SCC remains your trusted partner beyond May 2018. Our experts loook forward to providing you our full-scale REACH services in:

Defending your submissions

Preparation of dossier updates and dossier maintenance

You should be aware that by keeping your dossiers up to date, you may avoid being prioritized by ECHA’s technical tools. Authority requests for additional testing may also be avoided. ECHA made clear that they will also check older dossiers and apply the same criteria as for recently submitted dossiers.
SCC is the best partner to support you keeping your dossiers up to date: We understand what ECHA tools and manual checks focus on and have all the expertise to identify any potential weak points in your dossiers and to amend them, e.g. by preparing refined data waivers or read-across argumentations.

Communication with ECHA in the dossier evaluation phase

ECHA and the Member States evaluate the information submitted by participants in their registration dossiers, examining the validity of the testing proposals and the quality of the registration dossiers. As a result, registrants may be requested to provide further information such as new studies, literature or justifications.
It is important for you to note that ECHA will significantly reduce direct contact to registrants during the very short commenting phase of 4 weeks.
This means that you will have to work on complicated expert matters under considerable time pressure. SCC will be there for you: We understand these complicated matters and supporting our clients effectively in tough times is what we are known for.

Answering requests from ECHA in the course of substance evaluation

Independently from ECHA’s evaluation of the registration dossiers, Member States evaluate certain substances to clarify whether their use poses a risk to human health or the environment. For such evaluation any available information on a substance is studied. Essential parts of your dossiers may be challenged. In many cases read-across or category approaches are not easily accepted and extensive testing may be requested.
This is a field in which SCC has a lot of experience. We can support you by working out convincing read-across argumentation or concepts for performing selected bridging studies which may substantially reduce test costs compared to the full requested test programme.

Monitoring and defending your substances under CoRAP and SVHC

ECHA is legally required to publish their activities when selecting substances as Substance of Very High Concern (SVHC) or when prioritizing them for substance evaluation in the course of the Community Rolling Action Plan (CoRAP). We highly recommend that you carefully check ECHA’s respective published lists. If you find any of your substances on the CoRAP or SVHC lists, you should immediately organize the defence of the substance. Our experience shows how important it is to get in contact with ECHA and national Authorities as soon as possible to understand their concerns in detail.
Count on SCC: We have been working on these matters successfully for years.

 

Support in RAC (including preparation of CLH dossiers)

ECHA allows the applicant to defend his scrutinized substances in Risk Assessment Committee (RAC) meetings.
SCC can guide you through the procedures, develop meaningful defence strategies and also represent you in the meetings. Count on our knowledge and experience.

 

Planning, contracting out and monitoring of studies

If you cannot avoid performing new studies SCC’s partner labs are ready to conduct the necessary studies for you.
We offer GLP-compliant studies at competitive prices including independent study monitoring by SCC.

 

Preparing dossiers for new substances

Dossier preparation for new substances requires careful planning. SCC covers all aspects of dossier preparation, including literature searches and data-gap analyses, planning and performance of all necessary tests, performance of risk assessments and finally dossier preparation, submission and defence. Rely on SCC: We began working on new substance registrations well before REACH was implemented.

Preparing dossier updates for tonnage-band increases

Your production/import volumes and future sales have to be closely monitored so that you can prepare in time for a tonnage-band increase. Manufacturing at the higher tonnage band level is only possible after having uploaded the respective registration dossier update.
Count on our experience and routine.

REACH / CLP compliance audits

We offer hands-on support to clients for self-audits to check the robustness of the established processes and also in case of official inspections by EU regulatory bodies to avoid potential non-compliance issues.
Whether your role under REACH is that of a manufacturer, importer, downstream user, or an Only Representative (OR), thanks to its long-standing broad experience SCC offers adapted checklists and procedures to help you self-assess your degree of compliance with the latest regulations and to identify any risk areas proactively.