Margarethe Jaroszewski of 3E Company looks at the extra burden REACH Exposure Scenarios will bring
The REACH Regulation went into effect on 1 June 2007, simplifying but also complicating the compliance work for companies manufacturing or importing chemicals in Europe. As a result, all companies manufacturing, importing, distributing or using chemical substances on their own, in mixtures or in articles, are required to examine their chemical inventory closely for substances within the scope of the regulation to ensure compliance.
European Commission Regulation No. 453/2010 has amended and clarified the requirements to the contents of the EU Safety Data Sheet (SDS), which was originally developed in accordance with Title IV of REACH, Article 31. Title IV governs information in the supply chain.
The new content of Annex II is supported by the European Chemicals Agency's (ECHA's) Guidance on Compilation of Safety Data Sheets, the most recent version (1.1) being issued in December 2011 after four draft versions. Even with ample guidance, developing a comprehensive understanding of your company's obligations can be a complex undertaking. In summary, the additional and new requirements are:
- Having a new numbered SDS structure with 16 sections, where it is made clear that the section number is part of the section name and where the sub-sections need to be numbered as well
- In Sections 2 and 3 of the SDS to provide both new classifications according to the Classification, Labelling & Packaging (CLP) Regulation and old classification according to the Dangerous Substances and Dangerous Preparation Directives. Both types of information are required until 2015, when the transition period for the implementation of the CLP regulation will end
- Adding certain information to the SDS once the substances in the product are registered
- Additional disclosure of the reason(s) for listing a non-classified substance in Section 3 of the SDS at the EU level, such as being persistent, bioaccumulative and toxic (PBT) or very persistent, very bioaccumulative (vPvB), M-factors or community occupational exposure limits
- Providing Derived No Effect Levels (DNEL) and Predicted No Effect Concentrations (PNEC) in Section 8
- Integrating Exposure Scenarios (ESs) as part of and attached to the SDS
Of these new requirements, the introduction of the ES requirement is certainly the most complex and cumbersome. Given the vast amount of information required to ensure conformance, the creation of ESs will be an additional source of concern for manufacturers and importers already struggling to comply with rapidly evolving global regulations.
Exposure Scenarios are creating huge amounts of work for scientists
The new requirements impact companies manufacturing or importing 10 tonnes/year or more of a hazardous substance. If a company fulfills this description, it must provide ESs as an integrated part of its SDS. The new, longer document, known as an extended SDS (eSDS), must cover all 'identified uses' of a substance throughout its life cycle. An ES must include risk assessments for every use to ensure the substance is properly controlled at all times.
REACH Article 31, paragraph 7 states: 'Any actor in the supply chain who is required to prepare a chemical safety report according to Articles 14 or 37 shall place the relevant exposure scenarios (including use and exposure categories where appropriate) in an annex to the safety data sheet covering identified uses and including specific conditions resulting from the application of Section 3 of Annex XI. Any downstream user shall include relevant exposure scenarios, and use other relevant information, from the safety data sheet supplied to him when compiling his own safety data sheet for identified uses.'
Annex I defines an ES as: 'the set of conditions 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. These sets of conditions contain a description of both the risk management measures and operational conditions which the manufacturer or importer has implemented or recommends to be implemented by downstream users.'
'The level of detail required in describing an exposure scenario will vary substantially from case to case, depending on the use of a substance, its hazardous properties and the amount of information available to the manufacturer or importer. Exposure scenarios may describe the appropriate risk management measures for several individual processes or uses of a substance. An exposure scenario may thereby cover a large range of processes or uses. Exposure scenarios covering a wide range of processes or uses may be referred to as Exposure Categories.'
As the REACH regulation does not define the format of the ES, ECHA has developed some broadly accepted guidelines, which are based upon REACH and which suggest that the ES consists of four sections, all requiring detailed explanations: ES Scope, Contributing ESs for controlling Environmental, Worker & Consumer Exposure, Exposure Estimation and Guidance to Downstream Users (DSUs).
Compliant Exposure Scenarios
The main purpose of the ES is to provide conditions for the safe use of a hazardous substance, including a description of: the manner and process in which it is being used, including the quantity; the operational conditions, including the frequency and duration of specified operations; and, identifying comprehensive risk management measures that promote safer use of the substance, including process control, emission control, personal protective equipment, good hygiene/working practice, etc.
In many instances, however, multiple ESs will need to be provided. Consider the case of toluene, which is used in industrial spray painting where the following steps are involved: manual and/or automated mixing and filling of equipment, manual and/or automated cleaning of the equipment, manual spraying with local exhaust ventilation (LEV) and no respiratory/skin protection or without LEV but with respiratory/skin protection, closed-automated robot-spraying and either closed-automated or open-ventilated drying of the coated article.
The potential for environmental exposure is basically the same in each case (evaporation, spillage, etc.). However, the potential for human exposure varies significantly through the different processes. Therefore one contributing ES would be sufficient for the environment, but several different ones would be needed for workers, to ensure that each of the processes, or use cases, is sufficiently covered.
Ensuring efficient distribution
Once a conforming ES has been developed, it must be distributed to the recipients of said hazardous substance. Specifically, the ES must be supplied to the immediate DSU by the registrant, attached as an integrated part of the SDS in terms of paging and languages. The ES must also be supplied to subsequent DSUs, either as an attachment or integrated into the 16 sections. Finally, an ES for a mixture can be supplied to subsequent DSUs of mixtures as an attachment providing ESs for each (hazardous) constituent of the mixture.
DSUs have twelve months after they receive the REACH registration number and the eSDS from their supplier to update their own SDSs. In addition, as Article 35 states, workers must be granted access to the eSDS and eSDS-ES for the chemicals they use.
As per CEFIC guidance a supplier should only provide an eSDS when both the REACH registration number and the relevant ESs are ready, if ESs are needed at all. In the event that suppliers do not have the ES for communication ready and the registration number(s) is/are included, it is suggested that the author includes a phrase in Section 15 that the ESs are under development.
According to article 31(9) of REACH: 'Suppliers shall update the safety data sheet without delay on the following occasions: (a) as soon as new information which may affect the risk management measures, or new information on hazards becomes available; (b) once an authorisation has been granted or refused; (c) once a restriction has been imposed.'
Earlier draft versions of the ECHA's Guidance on Compilation of Safety Data Sheets discussed when major or minor updates should be considered. The final version emphasises that only such changes as mentioned in Article 31 (9) of REACH give rise to a legal obligation to provide updated versions to all recipients to whom the substance or mixture has been supplied within the preceding 12 months.
REACH compliance is no simple task. Developing comprehensive, compliant, and accurate ESs and eSDSs is incredibly time-intensive and could drain a company's in-house product stewardship and regulatory compliance resources. As such, companies are increasingly partnering with reliable outsourced solution providers.
While there is no single 'REACH Solution' that can be purchased that takes care of all aspects of REACH, there are reliable providers who are well-versed in data and information as it relates to global EH&S regulations and who thoroughly understand the EU regulatory environment that are available to help.