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New Applications Lodged for Further Lead Exemptions Under Rohs for Electrical and Electronic Equipment

Hong Kong traders may like to know that two new applications for exemptions for the use of lead were lodged with the European Commission, under Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (more commonly known as the RoHS Directive).

As Hong Kong manufacturers of all kinds of electronic products may know, the RoHS Directive regulates the use of certain hazardous substances in new electrical and electronic equipment (“EEE”) placed on the EU market. There are currently ten substances, including lead, that are on the list of regulated substances in the RoHS Directive.

Any EEE (including cables and spare parts) placed on the EU market must not contain more than a 0.1% concentration of lead unless the specific use of lead is excluded or exempted. Whereas Article 2(4) of the RoHS Directive lists specific products that are wholly excluded from the restrictions, such as large-scale stationary industrial tools, Annex III of the RoHS Directive sets out specific uses of the hazardous substances that are exempted from the restriction. One example is the use of lead in glass of cathode ray tubes.

The RoHS Directive enables economic operators to request that the Commission grant, renew or revoke exempted uses. As regards the two new applications recently lodged for certain lead uses, Hong Kong traders should know that the exemption is not limited to the applicants. Therefore, other companies may benefit from the exemptions, once these are granted. Therefore, if these applications were to be successful, the exemptions concerned may be of particular interest to Hong Kong-based electrical and electronic goods manufacturers exporting to the EU.

The first application, made by the European Association of Internal Combustion Engine Manufacturers (“EUROMOT”) and Caterpillar, supported by a coalition of associations, is for the use of lead in bearings and bushes of professional-use non-road equipment engines. The applicants argue that “large size engines and those that are required to be used in harsh or demanding environments need to use bearings and bushes that contain lead in order to achieve satisfactory reliability”.

The second application is made by Roche Diagnostics Ltd, a Swiss-based diagnostic solutions and pharmaceuticals company, for the use of lead in the solder used to attach Peltier elements in in-vitro diagnostics (“IVD”) analysis instruments that analyse samples from human blood and tissue samples for a variety of diseases.

In their application, Roche Diagnostics Ltd have argued that lead-free alternatives do not provide the same level of precision, which can have a detrimental effect on the analysis and, in turn, put patient safety at risk. Roche Diagnostics Ltd further submitted that if their application is not successful and leaded solder can no longer be used in its current instrument, laboratories may be forced to continue to use old instruments for longer than appropriate. If this is the case, Roche Diagnostics Ltd warned that the instruments may become unreliable and pose a risk to patient safety. 

The general position is that, if these applications are successful, Hong Kong businesses may be able to import their products into the EU market as long as they are in accordance with any specific requirement of use outlined by the Commission. However, exemptions granted will be limited in scope and duration. Therefore, Hong Kong traders should keep in mind whether a further application for extending the authorisation should be made and, if so, keep in mind this must be made at least 18 months before the exemption expires.

Applications for new exemptions must be made at least 18 months before the specific use of the substance comes under the scope of the RoHS Directive. The application can be made by a manufacturer, an authorised representative of a manufacturer or any economic operator in the supply chain. An application for an exemption must be in accordance with Annex V of the RoHS Directive. Annex V requires that the application, in clear wording, outlines the specific use applied for and provides a verifiable and referenced justification for the exemption. Additionally, the applicant must provide a summary of the application, an analysis of any alternative substances available and information on the reuse, recycling and treatment of waste EEE.

Within 15 days of receiving the application, the Commission will write to the applicant to inform them of receipt. The Commission will, without delay, inform Member States of the application and provide them with a copy of the application along with any supplementary information provided by the applicant. It is the Commission’s responsibility to evaluate the application and its justification.

It may be of interest to Hong Kong traders to know that the Commission will also prepare a summary of the application which will be made public before any decision is made.

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