RISK ASSESSMENT How to perform the risk assessment for one product covered by LVD (in accordance with the Commission Decision 2010/15/EU)

Evert van Wilgenburg Senior Product Safety Expert and Policy new Food and Consumer Product Safety Authority Netherlands

Guidance Guidelines for the ‘RAPEX’ assessment procedure (2010/15/EC) RAPEX > Rapid exchange procedure Quick exchange of information Prevents to supply products with a serious risk Effectiveness and consistency of market surveillance Helps to ensure a high uniform level of consumer health Notification procedure Article 12 and and Article 11 of the GPSD (2001/95/EC) Article 11 > non-compliant products > notification Article 12 > products with a serious risk > RAPEX notification Risk assessment - Rapex 22-10-2010

Guidance The Guidelines are addressed to all the authorities of Member States RAPEX criteria the product is a consumer product, the product is subject to measures that prevent, restrict or impose specific conditions on its possible marketing or use (‘preventive and restrictive measures’), the product poses a serious risk to the health and safety of consumers, the serious risk has a cross-border effect. Risk assessment - Rapex 22-10-2010

Risk assessment - Rapex 22-10-2010

Product assessment – Power supply Isolation separation via a transformer 230 V SELV terminals Risk assessment - Rapex 22-10-2010

RAG MODEL – IRAG WG Risk assessment - Rapex 22-10-2010

General information Risk assessment - Rapex 22-10-2010

Product hazards Risk assessment - Rapex 22-10-2010

Injury scenarios Risk assessment - Rapex 22-10-2010

Type of injuries Risk assessment - Rapex 22-10-2010

Severity of injuries Risk assessment - Rapex 22-10-2010

Probability factors Risk assessment - Rapex 22-10-2010

Calculated probability Risk assessment - Rapex 22-10-2010

Probability value Risk assessment - Rapex 22-10-2010

Risks Risk assessment - Rapex 22-10-2010

Assumptions Risk assessment - Rapex 22-10-2010

Another scenario/risk Risk assessment - Rapex 22-10-2010

General notes Risk assessment - Rapex 22-10-2010

Information sheets Risk assessment - Rapex 22-10-2010

For example Risk assessment - Rapex 22-10-2010

Product assessment – Power supply Isolation separation via a transformer Break down during the high voltage test 230 V SELV terminals Risk assessment - Rapex 22-10-2010

Risk assessment model – Product hazards Identify all hazards that may lead to a consumer injury or health damage. Consider all consumers, including the vulnerable. Electric shock Overheating Fire …… (see Hazard sheet of model) (use for every identified hazard a new row) Risk assessment - Rapex 22-10-2010

Risk assessment model – Injury scenarios (1) The exact hazard or defect in this product and the event that may result; the interaction of a person with the product during the intended and reasonably foreseeable use and the exposure to the hazard; the mechanism of injury. Connection to the power supply Phase is connected in most onerous way Transient (high power peak) on supply side High percentage of moisture Transformer isolation break down A person makes contact to the SELV circuit encompass The hands are wet An electric shock follows An earth leakage protection device shut down the supply Risk assessment - Rapex 22-10-2010

Risk assessment model – Injury scenarios (2) The exact hazard or defect in this product and the event that may result; the interaction of a person with the product during the intended and reasonably foreseeable use and the exposure to the hazard; the mechanism of injury. Connection to the power supply Phase is connected to in most onerous way Transient (high power peak) on supply side High percentage of moisture Transformer isolation break down A person makes contact to the SELV circuit encompass The hands are wet An electric shock follows An earth leakage protection device shut down the supply Blue: the shortest possible scenario Red: the result Risk assessment - Rapex 22-10-2010

Risk assessment model – Injury scenarios (3) The exact hazard or defect in this product and the event that may result; the interaction of a person with the product during the intended and reasonably foreseeable use and the exposure to the hazard; the mechanism of injury. Connection to the power supply Transformer isolation break down A person makes contact to the SELV circuit engripped (There are more scenario’s possible) (use for every scenario a new row) Blue: the shortest possible scenario Risk assessment - Rapex 22-10-2010

