Fera consultancy services support you through the regulatory processes required to register your chemical products and biocides in the EU.
Companies wishing to market any chemical products, including biocides,
in the EU need to register the products with relevant regulatory
frameworks. These include BPR for biocides, covering insecticides,
preservatives, disinfectants and rodenticides, and REACH for all other
chemicals, excluding medicines, food additives and plant-protection
Fera has the scientific and regulatory expertise to provide consultancy services to help you with every step of the process. Our experience derives from working in government, industry, contract research organisations and in regulatory consultancies. We have well-established working relationships with many competent authorities, which means we can support you to achieve product registrations effectively and efficiently.Our flexible approach means you can choose the consultancy service that best suits your needs. This could range from providing advice on specific issues to delivering a full package of consultancy support – including everything from data gap analysis, study design and dossier preparation and submission, through to post-submission query handling.
All chemicals manufactured or imported into the EU at quantities ≧ 1 tonne per annum need to be registered under REACH (EC 1907/2006). REACH is a European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of Chemicals.
It aims to improve the protection of human health and the environment from chemical risks while enhancing the competitiveness of the EU chemicals industry. The responsibility for managing the risks associated with the use of chemicals falls under the companies that place the chemicals in the market (manufacturers or importers).
To manage extensive registrations, the process has been phased into three deadlines. The next major deadline is May 2018 for substances in the 1-100 tpa band.
The Biocidal Product Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products and covers 22 different product types (disinfectants, preservatives, pest control products, anti-fouling and embalming fluids). The regulatory process that enables the marketing of biocidal products has two stages: the active substance approval followed by the biocidal product approval. If you wish to market biocidal products in the EU, or continue marketing existing biocidal products, you must ensure compliance with all BPR requirements.
Copyright © 2017 Fera Science Ltd. All rights reserved.