Registration Dossier

Administrative data

Endpoint:
activated sludge respiration inhibition testing
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because there is no emission to a sewage treatment plant
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING

According to REACH Annex VIII column 2, the study does not need to be conducted if:
— there is no emission to a sewage treatment plant, or
— there are mitigating factors indicating that microbial toxicity is unlikely to occur, for instance the substance is highly insoluble in water, or
— the substance is found to be readily biodegradable and the applied test concentrations are in the range of concentrations that can be expected in the influent of a sewage treatment plant.

According to ECHA’s „Guidance on information requirements and chemical safety assessment, Chapter R.5: Adaptation of information requirements“ of April 2010, „EXPOSURE BASED ADAPTATION AND TRIGGERING OF INFORMATION REQUIREMENTS … REACH provides for the option that information requirements may be adapted based on the justification… and that the likelihood of exposure to man or the environment is negligible.“ and „Terminology on adaptation: A variety of terms in relation to exposure based adaptations is used in column 2 of Annexes VIII-XI and in the revised Annex XI… The revised Annex XI( 3.2(c)), requires that “no release” should occur during the life cycle of substances incorporated into articles and that the “likelihood of exposure” to man and environment is “negligible” (= absence of exposure)“ and „Exposure based adaptations may be appropriate under the following conditions:
- exposure is absent (= exposure excluded) or not significant (= unlikely) throughout the life cycle of the substance for manufacture and all identified uses or
- when strictly controlled conditions apply throughout the life cycle of the substance for manufacture and all uses and
- no releases from the article life cycle stage (and subsequent waste life stage) is to be expected and consequently there is a negligible likelihood of exposure. Situation iii) only applies to substances incorporated into articles.“
Hence, the present exposure-based waiving is applicable also in the case of the release of an negligible amount, as the risk here in similarly controlled compared to “no release” and matches the wording of ECHA’s documents.

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 avoid a release of the substance in the environment, so nearly no exposure of the environment to the substance is given and only negligible amounts are released, so only negligible amounts of the registered substance are contained in the waste water treated by the STP, there are no other ways that may lead to the exposure of the water compartment in general; liquid waste of the process is burned in a waste incineration unit. Prior to the emission into the STP, waste water is (pre)treated in a water-oil separator (two-phase system). Due to the high LogPow value of the substance, ethoxyquin (CAS 91-53-2) will be dissolved in the oil phase to a great extent and only negligible amounts are expected to stay in the water phase. Therefore, significant exposure of the substance into the water compartment can be excluded.

In consequence, as no relevant emission to a sewage treatment plant is given, activated sludge respiration inhibition testing can be waived.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion