United States: Productwise Bitesize: The General Product Safety Directive

Cooley's Productwise Bitesize brings you a short introduction to the "General Product Safety Directive".

What is it called?

Directive 2001/95/EC on General Product Safety (the "GPSD"). It is currently under review. The European Commission has indicated it is planning to either amend the existing Directive or adopt a new Regulation in the second quarter of 2021.

What is it about?

The GPSD forms the basis of product safety obligations in the European Union for general consumer products. It imposes obligations on certain economic operators in a supply chain to ensure that only safe products are sold to consumers, and that consumers are adequately informed of any risks posed by products.

The GPSD sets out the "general safety requirement": producers shall "place only safe products on the market". A product is deemed safe if it meets legal requirements. There is a rebuttable presumption of safety where the product meets harmonised standards. In other cases, safety is assessed by reference to national standards, Commission guidance, industry codes of practice, the state of the art, and consumer expectations regarding safety.

The GPSD sets out a number of additional obligations:

• Producers should take steps to ensure they are aware of any risks their products may pose and be prepared to take corrective action, including warning consumers and withdrawing or recalling products.

• Distributors are required to act with "due care" to ensure compliance with safety requirements and should not supply products they know or should know are unsafe. They are required to monitor to safety of their products on the market.

• Both producers and distributors are obliged to notify the authorities if they become aware that they have placed an unsafe product on the market.

The GPSD also establishes the EU Rapid Alert System (RAPEX, also known as Safety Gate). This provides a portal for producers and distributors to notify multiple Member States via the European Commission. It also allows Member States to exchange information on product safety issues.

Who and what does it apply to?

The GPSD applies to 'producers' and 'distributors'. The terms are defined more broadly than they are typically used in business.

Producers can be:

• manufacturers (where established in the EU);
• anyone presenting themselves as the manufacturer who affixes their brand to the product;
• anyone who reconditions the product;
• manufacturer's representative (where the manufacturer is not established in the EU);
• importer into the EU (if the manufacturer does not have a representative in the EU); or
• other professionals in the supply chain "insofar as their activities may affect the safety properties of a product".

Distributors are professionals in the supply chain who do not affect the safety properties of a product.

The GPSD applies to consumer products where there are no specific provisions with the same objective in other EU legislation. Therefore, it complements sector-specific legislation such as the rules that apply to toys, electrical products, chemicals and other groups.  It does not apply to pharmaceuticals, medical devices or food.

Why does it matter?

The GPSD is a fundamental piece of European product safety legislation, and establishes a framework for the way in which certain businesses in the supply chain operate with regard to product safety.

While draft legislation has not yet been published, it seems likely that the GPSD's 20^th anniversary will see the explicit extension of the GPSD to the development, manufacture and supply of new technologies such as AI, Robotics, AR/VR, connected devices and products which incorporate these elements. For companies operating in this space, it will be important to review any proposals carefully to understand how they impact your product safety obligations.

What is being proposed?

We set out below the specific product safety challenges identified by the European Commission:

• New technologies. The Commission believes the growth of new technologies, such as AI and IoT, pose challenges to the current definition of products (including to what extent a product includes software) and create new risks (e.g. a product can become dangerous by not having sufficient cybersecurity protection, leaving it open to hacking). The Commission has also suggested that new technologies create uncertainty in relation to the concept of "placing on the market" (e.g. if products subsequently change as a result of software updates).
• Online sales channels.  The Commission feels that Member States do not have sufficiently effective instruments for online market surveillance and that product safety rules for online platforms are unclear. Several online marketplaces have signed voluntary commitments to improve the safety of products online. However, the Commission suggests that as these commitments are voluntary and many economic operators do not join, safety concerns are not effectively addressed and competition between economic operators may be affected.

• Insufficient recall effectiveness. The Commission suggests that the effectiveness of product recalls from consumers is low which means that too many dangerous products still remain in the hands of consumers.

• Market surveillance rules are complex, uneven and not fully effective. The Commission believes that market surveillance and customs authorities lack appropriate instruments and resources to enforce product safety rules, including tools to impose effective sanctions.

• Rules for food-imitating products. The legal framework for food-imitating products is applied differently in EU Member States currently.

The European Commission's public consultation on these areas has recently closed, and so we expect to hear more on the planned revision shortly.

Where can I find it?

The GPSD can be found here.

The European Commission page tracking the review of the GPSD can be found here.

Is there any guidance?

No specific guidance on the revision has been published, but the Commission's roadmap and impact assessment can be found here.  

We will keep you updated via Productwise as the review continues.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.