Posted on: 10/12/2012
Jonathan R. Cooper, Arun J. Kottha
View Latest Articles
Until recently, a properly crafted safety warning seldom interfered with the salability of a product. The 2006 European Union Machinery Directive (the "EUMD"), ratified by the European Union's member countries in late 2009, will likely create a great deal of interference.
Many U.S. manufacturers sell products in the United States and the European Union. In almost every case, such products are festooned with warning labels to prevent accidents and to avoid liability.
Warning labels are expensive. They must be designed, manufactured and applied. They must be made from special plastic that will withstand harsh environments. Care must be taken to ensure they are properly affixed and properly placed on the product.
Until recently, manufacturers have been able to design harmonized product warnings on products bound for the United States and the European Union. The EUMD threatens that ability. If the EUMD is followed to the letter, every warning on every product destined for a European Union state must consist of a pictogram, and any written warnings must be translated into the official language of the country of the product's destination. Manufacturers both importing from the United States and exporting to the European Union have four choices: (1) ignore United States warning standards and risk liability for insufficient warnings; (2) ignore the EUMD and risk product rejection in the European Union; (3) draft multiple translations of all words and message panels and apply them on a case-by-case basis or; (4) maintain one set of American National Standards Institute ("ANSI") style warnings for the United States market and another set of pictograms for the European market.
None of these solutions is attractive; all are potentially costly.
But this is not merely a financial decision. ANSI and the International Organization for Standardization ("ISO") designed the different warning schemes to promote and enhance the safety of the products produced. The warnings are based on an expectation that uniformity in format will enhance readability and compliance. Instituting a new set of requirements may interfere with that overarching goal.
A Brief History of the Standardized, Pictorial Warning Label
The story of modern, standardized, pictorial warning labels begins with the National Electrical Manufacturers Association ("NEMA"). Confronted with rising levels of "failure to warn" allegations involving electrical equipment in the early 1980's, NEMA's members set out to develop a warning label. Although electrical equipment was generally locked, tampering by vandals gave resulted in a number of serious injuries when children explored the interior of such equipment and were electrocuted. To combat the failure to warn claims, the manufacturers needed to develop a warning label effective for young children who either could not read or who could not grasp the severity of danger in the language. NEMA members developed the now-famous pictorial of "Mr. Ouch" and engaged in extensive testing of children of several ethnicities aged 2.5-6.5 years. The Mr. Ouch pictorial ranked the highest in "every major category relative to depicting a threat and inducing a safe response."
The beauty of Mr. Ouch was that it worked. The testing demonstrated that people, including children, recognized the symbol and were given the information necessary to avoid the risk of harm. From a products liability standpoint, manufacturers could prove that they had used an effective warning. This not only improved safety, it also improved a manufacturer's ability to defend its products. Mr. Ouch was the first standardized warning adopted by an industry.
Short of an actual survey of the effectiveness of a particular warning, manufacturers typically rely on compliance with consensus standards promulgated by bodies such as ANSI, which oversees the creation, promulgation, and use of thousands of norms and guidelines that directly impact businesses in nearly every sector of the U.S. economy.
In the case of warnings, the relevant standards have been promulgated under the ANSI Z535 committee since 1991.
The Z535 standards were designed to create something that was as effective as Mr. Ouch. The mantra of the ANSI warning system is threefold: alert a user to the danger; inform the user of the severity of the danger; and instruct the user how to avoid the danger. A combination of symbols, colors, and mandatory warning language accomplish all three.
The stated purposes of ANSI Z535 are: to establish a uniform and consistent visual layout for safety signs and labels applied to a wide variety of products; to minimize the proliferation of designs for product safety signs and labels; and to establish a national uniform system for the recognition of potential personal injury hazards for those persons using products.
There are four levels of severity denoted by the following four "signal words" (with corresponding colors): "DANGER" (white letters, red background); "WARNING" (black letters, orange background); "CAUTION" (black letters, yellow background); or "NOTICE" (white letters, blue background). A safety symbol displayed as an equilateral triangle surrounding an exclamation point, accompanies all signal words.
A product safety sign or label consists of a signal word panel and a mandatory message panel communicates the type of hazard, the consequence of not avoiding the hazard, and how to avoid the hazard. There are a number of specific instructions regarding the font, alignment, and other physical characteristics of the language used on the message panel. ANSI Z535 also instructs the manufacturer to avoid the passive voice and prepositional phrases.
