46 ELEMENTS SPRING 2017

The EU REACH Regulation (EC) 1907/2006 was implemented in 2007. The regulation was adopted to improve the protection of human health and the environment from the risks that can be posed by chemical substances and is designed to minimise the testing requirements using the ‘one substance one registration’ principle. Any substance used or imported into the EU is covered by REACH; Brexit will not remove REACH obligations where the EU market is concerned. This article discusses some of the challenges that remain for those companies yet to register for the 2018 deadline and for all registrants beyond the registration deadline.

REACH registration has been transitional since 2007: • 2009/2010 - initial pre-registration/registration for priority high

risk substances and substances produced in large volume >1000tonnes per annum (tpa);

• 2013 - the registration date for volumes of substances >100 tpa;and

• 31 May 2018 - the deadline for registration for substancesmanufactured or imported into the EU in volumes between 1-100tpa.

As of 11 January 2017, 10,557 substances have been registered. In the lower tonnage bands there are many users mainly SMEs, or importers yet to register; estimates are in the order of 25,000 substances remaining to be registered and up to 60,000 registrations. There is clear value in the data generated by REACH which can be used to comply with other EU legislation e.g. CLP, and a good dossier can be used as an asset for communications in the value chain.

SMEs and importers (1-100 tpa) may have registration obligations under REACH, and mixtures or articles may also contain substances that need to be registered individually by 31 May 2018. If the company is registering as a Lead Registrant then the advice is to have completed the registration dossier at least two months prior to the deadline to allow co-registrants use of the lead dossier for their own submissions. For those substances not yet pre-registered, late pre-registration may take place until 31 May 2017 – in two months’ time. Registration, either as a Lead Registrant or Member of a Joint Submission, can be expensive due to the testing and analysis that may be required even at the lower tonnage bands and therefore it is advantageous to know the process and activities in order to be as efficient and cost-effective as possible.

ECHA (the European Chemicals Agency) has prepared “Fact Pages” and provides training opportunities (online or in person) as do many individual consultancies. However, very often SMEs do not have in-house capacity or knowledge to prepare the dossiers – work that includes literature searches, data reviews, test commissioning and

risk assessment, read-across justification, preparation of robust study summaries – or to make the registrations. As a result they are reliant upon external consultancies that are being capacity squeezed through increased demand. A second key point is that laboratories are also experiencing an uptake in demand for the short term tests required in these tonnage bands and the earlier the tests are commissioned the more likely they will be completed in time.

Access to the Lead Dossier, which contains valuable base data referred to in the co-registrant dossier, is via a ‘token’. This is facilitated by a Letter of Access (LoA) which enables the ‘token’ to be issued. The LoA is sold by the Lead Registrant at a price based upon the labour effort to produce the dossier and the data acquisition costs shared between all registrants to that particular substance. The prices for the LoAs depend on the tonnage band of interest - the lower tonnage bands requiring access only to Annex VII and/or VIII information are the least expensive. Clearly, as more parties register, the costs are further reduced, and commonly there is an agreed re-imbursement mechanism to ensure that the costs are fairly shared by all registrants according to tonnage band. It is important to remember that if additional work is required by ECHA on the Lead Dossier (discussed later) after the 2018 deadline, the costs of this additional work are also shared by all existing registrants as part of their obligations.

Prior to buying an LoA, a company may view summary data on the ECHA dissemination portal and request details from the Lead Registrant e.g. the breakdown of costs contributing to the LoA price, or the contract (i.e. SIEF (Substance Information Exchange Forum) agreement). The responsiveness of the Lead Registrants and their representatives may be slow for a variety of reasons and it is worth reminding them of information requests on a frequent basis.

For existing registrants, dossier compliance check and substance evaluation by the regulator will necessitate activity to update and upgrade their dossiers long after 31 May 2018.

The ECHA guidance has been progressively updated in the years since 2008 and where previously a dossier might have met the requirements in 2010, this may not now be the case. Many dossiers submitted in 2010 and 2013 have not been updated since that time and ECHA has identified several issues with the quality of dossier submissions including:• Mis-classifications of substances;• Poor justifications for testing alternatives;• Insufficient data on the use and exposure scenarios especially

within the supply chain; and• The absence of robust risk management measures for those

exposure scenarios.

