Regulatory Support Across Europe
We have extensive experience in providing regulatory consultancy across Europe under EU-REACH, UK-REACH and for Switzerland. This includes working as lead or co-registrants and acting as an Only Representative (OR).
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Experienced team of regulatory scientists with wide-ranging insight into EU-REACH
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Over 680 EU-REACH registrations as either a lead or a co-registrant
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Over 1000 chemicals in 140 EU-REACH Only Representatives (ORs) contracts
EU-REACH
REACH in the EU aspires to create "the most comprehensive chemicals database in the world". The legislation came into effect on June 1, 2007 and applies to chemicals manufactured or imported into the EU/EEA in annual quantities of 1 tonne or more. EU-REACH aims to ensure that chemicals placed on the European market do not adversely affect human health or the environment. Under EU-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 EU-REACH and the evaluation of chemical safety.
We have 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 EU-REACH. In addition, we have expertise in compiling the chemicals dossiers you will need to maintain and update in line with changes in regulations and chemical usage.
Complying with REACH requirements for a chemical
EU-REACH requirements vary based on the type of chemical and the annual tonnage used. EU-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 EU-REACH, you need to intimately understand the current legislation and how it is applied. This 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' EU-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 EU-REACH, you need to be based in the EEA. If you are not, then you may 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 EU-REACH registration process
Over 40 experienced regulatory scientists sit in our regulatory teams in South Korea, Japan, Switzerland, the UK and the USA. Working in collaboration with our expert scientists, they can help you leverage existing data. This may mean providing robust arguments in support of waivers or developing intelligent testing strategies, leveraging the full range of in-silico, in-vitro or in-vivo assays, tailored to you. Collaborative working across data generation and regulatory strategy functions optimizes EU-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 lead or co-registrant
Our regulatory team has extensive experience of working in REACH consortia and as part of SIEFs. This includes acting as lead registrants or as co-registrants. As your partner, we can drive a registration forward, negotiate access to consortia or to EU-REACH dossiers and data, and manage all the technical and administrative aspects of registration and submission.
Experienced EU-REACH Only Representatives (ORs) 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 Only Representative services.