List of Classified Substances: 14 new and 19 amended entries from July 1

The new List of Classified Substances, published in the “Official Gazette of RS” No. 88/25, applies from July 1 of this year. The transition period has expired. From that date, manufacturers, importers and downstream users classify substances and mixtures according to the new harmonized entries.

The rulebook does not mark which entries are new and which are amended. We compared the text with the previous list and singled out the differences. According to our analysis, 14 new index numbers were added and 19 existing ones were amended. Please note that this is our own comparative analysis, not an official table of amendments.

Metals get a classification based on particle size

The biggest conceptual change concerns metals. Copper now has a harmonized classification, but only in the form with a specific surface area greater than 0.67 mm²/mg. It is classified as hazardous to the aquatic environment, acute and chronic category 1, with M-factors of 10 and 1.

Silver enters through two separate entries. Silver powder with a particle diameter above 100 nm carries M-factors of 10 and 10. The nano form of silver, with a diameter of up to 100 nm, carries M-factors of 1000 and 1000. Both forms are also classified as toxic to reproduction category 2 and for specific target organ toxicity after repeated exposure, category 2, with the nervous system as the target organ.

Massive lead, with a particle diameter of at least 1 mm, gets a separate entry with H360FD, H362 and H410.

The practical consequence is clear. Knowing the CAS number is no longer enough to classify a metal. You also need information on the physical form and particle size. Often even the supplier does not have that information, so it has to be requested in writing.

Nonylphenol ethoxylates enter as a group entry

Index number 604-100-00-0 covers nonylphenol ethoxylates. Twelve CAS numbers fall under a single index number, including branched and linear forms, as well as individual ethoxylates with different numbers of oxyethylene units.

The classification is the same for all of them: acute and chronic hazard to the aquatic environment category 1, M-factors 1 and 10.

This affects formulators of detergents, degreasers and textile auxiliaries. If your formulation contains any of those CAS numbers, you have to recalculate the classification of the mixture.

Amendments that touch everyday formulations

Several amended entries concern substances used in a large number of mixtures.

Dibenzoyl peroxide now carries M-factors of 10 and 10, together with Org. Perox. B, eye irritation 2 and skin sensitization 1.

Peracetic acid moves to acute toxicity category 2 for inhalation and dermal exposure, with skin corrosion 1A and M-factors of 10 and 100.

Benzisothiazolinone, a preservative found in water-based paints and cleaning products, gets acute toxicity 2 by inhalation and skin sensitization 1A with a specific concentration limit of 0.036%. That is a threshold below which many formulators have not been paying attention until now.

Diuron is classified as a carcinogen category 1B. Tetrabromobisphenol A also moves to carcinogenicity 1B.

The entries for resorcinol, 2-phenylphenol, metribuzin, dicamba, propyl gallate, transfluthrin, allyl methacrylate, S-metolachlor, pyraclostrobin, clothianidin, cymoxanil and benalaxyl were amended as well.

M-factors and ATE values change the calculation without changing hazard classes and categories

Some of the amendments do not add new hazard classes. They only change M-factors and acute toxicity estimates.

That change looks harmless until you run the calculation. Raising an M-factor from 1 to 10 shifts the threshold for H410 on a mixture by an order of magnitude. A mixture that yesterday passed without an environmental hazard label may today carry GHS09.

That is why a review of the formulation is mandatory even for substances that were already on the list before.

Practical steps

We recommend the following order of work.

1. Extract a list of all CAS numbers from your formulations.
2. Compare it with the new and amended entries from 88/25.
3. For metals, check the physical form and particle size with the supplier.
4. Recalculate the classification of all affected mixtures.
5. Update sections 2, 3 and 16 of the safety data sheet.
6. Check the other sections as well
7. Check labels and pictograms.
8. Update the data in the Chemicals Register for chemicals whose classification changes (when the time comes).

The first two steps do not have to be your job. The third always is, because the particle size data comes from the supplier. The rest depends on how you keep your records.

If you keep mixture compositions in spreadsheets and safety data sheets in documents, you copy every M-factor change into dozens of places. An error in a single copy stays unnoticed until an inspection.

An application for authoring safety data sheets and managing chemicals changes that workflow. You change substance data in one place, the mixture classification is recalculated automatically, and the safety data sheet and label are generated from the same data. The change history stays on record, so at any moment you know which version of a document was valid and when.

Chemplora was developed for exactly this kind of work. It automatically classifies mixtures according to the criteria of the classification, packaging and labelling regulations, tracks SKS entries and compiles safety data sheets in multiple languages.

If you are interested, contact me to get access to the application.

References:

• Ministry of Environmental Protection - Rulebooks and other acts: Introduction to the List of Classified Substances, Official Gazette 88/25
• Ministry of Environmental Protection - Table 1 of the Rulebook on the List of Classified Substances, Official Gazette 88/25