Product recall masterclass
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- Barnard Skinner
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1 Product recall masterclass Demystifying product risks
2 Programme Product recall: an accident waiting to happen? Regulatory framework and other legal issues Break Insurance aspects of recall risks Stuff happens: supply chain regulations and risks Analysis of a real deal
3 Product recall: an accident waiting to happen? Yuri Cosco Business Line Manager AgriFood, Vinçotte
4 What can be present in food that can injure people or make people sick? March 15, 2016
5 4 types of substances / organisms 1 microbiological hazards
6 4 types of substances / organisms 2 physical hazards
7 4 types of substances / organisms 2 physical hazards
8 4 types of substances / organisms 3 allergen hazards
9 4 types of substances / organisms 4 chemical hazards
10 4 types of substances / organisms CASE STUDY GOOD 2 MEAT
11 Regulatory framework and other legal issues Peter van den Broek Attorney-at-law and partner at Kennedy Van der Laan
12 Topics to discuss EU rules on corrective actions; food & non-food Recall; an international affair Liability for unsafe food/products
13 Regulatory framework A European affair: General Product Safety Directive (GPSD) General Food Law Regulation (GFLR) Specific regulations National Dutch regulations: Food and Commodities Act Commodities Act Decree on General Product Safety Specific regulations Belgium: comparable national regulations
14 Non-Food - GPSD March 15, 2016
15 General obligations producer under GPSD Permanent risk evaluation: is the product safe? Providing relevant information (adequate warnings) Being able to take appropriate action (traceability system, sample testing, registering complaints) Notifying competent authorities if the product is not safe Being able to take corrective actions Cooperate with authorities Note: Responsibility of all parties in supply chain!
16 When to notify (and take other actions)? Art. 5 GPSD: Producers and distributors (!) Know or ought to know On the basis of the information in their possession and as professionals That the product that they have placed on the market Poses risks to the consumer that are incompatible with the general safety requirement
17 Unsafe product? Every product that does not comply with the definition of a safe product : any product which, under normal or reasonably foreseeable circumstances of use, does not present any risk or only the minimum risks, considered to be acceptable Taking into account: characteristics of the product effect on other products presentation of the product categories of consumers at risk
18 Unsafe product? Risk assessment (EC Guidelines) March 15, 2016
19 Who to notify? General rule: authorities of all Member States where the product has been marketed or otherwise supplied to consumers Exception: only authority of Member State in which producer or distributor is established if: RAPEX notification; or Notification forwarded to other authorities Use Business Application form
20 What to notify? Details of authority(ies) receiving notification form Details of producer Details of product involved (brand, model, photo s) Details of hazard (results risk assessment) Details of corrective actions taken or to be taken (withdrawal, informing consumers, recall, modification, monitoring system) Details of suppliers/retailers (including number of products marketed)
21 Alert March 15, 2016
22 Actual recall of product? Only if necessary: if other measures do not suffice to ensure a high level of safety and health protection public alert in national and local newspapers issuing a press release distributing information at retail outlets publish the product safety issue and the recall action on your website organize collection actions through retail outlets and other actions
23 Food - GFLR March 15, 2016
24 When to take action? Art. 19 GFLR If a food business operator considers or has reason to believe that a food which it has imported/produced/processed/ manufactured/distributed is unsafe, it shall withdraw the food in question from the market inform the competent authorities thereof. Where the product may have reached the consumer, the operator shall also: inform the consumers of the reason for its withdrawal recall from consumers when other measures are not sufficient to achieve a high level of health protection
25 Unsafe food? injurious to health: food that is detrimental to health, both immediately and in the long term unfit for human consumption: food that is unacceptable for human consumption according to its intended use food that does not meet the relevant European and national food safety standards, but as such is not detrimental to health normal conditions of use of the food by the consumer information provided to the consumer
26 1. Food injurious to health March 15, 2016
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30 2. Unfit for human consumption March 15, 2016
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33 All parties in supply chain are responsible Van grond tot mond Van boer tot bord
34 Action: Tracing (provide info within 4 hours!) March 15, 2016
35 Action: Notify For NL, useful tool = NVWA Meldwijzer Who to notify? Authorities of all Member States where the product has been marketed NL: NVWA BE: FAVV
36 Notification through website authorities March 15, 2016
37 Other actions Withdrawal from the market Alert Actual Recall (if necessary)
38 What if the NVWA has a different view? How to challenge the view of authorities? Ask for formal order of authorities Lodge an objection & start summary proceedings (bestuursrechtelijk kort geding)
39 Recall a European affair with a European approach? Uniform rules: GPSD & GFL However: 1. Also national (specific) regulations 2. Authorities (like NVWA) only have competence in their own country 3. Authorities can make their own policy on enforcement of the (EU) regulations And how about outside Europe?
