EU and US Regulations on Instructions for Use: Find the Differences! (Part 2)

In the EU, a manufacturer can use European harmonized standards to comply with the relevant essential health and safety requirements of the CE marking directives and accordingly affix CE marking. Many of these CE marking directives also set requirements for instructions for use.
Although there are many similarities, the process of product compliance in the US is slightly different from the process of EU compliance.

Last week, Ferry Vermeulen and Michael Gerrits, discussed the EU requirements for insin the EU. In the next part, which is published next week, the US requirements for instruction for use are laid out, and a comparison is made with the EU rules.

[custom_headline type=”left” level=”h2″ looks_like=”h3″ accent=”false”]Product Safety in the US[/custom_headline]

[custom_headline type=”left” level=”h3″ looks_like=”h4″ accent=”false”]Introduction U.S. Federal Regulatory Framework

Product safety in the US is being regulated by various federal agencies. Once the Congress has enacted a product safety law, the appropriate federal agency (e.g., the Consumer Product Safety Commission, the Federal Trade Commission, the National Highway Traffic and Safety Administration, et al.) may create the regulations or rules to implement the law. Together, the enabling acts and laws and the final regulations provide a framework for the implementation and enforcement of most federal laws in the United States.

The nature and characteristics of the product or situation determines which Federal Agency is involved. An important federal agency when it comes to consumer product safety is the U.S. Consumer Product Safety Commission (CPSC). The CPSC aims to protect consumers from unreasonable risks of serious injury (or death) from products under its jurisdiction. The CPSC has jurisdiction over thousands of types of consumer products used in the home, in schools, in recreation, or otherwise. This includes products that pose a fire, electrical, chemical, or mechanical hazard or products that can injure children – such as toys, children’s apparel and textiles, cribs, power tools, cigarette lighters, and household chemicals.
The federal agencies are all independent agencies. Congress created the CPSC in the Consumer Product Safety Act (CPSA). In that law, the Congress directed the Commission to “protect the public against unreasonable risks of injuries and deaths associated with consumer products”.

In addition to the CPSA, the Consumer Product Safety Improvement Act (CPSIA) of 2008 is a United States law imposing new testing and documentation requirements. The CPSIA sets new acceptable levels of several substances and imposes new requirements on manufacturers of products covered by the CPSIA.
The CPSC attempts to achieve the goal to protect the public against unreasonable risks of injuries and deaths associated with consumer products through education, (mandatory) safety standards activities, developing and publishing regulations, enforcement of the statutes, banning products included. When the Congress has enacted a law, the federal agencies often develop or use existing standards to implement the law.

Section 102 of the CPSIA requires every manufacturer or importer of consumer products that are subject to a consumer product safety rule enforced by the CPSC to issue a certificate stating that the product complies with the applicable standard, regulation, or ban. Besides, it is or can be made mandatory by regulations and standards, that a product is tested by third party, the product is marked with the country of origin and that a manufacturer conducts recalls, if necessary.

The CPSC also inspects whether a product violates a specific statute or regulation. When CPSC staff determines violating cases, the CPSC Office of Compliance and Field Operations generally notifies the responsible firm and requests a specific remediation of the problem. The CPSA further requires importers, manufacturers, distributors, and retailers of consumer products to report to the CPSC about product risks. Specifically, these entities must report “immediately” to the CPSC any information that reasonably supports the conclusion that a product does not comply with:

  • CPSC safety regulations;
  • Contains a defect which creates a substantial product hazard;
  • Creates an unreasonable risk of serious injury or death.

[custom_headline type=”left” level=”h3″ looks_like=”h4″ accent=”false”]Regulated Products in the US[/custom_headline]

The several US Federal Agencies regulating products and situations are divided in the following main groups:

  • Health/ Body
  • Vehicles / Vehicle-Related Products
  • Hazards / Safety / Firearms
  • Other

The Health/Body group contains Federal Agencies covering alcohol, food, cosmetics and tobacco. The Vehicles group covers amongst others aircrafts, amusement rides, cars, boats and car seats. The Hazard/Safety/Firearms group contains Agencies taking care of ammunition, industrial & commercial products, radioactive materials etc. Besides products, the list contains many chemicals and substances, which cause injuries.
To collect the necessary information on the legal requirements applying to your product, first make sure in which jurisdiction your product is to be marketed and then which Federal Agency or Federal Agencies is (are) competent.

[custom_headline type=”left” level=”h3″ looks_like=”h4″ accent=”false”]Non-Regulated Products in the US[/custom_headline]

If you know the jurisdiction, but if your product is not on the lists of Regulated Products, you most likely market an unregulated product.
Unregulated Products do not have standards or bans. For all unregulated products you must report defective or dangerous products.

For most firms, there are two reporting requirements: Dangerous Products & Lawsuits. Regarding dangerous products, manufacturers, importers, distributors, and retailers are required to report to CPSC under Section 15 (b) of the Consumer Product Safety Act (CPSA) within 24 hours of obtaining information which reasonably supports the conclusion that a product does not comply with a safety rule issued under the CPSA, or contains a defect which could create a substantial risk of injury to the public or presents an unreasonable risk of serious injury or death. Regarding lawsuits, manufacturers of a consumer product are also required to report information about settled or adjudicated lawsuits to CPSC.

[custom_headline type=”left” level=”h3″ looks_like=”h4″ accent=”false”]Product Liability in the US[/custom_headline]

In the United States, there is no uniform product liability statute or common law. Each of the 50 states defines product liability law under its own standards, but typically product liability claims are brought under strict liability theory (is the product defective, irrespective of whether the manufacturer’s conduct was negligent), tort as in negligence (focus on the conduct of the manufacturer rather than the defect of the product), fraud (‘intentional tort’) or the warranty theory (contract). Further, most states have some form of consumer protective statute.

Within the US, product defects may be determined under a consumers’ expectations test or a risk utility test. The risk utility test tries to balance the utility of the product against the risks of its specific design. A product may be deemed defective on the basis of:

  • a manufacturing defect
  • a design defect
  • a warning defect

The failure to warn or to adequately warn of a reasonably foreseeable risk of the product sets a warning defect. Typical warning defects arises where:

  • inadequate (e.g. unclear of incomplete) warnings or instructions are given
  • the foreseeable danger of the product might have been minimized or avoided when the manufacturer (or another person responsible for the product compliance) would have provided reasonable warnings or instructions
  • the failure to provide such warnings or instructions rendered the product not reasonably safe.

The test for defects in design and warnings and instructions is very subjective and based on reasonableness factors to be decided by the jury. Determining when there is a duty to warn or instruct and how far that duty extends is one of the more difficult questions that needs to be answered by any manufacturer.

The (final) manufacturer, the manufacturer of individual components in the product or importer may be liable under a strict product liability claim for damage caused by a defective product. As well as for EU product strict liability claims, the causation standard applies that the injured person bears the burden of proving that the product defect caused this person’s injury.

[custom_headline type=”left” level=”h3″ looks_like=”h4″ accent=”false”]US Regulatory Framework and Instructions[/custom_headline]

Both mandatory standards and voluntary standards can provide for product specific requirements regarding instructions. Standards are voluntary unless “Incorporated by Reference” in a regulation. Regulations are always mandatory. Guidelines may be voluntary but are often de facto industry standards. Product specific standards may include requirements regarding the instructions for use. Besides this there are some commonly used standards that set out requirements for just the instructions for use.

Some commonly used standards for user’s instructions are:

  • IEC 82079-1 Preparation of instructions for use
  • ISO/IEC Guide 37:2012 – Instructions for use of products by consumers

Due to case law, warnings play a very important role in the US. According to this case law, a manufacturer has a duty to warn where: (1) the product is dangerous; (2) the danger is or should be known by the manufacturer; (3) the danger is present when the product is used in the usual and expected manner; and (4) the danger is not obvious or well-known to the user.

Another way to state this is that there is a defect in the warnings when reasonably foreseeable risks of harm posed by the product could have been reduced or avoided by providing reasonable instructions or warnings, and the omission renders the product not reasonably safe.

The fact that adequate instructions are provided assisting the operator in the correct operation of the product does not necessarily discharge the duty to provide an adequate warning. A warning may still be required to call attention to the dangers of using the product. Instructions affirmatively inform persons about how to use and consume products safely. Warnings alert users and consumers to the existence and nature of product risks. Generally, warnings tend to be negative statements about things not to do or affirmative statements about things always to do. Instructions tend to describe in more detail how to do something safely and correctly.

Because the importance of warnings in the US, a specific standard has been developed dealing with the content, location and presentation of warnings: ANSI Z535.6, Product Safety Information in Product Manuals, Instructions, and Other Collateral Materials.

[custom_headline type=”left” level=”h2″ looks_like=”h3″ accent=”false”]The EU en US compared[/custom_headline]

[custom_headline type=”left” level=”h3″ looks_like=”h4″ accent=”false”]The main differences between the process of compliance in the US and the process of EU compliance[/custom_headline]

  1. The US system does not use CE marking or any other (general) conformity marking.
  2. In the EU there is just one procedure to comply your regulated product with applicable legislation, namely by following the steps towards CE marking. In the US the kind of product and thus the applicable Federal Agency determines which steps to follow to comply your product.
  3. In the US, both the design of the product safety requirements and the inspection on compliance are done by the same federal agencies. In the EU the European Commission does the designing, but national authorities do the inspection.
  4. In the EU new directives are designed from scratch. In the US product requirements are based on national laws as enacted by the Congress.
  5. Standards are on a voluntary base in the EU as a rule, but can be mandatory in the US.
  6. In the US, some state laws and regulations are enacted which are more stringent than the federal laws. In the EU, European laws are harmonized at the same level for all member states.
  7. Case law in the US emphasizes a ‘general duty to warn’ against product risks.

These differences also have effect on the instructions for use that accompany a product. The requirements regarding the instructions for use, as set out by mandatory standards, should be followed strictly in the US. In the EU, the essential requirements as provided for in the legislation are mandatory and standards can be used on a voluntary basis in order to comply with those essential requirements. Another effect of the differences is that the ways warnings are designed, placed and formulated have a more central role in the US. When exporting from the EU to the US (or vice versa), the differences should be taken into account, so also the instructions comply with all laws and product liability will be minimized.

[custom_headline type=”left” level=”h3″ looks_like=”h4″ accent=”false”]Steps to CE marking[/custom_headline]

Each business that manufactures, imports or distributes must ensure or act with due care that the products they market are safe. By affixing the CE marking on a product, the product’s manufacturer declares conformity with all of the applicable pieces of legislation to achieve CE marking. The directives/regulations set out the requirements in general terms. As a result, essential requirements define the results to be attained, or the hazards to be dealt with, but do not specify the technical solutions for doing so. The precise technical solution may be provided by a harmonized standard or by other technical specifications at the discretion of the manufacturer. This flexibility allows manufacturers to choose the way to meet the requirements.

The following steps guide you through the process of CE marking:

  1. Identify the directives and/or regulations and harmonized standards applicable to the product
  2. Verify the product-specific requirements
  3. Identify whether an independent conformity assessment is required from a Notified Body
  4. Test the product and check its conformity
  5. Draw up and keep available the required technical documentation
  6. Draw up the EC Declaration of Conformity and affix the CE marking to your product

The following general steps will guide you through the process of compliance of your documentation (information, warnings, markings, instructions, sales presentation) with the relevant product safety legislation:

  1. Identify the directives and product specific harmonized standards applicable to the product
  2. Identify the requirements for drafting (user) instructions set out in the applicable relevant product legislation
  3. Identify the harmonized standards for user instructions. The EN-IEC 82079-1 is commonly used
  4. Draw up the instructions (and other technical documentation) according to the requirements

[custom_headline type=”left” level=”h3″ looks_like=”h4″ accent=”false”]Steps to US Consumer Product Compliance[/custom_headline]

As a business that makes, imports or distributes consumer products, it has a variety of acts and laws and final regulations to follow. The kind of product, and thus the applicable Federal Agency, determines which steps to follow exactly to comply your product with the legislation. For example, the following steps, as described on the CPSC website, will help guide you through the process of complying with federal government safety regulations concerning the products CPSC has jurisdiction over:

  1. Do you make a product for children?
  2. What regulations apply to my product?
  3. How do I test and certify my product?
  4. What are required labels for my product?
  5. What is mandatory reporting?
  6. I still need more help

The following steps will guide you through the process to fully comply the documentation of your product with the US standards, laws etc,

  1. Identify the applicable acts and laws and regulations for your product
  2. Identify the competent federal agencies for your product
  3. Identify which standards are mandatory for your product
  4. Identify which standards are voluntary for your product
  5. Identify the specific requirement for adequate instructions for use
  6. Identify the harmonized standards for user instructions. The EN-IEC 82079-1 and ANSI Z 535.6 are commonly used
  7. Verify the product-specific requirements from both the voluntary and mandatory standards
  8. Draw up the instructions (and other technical documentation) according to the requirements

[custom_headline type=”left” level=”h2″ looks_like=”h3″ accent=”false”]References[/custom_headline]–Standards/Products-Outside-CPSCs-Jurisdiction/–Standards/Regulations-Mandatory-Standards-Bans/–Standards/Voluntary-Standards/

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