The idea is that any person could, with a quick look, know the trouble ahead, the possible outcome, and how to avoid it. Manufacturers in the United States have now spent more than a generation teaching users and consumers to recognize and interpret ANSI-style warnings.
Compliance with ANSI Z535 also gives a manufacturer a litigation advantage. Compliance with ANSI Z535 allows the manufacturer to argue that it fulfilled its duty to warn by following the relevant consensus standard.
While the ANSI committees were honing the Z535 standards, the International Organization for Standardization ("ISO") was developing its own standard, using a different concept. While the ANSI standard was based on safety symbols, signal words, and message panels, ISO created a symbol-based system.
ISO is the world's largest developer and publisher of International Standards. ISO, a non-governmental organization, is a network of the national standards institutes of 161 countries, with its Central Secretariat in Geneva coordinating the system. ANSI is the official United States representative to ISO.
ISO 3864-2 establishes principles for the design of product safety labels. According to ISO 3864-2, the purpose of a product safety label is to alert persons to a specific hazard and to identify how the hazard can be avoided. In short, ISO and ANSI have similar goals – uniform systems to give users and others information about hazards, the severity of the hazards, and how to avoid them. The major difference is the method each system uses to achieve its goals.
To comply with the ISO regulations, businesses must use at least one of three types of safety signs: an equilateral yellow triangle (warning), a red circle with slash (prohibition), or a blue circle (mandatory action). A pictogram describing a hazard, an action, or an instruction will be included on each type of sign. The most familiar example is the no smoking "prohibition" sign. The ISO 3864-2 system utilizes three basic colors as signals for the severity of harm to be encountered (red for high, orange for medium, and yellow for low). Signal words can be associated with each level of severity: danger, warning, and caution, respectively. Each of these three levels of severity has an equilateral triangle surrounding an exclamation point in the appropriate color. Together they form a hazard severity panel. Note, however, that the use of signal words or a hazard severity panel is not mandatory. Stated differently, each label "shall be comprised of one or more safety signs," and may be "accompanied by a hazard severity panel." Finally, there is the option of adding supplementary safety information text which can include warnings such as: "ELECTRICAL HAZARD - Contact with Water Can Cause Electrical Shock." These language-based warnings, like the signal words, are permissive.
ISO vs. ANSI
ISO places a heavier reliance on pictorial warnings than ANSI. In fact, the ISO warning can be exclusively pictorial. By contrast, the ANSI standard mandates that a signal word and a message panel provide necessary information to the product user.
Neither the ANSI nor the ISO warning schemes has the force of law. The differences between these two approaches can cause potential litigation problems and possible safety issues. If a manufacturer, adhering to the ISO standard, exports its products to the United States, it is at risk for liability based upon failure to warn. The liability stems from the manufacturer's failure to warn to the relevant U.S. standards.
In addition, the goals of the two systems, while similar, are not exactly the same. ISO's goal is "to alert persons to a specific hazard and to identify how the hazard can be avoided," whereas ANSI's goals are to "establish a uniform and consistent visual layout for safety signs and labels applied to a wide variety of products; to minimize the proliferation of designs for product safety signs and labels; and to establish a national uniform system for the recognition of potential personal injury hazards for those persons using products." The ISO system is less concerned with variation and more concerned with adapting safety labels to specific situations. By contrast, ANSI is more concerned with a standardized system. ANSI's theory is essentially that although the warnings may not adapt to each unique situation, workers will be safer when conditioned to the same signal words and warning style year after year.
Using ISO warnings in the United States or ANSI warnings in Europe may have safety consequences. If the goal of each warning system is to provide a uniform system to provide readily understandable access to safety information, using a different system is problematic.
It is possible to (mostly) harmonize ISO and ANSI standards into a single hybrid warning label. For example, an ISO/ANSI hybrid warning label would be one with an ISO pictorial, accompanied by an ANSI-compliant message panel and signal word. This would ostensibly satisfy the ISO requirements and supply the required verbiage of the ANSI requirements. This solution is not perfect. The ISO system does not require any language at all in either a hazard severity panel or supplementary safety information text. If one does exercise such an option, ISO provides no guidance about the language that must be used. The colors and color schemes are slightly different. For example, including an ANSI-compliant message panel for a given severity of risk would not be exactly congruent in color with ISO. However, the hybrid label is very close to full compliance with both standards.
