CSA - CSR

The REACH Regulation is based on the principle that it is for the industry to ensure that the substances they manufacture, place on the market or use do not adversely affect human health and the environment.

A chemical safety assessment (CSA) is required for all substances subject to registration under REACH in quantities exceeding ten or more tonn/years. The CSA chemical safety assessment plays a major role since it is the instrument to ensure that all risks are identified and under control.

The Exposure Scenario is a set of conditions that describe how a substance is manufactured or used, and the measures necessary to control exposure to humans and environmental emissions.

The CSR is Chemical Safety Report, the instrument to record and doumentare chemicals.

THE CHEMICAL SAFETY ASSESSMENT

The Chemical Safety Assessment (CSA) is the process that identifies and describes the conditions under which the manufacturing and use of a substance is considered to be safe.

There are three major steps in the CSA process. These are:

1. HAZARD ASSESSMENT- collection and evaluation of all available data.

The CSA starts with the hazard assessment. The assessment normally comprises the following steps:

1. INFORMATION GATHERING AND EVALUATION
2. HAZARD IDENTIFICATION
3. CLASSIFICATION AND LABELLING
4. DERIVATION OF THRESHOLD LEVELS
5. PBT vPvB

Where the hazard assessment shows that the substance meets the criteria for classification as dangerous, it will be carried out an exposure assessment which will assess the levels of exposure. If the substance does not meet any criteria of dangerousness exposure assessment will not be required.

2. EXPOSURE ASSESSMENT - The exposure assessment is the process of measuring or estimating the dose or concentration of the substance to which humans and the environment are or may be exposed, depending on the uses of the substance.

An assessment needs to cover the production, all identified uses of the substance and the phases of the life cycle resulting from such use. Also includes the waste stage, and if the service-life of articles containing the substance. The exposure assessment consists of the following two phases:

1. DEVELOPMENT OF EXPOSURE SCENARIOS
2. EXPOSURE ESTIMATION

3. RISK CHARACTERISATION - Risk characterisation the exposure levels with the levels of each effect threshold are compared at this stage.

The exposure values will be compared with their respective threshold levels (DNEL/DMEL or PNEC) in the risk characterisation. Where no threshold level is available, a qualitative risk characterisation will be required.
The risk characterisation needs to be carried out for each exposure scenario in order to determine if the operational conditions and risk management measures ensure control of risks of the substance.

1. RISK CHARACTERISATION FOR PHYSICOCHEMICAL PROPERTIES
2. RISK CHARACTERISATION FOR HUMAN HEALTH
3. RISK CHARACTERISATION FOR THE ENVIRONMENT
4. COMBINED EXPOSURES

RISK UNDER CONTROL

The risk characterisation will determine if the risk to humans and the environment is under control or not for a given exposure scenario. Risk will be considered to be adequately controlled if:

• the likelihood and severity of an event occurring due to the physicochemical properties of the substance is negligible;
• the estimated exposure levels do not exceed the appropriate DNEL/DMEL or PNEC, and for substances for which a DNEL/DMEL or PNEC cannot be determined, the emissions and exposures are minimised by the implementation of the exposure scenario to the level that they do not pose risk.
• the exposure scenario that ensures that risks are under control then the safe use of the substance.
• If risks cannot be demonstrated to be under control, further iteration of the CSA will be required, until the final exposure scenario can be defined or the use of the substance has to be advised against. The final exposure scenario has to be attached to the extended Safety Data Sheet (eSDS) and be communicated down the supply chain.

CSR - CHEMICAL SAFETY REPORT

The chemical safety report documents the chemical safety assessment undertaken as part of the REACH registration process, and is the main source from which the declarant party to provide information to all users of chemicals through the exposure scenarios. It also provides a basis for other REACH processes such as substance evaluation, authorization and restriction.
The chemical safety assessment is carried out to demonstrate that the risks from exposure to a substance in the course of its manufacture and use, are checked when you apply specific operating conditions and risk management measures. These terms of use of a substance constituting the exposure scenario.
The chemical safety report should be easily understood in all its parts as stand-alone document and should include all relevant information for the chemical safety assessment. The principles applied in the risk assessment and exposure, the assumptions made and conclusions drawn should be transparent and well documented.

Experts CEPRA srl. have extensive experience in the field of risk assessment / management and are the ideal partner to guide you through the critical aspects of the preparation of the CSR.