4 Assessment of your Level of Compliance with Rigorous Control Print

Having compiled an inventory of the intermediates you are manufacturing and/or using, and having listed your company’s management systems, technical procedures and related documentation, you are now in a position to assess the level of your preparedness to manage intermediates under REACH, and the extent of your compliance with the concept of STRICTLY CONTROLLED CONDITIONS.  In its guidance notes, the ECHA indicates some key parameters for assessment of STRICT CONTROL/RIGOROUS CONTROL etc, and various guidance notes will be available from chemical industry organisations, such as CEFIC and EFCG among others.  As the CEFIC guidance notes may be more applicable to larger scale operations, and the EFCG guidance to fine chemical manufacturing, you may find it helpful to review these, together with any specific advice or information you might receive from other sources such as your national trade association or other industry sector group.  Advice may also be available from a helpdesk at your national competent authority, and there is a range of European organisations offering expert advice and consultancy for a fee.  As this is a fairly complicated procedure we recommend strongly that you take advice from industry colleagues or professional consultants if you feel your own resources are inadequate.

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For smaller companies working on smaller scale operations less detail may be required, and it may be more appropriate to work out a model that fits your circumstances, and here again we recommend that you seek help and advice from industry colleagues or other sources as may be appropriate.  However you work out a model, it is clear that a well documented approach will be essential to satisfy the authorities that you are operating within intermediates in the context of RIGOROUS CONTROL.  This documentation may be developed in the format of a written risk assessment, with measures for implementation, or a declaration of compliance, setting out the various control systems and technical measures, and may be subject to inspection and review by your national competent authority.

In table 4.1, some key parameters are listed (with reference to the ECHA and other guidance notes), with a summary of possible control measures (management systems and/or technical procedures), with commentary and reference as appropriate.  You may well want to include other topics in the review, which are relevant to your own particular industry sector, or geographic location or both.

Depending on the actual nature and size of your operation, not all of these parameters may be relevant for you, and you may be justified in taking a much simpler approach, especially if you are, for example, a downstream user of only a small number of intermediates. Table 4.1 should be used as a guideline, helping you focus on what applies to your operation, with examples of systems and technical control measures.

Table 4.2 is provided as an aid for your own self assessment, which you could complete for discussion with industry colleagues or technical experts or consultants.

Having reviewed table 4.1 with reference to the various guidance notes and sources of information listed above, you should be able to complete table 4.2, and on that basis decide if you are satisfied that you can work within STRICTLY CONTROLLED CONDITIONS, or could put a system in place which could provide for this.  Bear in mind always, especially for small companies, with relatively small operations, that simple systems and technical measures may be sufficient for your purposes, provided they offer the necessary degree of worker protection and are suitably documented.

On completion of the assessment, if you are satisfied either that you can comply with the requirement for STRICTLY CONTROLLED CONDITIONS or can put a programme in place to do this, you can proceed to prepare a declaration in suitable format.  If you are not satisfied that you are in a position to do that, you may want to review what would be needed to be able to work under STRICTLY CONTROLLED CONDITIONS, and then estimate the time and cost involved to do this.  You could then decide to repeat the exercise, or even not to proceed if you determine this is not feasible for cost reasons.  However, bear in mind, without a suitable system to provide for and demonstrate that you are working to STRICTLY CONTROLLED CONDITIONS, you will not be able to take advantage of the reduced registration facility provided by Articles 17-18 of REACH.

If you are an SME, and a downstream user rather than a manufacturer of intermediates, you should be able to get help and advice from your supplier, who is obliged in any case to provide you with safety data sheets and, depending on the tonnage, a chemical safety report. 