Enter the New European Requirements
Much of the work harmonizing ISO and ANSI warnings may be for naught due to the EUMD. Unless the EUMD is modified, any manufacturer selling a product in Europe will now need to comply with this new law, which introduces a third set of requirements for approved warnings.
These new requirements are the law. The European Union Parliament has power to legislate directives and regulations. Both have the force and effect of law. Regulations are self-executing, and effective and binding on the member states automatically and immediately. There is no country-by-country ratification process for the individual member states, even though they are sovereign nations. Directives, once approved by the Parliament, must still be enacted by each member state. Each member state may tailor a directive to its particular needs as long as its version remains aligned with the spirit of the directive. Directives generally set forth a series of goals and give a date by which each member state is to enact legislation to its effect.
Each of the European Union member states has now ratified the EUMD. The EUMD is applicable to machinery interchangeable equipment; safety components; lifting accessories; chains, ropes and webbing; removable mechanical transmission devices; and partly completed machinery.
Section 1.7 to Annex I, entitled "information," deals with warnings and accompanying instructions. The EUMD explicitly states a preference for pictorial-based warnings, presumably due to the diversity of languages spoken in the European Community. In fact, any
…written or verbal information and warnings must be expressed in an official Community language or languages, which may be determined in accordance with the Treaty by the Member State in which the machinery is placed on the market and/or put into service and may be accompanied, on request, by versions in any other official Community language or languages understood by the operators.
In short, any verbiage on a warning label must be translated in the official language(s) of the destination member state. If a product is sold to an entity near a border, the language problem may multiply. To comply with the EUMD, ANSI and ISO, multiple translations of the signal words and the message panels are required.
European Union Enforcement
With the EUMD in full force and effect in member states for over two years, EU member states have taken multiple actions to comply with the myriad of EUMD requirements. A brief overview of the approval process for machinery may be helpful: There are several ways a manufacturer can establish conformity with the EUMD. For machinery listed in Annex IV of the EUMD (e.g. circular saws, band-saws, vehicle servicing lifts), the manufacturer can
- construct a so-called technical file and ensure compliance with the file through self-certification,
- contact a "notified body" (an organization authorized by a member state) to certify that the machine satisfies the EUMD's requirements, or
- confirm that the machine was manufactured using a full quality assurance system by having a "notified body" assess and approve the quality system and monitor its application.
If the machine is not listed in Annex IV, the only option for the manufacturer is to self-certify compliance with the Directive.
Once the manufacturer of a machine has established conformity with the EUMD, it can prepare a Declaration of Conformity. The Declaration of Conformity appears in the machine's operation manual, and declares that the manufacturer guarantees each piece of equipment sold is in conformity with the Directive.
An accompanying regulation – automatically binding on all member states – notes that a machine presenting a "serious risk," must be recalled or withdrawn from the market. If a member state takes action in accordance with this provision, it must notify the European Commission immediately.
The EUMD was implemented by the United Kingdom through the Supply of Machinery (Safety) Regulations 2008 ("the Regulations"). The Regulations are enforced by the Health and Safety Executive (comparable to OSHA) for machinery used in the workplace, and by the Trading Standards Service for machinery used at home. When a machine is suspected deficient, the authority must serve the manufacturer in writing, stating that the machine has failed to comply with the requirements of the EUMD. The notice must include the reason the authority finds the machine deficient and the actions the manufacturer must take to bring the machine into EUMD compliance (whether through a product recall, withdrawal from the market, or the repair of a faulty product.)
The Health and Safety Executive (HSE) has published a guide for manufacturers selling new equipment in the UK taking the exact requirements from the Regulations. Not surprisingly, the Regulations require that any warning label be in English, which is exactly what the EUMD envisioned. The Regulations also advise a manufacturer is to refer to National, European, international, "or other specifications" when designing machinery. The equipment must, however, conform exactly to the "essential health and safety requirements" (including warnings requirements) set forth in the Regulations, which "are identical" to those found in the EUMD.
There are signs that the EUMD has some teeth. Although there have been no apparent actions relating to the warning language requirements specifically, there has been activity in the years since the EUMD's effective date. For example, in the UK, a Chinese-made angle grinder was voluntarily recalled because it failed to comply with the EUMD because of a sticky power switch.
