2015.12.01 Biocides and biostats, Legislation, Work environment

Labelling - formaldehyde and isothiazolinone

Those of us who are trying to keep up with developments in the chemicals legislation have had our work cut out during the autumn 2015. The major changes have concerned classification of biocides.

At present, many biocides do not have harmonised classification, which they must have if they are to be approved biocides under the EU's Biocidal Products Regulation. Numerous discussions are therefore under way within the EU concerning how different biocides should be classified.

Formaldehyde releasers

Discussions have been held during the autumn within Europe's Committee for Risk Assessment (RAC) regarding appropriate classification for three formaldehyde releasers; MBM, Oxazolidin/MBO and HPT. The industry has been eagerly awaiting the outcome of these discussions as they will provide a pointer as to how other formaldehyde releasers will be judged.

The discussions have been more heated than a parliamentary debate, with one camp asserting that the formaldehyde releasers should be classified on the basis of how much free (released) formaldehyde they contain and the other camp maintaining that they should be classified on the basis of how much formaldehyde they can release. If you are interested in finding out more on the different views, you can find them here. Material was recently published showing that RAC has agreed that the latter line has the strongest scientific evidence and will recommend that HPT and Oxazolidine/MBO are classified on the basis of how much formaldehyde they can release. In other words, they will recommend that both HPT and Oxazolidine/MBO have the classification, Carc. 1B, Can cause cancer. Discussions regarding the third formaldehyde releaser, MBM, are incomplete, but it is highly likely that RAC will take the same line there. View RAC's discussion and statement about HPT and Oxazolidine here.

Isothiazolinones

The discussions surrounding the classification of the isothiazolinone MIT have, if possible, been even more heated. Here it has primarily concerned the concentration at which MIT is allergenic. The proposal put forward was that 600 ppm should be a suitable limit. How this concentration limit was arrived at has been strongly criticised by everyone from researchers, doctors and institutions to member states, since it is based on a study in which the conclusion explicitly states that the results are not suitable for assessing concentration limit. However, there are also those who consider that the limit should be set even higher, at 1,000 ppm, since they think that the legislation does not support a lower limit value.

The researchers, doctors, institutions and member states that are criticising the proposal think that the limit should be set much lower, namely at 15 ppm, and some even lower, at 10 ppm. Their opinion is based, among other things, on the fact that the majority of other studies show that MIT produces reactions for sensitive people at levels as low as 50 ppm. Another reason that MIT in particular is under such scrutiny is that the number of people diagnosed with an MIT allergy has increased so dramatically in recent years that is has been likened by some to an epidemic.

MIT-allergy-increase-300x264.jpg

Source: Scientific Committee on Consumer Safety, Opinion SCCS/1557/15

Why has the MIT allergy become so much more common in recent years? The suggestion is that it is because MIT has replaced CMIT/MIT, a biocide that was previously very common. When it was observed a number of years ago that there was an increasing trend in the number of people with CMIT/MIT allergy, the classification of the biocide was changed to a much lower limit value of 15 ppm. The effect was a decline in the use of CMIT/MIT. In many cases MIT, that had no classification, was used instead. MIT is a very common biocide that is used in everything from shampoo to make-up, paint and metalworking fluids. In most consumer products, shampoo and paint for example, the content of MIT is below 100 ppm. Many of the people who have now become allergic to the substance have not come into contact with it other than through consumer products. 100 ppm is thus sufficient not only to produce a response in a person who is already allergic, but also sufficient to bring about an allergy in people who had not previously been allergic.

To sum up, it is highly likely that the outcome of the discussions will be that MIT is also given a low limit value of 15 ppm.

 

Chemicals legislation in the EU

Changes within the chemicals legislation are affecting the metalworking industry a lot right now. With our e-book, you can keep up to date. (CS)

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Hans Ahlgren
Hans Ahlgren

Hans introducerade processvätskerening inom Wallenius Water 2011 efter ett flertal lyckade fältinstallationer. Processvätskerening är idag ett av Wallenius Waters fokusområden. I dag arbetar Hans med strategisk partnerutveckling inom affärsområdet.

+46 8 120 138 37
moc.retawsuinellaw@nerglha.snah
Hans introduced process fluid purification within Wallenius Water in 2011 after several successful field installations. Today purification of process fluid is one of Wallenius Water's focus areas.

+46 8 120 138 37
moc.retawsuinellaw@nerglha.snah
Hans führte die Reinigung von Prozessflüssigkeit innerhalb Wallenius Water im Jahr 2011, nach mehreren erfolgreichen Feldinstallationen, ein. Heute ist die Reinigung von Prozessflüssigkeit eine der Schwerunkte von Wallenius Water.

+46 8 120 138 37
moc.retawsuinellaw@nerglha.snah

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