40 Liability where does it start and where does it stop? In principle: the polluter pays Most European law systems: full damages So: in principle full liability for defects However: liability often limited by contract / general conditions Companies should be aware of: Possibilities to limit the company s liability to customers (Note: not to consumers) Avoiding liability caps in contract with suppliers
41 Insurance aspects of recall risks Different risks, different solutions Johan Broeders Casualty Manager Benelux, Chubb
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44 Concept and viewpoints Definitions Recall or Recall Safety or quality? Recall damage: with whom? Finished products or ingredients / components?
45 Why do recalls happen? Design flaw Global supply chain Manufacturing defect Stricter product safety rules and regulations Human element
46 Financial impact of Recall March 15, 2016 RQA Product Recall Guide
47 Managing the risk Reducing/avoiding Assuming Transferring the risk Rigorous quality control Crisis management procedures Paying own losses Self insuring up to a certain amount for product recalls Supplier Before a recall Indemnification/hold harmless Additional insured status After a recall Recovering from supplier Recovering from supplier s insurer Insurer - Buying insurance
48 Insurance solutions for recall risks Who is buying product recall insurance? Experienced a product recall Witnessed a competitor suffering a recall Contractually required Potential for negative press / publicity / social media Risk Management decision Brand has become a critical asset and must be protected Protect the balance sheet to avoid potential D&O exposure
49 What solutions A one fits all policy? I. Consumables II. Consumer goods III. Ingredients IV. Component parts
50 I. Consumables Food & beverage, cosmetics, pharmaceuticals Contamination Mislabeling Tampering & Extortion Own damage: Replacement Reputation Business interruption
51 Coverage CPI schematic March 15, 2016 Property Damage Business Interruption TRIGGERS: Accidental contamination Mislabeling Governmental Recall Product Damage Damaged Product as a direct result of physical loss or damage to the Insured Product Loss of Gross Profit (direct) Investigation of contamination product Recall (absence of product from market) Loss of Gross Profit (extended) Brand Damage Loss of contract Malicious Tampering Related Coverage Manufacturing and distribution of replacement product Pre-recall expenses Consultant Costs Recall and Distribution Cost Related Coverage (Extra Expense) Minimum payroll Extortion Cost Clean-up costs (Extra Expense) Increased Cost of Manufacturing Rehabilitation Exp
52 Crisis Management Recalls can be very complex Manufacturing knowledge Recall knowledge? Use of a consultant has proven to limit potential damage Loss mitigation work Deployment of product recall 24/7 Hotline Consultant costs are unlimited and no SIR applies
53 Food / other coverage solutions? Loss mitigations costs (art. 7:957 BW) under CGL a real solution? (1st party only) Recall costs extension under CGL (3rd / 1st party) Pure financial loss extension under CPI (3rd party only)
54 II. Consumer goods March 15, 2016
55 III. Food: ingredients PL-driven CPI : not perfect fit Coverage solutions: Recall costs extension under CGL (3rd / 1st party) Pure financial loss extension under CPI (3rd party only) Extended Products Liability extension (EPH module Processing & Treatment )
56 IV. Component parts PL-driven Trigger? Blended Liability solutions Extended Product Liability (EPH-model) Mixing & Blending (module 4.2) Processing & Treatment (module 4.3) Removing & refitting (module 4.4) Defective Machinery (module 4.5)
57 Component parts / ingredients Third party losses like: Production costs (ie costs of machinery and staff to produce defective product) Damage to final product caused by defective ingredient Costs to rework / rectify defective products when technically possible Disposal costs of defective products when cannot be repaired /rectified Loss of profit / Loss of income / Business Interruption Costs incurred by the customer to remove the defective products and re-fit a correct one: transportation, delivery, searching / identification, staff costs Notes: No coverage if the Insured has installed or assembled the component himself Automotive suppliers specific coverage for 3rd party Auto Product Recall or dismantling/ reassembling costs.