Besides regulatory agency action, there is also the potential for private party litigation. The European Union parliament passed a product liability act directive in 1985. This directive adopts a strict liability standard: to establish liability, a claimant need only show a product "defect" that caused the injury or damage. The UK Parliament followed suit two years later (as it was required to), with the Consumer Protection Act of 1987. The act uses a consumer expectation test for liability: a "defect" is shown by demonstrating that the "the safety of the product is not such as persons generally are entitled to expect." There is no specific failure to warn claim. Rather, the idea is embodied in what the trier of fact may consider in determining whether the product is defective: (1) the manner in which a product is marketed; (2) any instructions or warnings that are given with it; (3) what might reasonably be expected to be done with it; and (4) the time the producer supplied the product. The Consumer Protection Act of 1987 applies to manufacturers, re-branders of products, and importers of products from outside euro zone countries, including products covered by the EUMD.
Harmonizing the United States' and Europe's Requirements: What Do We Do?
Following the ratification of the EUMD, designing one warning label that will pass muster in both the United States and Europe may be impossible. The main problem in this regulatory nightmare is the language requirement in the EUMD. By itself, it provides for an almost unworkable requirement of translating any text on warning labels into over 20 languages. It appears the only clear way to comply with the machinery directive's language requirements is to have no language at all. However, that warning would then fail to comply with ANSI Z535.4. Failure to comply with ANSI Z535 in the United States may make the product less safe. It will almost certainly make it harder to defend in the event of a failure to warn claim.
Limited options exist to solve this issue but none is ideal. The first option is to simply issue different warnings for products destined for the United States versus products destined for Europe. This possibility precludes the use of a universal warning label and increases costs due to the need to design and implement two warnings regimes, engage workers to install these warnings, and engage inspectors that insure that the proper warnings are used. Another possibility is to use an ANSI-compliant warning for the product for distribution across continents, and offer a method for obtaining a language translation to a subsequent European purchaser, such as an automated website which will send translated warnings to anyone who provides a serial number. This methodology does not solve the problem of retaining one universal warning label, and in fact, requires maintaining warning labels in myriad languages at increased cost. In addition, it underscores the main problem with the Machinery Directive: to comply with the strict letter of the EUMD, a manufacturer must keep on hand or affix a warning label to the product in all of the community languages. Moreover, the EUMD requires that the warning accompany the product. It is not clear that directing a buyer or user to a website will satisfy that requirement.
A third possibility is to use an entirely ISO pictorial warning in the United States and Europe. A purely unscientific survey of products being shown at trade shows by one of the authors indicates that many manufacturers seem to be drafting this sort of warning. However, such a plan creates a risk when a party is injured by a product is sold in the United States. The argument will be that the manufacturer failed to effectively warn because it failed to comply with the ANSI standard.
All of these options present a potential for eventually mastering the regulatory structure anomalies, but all have their drawbacks.
The overarching concern in all of this is the issue of worker safety. As counselors, we can advise our clients about the best way to prevail in a lawsuit, but it is far better to avoid lawsuits in the first place and promote safety as a company policy. The premise of the ANSI warning systems and the one permitted by ISO is to give the user quick information: a worker sees the word "Danger" in a certain recognizable format he has seen hundreds of times. That worker knows injury or death is a result of not following the instructions, and that same scheme is on every product. While the research on the effectiveness of ISO and ANSI warnings shows neither is significantly better at changing user behavior than a non-standardized label, adding a third varying scheme with no scientific basis will certainly not advance the cause of safety. If the EUMD precipitates a sudden deviation after 30 years of training workers what to look for, does this not run counter to the overarching concern for worker safety to which all warnings systems aspire? We shall see.
Jonathan R. Cooper
Tucker Ellis LLP
Arun J. Kottha
Tucker Ellis LLP
 See ISO 3864-2:2004 and ANSI Z535.4-2007, §2.2
 Kenneth Ross, "The Story of 'MR OUCH', Creation of a warning label", Product Liability Int'l, October 1983, pp. 152-154.
 See id.
 http://www.ansi.org/about_ansi/overview/overview.aspx?menuid=1, accessed 3/19/2012.
 ANSI Z535.4-2007, §2.2.
 Id. at §§5.1, 7.2.
 Id. at Annex B.
 http://www.iso.org/iso/about/discover-iso_how-the-iso-system-is-managed.htm, accessed 3/19/2012. A host of information about ISO can be found on their website, www.ISO.org, and copies of all referenced ISO standards can be purchased there as well.
 http://www.ansi.org/about_ansi/introduction/introduction.aspx?menuid=1, accessed 3/19/2012.
 http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=31020, accessed 3/19/2012.
