UEIL Health and Environment Committee
FORMALDEHYDE UPDATE
Brussels, 27 April 2010
Christian Eyler
Formaldehyde France - Legal Situation
• Formaldehyde releasers added to the list of cancerogene substances
• Workers should not be exposed to these substances
• Application from 1st Jan 2007, in France only
• The employer is obliged to
1. Replace by FormaldehydeFree product
if technically not possible:
2. Actions to limit the exposure of workers to a minimum, e.g.
- encapsulate the machines
- regular measurements
- regular medical checks
- etc.
Proposal for harmonised C&L by France
France is expected to submit a new proposal for harmonised classification and
labelling for formaldehyde to ECHA by end of September 2010. In December 2009
the submission date had been postponed for 9 months in order to take into account
the results of the IARC meeting in October 2009. In their October 2009 meeting in
Lyon IARC concluded in a split vote that there is sufficient evidence in humans of a
causal association of formaldehyde with leukemia (ZHANG study(!?)).
From FormaCare’s scientific perspective, the main focus will remain Nasopharyngeal
Cancer (NPC), as confirmed unanimously by IARC in October 2009. Leukemia
could be taken up by France to further strengthen the case for a stricter classification
than the current category in Europe.
This science-based exchange by FormaCare will be pursued vis-à-vis the European
Commission, where high-level dialogue has already commenced and with the
competent authorities of key Member States such as France, Germany and the UK.
The role of Germany will be very decisive as rapporteur in ECHA’s Risk Assessment
Committee (RAC) on the French Dossier.
Indoor Air Quality – WHO/EU
WHO expected to maintain limit values, EU guidelines still under review.
Work on guideline values established by the World Health Organization (WHO) for indoor
air quality is almost finished. The final version of the WHO publication is expected to be
available end of the second quarter of 2010 and will be taken into account by the
European Commission. If no change is made, which is still possible until end of April, it
seems as if the current values (0.08 ppm = 0.10 mg/m³) of the WHO will be maintained.
For reference, BG Guideline MWF median and
CRAM France results general average exposure = 0.02 mg/m³!!!
This is important since the European Commission’s preparatory work on indoor air limit
values so far generated very different results and conclusions. We are now waiting for the
revised version of the European Commission Joint Research Centre’s (JRC) INDEX report
which is thought to take WHO results into account.
FormaCare is planning to participate via CEFIC in a workshop in June to discuss and
promote a "Harmonised Framework on indoor material labelling schemes“
for Europe.
OEL-setting process
New proposal by SCOEL after study results in 2010, DNEL to be derived in parallel
Once results of the current inhalation study with human volunteers are available presumably by autumn 2010 - a new evaluation will be performed by the Scientific
Committee on Occupational Exposure Limits (SCOEL). This review will then be put to
consultation in a first step. The Commission could aim to establish occupational exposure
limit values (OEL) for the workplace that are indicative or binding.
In parallel, FormaCare will develop a so-called DNEL (Derived No-Effect Level) for
formaldehyde required under REACH. Manufacturers and importers must calculate
DNELs as part of their Chemical Safety Assessment (CSA) for any chemicals used in
quantities of 10 tonnes or more per year.
OEL-setting process
As part of the human health risk assessment DNELs are established based on the available
data on the intrinsic toxicological properties of a substance. The DNEL describes the dose
which is safe for humans, meaning that any exposure at or below the DNEL will not lead
to adverse effects and can be regarded as a safe level for humans. For all possible exposure
scenarios, including exposure at the workplace during production or use, the estimated
exposure level will be compared with the DNEL. If the exposure equals or is below the
DNEL, the identified use is safe and no additional measures have to be implemented.
Given that DNELs are not very different from OELs, ECHA’s RAC closely coordinates its
work with SCOEL to achieve possible alignments between the bodies’ activities with regard
to the setting of limit values. DNELs are thought to succeed OELs at some point. But in
an interim phase some questions regarding the relationship between OELs to be
established at EU-level, existing OELs at national levels and the DNEL remain and require
investigation and clarification in the course of the next months.
Formaldehyde - US
The U.S. Environmental Protection Agency (EPA) is currently working on the IRIS
(Integrated Risk Information System) assessment of formaldehyde. In December 2009,
the U.S. Environmental Protection Agency (EPA) notified FCI that the National Academy
of Sciences (NAS) will be asked to serve as the peer review body for EPA's ongoing IRIS
assessment of formaldehyde. The external peer review by NAS is expected to start in
autumn 2010 to be completed in spring 2011. The final assessment under IRIS is expected
to be completed by the second half of 2011.
In February 2010, FCI addressed the EPA to begin a dialogue about some of the science
issues that have been raised recently concerning formaldehyde. FCI made it very clear that
industry takes its responsibility to help provide a scientific basis for public health
protection very seriously. At the same time concerns were expressed, that several
fundamental key science issues have not received sufficient critical attention. According to
FCI, those issues are quite likely to be raised by the National Academy of Sciences
committee that will review formaldehyde’s IRIS profile.
Formaldehyde - US
Furthermore, in March 2010, the U.S. House of Representatives’ Subcommittee on
Commerce, Trade, and Consumer Protection held a hearing on the Formaldehyde
Standards for Composite Wood Products Act. FCI Executive Director, Betsy Natz,
attended the hearing in which no mention was made of leukemia.
End of 2009, the National Institute of Environmental Health Sciences NIEHS, a part of
which is the National Toxiocology Programme (NTP), nominated formaldehyde for
possible reconsideration as a “known carcinogen." FCI submitted extensive comments to
the NTP’s recommendation on formaldehyde. NTP has now scheduled the Board of
Scientific Counselors meeting June 20 – 21 2010, which will be held at NIEHS
headquarters in Research Triangle Park, NC. FCI will identify key scientists
to present at the meeting as well as formulate written comments
Formaldehyde - Europe
Actions:
- Contact established between Reinhard Strupp and Michael Rocker (26 April 2010)
- Meet with FormaCare/R.Strupp in Paris on 4 May 2010