Not withstanding the possible need for clarification of the dossier content or substance characteristics, there is an obligation underREACH to include all new data known to the registrant. As goodpractice this entails a regular (global) literature review.

For registrations containing testing proposals received by 1 June2018, ECHA has until 1 June 2022 to prepare the Draft Decisionson testing requirements. Therefore additional testing activitiesmay continue beyond 2025. For those substances already subjectto Draft or Final Decisions, the testing requirements are oftenonerous requiring careful preparation and complex organisationto ensure the validity and robustness of the data being generated.These tests, for example, OECD 443 (2 Cohorts) may require a yearor so for completion and occupy substantial physical laboratoryspace and personnel during this period. The GLP laboratorycapacity is quickly exhausted and, at the time of writing, there areonly a few laboratories with the relevant experience to implementthese tests. The long duration and expense of these tests (in theorder of €1 million) means that a key laboratory selection criterionused by registrants is the certainty of delivery of reliable results.Therefore early identification of potential need to laboratories isadvised.

In addition to tending to the lead dossier updates, Lead Registrantswill be responding to the many and varied requests from co-registrants and potential co-registrants. The ImplementingRegulation (EU) 2016/9 on joint submission of data and datasharing in accordance with Regulation (EC) No 1907/2006 and theGuidance on Data Sharing V3.1 January 2017 prepared by ECHA,describe clearly that data sharing under REACH should be fair,transparent and non-discriminatory. Many of the data sharingdisputes and Joint Submission disputes that have arisen resultfrom poor communications by Lead Registrants in relation toclarifications requested by potential registrants.

To ensure general alignment with the Guidance on DataSharing many consortia and Lead Registrants are reviewing theircost sharing rules and practices relating to the dossier. LeadRegistrants are preparing standardised financial data includingdata costs, labour effort and so forth and for various reasonsthis may take some time. The new potential registrant may befrustrated by the lack of response from the Lead Registrant andmay consider the delay a sufficient threat to their registration.Their recourse is to take the dispute to ECHA. At this point,ECHA will consider whether every effort has been made by theLead Registrant in a timely manner to provide the requestedinformation and to reach an agreement with the potential co-registrant. It is therefore critical to have the relevant materialsavailable within a reasonable time period.

Joint Submission disputes arise where access to the JointSubmission is ‘restricted’ for some reason. The One SubstanceOne Registration principle underpins the Joint Submission butunfortunately, there is an increasing frequency of instances wherepotential registrants find the LoA price unacceptably high andseek to ‘opt-out’ entirely from all end points without necessarilyhaving the justification for the opt-out or rights to data theysubsequently rely on. It is imperative for the Lead Registrant tomake every effort to enable access to the Joint Submission in theevent of ‘opt-out’ in a fair, transparent and non-discriminatorymanner and if necessary review the allocation of costs to ensurenon-discrimination.

In summary,• For potential new registrants (often SMEs and Importers and, in

certain circumstances, downstream users), there is an urgencyto be organised for registration in order to meet the 31 May2018 deadline.

• Laboratory and consultancy capacity is finite and will be takenup on a first come first served basis.

• Existing registrants have a continuing work load to maintaintheir registration dossiers.

• Responses to potential co-registrants should be timely with

information that is transparent, and cost sharing that is fair andnon-discriminatory

• Expect to have on-going costs relating to REACH for years tocome.

ReachCentrum SA and JSC are ERM Group Companies specialising in product regulation (REACH, Biocides and Agrochemical). ReachCentrum offers training in REACH and Biocides tools, and provides registrant support. JSC provides technical and regulatory expertise in all aspects of REACH, Biocides and Agrochemical legislation. For more information please contact: Emma Farthing, Richard Elsmore or Sam Wright.

