## 6.5.2. REACH environment

Author: Joop de Knecht

Reviewers: Watze de Wolf

Keywords: REACH, European chemicals regulation

Introduction

REACH establishes procedures for collecting and assessing information on the properties, hazards and risks of substances. At quantities of > 10 tonnes, the manufacturers, importers, and down-stream users must show that their substances do not adversely affect human health or the environment for the uses and operational conditions registered. The amount of standard information required to show safe use depends on the quantity of the substance that is manufactured or imported. This section explains how risks to the environment are assessed in REACH.

Data requirements

As a minimum requirement, all substances manufactured or imported in quantities of 1 tonne or more need to be tested in acute toxicity tests on Daphnia and algae, while also information should be provided on biodegradability (Table 1). Physical-chemical properties relevant for environmental fate assessment that have to be provided at this tonnage level are water solubility, vapour pressure and octanol-water partition coefficient. At 10 tonnes or more, this should be supplemented with an acute toxicity test on fish and an activated sludge respiration inhibition test. At this tonnage level, also an adsorption/desorption screening and a hydrolysis test should be performed. If the chemical safety assessment, performed at 100 tonnes or more in case a substance is classified based on hazard information, indicates the need to investigate further the effects on aquatic organisms, the chronic toxicity on these aquatic species should be determined. If the substance has a high potential for bioaccumulation (for instance a log Kow > 3), also the bioaccumulation in aquatic species should be determined. The registrant should also determine the acute toxicity to terrestrial species or, in the absence of these data, consider the equilibrium partitioning method (EPM) to assess the hazard to soil organisms. To further investigate the fate of the substance in surface water, sediment and soil, simulation tests on its degradation should be conducted and when needed further information on the adsorption/desorption should be provided. At 1000 tonnes or more, chronic tests on terrestrial and sediment-living species should be conducted if further refinement of the safety assessment is needed. Before testing vertebrate animals like fish and mammals, the use of alternative methods and all other options must be considered to comply with the regulations regarding (the reduction of) animal testing.

Table 1 Required ecotoxicological and environmental fate information as defined in REACH

1-10 t/y | Acute Aquatic toxicity (invertebrates, algae) Ready biodegradability
10-100 t/y | Acute Aquatic toxicity (fish) Activated sludge respiration, inhibition Hydrolysis as a function of pH Adsorption/ desorption screening test
100-1000 t/y | Chronic Aquatic toxicity (invertebrates, fish) Bioaccumulation Surface water, soil and sediment simulation (degradation) test Acute terrestrial toxicity Further information on adsorption/desorption
≥ 1000 t/y | Further fate and behaviour in the environment of the substance and/or degradation products Chronic terrestrial toxicity Sediment toxicity Avian toxicity

Safety assessment

For substances that are classified based on hazard information the registrant should assess the environmental safety of a substance, by comparing the predicted environmental concentration (PEC) with the Predicted No Effect Concentration (PNEC), resulting in a Risk Characterisation Ratio (RCR=PEC/PNEC). The use of the substance is considered to be safe when the RCR <1.

Chapter 16 of the ECHA guidance offers methods to estimate the PEC based on the tonnage, use and operational conditions, standardised through a set of use descriptors, particularly the Environmental Release Categories (ERCs). These ERCs are linked to conservative default release factors to be used as a starting point for a first tier environmental exposure assessment. When substances are emitted via waste water, the physical-chemical and fate properties of the chemical substance are then used to predict its behaviour in the Wastewater Treatment Plant (WWTP). Subsequently, the release of treated wastewater is used to estimate the concentration in fresh and marine surface water. The concentration in sediment is estimated from the PEC in water and experimental or estimated sediment-water partitioning coefficient (Kpsed). Soil concentrations are estimated from deposition from air and the application of sludge from an WWTP. The guidance offers default values for all relevant parameters, thus a generic local PEC can be calculated and considered applicable to all local emissions in Europe, although the default values can be adapted to specific conditions if justified. The local risk for wide-dispersive uses (e.g. from consumers or small, non- industrial companies) is estimated for a default WWTP serving 10,000 inhabitants. In addition, a regional assessment is conducted for a standard area, a region represented by a typical densely populated EU area located in Western Europe (i.e. about 20 million inhabitants, distributed in a 200 x 200 km2 area). For calculating the regional PECs, a multi-media fate-modelling approach is used (e.g. the SimpleBox model; see Section on Multicompartment fate modelling). All releases to each environmental compartment for each use, assumed to constitute a constant and continuous flux, are summed and averaged over the year and steady-state concentrations in the environmental compartments are calculated. The regional concentrations are used as background concentrations in the calculation of the local concentrations.

The PNEC is calculated using the lowest toxicity value and an assessment factor (AF) related to the amount of information (see section Setting safe standards or chapter 10 of the REACH guidance. If only the minimum set of aquatic acute toxicity data is available, i.e. LC50s or EC50s for algae, daphnia and fish, a default value of 1000 is used. When one, two or three or more long-term tests are available, a default AF of 100, 50 and 10 is applied to No Observed Effect Concentrations (NOECs), respectively. The idea behind lowering the AF when more data become available is that the amount of uncertainty around the PNEC is being reduced.

In the absence of ecotoxicological data for soil and/or sediment-dwelling organisms, the PNECsoil and/or PNECsed may be provisionally calculated using the EPM. This method uses the PNECwater for aquatic organisms and the suspended matter/water partitioning coefficient as inputs. For substances with a log Kow >5 (or with a corresponding log Kp value), the PEC/PNEC ratio resulting from the EPM is increased by a factor of 10 to take into account possible uptake through the ingestion of sediment. If the PEC/PNEC is greater than 1 a sediment test must be conducted. If one, two or three long-term No Observed Effect Concentrations (NOECs) from sediment invertebrate species representing different living and feeding conditions are available, the PNEC can be derived using default AFs of 100, 50 and 10, respectively.

For data rich chemicals, the PNEC can be derived using Species Sensitivity Distributions (SSD) or other higher-tier approaches.