Exposure risk management measures

Article 3(37) of REACH defines exposure scenarios as the set of conditions, including operational conditions and risk management measures, that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment [...] . 

Companies will be required to provide information on the identity and properties of a compound (including physical, chemical, toxicological, and ecotoxicological properties), the intended uses, the estimated human and environmental exposure, risks for humans and the environment, and proposals for risk management measures. Information requirements will depend largely on production volumes, but might be adjusted based on the intrinsic properties and conditions of use of individual substances. 

The first action is to gather existing available test data on the substance, including the conduct of a literature search. Additionally, usage and exposure data and risk management measures should be obtained. From this, the need for further information can be determined. 

Studies are not needed if the substance is a known genotoxic carcinogen and/or a germ cell mutagen and appropriate risk management measures are implemented. Also, the studies are not needed if the substance has no evidence of toxicity, there is no systemic absorption (from toxicokinetic data) and there is no significant human exposure. 

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). 

REACH introduces the concept of adequate control in EU chemical law. Traditionally, the term adequate control has been used to refer to good practice in the workplace. REACH now redefines adequate control in the form of risk management measures detailed in an exposure scenario necessary for the control of hazardous properties. Through a set of systematic procedures, risk management measures must be selected to reduce exposure below which adverse effects to human health or the environment are likely to occur (i.e., a DNEL, DMEL or PNEC). There is debate as to whether a concept of a safe level of exposure reduction, similar to adequate control, can apply to non-threshold carcinogens and mutagens, endocrine disruptors, persistent, bioaccumulative and toxic (PBT) or VPVB substances (e.g., [270]). Industry may need to demonstrate that exposure to these substances is always avoided or minimised, as specified in Annex I of the REACH Regulation. 

When levels of safety for risk management measures do not adequately cover variations in the use of assessment factors or differences in anticipated exposure levels in risk assessment data (see also [477])... 

A group of members of the Association of the Netherlands Textile Industry investigated the potential risks posed by the use of several chemicals used in the production of overalls. Monitoring employee exposures identified areas where additional risk management measures were required. Consultation with upstream producers and a large downstream customer also enabled the companies to improve final product quality. 

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. 

Risk management measures for new and existing chemicals, which may be taken after a risk/benefit evaluation, can be in the form of recommendations for safe use, labelling or occupational exposure limits. Most developed countries also have legal provisions for banning chemicals, or restricting their use to safe conditions. 

The chemical safety assessment has to consider the manufacture or preparation of the substance as well as all identified uses. An identified use is a use of a substance or preparation containing it that is intended by a person involved in the supply chain or that is made known to him in writing by an immediate downstream user. The assessment shall consider all stages of the life cycle of the substance resulting from its manufacture and identified uses. The assessment has to be based on a comparison of the potential adverse effects of the substance with the known or reasonably foreseeable exposure of man or the environment, taking into account implemented and recommended risk management measures and operational conditions. 

Where a chemical safety report is required, the relevant DNELs and PNECs have to be added in Section 8.1 Exposure limit values , and in Chapter 8 Exposure controls/Personal Equipment". A summary of the risk management measures should be given in Section 8.2 Exposure Controls if a chemical safety report is required. 

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. 

Risk-management measures Safety Data Sheets Specific Exposure Scenario Small-to-medium-enterprise( s) Sector of Use Category Substance(s) of very high concern TechnicalGuidance document Weight/weight... 

The risk management measure promoted by regulators and governments of nanomaterials is the "As Low As Reasonably Practical" (ALARP) approach (Workcover NSW, 2008 SWA, 2009a). There is a fundamental problem with this approach. ALARP is based on balancing the risk of exposure against the cost to lower the risk further to, what is commonly referred to as, a "tolerable risk." Effectively, ALARP defines risk as an economic decision—do I spend the money or not Regrettably, experience shows us, too often, that the answer is not. 

Governments, regulators, and risk assessors around the world will have to continue to grapple with these uncertainties for the short-to-medium term, but so too will employers who wish to implement additional risk management measures in order to minimize any potential risks, such as those associated with worker exposure to certain free nanoparticles (see also Monica and van Calster, 2009). 

When these standards are met, the registrant proceeds to document the conclusions of the CSA in a CSR which is submitted to ECHA. The final exposure scenario(s), which define the operational conditions and risk-management measures required to ensure the safe use of the substance, are communicated to downstream users through the Safety Data Sheet (SDS). 

Substances of particular concern are included in the Community Rolling Action Plan, or CoRAP. Once a substance is on the CoRAP, the Member State performing the review has one year to determine that the risk is in fact acceptable, or else that the registrants must provide more information to characterize a potential risk. If the latter, then submittal of an updated registration dossier triggers a second one-year review period. This second evaluation may find that the additional information demonstrates that manufacture and use of the substance do not present a significant risk. Alternatively, the Member State may propose risk-management measures such as occupational exposure limits or authorization or restriction procedures [109]. 

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