EU Product Safety and Market Surveillance
Reforms
How will this impact businesses – Lawyers' view
BIICL seminar, 2 October 2013
Claire Taylor and Sylvie Gallage-Alwis
London/Paris
Hogan Lovells www.hoganlovells.com

Proposed General Product Safety Regulation

• Introduction of specified obligations for each party in the supply chain:
– "manufacturers" (strict obligation to ensure compliance)
– "importers" (also required to ensure compliance)
– "distributors" (must "act with due care" and "verify" the manufacturer's and importer's compliance)
• Requirements for product information more clearly identified:
– Type, batch, serial number of other ID element
– Name, trade name/mark, and contact address of manufacturer (and, if applicable, importer)
– Instructions and safety information
Hogan Lovells www.hoganlovells.com

• 9 New Approach CE marking Directives already being aligned with NLF Decision
• Products subject to New Approach harmonised requirements will not be subject to the similar specified obligations in the GPSR
• Unclear whether products subject to other EU harmonised requirements will also be exempt:
– " shall not apply to products subject to requirements designed to protect human health and safety laid down in Union harmonisation legislation or pursuant to it."
Hogan Lovells www.hoganlovells.com

• Obligation to have a technical file
• Obligation to take action where reason to believe that a product is not safe " or is otherwise not in conformity with this Regulation "
 What is the scope of such an obligation?
Obligation to recall? What is the scope of the exemption of Article 13?
Hogan Lovells www.hoganlovells.com

• Distributor becomes key actor
• Must check the manufacturer and importer's labeling work
• Must ensure that necessary corrective actions are taken if product is unsafe or not in conformity with Regulation
• Should order or withdraw recalls
 If liability is at stake – successive/chain liability?
Hogan Lovells www.hoganlovells.com

• Origin marking for all consumer products
– Community Customs Code rules to determine origin:
• Country in which product was "wholly obtained or produced"
• Where production involved more than one country, where it underwent its " last, substantial, economically justified processing or working …resulting in the manufacture of a new product or representing an important stage of manufacture ".
– Is it necessary?
• Manufacturer and importer details already labelled for traceability purposes
• Product is required by the GPSR to be safe – is its origin necessary information?
Hogan Lovells www.hoganlovells.com

• Electronic traceability systems for products that
" due to their specific characteristics or specific conditions of distribution or use " are " susceptible to bear a serious risk to health and safety of persons "
• What type of products does the Commission have in mind?
• Scope of Article 2.4 exemption?
Hogan Lovells www.hoganlovells.com

Proposed Market Surveillance of Products
Regulation

• Powers of market authorities to take action codified in one Regulation
• Authorities can react not simply where the product presents a health and safety risk
• Authorities can react for both consumer and nonconsumer products
Hogan Lovells www.hoganlovells.com

• National authorities to cooperate with economic operators and encourage voluntary action
– Principle of proportionality expressly recognised
• Authorities required to carry out risk assessment
– Based on "available scientific and technical evidence"
– Due consideration to be taken of test results and risk assessment conducted by manufacturer etc or other authority
– No reference to Decision 2010/15/EU
Hogan Lovells www.hoganlovells.com

• RAPEX originally used for reporting consumer products posing serious risk to health and safety
• Since 1 Jan '10, Reg 768/2008 required reports of any product posing a serious risk of any kind
• RAPEX now to be used more generally to report corrective actions and measures taken by authorities
• RAPEX website used since May 2013 to publish
– All risk types (not just health and safety)
– All risk levels (not just serious risks)
– Risks involving professional and consumer products
Hogan Lovells www.hoganlovells.com

www.hoganlovells.com

• No need of risk anymore – authorities can require businesses to rectify formal non-compliances
• Towards a French-inspired system?
• Would consumers really understand?
• Potentially onerous obligation www.hoganlovells.com