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Management of Intermediates under REACH: A Risk Assessment Approach
EFCG: European Fine Chemicals Group 

1.      Summary and Introduction 

Articles 17-18 of the REACH regulation provide for a reduced registration regime for intermediates provided that manufacturers and users of these substances can demonstrate compliance with the concept of “rigorous control”.  Following detailed discussion between the chemicals industry and the regulatory authorities, updated guidance notes on intermediates were published by ECHA (the European Chemicals Agency) on 18 February 2008, and are available on the ECHA website at http://echa.europa.eu, which seek to define this concept in more detail and which, at least to some extent, take account of the wide variations among different sectors and companies within the chemical business area.  From various discussions in the industry, and with competent authorities and other observers, it is clear that the concepts “rigorous control”/”strict control”/”closed systems” may be subject to different interpretation, and it is clear that the exact nature of the manufacture and usage of the substance must be taken into account. 

For manufacture of fine chemicals and intermediates, whether by SMEs or larger companies, discontinuous batch production is common, and it is in most cases impossible or impractical to design working systems with completely closed conditions.  Typical operations,where “closed systems” cannot be maintained, include sampling, discharging to discontinuous centrifuges and dryers, cleaning vessels for maintenance, and so on.  This concept is acknowledged in the ECHA guidance notes, albeit with the indication that some degree of engineering control would be required, whereby reliance on personal protective equipment (PPE) is not considered a first line measure. 

Article 18.4 of the regulation, and Section 2.1.1ff of the guidance notes require that rigorous control is maintained throughout the process, from manufacturing through workup, through control of emissions, cleaning, training and documentation.  Noting that many companies have: 

  • Standard management and control systems in place (including ISO 9000/14000 etc) with generally well documented procedures and controls for managing all aspects of operations), and 
  • Standard systems to ensure and demonstrate compliance with a wide range of other existing regulations (including 98/82/EC (major accidents), 96/61/EC (IPPC), 98/24/EC (Chemical Agents Directive) and so on). 

EFCG has argued in effect, that these systems provide for, and demonstrate rigorous control, and this had been acknowledged, at least to a certain extent, by the authorities.  However, it seems clear that one may not rely on simply having these systems in place, but that it will be necessary to prepare specific documentation to demonstrate compliance with the concept of “rigorous control”, probably in the form of a Risk Assessment, and defining the potential hazards or risks that might be associated with the manufacturer and/or use of intermediates, and showing how manufacturers have put systems in place to manage these risks. 

2.      Risk Assessment

Framework The EFCG approach is to try to develop a risk assessment framework, using a common approach which could be used by fine chemical companies and SMEs, which would facilitate both industry and regulatory authorities, while allowing individual companies to “tailor” the documentation to take their own particular concerns into account, and correspond also with national standards and codes of practice.  It is suggested, therefore, that a risk assessment could be performed in two parts, the first relating to production and related operations in general, much of which will be common to the industry, and the second to operations with particular substances, which may need to be examined separately. 

It is proposed in the first part of the document to refer to standard systems in place, and to operational controls installed to ensure and demonstrate compliance with other legislation.  In the second part of the document,  individual substancescould be listed in a table, suitably classified, cross referencing these in some concise manner to an index of specific risk management measures.  For the purposes of a compliance inspection it is suggested that manufacturers would include cross links to other risk assessments in place, and to the various related documentation and to any “master lists”, which are already required to be kept on file. 

3.      Introduction and Methodology 

Reference is made to the REACH Regulation (EC/1907/2006), to the guidance notes for intermediates published by the European Chemicals Agency, and to such company documents that relate to other risk assessment procedures carried out under company policy or national legislation. 

Whereas manufacture and/or use of the intermediates under the reduced registration regimes, is allowed, if, as required by Articles 17/18 of the regulation, the substances are “rigorously controlled by technical means” throughout the manufacturing or usage process, the regulation and the guidance notes require that consideration is given to various aspects of rigorous control over the different stages of manufacture or usage, and certain concepts are identified, either implicitly or explicitly.    

As a  Risk Assessment defines specific hazards,groups exposed to the hazards and the extent of the exposure, ( and defines appropriate risk management measures) it is clear in the case of manufacture and/or usage of intermediates under REACH that the primary hazard is exposure to substances which have not been fully tested. It follows therefore that exposure to the substance through the various stages of the manufacture and application will be the key concern.  It is noted in this context that intermediates are by their very nature not made available to the general public, and tend to be used only by trained workers within the manufacturing industry. 

As indicated in the ECHA guidance notes, the extent of exposure and identification of individual or groups concerned should be examined by operational topics, such as those listed below: 

  • Manufacture of intermediates including assessment of reaction systems 
  • Isolation and purification of intermediates 
  • Process emissions and worker exposure 
  • Procedures for cleaning and maintenance 
  • Procedures in case of accident 
  • Training and supervision 
  • Documentation 

Turning to the definition of appropriate risk management measures, it is clear that reference can be made to management systems in place in the company (i.e. ISO 9000, EMS, etc) relating to quality, safety and the environment, and to standard operating procedures.  Reference can be made also to those systems a company has put in place to satisfy its obligations and to demonstrate compliance with other legislation. 

4.      Proposed Documentation 

It is proposed that a general risk assessment might be performed as indicated above, covering standard operations and organisational elements, as these will be common for all manufacturing applications within the company and even have much in common with the industry in general. A specific risk assessment covering any specific references to individual substances or operations, could be documented in the form of a master substance list, which will contain references to any specific hazards and specific risk management measures employed.  Much of this information should be available from a company’s response to other legislation, from manufacturers catalogues and scientific literature, and from trade and professional organisations.  In many cases appropriate risk management measures can be derived by reference to related substances or operations, and from published guidelines. 

5.      Further Development 

As it appears likely  that various industry sectors may develop approaches to this question in parallel,  it is recommended that individual companies would consult their respective various trade and professional organisations Including, for example, EFCG, website   http://www.efcg.cefic.org/, who should be able to counsel their members in terms of the most appropriate approach for them. 

 

Last Updated ( Monday, 08 December 2008 )
 
© 2017 REACH Regulation: Registration, Evaluation, Authorization and Restriction of Chemicals: REACH Legislation