ReachCentrumAvenue Edmond van Nieuwenhuyse 6, Brussels B-1160, Belgiumtel: +32 2 6767459 efarthing@reachcentrum.eu

JSC International LimitedThe Exchange, Station Parade, Harrogate, HG1 1TStel: +44 1423 520245 richard.elsmore@jsci.co.uksam.wright@jsci.co.uk

References:www.echa.europa.euhttps://echa.europa.eu/press/press-material/pr-for-reach-2018ECHA Guidance on Data Sharing V3.1 January 2017

REACH Regulation – here to stay

46 ELEMENTS SPRING 2017

The EU REACH Regulation (EC) 1907/2006 was implemented in 2007. The regulation was adopted to improve the protection of human health and the environment from the risks that can be posed by chemical substances and is designed to minimise the testing requirements using the ‘one substance one registration’ principle. Any substance used or imported into the EU is covered by REACH; Brexit will not remove REACH obligations where the EU market is concerned. This article discusses some of the challenges that remain for those companies yet to register for the 2018 deadline and for all registrants beyond the registration deadline.

REACH registration has been transitional since 2007: • 2009/2010 - initial pre-registration/registration for priority high

risk substances and substances produced in large volume >1000tonnes per annum (tpa);

• 2013 - the registration date for volumes of substances >100 tpa;and

• 31 May 2018 - the deadline for registration for substancesmanufactured or imported into the EU in volumes between 1-100tpa.

As of 11 January 2017, 10,557 substances have been registered. In the lower tonnage bands there are many users mainly SMEs, or importers yet to register; estimates are in the order of 25,000 substances remaining to be registered and up to 60,000 registrations. There is clear value in the data generated by REACH which can be used to comply with other EU legislation e.g. CLP, and a good dossier can be used as an asset for communications in the value chain.

SMEs and importers (1-100 tpa) may have registration obligations under REACH, and mixtures or articles may also contain substances that need to be registered individually by 31 May 2018. If the company is registering as a Lead Registrant then the advice is to have completed the registration dossier at least two months prior to the deadline to allow co-registrants use of the lead dossier for their own submissions. For those substances not yet pre-registered, late pre-registration may take place until 31 May 2017 – in two months’ time. Registration, either as a Lead Registrant or Member of a Joint Submission, can be expensive due to the testing and analysis that may be required even at the lower tonnage bands and therefore it is advantageous to know the process and activities in order to be as efficient and cost-effective as possible.

ECHA (the European Chemicals Agency) has prepared “Fact Pages” and provides training opportunities (online or in person) as do many individual consultancies. However, very often SMEs do not have in-house capacity or knowledge to prepare the dossiers – work that includes literature searches, data reviews, test commissioning and

risk assessment, read-across justification, preparation of robust study summaries – or to make the registrations. As a result they are reliant upon external consultancies that are being capacity squeezed through increased demand. A second key point is that laboratories are also experiencing an uptake in demand for the short term tests required in these tonnage bands and the earlier the tests are commissioned the more likely they will be completed in time.

Access to the Lead Dossier, which contains valuable base data referred to in the co-registrant dossier, is via a ‘token’. This is facilitated by a Letter of Access (LoA) which enables the ‘token’ to be issued. The LoA is sold by the Lead Registrant at a price based upon the labour effort to produce the dossier and the data acquisition costs shared between all registrants to that particular substance. The prices for the LoAs depend on the tonnage band of interest - the lower tonnage bands requiring access only to Annex VII and/or VIII information are the least expensive. Clearly, as more parties register, the costs are further reduced, and commonly there is an agreed re-imbursement mechanism to ensure that the costs are fairly shared by all registrants according to tonnage band. It is important to remember that if additional work is required by ECHA on the Lead Dossier (discussed later) after the 2018 deadline, the costs of this additional work are also shared by all existing registrants as part of their obligations.

Prior to buying an LoA, a company may view summary data on the ECHA dissemination portal and request details from the Lead Registrant e.g. the breakdown of costs contributing to the LoA price, or the contract (i.e. SIEF (Substance Information Exchange Forum) agreement). The responsiveness of the Lead Registrants and their representatives may be slow for a variety of reasons and it is worth reminding them of information requests on a frequent basis.

For existing registrants, dossier compliance check and substance evaluation by the regulator will necessitate activity to update and upgrade their dossiers long after 31 May 2018.

The ECHA guidance has been progressively updated in the years since 2008 and where previously a dossier might have met the requirements in 2010, this may not now be the case. Many dossiers submitted in 2010 and 2013 have not been updated since that time and ECHA has identified several issues with the quality of dossier submissions including:• Mis-classifications of substances;• Poor justifications for testing alternatives;• Insufficient data on the use and exposure scenarios especially

within the supply chain; and• The absence of robust risk management measures for those

exposure scenarios.

