all relevant Directives in force at the time of product entry into the E.U. A file containing the CE Mark in various graphic forms (JPG, GIF, PDF, TIF, etc.) is available here. The file is called ce-mark.zip. A file containing a template for a Declaration of Conformity (in MS Word Format) is also available here, as dofc-tpl.doc.

    We also provide a weekly update of articles of interest from the Official Journal of the European Community.

Do components have to be CE Marked in order to market them in the E.U.?

Generally no, it is the system integrator's responsibility to evaluate the end product for conformity with CE Marking requirements. However, safety components must be evaluated for conformity with CE Marking requirements, and must be accompanied by a Declaration of Conformity stating that this has been done. Additionally, many end-product manufacturers are requiring by contract that vendor parts be CE compliant in order to make the system CE evaluation easier.

We manufacture in volume, do we have to evaluate each individual product or just evaluate the prototype for CE compliance?

Once a representative product has been deemed to meet the CE Marking requirements, all subsequent products can be declared compliant provided that the manufacturer maintains a legitimate and comprehensive quality assurance program.

My product is U.L. listed and manufactured by an ISO 9000 company. Isn't that enough to meet CE Marking requirements?

No. U.L. listed products have been evaluated primarily from a fire protection standpoint. The CE Marking process evaluates a product from a systems safety perspective, with fire protection merely being one factor of many. Additionally, while ISO 9000 certainly qualifies as the legitimate QA program required in the last question, note that ISO 9000 is not required under the CE Marking Directives. However, this information contained within the U.L. files and the ISO 9000 program documentation would be useful in demonstrating at least partial compliance with CE Marking requirements.

I am merely a distributor to products, not a manufacturer. In other words, I buy products, place my company's nameplate on the product, and export them to the E.U. What responsibilities and/or liabilities do I have under the new E.U. Directive?

Under the E.U. Products Liability Directive, liability for damage or injury caused by a defective product can attach to "the manufacturer of a finished product, the producer of any raw material of the manufacturer of a component part, and any person who, by putting his name, trademark or other distinguishing feature on the product, presents himself as its producer." In the case of a manufacturer whose product is distributed in the E.U. without their permission, the Products Liability Directive specifies that "a producer shall not be liable if he proves that he did not put the product into circulation."

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Alvin Weinstein and Charles Seyboldt can also be reached at:

Weinstein Associates
19 Ridgeview Drive
Standish, Maine 04084
(207) 893-0352
(800) 893-8142 (fax)