REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Report on the availability of mercury-free button cells for hearing aids, in accordance with Article 4.4 of Directive 2006/66/EC of the European Parliament and of the Council on batteries and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC
Date: 2014-10-15
Institutions: European Commission
Subjects: derogation from EU law, electricity storage device, facilities for people with disabilities, mercury, physically disabled person, waste recycling













EUR-Lex - 52014DC0632 - EN











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52014DC0632

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Report on the availability of mercury-free button cells for hearing aids, in accordance with Article 4.4 of Directive 2006/66/EC of the European Parliament and of the Council on batteries and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC /* COM/2014/0632 final */









1.                      
Introduction
Under
Article 4.2 of Directive 2006/66/EC on batteries and accumulators
and waste batteries and accumulators (the Batteries Directive), as amended in
2013[1],
the prohibition to place on the market mercury-containing batteries
or accumulators shall not apply to button cells with a mercury content of no
more than 2 % by weight until 1 October 2015.
While in 2012 a
report commissioned by the Commission concluded that alternatives to
mercury-containing button cells for all applications were available[2],
the Commission was requested in the amended Directive to conduct another,
specific study to confirm this conclusion.
More
specifically, Article 4.4 of the amended Batteries Directive stipulates that 
"As regards
button cells for hearing aids, the Commission shall maintain under review the
exemption referred to in paragraph 2 and report to the European Parliament and
the Council on the availability of button cells for hearing aids which are in
compliance with paragraph 1(a) no later than 1 October 2014. Where justified
due to the lack of availability of button cells for hearing aids which are in
compliance with paragraph 1(a), the Commission shall accompany its report by an
appropriate proposal with a view to extending the exemption referred to in paragraph
2 with regard to button cells for hearing aids".
The purpose of
this report is to inform the European Parliament and the Council of the
Commission's findings on the availability of button cells for hearing aid
devices containing no more than 0,0005% of mercury by weight.
2.           Findings
2.1.        Introduction
To prepare the
present report, the Commission collected and assessed available information as
regards mercury-free button cells used in hearing aids devices, focussing
primarily on their technical and commercial availability and then, on the
likely impact on users, as regards performance and financial aspects. 
The Commission
requested the services of independent consultants who reviewed relevant
literature and knowledge, and held consultations with all major producers and
manufacturers of batteries and hearing aid devices as well as with patients'
and hearing aid associations.[3] 
The reliability
of the results of the consultation is ensured, in the opinion of the
Commission, by the size of the market share of the producers and manufacturers
of batteries and hearing aid devices that have been consulted. Their fair
cooperation, even acknowledging usual limits applicable to sensitive
business-related information, should be highlighted.
Particular
attention was paid to the lessons learnt after the adoption of bans on
mercury-containing button cells in the United States where 30 states have
passed (or proposed) legislation in this respect.
In the opinion
of the Commission, the use of different but complementary sources has allowed
coming up with a wide-ranging and detailed appraisal of the situation, beyond
the issues strictly related to the security of supply requested by the
Directive. 
The resulting
conclusions obtained by the consultants have provided solid foundations upon
which the Commission has completed its own evaluation and prepared the present
report.
2.2.        Key
findings 
On the basis of
the mentioned study, which the Commission considers being a solid study with
sound findings and conclusions and based on robust data and evidence, and own
evaluation work carried out, the Commission arrives at following conclusions:
(1)         
Viable
mercury-free alternatives exist for button cells used in hearing aids. The most
frequently used types make use of zinc air technology, which has been developed
by several firms. Other technologies also exist (e.g. Nickel Metal Hydride),
but its use is less spread and is limited to devices not needing high power
delivery or that allow less stringent usage patterns. 
(2)     As
confirmed during the consultation and taking into consideration current levels
of production, the security of supply of button cells for hearing aid devices
will not be put at risk after the exemption for mercury-containing button cells
expires on 1 October 2015. Those product types for which mercury-free
alternatives are unlikely to be available (i.e. the smallest size 5 cells) are
being phased out by the industry, independently of the shift to mercury-free
products.
(3)     Experience
gained in the United States after the introduction of similar bans of
mercury-containing button cells shows that issues that initially appeared in
relation to the performance and usability of mercury-free alternatives for
hearing aids have been overcome as a result of new technological developments
and the expansion of markets. The performance issues facing some of the first
generation mercury-free button cells for hearing aids supplied in the United States in 2010 have now been solved. While, depending on brands and models, a
reduction of the lifespan of batteries by around 2–10% has been identified,
current technical developments are expected to further improve performance.
(4)     Cost
differences between mercury-free and mercury-containing button cells used in
hearing aids might appear in the EU market, as it has been the case in the US. An earlier study prepared for the Commission estimated the costs of mercury-free button
cells to be some 10% higher.[4]
While at present the differences in retailing prices appear to be higher[5],
a ban on mercury-containing button cells for hearing aids in the EU is expected
to reduce price differences. This is due to larger markets and economies of
scale and the removal of inefficiencies in production systems for those
manufacturers that reorganize their production capacity to one single product
line.
(5)     The
expiry of the exemption for mercury-containing button cells is expected to
promote innovation. This will shorten the time needed to improve the
performance of mercury-free products and enable new products to meet the needs
of more developed devices that require higher power delivery.
(6)     As
regards the security of supply of mercury-free button cells for hearing aid
devices no particular concerns were raised by the patients' and hearing aid
associations consulted as part of the study commissioned by the Commission. 
3.           Conclusion
Expiry of the
exemption for mercury-containing button cells as of 1 October 2015 is not
expected to entail problems as regards the availability of button cells used in
hearing aid devices. Consequently, there is no need to extend the exemption
enshrined in Article 4 of Directive 2006/66/EC.
[1]  OJ
L 266 26.9.2006, p.1-14; last amendment by Directive 2013/56/EU of the European
Parliament and of the Council of 20 November 2013, OJ L 329, 10.12.2013, p.
5–9.
[2]  BIO Intelligence
(2012) "Study on the Potential for Reducing Mercury Pollution from Dental
Amalgam and Batteries," Report for European Commission DG Environment,
July 2012, in particular section 7.1, option 2 (page 123) in conjunction with
the concluding section 9.2 (page 135).
[3] Eunomia
& Öko Institut e.V. (2014) "Availability of Mercury-free Button Cells
for Hearing Aids"Report for DG Environment, August 2014.
[4]  BIO
Intelligence (2012) "Study on the Potential for Reducing Mercury Pollution
from Dental Amalgam and Batteries," Report for European Commission DG
Environment, July 2012, page 117.
[5]  For instance, US
internet sale prices for a pack of six size 10 cells range from $ 3.25 to $
3.95 for conventional hearing aid button cells and from $3.95 to $ 4.95 for
mercury-free cells, depending on brands and sellers.