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CASE STUDY: How the toolbox might be used. Print

This case study illustrates how different functions within an organisation could use the toolbox to help them with REACH compliance. 

Scenario:     

Company X is an SME which manufactures a range of proprietary substances for use in industrial cleaning applications.  Most of their products are mixtures formulated from bought-in substances and chemicals they synthesise in-house.  They want to know which substances they will have to register under REACH, and what they need to do.

 

Potential users within the organisation:

 

Formulations Chemist, H&S Advisor, Purchasing Manager, Sales team

Preconditions:

They know the composition of their products.  They understand the chemistry of the individual components, and have an inventory of substances they manufacture and buy in.  They have access to the Toolbox.

 

Using the Toolbox: 

Confirmation their Obligations

The H&S advisor uses ‘Your REACH Obligations’ tool within the toolbox in order to identify which components of their products need to be registered.  The Toolbox also tells them that they have different obligations dependent on whether they are the manufacturer, importer, or downstream user of each substance, and this enables them to split their inventory into two separate lists: those they will need to register and those which should be registered by their suppliers.  The Toolbox gives them a simple statement of their obligations under REACH for each substance, including registration deadlines and information requirements as appropriate.

Downstream Uses

The Purchasing Manger is brought in to help comply with their obligations as downstream users.  He identifies that there are other substances they buy that do not end up in products, but may also be covered by REACH, e.g. processing aids and degreasers.   These are added to the inventory of downstream use substances. 

 

The Purchasing Manager uses the guidance for Downstream Users and links to standardised letters in the Toolbox to communicate with his suppliers.  He is particularly concerned that registrations of substances upstream will not cover their application, as they use some substances in a novel way.  He identifies that one substance/use will not be supported by the manufacturers registration.  The toolbox advises that in this case they must either stop using the substance or submit a chemical safety report (CSR) independently.  The toolbox provides guidance on how to go about this, and further action on this substance is passed to the Formulation Chemist.

Registration

The Formulations Chemist uses the Toolbox to find out what needs to be done to register the substances they manufacture. 

 

The Toolbox helps him to identify the substance data required to complete the technical registration dossier for each substance.  They do not own all the data they need.  The Toolbox provides guidance on how this data may be obtained, including data searches, data sharing and testing.

 

Links are provided to external substance information databases which help fill some of the data gap, but information on environmental toxicity and environmental fate properties are still sketchy.  He knows that testing for these properties can be costly, and needs to know if they will need to commission the tests or not. The Toolbox helps him to apply (Q)SAR models to predict whether or not his substances are PBTs (persistent, bioaccumulative and toxic), and provides guidance on whether this provides sufficient evidence for registration purposes.   One of the substances is identified as a PBT and may need to be authorised for use after registration.  He finds further information on the authorisation process within the toolbox.

 

Meanwhile, other manufacturers of the same substance have pre-registered, and the Company are invited to take part in the Substance Information Exchange Forum.  This will allow for data sharing in order to avoid excessive testing and keep costs to a minimum.   The Toolbox provides a basic guide to SIEFs and registration consortia.

 

Information held in the Toolbox helps him to prepare estimates of registration fees, authorisation fees, and the cost of obtaining the remaining data required for registration.  He presents the estimates, to his management team for a decision on whether to proceed with registration for each substance.

 

The Toolbox has also identified that a Chemical Safety Assessment (CSA) must be performed for each substance manufactured above 10 tonnes per annum.  This will involve risk characterisation based upon the hazard classification of the substance and development of exposure scenarios for each stage of manufacture and use.   The toolbox provides guidance on what needs to be done.

 

He knows that is some cases they are not fully aware how their customers use their products.  The Toolbox provides links to standardised letters to help them gather this information.   A member of the Sales Team is drafted in as extra resource. 

In preparing the documentation for registration the Formulations Chemist knows that he does not have all the information, in-house facilities or skills required to generate all the necessary information.   The Toolbox ensures he is equipped to talk to his colleagues, suppliers, customers, external service providers and  consultants in order to ensure that the Company’s REACH registration needs are met.

Last Updated ( Friday, 14 March 2008 )
 
© 2017 REACH Regulation: Registration, Evaluation, Authorization and Restriction of Chemicals: REACH Legislation