Ethoxyquin

Toxicity to soil macroorganisms except arthropods

Administrative data

Endpoint:

toxicity to soil macroorganisms except arthropods: short-term

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because direct and indirect exposure of the soil compartment is unlikely

Justification for type of information:

According to REACH Annex IX column 2, studies on effects on terrestrial organisms do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely.

The substance is manufactured as a feed additive only, no other uses were identified. Ethoxyquin as such is listed in the European Union Register of Feed Additives pursuant to Regulation (EC) No 1831/2003, on Annex I: List of additives (Released 19.09.2016, Edition 241), by the DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY, Directorate E - Food and feed safety, innovation, Unit E5 – Animal nutrition, veterinary medicines. As an approved feed additive, it is hence completely covered under the feed and food law and so not under the scope of REACH. Due to a change of the therein legally specified impurity profile, the substance as it is produced, does not fulfill these requirements any more, and is therefore, as a chemical substance not covered by other legislations, subject to REACH. After manufacture however, the substance will be directly purified to match the legal requirements for a feed additive. Hence, after purification the feed and food law will be applicable again, and the substance is no longer subject to REACH. Hence, only the very short service life of manufacture and transport needs to be regarded under REACH. During that period, sufficient precautions and safety measures are taken to completely avoid a release of the substance in the environment, so no exposure of the environment to the substance is given: Emission to the soil compartment can be completely ruled out during the manufacture of the substance. All relevant manufacture processes take place indoor. Loading operations to be performed prior to shipment of the substance do not bear a risk for soil exposure either.

In consequence, as no release into the environment and hence soil is given, testing for toxicity to soil macroorganisms can be waived.