Product Safety Reporting Requirements in the European Union

Transcription

1 Product Safety Reporting Requirements in the European Union Joanne O Donnell Senior Regulatory Compliance Specialist September

2 AGENDA 1. Overview of EU General Product Safety Directive 2001/95/EC (GPSD) 2. Criteria for notification of dangerous products 3. Notification procedure (By who? To whom? How? When?) 4. Penalties 5. RAPEX - Rapid Alert System 6. Proposed changes

3 OVERVIEW OF EU GENERAL PRODUCT SAFETY DIRECTIVE 2001/95/EC (GPSD) Entered into force on 15 January 2004 Replaced Directive 92/59/EEC The purpose of this Directive is to ensure that products placed on the market are safe - Article 1 Applies to all manufacturers who place products on the EU market regardless of where manufacturer is located Applies regardless of how product is sold - directly or electronically

4 OVERVIEW OF EU GENERAL PRODUCT SAFETY DIRECTIVE 2001/95/EC (GPSD) - cont d Producers to inform competent authorities: if they know / ought to know on the basis of information in their possession and as professionals that a product placed on market poses a risk to consumers that is incompatible with the general safety requirement Isolated circumstances or products excluded from obligation to notify

5 OVERVIEW OF EU GENERAL PRODUCT SAFETY DIRECTIVE 2001/95/EC (GPSD) - cont d Article 5(1): Producers shall adopt measures enabling them to: be informed of risks their products might pose; choose appropriate action including withdrawal from the market; and adequately and effectively warning consumers; or Recall No express obligation to conduct a product recall!!!!!!

6 HELP!!!! I THINK I MAY HAVE PLACED A DANGEROUS PRODUCT ON THE EU MARKET

7 NOTIFICATION CRITERIA Product within scope of GPSD i.e., intended for / likely to be used by consumers? Product on the EU market? Dangerous product? (evidence) Preventive and corrective action required? Similar obligation established by other sector / product specific EU legislation?

8 Products in scope of GPSD: Outdoor furniture Gymnastic / stationary training equipment Child use / care articles Window blinds Cigarette lighters NOTIFICATION CRITERIA

9 IS MY PRODUCT UNSAFE? NOTIFICATION CRITERIA Safe product is one that under normal / reasonably foreseeable conditions of use does not present a risk or only minimum risks consistent with high level of protection for safety & health of persons taking into account: product characteristics including composition, packaging, instructions; effect on other products, if reasonably foreseeable; presentation - labelling, warnings & instructions and categories of consumers - children & elderly.

10 DEMONSTRATING COMPLIANCE Products are deemed safe if they comply with: Specific rules of national law; Harmonised EU standards; National standards transposing EU standards; Commission recommendations; Codes of practice; State of the art & technology or Reasonable consumer expectations.

11 One of the best practice methods for assessing consumer product risk Examines: hazard type (chemical, mechanical electrical, heat, radiation, etc.); type of consumers (children / elderly); injury scenario; determination of probabilities and determination of risk level. HOW DO I ASSESS THE RISK? EU RISK ASSESSMENT GUIDELINES (RAG) TOOL

12 NOTIFICATION PROCEDURE WHO? If Producer is first to have evidence of dangerous product, he must inform the national authority and retailers / distributors. If Distributor is first to have evidence, he must inform authorities if receives product hazard information from manufacturer / importer, unless they know the latter already contacted the authorities.

13 NOTIFICATION PROCEDURE AM I A PRODUCER? Definition of Producer in GPSD: Manufacturer when established in the EU; Any other person presenting himself as manufacturer by affixing name/tm to the product Manufacturer's representative, when outside the EU Importer if no representative established in the EU Other professionals in supply chain, if their activities affect product safety

14 NOTIFICATION PROCEDURE WHERE? Market surveillance/enforcement authorities of each MS where the product is marketed /supplied MS then informs Commission & other MS via RAPEX A list of the designated MS authorities is on the Commission s website

15 NOTIFICATION PROCEDURE HOW? GPSD Business notification form; Translations required; Content: Authorities / companies receiving the form; Producer / distributor sending the form; Product brand, model, photographs; Details of hazard (type and nature); Corrective action taken / planned and Companies in possession of affected products

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23 NOTIFICATION PROCEDURE WHEN? Notification should be sent without delay: in the case of serious risk, within 3 calendar days in other cases, within 10 calendar days. Emergency situation authorities must be informed immediately and by the fastest means Do NOT delay in submitting the notification because part of the information on the dangerous product is not yet available

24 NOTIFICATION PROCEDURE WHAT NEXT? Receiving authority may ask for additional info or request further action Authority may require enforcement and / or require producers / distributors to cooperate on market surveillance / inform public If RAPEX notification is required (i.e., serious risk), authority must send RAPEX notification to the Commission to be transmitted to all Member States

25 ENFORCEMENT & PENALTIES GPSD does not impose specific penalties for noncompliance i.e., failure to notify MS to adopt rules on penalties applicable to infringements - effective, proportionate, and dissuasive Max penalties vary greatly e.g. UK - 12 months imprisonment and/or 20,000 fine (22,000 Euros) Ireland - 3 months imprisonment and/or 3,000 fine Czech - CZK 50 million fine ( 1.9m)

26 RAPID ALERT SYSTEM Weekly Notification Reports for serious risk products

27 RAPID ALERT SYSTEM (RAPEX) 31 countries (EU, Iceland, Liechtenstein and Norway) Notification system for MS to quickly exchange info where a product: Presents a serious risk to consumers and Is available in more than one EU country Dangerous non-food products intended for consumers/ professionals Non-compliant products notified in the database. Alerts published weekly Includes notifications to other countries

28 RAPEX STATISTICS 2016

29 RAPEX STATISTICS 2016

30 EXAMPLE OF RAPEX NOTIFICATION The dreaded Fidget Spinner! 4 RAPEX notifications in 1 month Risk Type: Chemical, Injuries Measures taken by economic operator: Recall, withdrawal Measures ordered by public authority: Ban Country of Origin: China

31 EXAMPLE OF RAPEX NOTIFICATION LED lights Subject of TEN RAPEX notifications recently Risk type: Electric shock Measures ordered by public authorities: Ban Country of Origin: China

32 PROPOSED CHANGES February Commission announced draft consumer product safety and market surveillance regime to repeal GPSD. Aim: provide more uniform safety rules for products currently regulated under different / overlapping legal frameworks Due to EIF on 1 January not yet finalised. Draft Regulation on consumer product safety - simplify and consolidate existing rules; Draft Regulation on market surveillance for products - unify and simplify existing legislation Note: shift from "Directive" to a "Regulation

33 PROPOSED CHANGES (cont d) No significant change to GPSD safety requirements; Clearer responsibilities on labelling, identification, product info & corrective actions; Enhanced info sharing between MS authorities; Improved traceability of products - "country of origin"; Prepare and retain technical documentation, including a documented risk assessment Streamlined notification procedures for dangerous products - RAPEX to extend to ALL risks

34 CONCLUSION KEY THINGS TO REMEMBER: DON T PANIC!!!! Be proactive plan ahead Decide whether to take action - assess risk If corrective action needed - act quickly Contact MS authorities ASAP Communicate effectively Document everything Engage proper expertise Learn from your experience

35 Thank You For more information contact: Joanne O Donnell Senior Global Regulatory Compliance Specialist T +353 (0) E j.odonnell@complianceandrisks.com