In a press release of 24 November 2010 the European Commission announced that the European Parliament has voted to revise the RoHS directive (EU legislation on the use of hazardous substances in electrical and electronic equipment). The draft legislation, proposed by the Commission in 2008, should, according to the Commission, strengthen the existing law by streamlining procedures for future substance restrictions and by making it coherent with other chemicals legislation, such as REACH. Today’s vote confirms the first reading agreement with the Council on the revised legislation.
The RoHS Directive has prevented many thousands of tonnes of banned substances from being disposed of and potentially released into the environment since it came into force in 2003. It has led to important changes in the design of electrical and electronic products in the European Union and worldwide and facilitates the recovery of many rare substances and materials used in electronics.
RoHS currently covers a vast spectrum of products that use electricity, including small and large household appliances, IT and telecommunications equipment and consumer goods such as radios, TV sets, video cameras and hi-fi systems but NOT medical devices. Under the present directive medical devices manufacturers were dealing with RoHS issues mainly through their supplier’s actions to conform to RoHS requirements, e.g. components. That will change with the new directive: it will extend its scope to include medical devices.
Key elements include:
- greater coherence with other EU legislation, such as REACH and the new legislative framework for the marketing of products
- The extension of the scope to all electrical and electronic equipment, including medical devices and monitoring and control instruments.
- Electrical and electronic equipment that was outside the scope of the current RoHS Directive but which will be covered by the revised Directive, does not need to comply with the requirements during a transitional period of 8 years, giving producers time to adapt;
- A lighter and more effective mechanism for reviewing or amending the list of banned substances is introduced, enabling further substances to be considered on the basis of scientific evidence and specific criteria, and in line with REACH. Changes may then be made through comitology;
- The rules for granting exemptions from the substance ban are further streamlined to provide legal certainty for the economic operators and to ensure coherence with REACH;
- Important definitions are clarified to ensure the directive is applied in a harmonised manner throughout the EU.
- Better enforcement of the Directive at national level will be achieved through alignment with the marketing of products legislative package.
It is interesting that notified bodies are being granted a role in the process for exemptions of the requirement to substitute substances with less harmful ones.
But we knew this already from the 2008 proposal. The Parliament did however propose a number of additional changes in the document that it approved.
So, what is new?
Let’s take a look at the Parliament’s proposed changes for medical devices speciflically:
- the definition of medical device was amended: a medical device within the meaning of point (a) of Article 1(2) of Directive 93/42/EC which is also electrical and electronic equipment (underlined text added) – nothing shocking, otherwise it would not fall within the scope of the RoHS directive.
- active implantable devices are now completely excluded from the scope of RoHS – and not provisionally until 2020 as was the case in the earlier draft
- the Annex II substances ban does not apply (for the deadlines listed) to cables or spare parts for the repair,the reuse, the updating of functionalities or upgrading of capacity (the underlined text is new) for medical devices
- The Annex II substances ban now applies to medical devices which are placed on the market three years after the date of entry into force of the newDirective (this was 1/1/2014) and to in vitro medical devices which are placed on the market from five years after the date of entry into force of this the new Directive (this was 1/1/2016) – the dates will shift and manufacturers will have more time than originally planned if the directive is not adopted before 1/1/2011 (unlikely to happen)
- The procedure for amending the list of applications exempted from the restriction in Article 4(1) specific to medical devices and monitoring and control instruments (Annex IV of the amended draft) has changed – the Commission had proposed comitology as process but this has changed to ‘individual delegated acts’ pursuant to article 290 Lisbon Treaty
What happens next?
The text voted on will now need to be formally adopted by the Council. So, the Council needs to agree with the changes proposed by the Parliament. The new Directive will enter into force 20 days after its publication in the Official Journal of the European Union. Member States will then have 18 months to transpose it into national law. Until then, the existing RoHS Directive (Directive 2002/95/EC) continues to apply.