Are there any statutory criteria under which a product must be recalled or other corrective action be taken?
In the European Union, obligations to deal with product safety risks arise under:
- the General Product Safety Directive (2001/95/EC);
- the law of negligence; and
- express obligations in sector-specific legislation.
The General Product Safety Directive sets out the obligations of both producers and distributors to deal with product safety risks. Under Article 5(1), producers must adopt measures commensurate with the characteristics of the products which they supply, enabling them to be informed of risks the product might pose and choose appropriate actions, including:
- warning consumers;
- withdrawing the product from the market; and
- recalling the product from consumers (where necessary).
Such appropriate action shall be undertaken on a voluntary basis or at the request of the competent authorities under Article 8(2). Recalls shall take place only as a last resort, where other measures would not suffice to prevent the risks involved, in instances where the producers consider it necessary or where they are obliged to do so further to a measure taken by the competent authority.
Under Articles 6 and 8, member states must put in place a system under national law that allows for appropriate action to be taken, including the recall of consumer products where necessary. Most EU member states have given enforcement authorities the power to compel a company to initiate a recall or even conduct the recall themselves. Therefore, much of the actual procedure governing the taking of appropriate action, including the recall of products, is established under national law.
The criteria for determining what corrective action should be taken, including recall, is done by reference to risk assessment. The risk assessment methodology contained in the European Commission’s “Guidelines for the notification of dangerous consumer products to the competent authorities of the member states by producers and distributors in accordance with Article 5(3) of Directive 2001/95/EC” was effectively superseded by the more sophisticated methodology published by the commission in November 2018 in the form of EU Decision 2019/417, which lays down new guidelines for the management of the EU Rapid Alert System (RAPEX) established under Article 12 of Directive 2001/95/EC.
Some individual products have specific rules or guidelines for recall, notably medicinal products and medical devices. Voluntary industry guidelines exist in other sectors such as motor vehicles and the retail sector.
A guide for businesses on how to undertake a corrective action programme entitled “Corrective Action Guide: Guidelines for Businesses to manage Product Recalls & other Corrective Actions” was published by the European Commission in 2012. The guide was prepared by the Product Safety Enforcement Forum of Europe in consultation with various stakeholders.
The European Commission also now offers an online risk assessment app to assist businesses in preparing risk assessments in line with the commission methodology.
What rules and procedures govern notification of the product recall to government authorities and the public?
When a product placed on the market poses risks to consumers that are incompatible with its general safety requirement, Article 5(3) of the General Product Safety Directive requires producers and distributors to immediately notify the competent authorities of the member states where the product is in circulation.
Procedures exist for notification of measures and exchange of information between member states and the European Commission:
- When a member state takes measures that restrict the placing on the market of products or requires their withdrawal or recall, it must inform the European Commission (Article 11).
- When a member state adopts, recommends or agrees with producers or distributors measures or actions relating to products that present a serious risk, and the effects of those actions or measures may go beyond its own territory, it must immediately notify the European Commission through the RAPEX (Article 12).
- When the European Commission becomes aware of a product posing a serious risk to consumers in the European Union it may, after consulting with the member states, require temporary measures to be taken (Article 13). In practice, the commission does not usually act unless requested to do so by a member state.
Repairs, replacements and refunds
What rules and procedures govern repairs, replacements and refunds for defective products?
Recall is just one possible corrective action for responding to post-marketing information that a product may be unsafe to use. The range of responses also includes:
- amending product information issued with new products – for example:
- stipulating that the product is not to be used under certain circumstances; or
- including a warning in the product information about use in particular circumstances or about the possibility of encountering specified untoward events;
- in case of certain products with potentially unavoidable hazards (eg, medicinal products and pesticides), supplying the products to specialist intermediaries;
- changing the design of the product; and
- requesting distributors and users to carry out modifications to the product (ie, retrofit) or discard the product.
Article 5 of the General Product Safety Directive sets out the relevant measures that may be adopted in response to a product safety risk.
What penalties apply for non-compliance with the legal provisions governing product recalls?
Article 7 of the General Product Safety Directive leaves it to the individual member states to enact rules and penalties applicable to infringements of the national provisions adopted under the General Product Safety Directive. The General Product Safety Directive specifies only that the penalties provided for must be "effective, proportionate and dissuasive".