REACH in the EU aspires to create "the most comprehensive chemicals database in the world". The legislation came into force on June 1, 2007 and applies to chemicals manufactured or imported into the EU/EEA in annual quantities of 1 tonne or more. REACH aims to ensure that chemicals placed on the European market do not adversely affect human health or the environment. Under REACH, manufacturers or importers must register chemicals with the European Chemicals Agency (ECHA). ECHA, working with member state competent authorities, is responsible for the technical administration of REACH and evaluation of chemical safety.
Covance has a long history of supporting clients through the EU regulatory process. As our partner, you will benefit from insight gained from previous regulatory successes under the prior NONS regulation and now REACH. In addition, Covance has expertise in the chemicals dossiers you will need to maintain and update in line with changes in regulations and chemical usage.
- Experienced team of regulatory scientists with wide-ranging insight into REACH
- Over 680 REACH registrations as either a lead or co-registrant
- Over 1000 chemicals in 140 REACH Only Representatives (ORs) contracts
Complying with REACH requirements for a chemical
REACH requirements vary based on the type of chemical and its annual tonnage usage. REACH regulations are constantly evolving, so endpoint requirements can change. In addition, the use of a chemical may change, and this can impact safety assessments. To comply with REACH, you need to intimately understand the current legislation and how it is applied. That means knowing what tests are needed, how to interpret them in line with regulatory guidance and how to compile the data into a comprehensive dossier.
Understanding your role as a lead or co-registrant under REACH
With the 'one substance, one dossier' REACH rule, you need to work with other companies who manufacture or import the same chemical. This means identifying, negotiating and contracting with other registrants and understanding how to fulfill your agreed role.
Registering for REACH when based outside the EU or EEA
To register for REACH, you need to be based in the EEA. If you are not, then you need an Only Representative (OR) registrant who is. The OR takes on the legal responsibility of complying with REACH requirements on your behalf.
Guiding you and your chemical through the entire REACH registration process
Over 40 experienced regulatory scientists sit in our European regulatory team. Working in collaboration with our expert scientists, this team can help you leverage existing data. Using QSARs and read across we can produce expert waivers for your chemical. If that is not appropriate, we can develop intelligent testing strategies tailored to you. Collaborative working across data generation and regulatory strategy functions optimizes REACH compliance and registration success. Our expertise has been amassed from a range of chemical types such as biofuels, fatty acids, enzymes and cosmetics.
Extensive consortium experience as a both lead or co-registrants
Our regulatory team have extensive experience working in REACH consortia and as part of SIEFs. That includes acting as lead registrants or as co-registrants. As your partner, we can drive a registration forward, negotiate access to consortia or to REACH dossiers and data, and manage all the technical and administrative aspects of registration and submission.
Experienced REACH OR for multiple companies and chemicals
Allow our dedicated team of regulatory specialists to take on the legal responsibilities for your REACH registration in the EU. Find out more about our OR services here:
Guiding you through the Brexit regulatory uncertainties
The exit of the UK from the EU impacts UK-based manufacturers or importers wanting to maintain access to the EEA market. It could also impact downstream processes. Find out more about how Covance can help you navigate Brexit complexities: