The US and EU regulations on instructions for use: A world of difference?

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Product Safety in the EU

Introduction CE marking

The European New Approach Directives form the starting point of the CE marking (Conformité Européenne). CE marking is a key indicator of the compliance of a product with the relevant EU legislation. When a product complies with the applicable EU legislation, the free movement of products within the European market is enabled. By affixing the CE marking on a product, the product’s manufacturer (the importer of a product from outside the EU is legally considered as the manufacturer too) declares, on his sole and ultimate responsibility, conformity with all of the legal requirements to achieve CE marking. With this, the manufacturer ensures validity for that product to be sold throughout the European Economic Area, as well as Turkey. The procedure of CE marking also applies to products made in third countries, which are sold in the EEA and Turkey. The European Commission draws up the legislation. Accordingly, the EU member states have to implement the exact legislation in their national laws (except for Regulations that are directly applicable).

What CE marking (not) means:

• CE marking merely states that the product is assessed on safety, health and environmental protection requirements before being placed on the market and thus satisfies the legislative requirements (e.g. a harmonized high level of safety) to be sold there;
• The CE mark means that the manufacturer (or its authorized representative or the importer) has verified that the product complies with all relevant essential requirements of the applicable directive(s) and/or regulations.
• The CE mark can indicate that a notified body, if required by the applicable directive(s) and/or regulations (for certain products that present inherently higher risks), has examined the product. A notified body is an independent organization, appointed by national authorities, that performs the safety check.
• CE marking, however, does not indicate that the product has been approved as safe by the European Union or by another authority.
• The CE mark is not an indication that a product was made in the EEA.

When a product is subject to CE marking, it is the manufacturer’s responsibility to carry out the conformity assessment, to draw up the technical file and the EC declaration of conformity and to affix CE marking on the product. It’s the responsibility of distributors to verify the presence of both the CE marking and the required documentation. If the product is being imported from a country outside the EU, it is the importer’s responsibility to ensure that the manufacturer outside the EU has undertaken all the required steps and that the documentation is available upon request.

Regulated Products in the EU

Not all products are part of CE marking and thus not all products have to bear the CE marking logo. In fact, the CE mark shall be affixed only to products to which its affixing is provided for by specific EU harmonization legislation. CE Marking harmonization legislation (European Union legislation that require the affixing of a CE mark to the products covered by them) have been developed for product groups like medical devices, machinery, toys and radio and telecommunications terminal equipment. In total there have been developed pieces of legislation for over 20 product groups.

Non-Regulated Products in the EU

Consumer products

The General Product Safety Directive 2011/95/EC (GPSD) has been developed to ensure a high level of product safety throughout the EU. The GPSD applies to all consumer products that are not (or just partly) covered by specific EU sector legislation (e.g. outdoor furniture, gymnastic equipment, child use and care articles, lighters, floating leisure articles for use on and in the water). The Directive also complements the provisions of sector legislation which do not cover certain matters, for instance in relation to importers’ obligations and the authorities’ powers and tasks. The objectives of the GPSD are both to protect consumer health and safety (by ensuring that only safe consumer products will be placed on the EU market) and to ensure the proper functioning of the internal market.

The GPSD gives a generic definition of what a safe product is. According to this definition, a safe product:

“shall mean any product which, under normal or reasonably foreseeable conditions of use including duration and, where applicable, putting into service, installation and maintenance requirements, does not present any risk or only the minimum risks compatible with the product’s use, considered to be acceptable and consistent with a high level of protection for the safety and health of persons (…)”

In particular, the Directive takes the following points into account:

1. the characteristics of the product, including its composition, packaging, instructions for assembly and, where applicable, for installation and maintenance;
2. the effect on other products, where it is reasonably foreseeable that it will be used with other products;
3. the presentation of the product, the labeling, any warnings and instructions for its use and disposal and any other indication or information regarding the product;
4.  the categories of consumers at risk when using the product, in particular children and the elderly.`

Products must comply with the given definition. In the absence of specific EU harmonization rules, the safety of a product is assessed in accordance with:

• European (harmonized) standards,
• Rules or standards drawn up in the Member State in which the product is marketed,
• EU technical specifications,
• Codes of good practice (e.g. Tampon Code of Practice),
• The state of the art, and
• The reasonable expectations of consumers.

Professional products

For non-regulated non-consumer goods no EU harmonization legislation exists. As a result, these products shall conform to the specific rules of national law of the Member State(s) in whose territory the product is marketed and laying down the health and safety requirements which the product must satisfy in order to be marketed.

Product Liability in the EU

As a manufacturer, importer or distributor you should make sure that the products you market are safe and comply with the applicable product safety legislation. You can be held responsible for damage caused by defects to your products. By ensuring that your products comply with the relevant safety requirements, you will generally avoid product liability claims for defective products.

Directive 85/374/EEC concerning liability for defective products lays down the principles of product liability in the EU. This Directive establishes the principle of liability without fault applicable to producers. Where a defective product causes damage to a consumer, the producer may be liable. The legislation applies to all movable products, e.g. consumer products, pharmaceuticals, agricultural products and electricity. All circumstances are taken into account when deciding whether a product is defective, including:

• The manner in which a product is marketed (including sales literature);
• Any instructions or warnings that are given with it;
• What might reasonably be expected to be done with it;
• The time the producer supplied the product.

The producer will be held responsible if there is a causal relationship between the defect in a product and the damage, meaning that it is clear that the product was defective and the defect caused the damage.

CE marking and instructions

The fundamental requirements, as set out in the CE marking directives, also include requirements regarding documentation (user’s manual, installation instructions, maintenance prescriptions, EC declaration). Most directives require “adequate” instructions for use. In the more detailed (product specific) harmonized European standards can be found how to meet these requirements technically.

The European harmonized standard EN-IEC 82079–1 Preparation of Instructions For Use gives concrete (minimal) requirements for the instructions for use.

Product Safety in the US

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. 

Regulated Products in the US

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.

Non-Regulated Products in the US

If you know the jurisdiction, but if your product is not on the lists of Regulated Products, you most likely have 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.

Product Liability in the US

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 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.

US Regulatory Framework and Instructions

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 standards had 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

The main differences between the US and the EU

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.

Steps to CE marking

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

Steps to US Consumer Product Compliance

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——–

This blog has been co-written with Michael Gerrits, LL.M. As an attorney Michael advises companies at the core of their business (Safety, CE marking, product legislation and intellectual property). Michael serves clients including the following sectors: Manufacturing Industry, Engineering Industry, Oil & Gas, Energy, Chemistry, Metal & Technology, Offshore, Government, Lifts & Transport. He speaks regularly at training courses and symposiums.