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Registration of Phase-in Substances

One of the objectives of REACH is the identification and control of substances which pose a high risk to human health and the environment. Since 1981 all new substances, those now termed non phase-in, have had to undergo extensive toxicological study and registration before being placed on the EU market and will continue to do so under REACH. However the vast majority of substances existed before the legislative changes in 1981 and, for most, their intrinsic hazards have not been adequately investigated. 

Under REACH these "old" substances will be examined in accordance with modern test methods which will place our understanding of their risk to human health and the environment on a par with all "new" substances. They will also require registration. As the deadlines for this are phased based on tonnage and toxicity, these substances are collectively identified as phase-in substances.

Registration is the process by which manufacturers and importers submit to ECHA a dossier which details the phys-chemical and toxicological properties of their substance and provides guidance on hazard, risk and safe use.

ECHA have acknowledged that it would be repetitive, costly and impractical to ask all companies registering a phase-in substance to produce their own registration dossier from first principles. This would duplicate effort and result in unnecessary studies being undertaken: of particular concern are studies on vertebrates. In addition, it could potentially result in conflicting opinions on the risk of a particular substance. Therefore in order to minimise testing, avoid duplication and reduce cost, ECHA devised a system which encourages companies to collaborate, share data and share the cost of creating the robust study summaries that are required as part of the registration dossier. Within this system is a tool designed to facilitate communication and collaboration between companies with an interest in the same substance. This is the Substance Information Exchange Forum or SIEF.

Within a SIEF a company (or its representative) with a need to progress the registration of a substance will identify itself and survey SIEF members for their willingness to participate in a collaborative effort to derive a Lead Registration Dossier. The survey will also ask if the SIEF members can provide any relevant study data and if there are any objections to a particular company acting as Lead Registrant.

Having been identified by the SIEF survey, companies willing to participate in a joint effort to prepare a full registration dossier now do so, often using the legal framework of a consortium to manage the process and share the cost. When consortia are formed they often engage service providers such as ReFaC to provide professional management and carry out the study services required to prepare the Lead Registration Dossier. Sometimes industry associations elect to pursue the registration of substances on behalf of their members and, in doing so, fulfil the consortium management role. However, study services and dossier creation are usually sub-contracted to service providers like ReFaC.

The cost of the collaborative effort to derive the Lead Registration Dossier is shared by the participants and those non-participants who later identify themselves as wishing to purchase access rights to the shared information component of the Lead Registration Dossier. The sharing of information is done under a Letter of Access (LoA) system.

Once it is created, the Lead Registration Dossier is submitted by the Lead Registrant to ECHA for registration. When this is confirmed, a Letter of Access, which takes the form on an electronic token is issued to others wishing to refer to information in the lead dossier for purposes of pursuing their own registration. This token is inserted in the dossier of collaborating companies, who submit their own dossier for registration. This is termed a “Joint Registration Dossier".

Industry guidelines exist to try and ensure that the cost of developing the shared information in the Lead Registration Dossier are apportioned fairly amongst all the joint registrants. REACH requires the cost sharing procedures to be fair and transparent.

Having registered a phase-in substance in accordance with their tonnage band companies have a duty to maintain their registration dossier and update it as required by REACH. If at a later date the tonnage concerned increases, the registration dossier must be updated to include the information requirements of the new tonnage band. If this has originally been acquired under a Letter of Access, this will entail acquiring additional access rights to the shared information in the Lead Dossier.

The registration tonnage bands are:

·         1 - 10 tonnes/year

·         10 - 100 tonnes/year

·         100 - 1000 tonnes/year

·         >1000 tonnes/year

ReFaC provides a complete service to assist companies pursue registration of phase-in substances, from SIEF survey to dossier preparation, from robust study summaries to consortium management. Contact ReFaC for more information and assistance.

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