RoHS recast: industry hammers case for medtech exemptions

The European electromedical industry association COCIR has once again stressed the need for medical equipment to remain out of the scope of the directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (Directive 2002/95/EC)^1,2.

In view of the upcoming European Parliament Environment committee vote on the proposal for a recast of the so-called RoHS Directive, COCIR has worked together with other trade associations in the electrical and electronic industries to draft a joint position paper, as well as issuing one on its own.

In its position paper, COCIR, which represents the electronic, radiological and IT industries, says that it fully supports “essential additional exemptions for medical devices”. The association warns that because its members manufacture highly innovative and complex healthcare technologies with comparably long lifecycle expectation and many potential failure mechanisms (associated with substitutes), including medtech within the scope of RoHS could affect long-term reliability of medical equipment.

In COCIR’s view, it is vital to:

• provide the European Union market with safe and effective medical devices that contribute to a better healthcare system and improve citizens’ quality of life; and
• ensure sufficient time to find alternative components (research), redesign products, conduct validation and reliability testing and obtain market approval to comply with the Medical Devices Directive.

If such exemptions are not validated, COCIR fears that the availability of medical devices and the future development of new technologies will be compromised. The trade association adds that it has been proven that none of the apparent substitutes are suitable as of today.

Joint response

Together with the other associations, COCIR also calls for support to:

• clarify RoHS scope exclusions;
• introduce formats, timelines and grace periods for RoHS exemptions case by case;
• establish a structured stakeholder consultation mechanism;
• assess the added value of the RoHS Directive during the review process for Regulation (EC) No 1907/2006 on the registration, evaluation, authorisation and restriction of chemicals (REACH), and, in the meantime, align RoHS with REACH to the maximum extent; and
• align RoHS with the New Legislative Framework, and in particular to make use of European Standardisation Committees to harmonise relevant standards.

Joint industry statement

The joint industry statement, meanwhile, issued just ahead of COCIR’s position, calls for “a thorough representative impact assessment at EU level and scientific evidence for any major change to the existing Directive”.

It warns the concept of an open scope is “particularly unjustified” and that the impact of such far-reaching modifications have not been subject to any impact assessment.

It also calls for scientific evaluation on the basis of a comprehensive and consistent methodology before any new substance restrictions are introduced. Setting new restrictions without a proper assessment “bears unforeseeable risks and negative consequences, especially at the level of product reliability and safety”.

The group also believes that a better exemptions mechanism is an indispensable prerequisite for providing legal certainty in time and making implementation work in practice.

Ensure compatibility with REACH

An RoHS Directive that is complementary to REACH needs to be fully consistent with the EU’s horizontal chemical management law to avoid double regulation and conflicting requirements, the joint industry statement says.

REACH provides a fully harmonised framework for chemicals management across the EU and includes in its scope substances used by the electrical and electronic industries. So, to provide legal certainty, “it is vital that any additional substance restrictions introduced under RoHS follow REACH criteria and procedures”: in particular, they should use all information produced within REACH’s chemical risk assessment.

The joint statement also expresses the view that the RoHS Directive is not the appropriate framework for nanomaterials, since these are used in a wide range of different applications far beyond the electrical and electronics equipment industry.

Indeed, nanomaterials are covered by the REACH Regulation and many related activities are currently ongoing in the European Commission with a view to the REACH review 2012.

Proposals to assess the added value of RoHS during the ongoing REACH review process are, in industry’s view, helpful in striving for better legal consistency and legal certainty.

REACH safety data sheets

Separately, the commission has adopted a regulation amending the REACH annexes relevant for safety data sheets³. The revision brings the SDS requirements into line with the Regulation on Classification, Labelling and Packaging (Regulation (EC) No 1272/2008) and with the guidance on the preparation of SDSs as laid down in the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) of the United Nations.

References

1. Joint Industry statement on Restriction of Hazardous Substances (RoHS) Directive, 31 May 2010, www.cocir.org/uploads/documents/67-1031-joint_eee_and_machinery_manufacturers_statement_on_rohs_recast_2010_05_28.pdf

2. COCIR additional statement on RoHS Recast on Medical Device exemptions, 1 June 2010, www.cocir.org/uploads/documents/68-1032-cocir_position_on_rohs_exemptions_1_june_2010_one_page.pdf

3. European Commission press release, 2 June 2010, http://ec.europa.eu/enterprise/newsroom/cf/itemlongdetail.cfm?item_id=4329&lang=en