The Chemical Safety Report

A Chemical Safety Report (CSR) is required for substances registered at 10 tonnes per annum (i.e., with Annex VI data). The burden on industry has been eased in the final proposal (a. 12), because in earlier drafts, such as the consultation document (a. 11), a CSR would have been needed for all registered substances. 

A CSR is a risk assessment, following the general provisions of Annex I of the proposed REACH Regulation, with extra guidance in Annex IB for substances that are components of preparations. These general principles correspond with the current EU practice for notified new substances and priority existing substances, as described more fully in Section 14. The ECA will develop software to help registrants prepare the CSR. It is essential to have input from downstream users to prepare the risk assessment for the CSR, which 

Substances that are used only to formulate cosmetics or to manufacture food-packaging materials are dual regulated they still have to be registered under REACH, although they are subject to separate EU measures that involve an evaluation of their safety to humans. Hence, in order to avoid duplication of work, the REACH CSR only has to include an environmental risk assessment. 

The CSR also includes an assessment of whether the substance is classed as PBT or vPvB according to the Annex XII criteria (Table 7). These substances would be of very high concern and have to be authorised (Section 7). 

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For these substances, the waste life stage of the substance needs to be covered by suitable exposure scenarios, the corresponding exposure estimation and the related risk characterisation. The conditions ensuring control of risk in the waste life stage of the substance need to be documented in the chemical safety report (CSR) and also communicated in the supply chain by means of the extended safety data sheet. [19]. 

In the chemical safety report, the hazard assessment of a particular substance is based on the data set provided in the technical dossier. This contains substance-specific information on physicochemical properties as well as on toxicological and ecotoxicological hazards. One objective of the hazard assessment is the substance s hazard identification, which comprises the determination of its physicochemical and hazardous properties for the purpose of classification. Concerning human health hazards, both human and nonhuman information is taken into consideration and evaluated with respect to the classification criteria laid down in the Dangerous Substances Directive and in the CLP Regulation, respectively. However, in most cases human data do not exist, so the hazard identification has to be based on data from animal experiments. With respect to teratogenicity, this hazardous property may in principle be detected in the following toxicity studies ... 

EU (2005) Work Package 1. Development of the concept of exposure scenarios. General framework of exposure scenarios. Scoping study for technical guidance document on preparing the chemical safety report under REACH, final report. European Union, European Chemicals Bureau (REACH Implementation Project 3.2-1A Lot 1 Commission Service Contract No. 22551-2004-12 FISC ISP BE ... 

For all substances manufactured or imported in quantities of more than 10 tonnes per year, a chemical safety assessment (CSA) has to be carried out and the results summarized in the chemical safety report (CSR). A CSR is not necessary for preparations in which substances are present above the consideration hmit mentioned in the Dangerous Preparation Directive 199/45/EC [8-4] or in annex I of the Dangerous Substance directive 67/548/EEC [8-5]. The CSR should consist of the following sections ... 

Inclusion of exposure scenarios (ES) including any risk management measures, where required, in an Annex to the SDS. The ES are attached to the SDS by the registrants after submission of the CSR as part of the registration dossier to ECHA. The information in the SDS should be consistent with the information in the chemical safety report (CSR) for that substance, or a mixture if a CSA for the mixture is available. 

Cenfral to regisfration is fhe Chemical Safety Assessment (CSA), in which the registrant identifies and describes the conditions under which the manufacturing and use of a subsfance are considered to be safe. A CSA must be performed by registianfs for substances manufactured and imported in quantities at or above 10 tonnes per year and by downstream users if their uses are not addressed by their supplier. The CSA entails three major steps, hazard assessment, exposure assessment, and risk characterization, which are documented in the Chemical Safety Report (CSR). Figure 3.4 summarizes the process [95]. 

The Chemical Incidents Report Center (CIRC) is an incident database initiated by the U.S. Chemical Safety and Hazard Investigation Board. An online search of this database (www.chemsafety.gov/circ), as well as a more general web search, may be a good starting point for a literature survey. 

Exposure scenarios specify the conditions in which the chemical is to be used (including the protective equipment to be used, working practices, products it is incorporated into, how consumers use those products and how these are disposed), limiting the range of the conditions that must be considered in the exposure assessment. The exposure scenario is annexed to the chemical safety data sheet that is passed to downstream users of the chemical. Those downstream users are required to pass information back to their suppliers about their use of the substance, the exposure to the substance involved in that use and the practicality of specified risk reduction measures. If a use is significantly different from those identified in the CSA, the user must report this to the European Chemicals Agency and prepare its own CSA, or ask the manufacturer to revise the CSA to include that use. 

According to the novel European regulations named REACH System (Registration, Evaluation, Authorization of Chemicals), every chemical substance introduced into the market at the total amount of more than 1 ton per year has to be registered in the European Chemicals Agency (ECHA). Moreover, if the yearly production or import of the substance exceeds 10 tons, a comprehensive Chemical Safety Report (CSR) is required for the registration [1, 2],... 

If a Chemical Safety Report is not needed (i.e. below 10 tonnes), the following additional sections of information will be required at registration ... 

Although not stressed by the regulations, the objective of the incident investigation should be the development and implementation of recommendations to ensure the incident is not repeated. This objective should apply not only to the process involved, but also to all similar situations having the same potential. In major incidents, the Chemical Safety Board s investigation of reports serves as a vehicle to communicate to a much broader audience than the organizations that had the incident. 

Even more significantly, risk assessment responsibilities have been devolved to the private sector. Registration of chemicals produced or imported in quantities of at least 10 t per manufacturer and per year (pm/py) must be accompanied by a Chemical Safety Report (CSR), which is a renamed but other otherwise largely unchanged risk assessment as formerly required from NRAs under Directives 67/548/EEC20 and 93/67/EEC.21... 

The latter deadline is set nearly 20 years after the ministerial call for a new chemicals policy in the EU. Above 10 t, a Chemical Safety Report with data on a relatively large set of parameters, including data on intrinsic properties, exposure scenarios and risk management measures, is to be included in the registration (Article 14, Annex 1). For substances in quantities of 1-10 t, a technical dossier with more basic data (Article 10) is stated to be sufficient. Concerning so-called non-phase-in substances , i.e. basically those not being produced or marketed before REACH, the registration provisions entered into force on 1 June, 2008 (Article 141). 

Integrated Pollution Prevention and Control (IPPC), it must cover all intended uses through a specified branch of a supply chain. Under REACH, the results of such chemical safety assessments must be documented as chemical safety reports (CSR). 

In terms of the practicality of implementing REACH, no chemical safety report (CSR) appears to exist at the time of regulatory enactment of REACH. The concept of a CSR has therefore never been tested. The extent to which a substance-specific CSR can cover more than one specific use or be incorporated into safety data sheets (SDS) for preparations (i.e., chemical mixtures) needs development. 

A Chemical Safety Report that documents chemical risk assessments must be prepared for substances that a company manufactures or imports at >10 tonnes per year. If a substance is identified as dangerous or very persistent and very bioaccumulative (VPVB), a set of exposure scenarios detailing the relevant risk management measures necessary to reduce exposures must be attached as an Annex to existing Safety Data Sheets. 

A chemical safety report is required when manufacturers and importers use 10 tons or more of a substance per year. The report must outline the... 

ECHA (2008c). Guidance on information requirements and chemical safety assessment. Part E Chemical Safety Report. Guidance for the Implementation of REACH, htq) //reach.jrc.it/docs/guidance docu-ment/information requirements part f en.pdf vers=20 08 08, 1—10. 

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