August 6, 2012
The long anticipated revision of the Waste Electrical and Electronic Equipment (WEEE2) Directive (2012/19/EU) was published in the Official Journal, L197, on the 24th of July 2012. The Directive arrives just over a year after its sister Directive 2011/65/EU on the Restriction of Hazardous Substances (RoHS2). The stated aim of WEEE2 is to:
“…protect the environment and human health by preventing or reducing the adverse impacts of the generation and management of waste from electrical and electronic equipment (WEEE) and by reducing overall impacts of resource use and improving the efficiency of such use in accordance with Articles 1 and 4 of Directive 2008/98/EC, [Waste Framework Directive] thereby contributing to sustainable development.”
The WEEE2 Directive enters into force on the 13th of August 2012 and Member States have until the 14th of February 2014 to transpose the Directive into national law and may set more ambitious rates for separate collection than that specified in the Directive. It should be noted that the Commission is empowered to update various aspects of WEEE2 in the light of technical and scientific progress via delegated acts which gives greater flexibility but also means that WEEE2 will become a much more ‘light-footed’ and dynamic piece of legislation than its predecessor.
Whereas it is mainly of interest to the waste and recycling industries there are a number of aspects to the Directive that have consequences for the medical device industry. Probably the most significant change is that after a transition period from when the Directive enters into force until the 14th of August 2018 the equipment categories will be reduced from the current ten to six. The RoHS2 Directive has retained the equipment categories set out in the original WEEE Directive from which it derived them, actually incorporating them into Annex I of RoHS2 with the addition of ‘Category 11’ expanding the scope of RoHS to all Electrical and Electronic Equipment (EEE) unless specifically exempted. After the 14th of August 2018 the current ten categories used by WEEE1 will become six as follows (See Directive for full descriptions.):
- Temperature exchange equipment
- Screens, monitors, and equipment containing screens having a surface greater than 100 cm2
- Large equipment
- Small equipment
- Small IT and telecommunication equipment
Medical equipment will fall within categories 4 and 5, the delineation between ‘large’ and ‘small’ being if the equipment has any external dimension greater than 50cm. An exemption still exists for “…medical devices and in-vitro diagnostic medical devices, where such devices are expected to be infective prior to end of life, and active implantable medical devices.” (Article 2.4(g))
Until now any medical equipment entering the waste stream has not had to meet any recovery and recycling targets, however this will change from the date of entry into force of WEEE2 (13 August 2012) From then medical devices will be subject to a recovery target of 70% and a recycling target of 50%. These targets will be increased on 15 August 2015 to 75% and 55% respectively. After the introduction of the new equipment categories on 15 August 2018 the recovery and recycling targets for medical devices will become 85% and 80% respectively for ‘Large’ equipment (Cat. 4) and remain at 75% and 55% respectively for ‘Small’ equipment (Cat. 5). There is a greater emphasis on ‘reuse’ as well though of course reuse of medical devices is a very sensitive subject and as in all things related to medical devices patient and user safety must remain paramount.
The requirements for distance sellers (e.g. over the internet) have been tightened up with a requirement for distance sellers to register in countries into which they wish to sell, or alternatively to have an ‘authorized representative’ in that Member State who will register on their behalf. (Note it is only necessary to have one authorized representative in the EU for the medical device directive) In addition to registration, producers will still have to provide data on the category and weight of EEE they place on the market and information on what is will be required in terms of registration and reporting is given in Annex X. It has to be understood that the data in Annex X will be derived from a number of sources and not all will (or can) come from the producer. It is expected that most medical device producers will meet their registration and data obligations under WEEE2 through compliance schemes. As with WEEE1 products will need to be labelled with the ‘Crossed out Wheely bin’ (Annex IX) indicating that devices must not be placed in the “..unsorted municipal waste” stream.
One of the most controversial proposals in WEEE2 from the standpoint of the medical device industry was the requirements for EEE shipped across national borders. This was perceived to be a major issue as medical device companies ship non-working devices across borders all the time, whether for repair, reconditioning or investigation. There has long been a problem with EEE being shipped to developing countries under the pretext of being for ‘reuse’ when in fact it was destined for suboptimal recycling with consequent risks to those recycling hazardous products as well as the risk of pollution to the environment. The EU signed the Basel Convention on the Control of Trans-boundary Movements of Hazardous Wastes and their Disposal in 1989 and the changes to the WEEE Directive reflect that policy. Annex VI of WEEE2 gives the requirements for ‘used’ EEE that is not WEEE being shipped across borders, and amongst its requirements are evidence that the device is functional if it is not to be perceived as illegally shipped waste EEE. A derogation does exist “…where it is documented by conclusive proof that the shipment is taking place in the framework of a business-to-business transfer agreement’ for repair or for the investigation of a failure. However what constitutes ‘documented by conclusive proof’ remains to be seen and has the potential to vary from Member State to Member State.
WEEE2 represents a significant tightening of the legislation surrounding the disposal of waste EEE and it will be necessary for medical device producers to review the legislation and if necessary liaise with their compliance schemes on meeting the new requirements. The shipping of non-functioning EEE across borders is likely to also get more complicated though it is too early to tell what the exact implications are likely to be.
Eucomed Environment Consultant