58 Resuming One fits all policy? I. Consumables Recall costs extension in GL CPI-cover II. Consumer goods Recall costs extension in GL Standalone (if available..) III. Ingredients Recall costs extension in GL Extended PL : Processing & treatment IV. Component parts Recall costs extension in GL Extended PL : Removal & refitting
59 Analysis of real deals March 15, 2016
60 Case I. Food answers Risk Assessment & Insurance Incidents 1. A.1 Injury claims consumers B.1 Recall notification costs B.3 Shipping and additional logistics charges, warehousing B.4 Value of recalled products, replacement costs B.5 Retailer admin charges B.6 Cost of production stoppage /shutdown (BI) B.7 Lost sales due to recall B.8 Post recall advertising /brand recovery (rehabilitation costs) Coverage I. Coverage II. Coverage III. B.9 Recourse by Sjoppie for injury claims consumers B.10 Recall costs Sjoppie B.11 Claim Sjoppie for value of recalled products, replacement costs B.12 Claim Sjoppie for lost sales due to recall C.1 Recourse by Dr. Cooker for injury claims consumers C.2 Claim Dr. Cooker for recall notices in press C.3 Claim recall expenses Dr. Cooker C.4 Good2Meat replacement costs C.5 Product liability claim Dr. Cooker-> G2M (property damage meals) Incident Dr. Cooker claim for recall costs + admin charges Coverage I. Coverage II. Coverage III. 2. Good2Meat own replacement costs 3. Product liability claim Dr. Cooker towards G2M (property damage meals) 4. Dr. Cooker claim for lost sales due to recall 5. Lost sales G2M due to cancelation of the contract with Dr. Cooker
61 Stuff happens: supply chain regulations and risks Caspar ter Horst Managing Director, ProductIP
62 SAFETY HAS BECOME WELL-BEING March 15, 2016
63 REALITY CHECK Waste of Electrical and Electronic Equipment source:
64 REALITY CHECK 50% of powerbanks investigated failed to comply with RoHS directive. 100% of the 35 LED bulbs investigated failed to comply with any of the applicable directives. source: and
65 PIECE OF CAKE LTD. March 15, 2016
66 PIECE OF CAKE LTD. ONE PRODUCT ONE PCS / DAY / PERSON WE SELL OR GIVE AWAY
67 CONSUMERS BUY BRAND PROMISE Any economic operator that either places equipment on the market under his own name or trade mark or modifies equipment in such a way that compliance with this Directive may be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer. source:
68 NEW LEGISLATIVE FRAMEWORK MANUFACTURER / BRAND-OWNER IMPORTER DISTRIBUTOR (RETAIL, ecommerce) AUTHORISED-REPRESENTATIVE THE ACTUAL FACTORY IS NOT MENTIONED
69 RISK ASSESSMENT MUST EAT BEFORE CONDITIONS OF STORAGE PACKAGING IS FOOD CONTACT MATERIAL INFORMATION ON THE PACKAGING TRACEABILITY CAN PARTS END UP IN THE PIE QUALITY / TASTE?
70 INTENDED USE source:
71 - RECORD? March 15, 2016
72 UNINTENDED USE! March 15, 2016
73 Do not think like a consumer!
74 RED & GOLDEN DELICIOUS IT S GOING TO BE DELICIOUS!
75 KNOW APPLES FROM ORANGES RED DELICIOUS & GOLDEN DELICIOUS TASTE GREAT BUT ARE UNSUITABLE FOR APPLE PIE (SAME AS GALA AND CORTLAND!)
76 WE GO PREMIUM! March 15, 2016
77 DON T YOU WORRY MY FRIEND! March 15, 2016
78 DON T YOU WORRY MY FRIEND! IT S GOING TO BE DELICIOUS!
79 WHERE CAN I FIND THE RoHS COMPLIANT PRODUCTS? March 15, 2016
80 Formal compliance Technical File
81 THIS IS NOT NEW! March 15, 2016
82 China? Brands lacking manufacturing DNA!
83 RAPEX: EU NON-FOOD RECALLS source:
84 Success not regulations make things complex! March 15, 2016
85 CONSUMER EMPOWERMENT source:
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87 Analysis of a real deal March 15, 2016
88 Case II. Non-Food answers Risk Assessment & Insurance Case A. safety critical defects Coverage I. Coverage II. Coverage III. 1. Notification costs 2. Other recall costs 3. Removal/refitting costs 4. Business interruption claim Phoenix Case B. off spec parts 1. Removal/refitting costs Coverage I. Coverage II. Coverage III. 2. Business interruption claim Phoenix
89 Chubb. Insured.
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