 ISO 3864-2:2004, §6.2.
 Id. at §4.3.
 Id. at §5.3.
 Id. at §5.1 ("If the level of hazard severity is to be indicated…").
 Id. at §6.1.
 Id. at §§3.15, 6.1.
 Id. at §6.1.
 ISO 3864-2:2004; http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=31020.
 ANSI Z535.4-2007, §2.2.
 For example the EUMD was enacted in 2006, and gave a deadline to enact legislation by June 29, 2008, with an effective date of such legislation of December 29, 2009 at the latest. 2006/42/EC, Art. 26, ¶ 1. A copy of the English version of the directive can be found at http://eur-lex.europa.eu/LexUriServ/site/en/oj/2006/l_157/l_15720060609en00240086.pdf, accessed 3/19/2012.
 2006/42/EC, Art. 1, ¶ 1. The EUMD, however, exempts a number of items commonly viewed as machinery: site hoists, weapons, devices for lifting personnel, consumer products, certain farm tractors, electrical equipment (including a variety of items from consumer electronics to high voltage switchgear), certain safety devices, vehicles for transport of persons and cargo (land, sea and air), machinery for "nuclear purposes," military equipment and a variety of highly specialized machines. Id. at Annex I, §1.7
 2006/42/EC, Annex I, §1.7.
 See n. 24, supra.
 A machine's technical file contains details of a hazard and risk assessment in which categories of risk are identified. 2006/42/EC, Annex VII. The file then details how the machine complies with the EUMD, using detailed drawings of the equipment and any calculations or test results. 2006/42/EC, Annex VII (A)(1)(a). For example, the file will detail each essential health and safety requirement (and how the machine complies or actions that must be taken in order for it to comply), and then address numerous other requirements. 2006/42/EC, Annex VII (A)(1)(a).
Because most machines that are CE marked are self-certified by the manufacturer, technical files are not typically examined until an incident occurs. In the case of an incident, the member state's agency responsible for consumer safety will request the machine's technical file. The EUMD requires manufacturers based outside of the EU appoint a person based in the EU to be responsible for providing the technical file to the national authorities if so requested. 2006/42/EC, Annex VII(2). Non-EU manufacturers who previously self-certified their machines, are now burdened with having to establish a link with a European company/individual before they are able to sell their machine in the EU.
 2006/42/EC, Art. 12, ¶1; 2006/42/EC, Art. 14.
 2006/42/EC, Art. 12, ¶2.
 2006/42/EC, Annex II, (1)(A)(4).
 EU Regulation No. 765/2008, Art. 20. A copy of the english version of this regulation can be found at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0030:0047:en:PDF, accessed 3/19/2012.
 Id. at Art 22.
 Statutory Instrument 2008:1597.
 Id. at part 6(21)(2)
 Id. at part 6(21)(3).
 Id. The maximum penalty under the Regulations is two years imprisonment and/or a fine. Part 6(22)(a), (b). The Regulations also note that any incident that involves injury or damage to a consumer will also fall within the scope of other UK safety legislation, so further sanctions may be applied.
 See http://www.hse.gov.uk/pubns/indg270.pdf, accessed 3/19/2012.
 See http://webforms.sgs.com/v4/corp/safeguards/pdf/PRODUCT-RECALLS-Consumer-Products-February-01-15.pdf, accessed 3/19/2012.
 85/374/EEC. A copy of the English version of the directive can be found at http://www.delpak.ec.europa.eu/cpn/Supply%20Contract-Generators-08-03-11/Generators%20-%20EU%20Directive%201985%20-%201999%20on%20product%20liability.pdf, accessed 3/19/2012.
 Id. at Art. 2
 1987 c. 43. A copy of this legislation can be found at http://www.legislation.gov.uk/ukpga/1987/43/pdfs/ukpga_19870043_en.pdf, accessed 3/19/2012.
 Id. at § 3.
 Id. at § 3 (2)(a)-(c).
 Id. at § 2(2)(a)-(c). Any supplier in the distribution chain can be held primarily liable if it withholds certain information (if requested by the plaintiff) regarding the identity of the manufacturer or re-brander of the product.
 2006/42/EC, Annex I, § 1.74.
 See n. 23, supra.