REACH-SERV arrow Intermediates arrow Introduction
1 Introduction Print

Articles 17-18 of the REACH regulation provide for a reduced registration regime for intermediates, provided that the manufacture and use of these substances is carried out under strictly controlled conditions, in that the substances are rigorously contained by technical means during its whole lifecycle.  This was a late addition to the REACH text, and there has been considerable discussion on the exact interpretation of these concepts.  Following detailed discussion between the chemical 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.  These guidance notes seek to define this concept in more detail and, 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 concept of  “STRICTLY CONTROLLED CONDITIONS” and ”RIGOROUS CONTAINMENT” may have different meanings for difference groups, and it is clear that the exact nature and scale of the manufacture and usage of the substance must be taken into account.  In actual practice, RIGOROUS CONTAINMENT would best be guaranteed by working within “CLOSED SYSTEMS”, but for manufacture of fine chemicals and intermediates discontinuous batch production is common, and in most cases it would be impossible to design working systems with completely closed conditions.  Typical operations where closed systems cannot be maintained could include sampling, discharging to discontinuous centrifuges and dryers, cleaning vessels for maintenance and so on.  This reality is acknowledged in the ECHA guidance notes, however, with the clear indication that STRICT CONTROL/ RIGOROUS CONTROL must be provided by other means, involving some balance of management systems and technical/engineering control, and reliance on personal protective equipment (PPE) is not regarded as a first line measure, or satisfactory without other measures.  Bearing in mind that the objective is to minimise operator exposure to substances that have not been fully tested under the REACH regime, where closed systems are not possible a suitable alternative must be provided which will consist of a balance, appropriate to the particular circumstances of the particular company, of management systems, engineering planning and specific technical measures or controls, with appropriate training for employees.  For example, for a small installation, this might consist of a management plan, with some segregation of equipment, suitable ventilation, use of appropriate PPE, provision of training and suitable documentation of all of these points. 


The need for STRICTLY CONTROLLED CONDITIONS/RIGOROUS CONTAINMENT applies, whether you are manufacturing or using intermediates or are both a manufacturer and user.  Although the requirements for manufacturers will be more extensive and demanding than for a downstream user, and it will be clear, for example, that higher volume throughput with more hazardous substances will require rather more work than small scale batch operations with less harmful substances, even a small company, using a small number of substances, must comply with the system if it is to be able to continue its operations.  ECHA, in its guidance notes, and the member states, through their contact with industry in each country, acknowledge that there are differences in size, scale and complexity of operations, especially among SME’s involved in batch manufacturing operations, and it is clear that different companies may have different systems of compliance in place.  However, even simple systems for relatively small scale operations must still contain a balance of management system and technical procedures with provision for documentation and review, as a basis for future inspection by the national competent authority. 

For batch processing operations, especially on smaller scale, completely closed systems may not be practicable, but other methods and systems may be workable, including suitable layout, ventilation and the use of personal protective equipment, with provision for training.  Most companies working with chemicals will have management systems in place, such as ISO 9000 etc, and will probably have documented operating procedures, including handling and storage of chemicals, safety and emergency planning and all will be familiar with the concept of safety data sheets. 

It should be clear from the foregoing, that if you are involved in the manufacture or use of chemical substances as intermediates, and want to continue to do this, without incurring the high costs of full registration under REACH, you will have to ensure that your operation complies with the requirements for strictly controlled conditions.  However, if you are already engaged in manufacture or use of intermediates, you will probably have some management systems in place, with production and various technical measures, supported by training.  You will probably already be familiar with chemical nomenclature, and with safety data sheets and the various requirements for labelling and packaging.  You will already be subject to various sets of European and national legislation on safety and worker protection, environment and other matters, and will probably have suitable quality control procedures in place.  In effect, you may already have the basis of a management system for compliance with this concept of “STRICTLY CONTROLLED CONDITIONS”, and our aim in the following sections is to guide you through the various steps of compiling the necessary information before making an assessment.  In working through the following steps you should be able to decide what needs to be done, and determine the cost of doing this, so that you can make an appropriate business judgement. 

We recommend very strongly, if you feel that your own resources are inadequate for the task, that you would seek expert advice from a suitable source, which might include colleagues in industry or customers/suppliers, or a national or European trade federation or possibly a help desk at your national competent authority.

As well, there is now a range of specialist REACH consultancies offering advice and assistance for a fee (you will find references and links to national and European trade associations and other useful sources in this toolbox). 

In the next section we provide some information and examples to help you through the process of assessment.  You may be able to do this on your own or you may need to take advice from a national trade association, or some technically competent person.  At the end of the assessment, you should then be able to decide what needs to be done, and develop a plan. 

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In the table 2.2 it is assumed that listed substances are used rather than manufactured, and some typical information is provided and a blank table (2.3) is also provided.

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Last Updated ( Friday, 07 August 2009 )
 
© 2017 REACH Regulation: Registration, Evaluation, Authorization and Restriction of Chemicals: REACH Legislation