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New Set of Exemptions under EU Rohs Law Published

On 10 April 2014, the Official Journal of the EU published two new directives amending framework Directive 2011/65/EU on the restriction of hazardous substances in electrical and electronic equipment (RoHS). The amendments will allow Hong Kong’s electronics goods exporters to benefit from some specific new exempted applications of lead and mercury. These new exemptions are added to Annex IV of the framework RoHS Directive (listing exemptions specific to medical devices and monitoring and control instruments).

The RoHS Directive, originally adopted in 2002 and recast (made stricter) in 2011, bans from the EU market electrical and electronic equipment (EEE) that contains six hazardous substances. Hong Kong’s manufacturing community will already be familiar with these: the hazardous substances and their maximum concentration values by weight in the homogeneous materials comprising any EEE are lead (0.1%), mercury (0.1%), cadmium (0.01%), hexavalent chromium (0.1%), polybrominated biphenyls (PBB) (0.1%) and polybrominated diphenyl ethers (PBDE) (0.1%).

Despite the general restrictions, economic operators can benefit from a number of exemptions. Under the RoHS Directive, exemptions are granted for specific substances used in particular applications. The two newly published directives set out the following exempted applications:

Commission Delegated Directive 2015/573: This Directive states that blood, body fluid and body gas analysers serve as a critical analytical instrument in many diagnostic and therapeutic procedures. In turn, lead is required as a stabiliser in the processing of the PVC for the sensor cards. Although research of substitutes is ongoing, a suitable alternative to this use of lead has not yet been found. The use of lead in PVC sensors for blood, body fluid and body gas analysis used in in-vitro diagnostic medical devices should therefore be exempted until 31 December 2018.

Annex IV to Directive 2011/65/EU is therefore amended as set out in the Annex to new Directive 2015/573. In said Annex IV, the following point 41 is added: “41. Lead as a thermal stabiliser in polyvinyl chloride (PVC) used as base material in amperometric, potentiometric and conductometric electrochemical sensors which are used in in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases. Expires on 31 December 2018.

Commission Delegated Directive 2015/574: This Directive stipulates that mercury is used in electric rotating connectors in medical devices for intravascular ultrasound imaging. Any substitution of mercury, or of the specific component, would shorten product life or impair performance significantly. Both the substitution of mercury in the connector and the elimination of mercury via substitution of the connector or the device are technically impracticable or have negative overall impacts due to an impact on patients’ health. The use of mercury in electric rotating connectors used in intravascular ultrasound imaging systems capable of high operating frequency modes of operation (> 50 MHz) should therefore be exempted until 30 June 2019.

Thus, in Annex IV to Directive 2011/65/EU, the following point 42 is added: “42. Mercury in electric rotating connectors used in intravascular ultrasound imaging systems capable of high operating frequency (> 50 MHz) modes of operation. Expires on 30 June 2019.”

Both the directives mentioned above will enter into force on the twentieth day following that of their publication (i.e., following 10 April 2015). They will have to be implemented by Member States by the last day of the ninth month after their entry into force.

Hong Kong companies exporting any shipments of EEE to the EU should be reminded that unless their goods fall out of the scope of the RoHS Directive (as outlined in its Article 2(4)) or are exempted by one or more entries in Annexes III or IV of the Directive, the heavy metal substance restrictions will apply.

Please click the following to read:
Directive 2015/573
Directive 2015/574

Content provided by Picture: HKTDC Research
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