To assist your company or consortium in addressing all technical issues associated with REACH, RSA is pleased to announce a further development of its strategic partnership with WCA Environment with the launch of:

Likely issues for 2011 and preparation for 2013 registrations

2011 will bring further challenges to industry for compliance with REACH as issues resulting from the 2010 registrations are addressed, including

• incomplete/rejected registrations
• dossier updates / ECHA guidance updates
• ECHA evaluation of data and responses to testing proposals
• consequences of changes in classification and labelling

For the 2013 submissions for ‘100-1000 tonne’ substances, we foresee issues with

• more SMEs involved with less in-house technical and regulatory support
• difficulties in understanding the costs and planning resources to ensure compliance with REACH 2013
• many data-poor substances that will need to rely on ‘weight of evidence’ and ‘read-across to other substances’ to avoid unnecessary additional testing
• formation of analogue and UVCB categories
• differences in the data requirements that may affect cost of Letter of Access (LoA), for substances registered in 2010 but also to be registered at lower tonnage.

Track record

RSA has a proven track record in all of the above issue areas.

With a high degree of scientific expertise, RSA has already

• prepared quality human health sections of REACH dossiers for hundreds of individual substance registrations as well as those for analogue and UCVB substance categories
• been active as a member of the technical service team for the Lower Olefins and Aromatics REACH Consortium
• been the lead technical provider for the Acetyls REACH Consortium
• provided technical services directly to individual companies
• independently reviewed REACH dossiers prepared by third parties.

RSA is well-placed to provide reliable guidance to registrants. With many years of experience working within industry, RSA understands business pressures and their consequences. We also have wide familiarity of communicating and engaging with European and Member State regulatory authorities.

Technical capabilities for REACH in 2011 and beyond

From detailed specific issues or human health elements of CSA to whole Consortium/ SIEF management

RSA has a team of highly qualified and reputable toxicologists and regulatory affairs specialists providing expert human health assessment, be it on specific issues e.g. carcinogenicity, mutagenicity, reprotoxicity, endocrine disruption, or evaluation and completion of all the human health elements of the CSA including DN(M)EL derivation and C&L.

In addition, in combination with our technical partners, legal and management consultants we can manage the whole process including all technical input and Consortium/SIEF management.

Primary partners to date

• WCA Environment
• Penman Consulting
• ReachCentrum

Responses to questions from ECHA – Experience in ‘read-across’ and mammalian testing

At least 1500 testing proposals have been submitted under REACH 2010 and it is expected that there will be some questions from ECHA on the need for specific studies and details of study design. RSA has experts, with many years of experience, in all the key toxicology disciplines and has particular experience in evaluating integrity of ‘read-across’ to other chemical substances. RSA is, therefore, ideally positioned to respond to such questions related to the mammalian toxicity testing proposals, having regularly communicated and engaged in technical and regulatory debate with European and Member State regulatory authorities.

Toxicology study management and monitoring

Where toxicology studies need to be commissioned, whether as the result of ECHA acceptance of test proposals or for 2013 registrations, RSA is ideally positioned to provide assistance. Our experts, have a long history of working together to design, monitor, report and interpret guideline and investigative toxicology studies. We are able to help with protocol design, whether for long-term regulatory studies (e.g. as defined under REACH Annex IX and X) or more open-ended research studies. RSA can also manage/monitor the studies on a client’s behalf, reviewing the resulting data and draft reports, preparing appropriate robust summaries and creating, or revising, endpoint summaries in IUCLID/CSA as well as assessment of any impact on classification and/or DNELs.

CLP Harmonisation Process – Expert evaluation and technical support

As the CLP harmonisation process progresses, RSA can provide expert evaluation and technical support to enable industry to meet their legal and business obligations on classification issues.

REACH Dossier Review and Updates – Independent review and evaluation

For a number of reasons, individual companies and consortia may need to revise the dossiers already submitted. RSA offers a service of independent review and evaluation of dossiers, with a view to providing updated submissions which comply with continually evolving ECHA guidance. We also are pleased to peer review dossiers which are in preparation for 2013 submissions.

Representation/Advocacy – Technical and regulatory support in meetings

In some instances consortia member companies may wish to have a technical and/or regulatory representative to assist them in consortium meetings and with review of technical issues where in-house resource is lacking. RSA is delighted to provide these services.

REACH 2013 Costs of Registration (CORe) Services – What will it cost? Can it be less?

The potential costs of registration (CORe) will be high on the business agenda as the second stage of registration of ‘100-1000 tonne’ substances in May 2013 approaches. The costs associated with registration need to be minimised and clearly understood for business planning and to ensure maintenance of markets. RSA has extensive experience of early evaluation of data sets and development of costed-plans that highlight the risks and benefits of different strategies, ensuring that the registration deadline is met in a timely fashion and to budget.

In relation to the chemical safety assessment, some of the substances may be data-poor and it will be critical to understand at an early stage whether data gaps need to be filled by expenditure in commissioning studies or alternatively whether they can be waived, with, for example, read-across and weight of evidence arguments. RSA has extensive experience in building weight of evidence approaches based on, for example, structure activity relationships and an in-depth understanding of mechanisms of toxicity, which we have latterly applied in the context of REACH.

Potential ways of minimising costs with innovative, yet sustainable and practical solutions may be, for example

• formation of consortia for substances of common interest, catalysed by the companies or via our ‘match-making’ consortium formation service
• identifying where there may be potential for read-across for individual substance dossiers or where a category approach (analogue or UVCB) may be appropriate, covering multiple substances
• using targeted, pertinent searches to ensure all data available for a substance/category members are identified

Letter of Access (LoA) Costing may not be straightforward – where substances have already been registered in 2010 (>1000 tonnes or CMR), the LoA cost for companies registering in the lower tonnage band may not be easy to calculate. The lesser data requirements for the lower tonnage band mean that the LoA costs established for the >1000 tonnage band may need to be revised. RSA can provide a technical review of the submitted >1000 tonnage band dossiers to determine those necessary or unnecessary elements for the lower tonnage band, and costings. Other factors affecting the cost of the LoA, such as additional studies/information requested by ECHA in the >1000 tonnage band review, can also be evaluated enabling accurate re-costing of the LoA.