Risk assessment model – Type of injuries For each hazard identified, describe the injury resulting from the injury scenario. If you select a hazard form the Hazard List, a typical injury(ies) will be filled in here. Make this more specific by describing both the injury and the body part. Click here to consult the Injury Scale. Electric shock (See also under burns as electric current can cause burns) Local effects (temporary cramp or muscle paralysis) - Electrocution Risk assessment - Rapex 22-10-2010

Risk assessment model – Severity of injuries Assign from the Injury Scale: 1 to 4. Click into cell below. 1 Electric shock (See also under burns as electric current can cause burns) 2 Local effects (temporary cramp or muscle paralysis) 3 - 4 Electrocution Risk assessment - Rapex 22-10-2010

Risk assessment model – Probability of factors For each hazard identified, estimate the probability for each step in the scenario (event, interaction and injury) e.g.: 1/10; 1/100; 1/8 Connection to the power supply 1/1 Transformer isolation break down 1/1000 A person makes contact to the SELV circuit engripped 1/4 For one product during the total life time Risk assessment - Rapex 22-10-2010

Risk assessment model – Calculated probability Calculated value of probability factors, e.g. 1/10 x 1/100 x 1/8 = 1/8.000 (Connection to the power supply) 1/1 X (Transformer isolation break down) 1/1000 X (A person makes contact to the SELV circuit engripped) 1/4 = 1/4000 For one product during the total life time Risk assessment - Rapex 22-10-2010

Risk assessment model – Probability value Select the scale value corresponding to the calculated value, e.g. 1/8.000 corresponds to "> 1/10.000" (Connection to the power supply) 1/1 X (Transformer isolation break down) 1/1000 X (A person makes contact to the SELV circuit engripped) 1/4 = 1/4000 = > 1/10 000 For one product during the total life time Risk assessment - Rapex 22-10-2010

Risk assessment model – Assumptions Connection to the power supply 1/1 Every product has the construction failure Transformer isolation break down 1/1000 Transients in the power source OR pollution of the transformer OR ageing of isolation layers, which can lead to bridging of the isolation in the transformer (in time the probability of failure increases); one off ten overall possibilities of a product becoming defect A person makes contact to the SELV circuit engripped 1/4 The terminals on the outside of the product OR extension leads connected to those terminals Or the connected external peripheral equipment parts under main voltage become directly accessible. If peripheral equipment is metal encased with a common earthing also the encasing can become connected to the main voltage. Risk assessment - Rapex 22-10-2010

Risk assessment model – Risks (1) Combined result from the risk table: Serious to Low Risk Risk assessment - Rapex 22-10-2010

Risk assessment model – Risks (2) Risk assessment - Rapex 22-10-2010

Risk assessment model – Risks (3) Risk assessment - Rapex 22-10-2010

Actions if necessary All categories of preventive and restrictive measures ….., including measures: marking a product with appropriate warnings on the risks it may present; making the marketing of a product subject to prior conditions; warning consumers of the risks that could be posed by a product for certain persons; temporary ban on the supply, offer to supply and display of a product; ban on the marketing of a product and any accompanying measures; withdrawal of a product from the market; recall of a product from consumers; destruction of a withdrawn or recalled product. (see par. 2.2.1 of the guide) Risk assessment - Rapex 22-10-2010

Thank you for your attention Evert van Wilgenburg Senior Product Safety Expert and Policy Chairman LVD-AdCo 2010 ........................................................................ Division Primex new Food and Consumer Product Safety Authority Westelijke Parallelweg 4 | 3331 EW | Zwijndrecht | TVE Postbus 3000 | 3330 DC | Zwijndrecht | Netherlands T 0031 (0)78 6112100 F 0031 (0)78 6112200 evert.van.wilgenburg@vwa.nl The AID, PD and VWA are building one new Food and Consumer Product Safety Authority. Risk assessment - Rapex 22-10-2010