Not withstanding the possible need for clarification of the dossier content or substance characteristics, there is an obligation under REACH to include all new data known to the registrant. As good practice this entails a regular (global) literature review.

For registrations containing testing proposals received by 1 June 2018, ECHA has until 1 June 2022 to prepare the Draft Decisions on testing requirements. Therefore additional testing activities may continue beyond 2025. For those substances already subject to Draft or Final Decisions, the testing requirements are often onerous requiring careful preparation and complex organisation to ensure the validity and robustness of the data being generated. These tests, for example, OECD 443 (2 Cohorts) may require a year or so for completion and occupy substantial physical laboratory space and personnel during this period. The GLP laboratory capacity is quickly exhausted and, at the time of writing, there are only a few laboratories with the relevant experience to implement these tests. The long duration and expense of these tests (in the order of €1 million) means that a key laboratory selection criterion used by registrants is the certainty of delivery of reliable results. Therefore early identification of potential need to laboratories is advised.

In addition to tending to the lead dossier updates, Lead Registrants will be responding to the many and varied requests from co-registrants and potential co-registrants. The Implementing Regulation (EU) 2016/9 on joint submission of data and data sharing in accordance with Regulation (EC) No 1907/2006 and the Guidance on Data Sharing V3.1 January 2017 prepared by ECHA, describe clearly that data sharing under REACH should be fair, transparent and non-discriminatory. Many of the data sharing disputes and Joint Submission disputes that have arisen result from poor communications by Lead Registrants in relation to clarifications requested by potential registrants.

To ensure general alignment with the Guidance on Data Sharing many consortia and Lead Registrants are reviewing their cost sharing rules and practices relating to the dossier. Lead Registrants are preparing standardised financial data including data costs, labour effort and so forth and for various reasons this may take some time. The new potential registrant may be frustrated by the lack of response from the Lead Registrant and may consider the delay a sufficient threat to their registration. Their recourse is to take the dispute to ECHA. At this point, ECHA will consider whether every effort has been made by the Lead Registrant in a timely manner to provide the requested information and to reach an agreement with the potential co-registrant. It is therefore critical to have the relevant materials available within a reasonable time period.

Joint Submission disputes arise where access to the Joint Submission is ‘restricted’ for some reason. The One Substance One Registration principle underpins the Joint Submission but unfortunately, there is an increasing frequency of instances where potential registrants find the LoA price unacceptably high and seek to ‘opt-out’ entirely from all end points without necessarily having the justification for the opt-out or rights to data they subsequently rely on. It is imperative for the Lead Registrant to make every effort to enable access to the Joint Submission in the event of ‘opt-out’ in a fair, transparent and non-discriminatory manner and if necessary review the allocation of costs to ensure non-discrimination.

In summary, • For potential new registrants (often SMEs and Importers and, in

certain circumstances, downstream users), there is an urgencyto be organised for registration in order to meet the 31 May2018 deadline.

• Laboratory and consultancy capacity is finite and will be takenup on a first come first served basis.

• Existing registrants have a continuing work load to maintaintheir registration dossiers.

• Responses to potential co-registrants should be timely with

information that is transparent, and cost sharing that is fair and non-discriminatory

• Expect to have on-going costs relating to REACH for years tocome.

ReachCentrum SA and JSC are ERM Group Companies specialising in product regulation (REACH, Biocides and Agrochemical). ReachCentrum offers training in REACH and Biocides tools, and provides registrant support. JSC provides technical and regulatory expertise in all aspects of REACH, Biocides and Agrochemical legislation. For more information please contact: Emma Farthing, Richard Elsmore or Sam Wright.

ReachCentrumAvenue Edmond van Nieuwenhuyse 6, Brussels B-1160, Belgiumtel: +32 2 6767459 efarthing@reachcentrum.eu

JSC International LimitedThe Exchange, Station Parade, Harrogate, HG1 1TStel: +44 1423 520245 richard.elsmore@jsci.co.uk sam.wright@jsci.co.uk

References: www.echa.europa.euhttps://echa.europa.eu/press/press-material/pr-for-reach-2018ECHA Guidance on Data Sharing V3.1 January 2017

REACH Regulation – here to stay

ELEMENTS SPRING 2017 47

REACH 2018