Redebel Regulatory Affairs REACH
RRA offers you strategic regulatory expertise thanks to its involvement in REACH since the latter’s entry into force. Our experts help you identify and comply with the requirements laid down in Regulation (EC) No 1907/2006.
Active substances are the building blocks of REACH. Our experts guide you to understand your company's obligations within the supply chain. However, REACH is not limited to registering a substance and authorising a legal entity to place it on the market.
Downstream users must also comply with certain requirements that may involve providing information via a safety data sheet or conducting their own exposure scenarios.
Our experts will assist you in placing your substance on the market and keeping it there and/or keep it in use.
REACH is considered as stand-alone and cross-cutting legislation due to its impact on non-active substances (co-formulants) of plant protection products and biocides.
Our Offer
Strategic analysis and regulatory consulting
Compare application with regulatory requirements to advise the best possible procedure / opportunity.
The first step is to identify the role of your company with regard to these substances and the uses you make of them. This diagnostic step is particularly essential under REACH.
Checking the status of your substance
Is your substance on the list of candidates subject to authorisation or restriction? Does your substance need to be registered? Is it already registered?
Support in conducting and monitoring of laboratory studies
If new analyses need to be conducted, the choice of laboratory is vital. Knowledge of the product being tested and of the test principle is important for its proper design and to anticipate any potential pitfall.
Drafting of the registration application
Our team prepares the application adhering to the latest requirements and technical guidelines to ensure full compliance with regulatory obligations while anticipating all potential issues. We help you complete the application (individual part —including drafting of the CSR— and joint part) in IUCLID format from inquiry to submission.
Submission of the registration application to ECHA in the proper format
Efficient monitoring of the evaluation process and interactions with relevant authorities (ECHA or relevant Member State)
Our job does not end when the file is submitted. We remain available to respond to any requests for further information.
Verification of substance uses
As the uses covered under REACH are almost endless, ECHA has defined a system of specific descriptors (PROC, PC, ERC, etc.) and the different industrial associations have defined generic exposure scenarios. We will help you to cover the uses relevant for you and/or to translate the uses received in the eSDS of your suppliers. If necessary, we can assist you in drafting a DU CSR.
REACH as cross-cutting legislation
RRA has the needed skills and expertise in legislation related to plant protection and biocidal products. These laws govern active substances and formulations in general. REACH comes into play here as cross-cutting legislation owing to its impact on co-formulants. We can help you check their registration status and/or the need to cover their use.
Our experts have helped many companies to meet registration requirements in 2010, 2013 and 2018 for lead registrants and also for co-registrants and continue to do so.
Naturally, we have been and continue to be active between these deadlines.
