EU REACH regulatory and scientific support
REACH ((EC) 1907/2006) is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals. REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1 June 2007.
Since then, we have prepared more than 700 lead dossiers for phase-in and non-phase-in substances. We handled more than 50 PPORD notifications, far more than 1,000 (late) pre-registrations / inquiries and well over 1,000 CLP notifications. We bring long-standing experience with intelligent testing strategies, read-across, data bridging, QSAR, group/category approaches, PBT/vPvB assessment as well as planning and monitoring of all dossier-relevant studies.
Testing packages
In cooperation with international GLP-certified laboratories, we can offer you testing packages at highly competitive prices, including professional and independent monitoring by SCC experts.
Chemical substance coverage
We are experienced in and can support you with the registration of all types of substances, such as mono and multi-constituent substances, nano-materials and UVCBs, both inorganic and organic.
EU REACH regulatory tools and models
We have excellent and long-standing experience with all regulatory tools and models used under EU REACH, such as IUCLID, REACH-IT and risk-assessment tools such as Chesar, EASYTRA, ConsExpo, Stoffenmanager®, Advanced Reach Tool (ART) and RISKOFDERM.
Evaluation process guidance
Our experts support and guide our customers through the entire evaluation processes handled by ECHA and the Member States, including CoRAP, SVHC and CLH dossiers.
Our REACH services at a glance
Preparing dossiers for new substance registration
Dossier preparation for new substances requires careful planning. SCC supports you with all aspects of the dossier preparation, including literature search and data-gap analysis, planning and monitoring of all necessary tests, carrying out risk assessments and finally writing, submitting and defending the dossier.
You can rely on SCC: We have been working on new substance registrations well before and ever since the implementation of REACH.
Preparing dossier updates for tonnage-band increases
Your production/import volumes and future sales have to be closely monitored to prepare for a tonnage-band increase in time. Manufacturing at a higher tonnage band level is only possible after having submitted a respective registration dossier update.
Let SCC help you with this: Count on our experience and expertise!
Defending your submissions
With ECHA intending to check all dossiers and applying the same criteria irrespective of the submission date, keeping your dossiers up-to-date is critical. We can help you avoid authority checks and requests for additional testing, both for recently submitted and older dossiers.
SCC understands what the ECHA tools and manual checks focus on and have all the expertise and experience to identify and update potential weak spots in your dossiers, for example by preparing refined data waivers or read-across argumentation.
SCC is the best partner to support you to keep your dossiers up to date.
Communication with ECHA
During the dossier evaluation and validation of testing proposals and data quality, ECHA and Member States may request further information such as new studies, literature or justifications. With commenting period of only 4 weeks, the pressure on the industry is high.
When it comes to substance evaluation by ECHA and Member States and the need to provide compelling and valid arguments, you can trust SCC. This is one of our fields of expertise. We can help you develop convincing read-across argumentation and sound concepts for performing selected bridging studies to substantially reduce test costs as compared to often requested full test programmes.
There is no reason for concern, as long as you rely on SCCs regulatory experts who understand their job and can efficiently support you.
Monitoring and defending your substances under CoRAP and SVHC
When your substance gets listed as Substance of Very High Concern (SVHC) or prioritised for substance evaluation under the Community Rolling Action Plan (CoRAP), you need to take immediate action. On your behalf, SCC can take care of all necessary tasks, starting from monitoring your substances, through initiating prompt inquiries by the authorities for clear understanding of their concerns to finally defending your substances.
Count on SCC, we have been successfully handling these issues for years.
Support in RAC issues (including preparation of CLH dossiers)
On your behalf, SCC will guide you through all procedures, from developing effective defence strategies for your substances scrutinised by ECHA, through preparing CLH dossiers, to representing you in the Risk Assessment Committee (RAC) meetings.
Rely on our expert knowledge and experience.
Planning, contracting and monitoring of studies
If new studies need to be performed, SCC will help you design and contract necessary studies by advising you on the laboratories best suited to meet your individual needs. We also offer GLP-compliant studies at competitive prices in cooperation with international GLP-certified laboratories, including independent study monitoring by SCC.
Rely on our experts who understand their job and can effectively support you.
REACH and CLP compliance audits
Our hands-on support for self-audits enables our customers to check the robustness of their established processes. This helps to avoid potential non-compliance issues during an official inspection by an EU regulatory body.
Irrespective of whether you are a manufacturer, importer, downstream user, or an Only Representative (OR), we provide you with checklists and procedures appropriate for your situation.
SCC can help you self-assess your state of compliance with the latest regulations and proactively identify any areas of concern.
Alongside regulatory & scientific support, we cooperate with our partner GBK Regulatory Compliance to round out our services by offering solutions to our customers to meet their technical and documentation needs, such as safety data sheets, poison centres notifications and hazardous goods services.
Don't hesitate to contact us to learn how we can help you twith your chemical compliance.
