RECLASSIFICATION OF FORMALDEHYDE IN THE EU
The Risk Assessment Committee (RAC)1 decided on 7th
December 2012 to classify formaldehyde as CMR2 carcinogenic
category 1B and category 2 mutagenic. Category 1B means that
there is sufficient evidence for CMR properties, which could be
detected in animals, but human carcinogenic is only suspected.
This classification will be implemented in the EU until 1st
January 2016 by the amending regulation ((EU( No.2016/491)
according to the 6th ATP3 of CLP4-regulation.
In the near future, it can be assumed that other countries/nations
will follow and possibly adopt this classification. In particular
this assumpion considers Canada and the United States, where
classification and potential ban of use of formaldehyde releasing
substances in metalworking fluids have already been discussed
ower the last years.
1st January 2016, formaldehyde was reclassified as carcinogenic and mutagenic.
“With the reclassification in terms of carcinogenicity, EU intends to ban the use of formalin… ESP (European Society of Pathology) took seriously into consideration this issue…and have been trying to convince the European Parliament and the Council that they should make an exception so that pathology laboratories may continue to use this indispensable fixative.”
European Society of Pathology, Newsletter, winter 2017.
“Formalin Risk free”
As of 1 January 2016, EU Regulation No. 605/2014 came into force, which reclassifies formaldehyde as a carcinogenic product. This regulation has had a significant impact on the methods of use and management of formaldehyde in hospitals. SecurBiop® and FORMALeasy® were born to meet this need.
The risks associated with the substance identified by studies on the subject are manifold. Some of these risks act in the short term: they are the purely irritative effects of the substance, which affect the eyes, respiratory mucous membranes and skin. These effects may vary depending on the age, physical condition and susceptibility of the subject to the substance.
As for the carcinogenic effects, which occur in the long term, the IARC (International Agency for Research on Cancer) has reported several cases of tumor appearance related to the exposure of the subjects in question to formalin.
.
| CMR-attribute | Classification of the substance |
Classification of the mixture |
|---|---|---|
| mutagenity | muta.2; H341 | conc. ≥ 1% muta.2; H341 |
| carcinogenitycarc. | 1B; H350 | conc. ≥ 0,1% carc. 1B; H350* |