EU - Amendment on Part 1 of Annex VI to CLP Regulation

​Member States and stakeholders have requested that a number of the notes set out in subsection 1.1.3 of Part 1 of Annex VI to Classification, Labeling and Packaging of substances and mixtures (CLP) Regulation has to be amended as some of the notes related to substances are inaccurate and bring in some uncertainty as to the correct interpretation of legal obligations.

In particular, some of those notes could be interpreted as not requiring the substances to be classified at all under certain conditions. However, in fact, they should not be covered by the harmonized classification and labeling but should still be subject to classification in accordance with Title II of CLP Regulation (self-classification). Therefore, the European Commission decided to improve the wording of those notes by amending point 1.1.3.1 and 1.1.3.2 of Part 1 of Annex VI of that Regulation.

Point 1.1.3.1, notes J to R are replaced by the following new notes.

Note J: 

The harmonized classification as a carcinogen or mutagen applies unless it can be shown that the substance contains less than 0.1% w/w benzene (Einecs No 200-753-7), in which case a classification in accordance with Title II of this Regulation shall be performed also for those hazard classes.

Note K:

The harmonized classification as a carcinogen or mutagen applies unless it can be shown that the substance contains less than 0.1% w/w 1,3-butadiene (Einecs No 203-450-8), in which case a classification in accordance with Title II of this Regulation shall be performed also for those hazard classes. Where the substance is not classified as a carcinogen or mutagen, at least the precautionary statement (P102-)P210-P403 shall apply.

Note L:

The harmonized classification as a carcinogen applies unless it can be shown that the substance contains less than 3% of dimethyl sulphoxide extract as measured by IP 346 ("Determination of polycyclic aromatics in unused lubricating base oils and asphaltene free petroleum fractions - Dimethyl sulphoxide extraction refractive index method" Institute of Petroleum, London), in which case a classification in accordance with Title II of this Regulation shall be performed also for those hazard class.

Note M:

The harmonized classification as a carcinogen applies unless it can be shown that the substance contains less than 0.005% w/w of benzo[a]-pyrene (Einecs No 200-028-5), in which case a classification in accordance with Title II of this Regulation shall be performed also for those hazard class.

Note N:

The harmonized classification as a carcinogen applies unless the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen, in which case a classification in accordance with Title II of this Regulation shall be performed also for those hazard class.

Note P:

The harmonized classification as a carcinogen or mutagen applies unless it can be shown that the substance contains less than 0.1% w/w benzene (Einecs No 200-753-7), in which case a classification in accordance with Title II of this Regulation shall be performed also for those hazard classes. Where the substance is not classified as a carcinogen or mutagen, at least the precautionary statements (P102-)P260-P262-P301 + P310-P331 shall apply.

Note Q:

The harmonized classification as a carcinogen applies unless one of the following conditions is fulfilled:

- a short term biopersistence test by inhalation has shown that the fibers longer than 20 μm have a weighted half-life less than 10 days; or

- a short term biopersistence test by intratracheal instillation has shown that the fibers longer than 20 μm have a weighted halflife less than 40 days; or

- an appropriate intra-peritoneal test has shown no evidence of excess carcinogenicity; or

- no relevant pathogenicity or neoplastic changes are noted in a suitable long term inhalation test.

Note R:

The harmonized classification as a carcinogen applies except in the case of fibers with a Length Weighted Geometric Mean Diameter (LWGMD) minus two geometric standard errors greater than 6 μm​, as measured in accordance with Test method A.22 in the Annex to Commission Regulation (EC) No 440/2008.

Point 1.1.3.2, Notes 8 & 9 are replaced by the new notes:

Note 8:

The classification as a carcinogen shall apply unless it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is less than 0.1%.

Note 9:

The classification as a mutagen shall apply unless it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is less than 1%.​