November 14, 2017
I am delighted to inform you about the latest developments on the policy front. A lot has happened since February: ANSES published its RMOa conclusions and the European Commission has started the process of proposing a Binding Occupational Exposure Limit (BOEL) for formaldehyde. Meanwhile, industry has submitted additional information in the context of the REACH evaluation.
Last March the French ANSES published the conclusions of the risk management option analysis they had been conducting on formaldehyde since 2015. As you may recall, the exercise focused on occupational exposure. ANSES confirmed the intermediate status of formaldehyde for chemical synthesis and the manufacturing of resins and identified a BOEL as one of the most relevant option to manage risks due to formaldehyde occupational exposure. However, the French agency still expressed concerns regarding the timing needed to adopt a BOEL and did not discard the identification of formaldehyde as a Substance of Very High Concern due to the recent reclassification.
ANSES’ opinion is now on the desk of the French Ministry of ecological and solidarity transition which should publish their final recommendations in coming weeks or months. Formacare has had the opportunity to change views with them in that regard.
A few weeks after ANSES published its opinion, the European Commission announced that a third revision of the Carcinogen and Mutagen Directive (CMD) would be carried out in 2018. Formacare met with the European Commission (DG Employment and Social Affairs) in July 2017 and it was confirmed that formaldehyde was among the substances prioritised under the CMD. An impact assessment is currently ongoing (Formacare has shared data) and we expect the publication of the Commission’s proposal before the summer next year.
This development is consistent with Formacare’s efforts. For approximately two years, Formacare has advocated in favour of a BOEL for formaldehyde on the basis of the SCOEL recommendation (0.3ppm). Should the process follow the announced timeline, French authorities should be confident that a BOEL could be adopted within a reasonable time frame.
Last month the formaldehyde industry submitted to ECHA new data as requested 2 years ago when the Netherlands came to the conclusion that information was missing regarding indoor air emission sources of formaldehyde. Dutch authorities have now a year to evaluate this new data and come to final conclusions on indoor air exposure.
It should however be noted that the European Commission has also recently developed some interest on consumers uses of formaldehyde and is aiming to assess whether consumers are exposed to an unacceptable risk.
Formacare has recently met with the European Commission on this matter and will closely monitor the situation and engage when needed.
All the best,
Steven Van de Broek