Hogan Lovells 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

Proposed General Product Safety Regulation

Lovells Streamlining with NLF Decision 768/2008 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

Lovells Streamlining with NLF Decision 768/ 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."

Lovells General obligations that will be new for many manufacturers 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?

Lovells New obligations for distributors 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?

Lovells Other new obligations for manufacturers 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?

Lovells New obligations for particular manufacturers? 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?

Proposed Market Surveillance of Products Regulation

Lovells Increased powers of authorities 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 non- consumer products

Lovells Approach to risk 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

Lovells RAPEX 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

Formal non-compliance – how far should we go? 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