Background

In August 2017, the German authorities submitted an Annex XV dossier in which they proposed to change the harmonised classification of 2-butoxyethanol as shown in table 1. Public comments could be submitted until 1st December 2017. The Annex XV dossier together with the comments are currently under review by the other Member States and will probably be discussed at a RAC meeting later in 2018.

Table 1: Overview of classifications applicable for 2-butoxyethanol

Current Annex VI entry

REACH dossier

Annex XV proposal

Acute Tox 4 (oral)

Acute Tox 4 (oral)

Acute Tox 4 (oral); ATE= 500 mg/kg bw

Acute Tox 4 (dermal)

 

Acute Tox 3 (dermal); ATE = 300 mg/kg bw

Acute Tox 4 (inhalation)

 

Acute Tox 3 (inhalation); ATE = 3 mg/L

Skin Irrit 2

Skin Irrit 2

Skin Irrit 2

Eye Irrit 2

Eye Irrit 2

Eye Damage 1

   

STOT RE 2 (blood)

Actions taken by the Glycol Ethers REACH consortium

During the public commenting period, the Glycol Ethers REACH consortium vigorously challenged the proposed changes to the classification, as the REACH registrants believe this proposal is not warranted based on the scientific data available. For the acute toxicity and STOT(RE) endpoints, the new classifications are not warranted based on the known differences in toxicological response between humans and laboratory test animals, with humans much less sensitive, while the proposed eye irritation classification is not in line with past C&L decisions on EGBE of which the REACH registrants believe were appropriate based on a consideration of all data available.

Whilst the Glycol Ethers REACH consortium believes the current harmonised classification is acceptable, the consortium has submitted comprehensive data to indicate that even this is an over classification and that the a classification based on the available data that is relevant to humans is as follows:

  • Acute Toxicity Cat 4 by oral route (not classified by other routes)
  • Eye Irritation Cat 2 (specific concentration limit 20%)
  • Skin Irritation Cat 2

Following documents were submitted during the public consultation period:

Impact of proposed classification

If the proposed Acute Tox 3 classification will be formalised, this will induce substitution of 2-butoxyethanol in the printing ink sector. According to the exclusion policy of the European Printing Ink Association (EUPIA), substances with an Acute Tox 3 classification are not allowed in printing ink and related products and should be substituted. This policy may also be applicable in the coating sector in general.

If 2-butoxyethanol would be classified as Eye Damage 1, the general concentration limit of 3% will be applicable in formulation of detergents. This will also limit the use of 2-butoxyethanol in this sector.