TopicManagement Systems/ Technical ControlsComment
Organisation and ManagementCertified management systems such as ISO 9000/ ISO 14000/EMAS/Safety management systems/other management systems.  Technical measures put in place to implement these systems.Systems should provide for review, documentation, and control of change; most effective if subject to independent audit.
TrainingDocumented company training procedures, with regular assessments, perhaps with a system of authorisation or employees for specific tasks after completing certain stages of training.  Technical measures put in place to implement these systems.Training procedures can be incorporated into one of the management systems above and can also be summarised in a document such as a "company employee handbook".  This should include specific training on handling and usage of chemical substances, classification and labelling, safety and the proper use of personal protective equipment.
Manufacturing Operations 1: Handling, Storage and Loading of Intermediates to Manufacturing OperationsQuality control system for incoming raw materials.  Documented warehouse controls and procedures.  Documented procedures for loading intermediates to reaction equipment, use of any specialised equipment, provision for suitable ventilation, and definition of appropriate personal protective equipment, and training and its use.  List technical measures put in place to implement these systems.Refer to European and national legislation as indicated in section 3.  Make reference to specific written risk assessments you may have carried out for other reasons and/or response to other legislation.  Document standard operating procedures in place for loading etc.
Manufacturing Operations 2:Systems for managing plant operations with layout and engineering drawings, preventive maintenance and any special equipment or precaution required by the nature of your work.  List technical measures put in place to implement these systems.These systems can be cross referenced to others, and should be reviewed at regular intervals.
Manufacturing Operations 3:  Emissions to the Environment from Plant Operations using or Producing IntermediatesRefer to IPPC licence or other environment permit, and to systems such as ISO 14000/ EMAS/other system put in place to ensure compliance with the licence conditions.  All discharges should be managed within licensed condition limits, and all waste disposed of with the limits set down by the European waste legislations.  List technical measures put in place to implement these systems.Refer to IPPC  or other permits and licences, and to environmental managment systems.  List SOP's and technical measures.
Manufacturing Operation 4: Sampling and AnalysisDocument systems and technical measures used for sampling and analysis.  It may not be possible to do this under "closed system conditions", in which case a practical system to suit your conditions should be defined and documented, which may include some segregation of facility, local ventilation, and use of appropriate PPE.  List technical measures put in place to implement these systems.Document SOP's, other technical measures, and ensure these are cross referenced to your training procedures.
Manufacturing Operations 5: Purification and Completing the ProcessDocument working systems and technical measures, including SOPS's and process controls.  List technical measures put in place to implement these systems.Where closed systems are not appropriate, define a suitable working system for your conditions or your circumstances, including segregration, ventilation, any special precautions or specialised equipment, use of and training on PPE.
Manufacturing Operations 6: Cleaning and MaintenanceDocument specific procedures for cleaning equipment and inspection to confirm this.Maintenance only carried out on cleaned equipment using permit to work system.  Document authorisation procedures and work permits.
Manufacturing Operations 7:  Packaging, Storage and Despatch of Finished Product.Define systems for packaging, labelling, storage and despatch of intermediates for later use in-house or transport to customer.  Document proceedures for labelling in accordance with EU and GHS regulations, and for providing standard documentation, to include safety data sheet (SDS) in the working language of that member state to which material is despatched.  List technical measures put in place to implement these systems.Safety data sheet (SDS), will be provided by your supplier if you are a downstream user, possibly also with a chemical safety report (CSR), for substances used in larger quantities.  Regular contacts with suppliers, customers and trade associations is recommended to ensure documentation is adequate.
Any Specialised Unit OperationDefine working systems and technical measures as appropriate, ensure these are documented, and possibly incorporated within a general management system.  List technical measures put in place to implement these systems.Technical advice may be available from supplier/customer or trade association/ expert consultants.
Special Handling ProceduresIf special handling procedures are required for a particular substance, document systems and technical measures and cross reference these to overall systems as before.   Ensure that appropriate operator training is provided and if it is not possible to work in a closed system, that another suitable system is designed and documented.  List technical measures put in place to implement these systems.Expert advice may be available from supplier/trade association/technical consultancy.
Any Specific Industry Sector or Geographic RequirementOther specific measures or procedures requried by your industry codes of practice?  Are you required to have technical measures in place to comply with national or local legislation or rules?Take advice from trade associations.

Table 4.1 Strictly Controlled Conditions: Examples of Possible Management Systems and Technical Controls which might be put in place, with reference to key topics and parameters listed in ECHA and other guidance notes.

TopicSpecific ResponseReference/Commentary
   
   
   
   
   
   
   
   
   

Table 4.2 Blank table

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Last Updated ( Friday, 07 August 2009 )
 
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