ATOUT CHIMIE is a French service provider and trainer working on european regulations as REACH, Biocides. Our team of engineer and PhD doctors in QSE, toxicology and ecotoxicology has realized more than 200 REACH registrations and biocidal products authorisations so far. And we now help our clients to handle cost and data sharing issues, managing reach and biocide consortiums.
REACH regulation (EC n°1907/2006)
REACH registration is based on the "one substance, one registration" (OSOR) principle. This means that manufacturers and importers of the same substance have to submit their registration jointly (in a "joint submission"). The analytical and spectral information provided should be consistent and sufficient to confirm the substance identity profile (SIP) and sameness.
In fact, in order to comply with REACH, Lead Registrants (LR) have to organise cost and data sharing among Substance Information Exchange Forums (SIEF) members. In particular, REACH article 27 organises the data sharing process, as follows:
- potential registrant is to request information from previous registrant(s);
- obligation to make every effort to reach agreement for both parties;
- obligation to make every effort to share costs in a fair, transparent and non discriminatory way;
- communication between previous and potential registrants of information in case of agreement;
The implementing regulation on data sharing n°2016/9 enforced this process under REACH precising the refunding mecanisms and the “one substance one registration” OSOR principle.
ATOUT CHIMIE handles SIEFs on behalf of Lead Registrants, in particular concerning:
- Preparation of cost/data sharing material
- Communication with pre-SIEF members
- Elaboration of Contracts and LoA management in collaboration with jurists
- letters of access,refundings
- SIEF follow-up
- REACH registration update
- Audit of REACH registration dossier quality and compliance
- REACH evaluation follow-up which may lead to harmonized classification, restriction and authorisation of the substance.
BIOCIDAL PRODUCTS regulation (CE n°528/2013)
Data and cost sharing principles also apply in the framework of biocide active substance approbation and authorisation (AMM). ATOUT CHIMIE work on biocidal products families to allow consortium members to share the regulatory fees and access to larger market area, as proposed in the Union authorisation process for example.
Of course, agreement on the terms of the collaboration and confidentiality is a prerequisite to form a consortia. Our role is then to facilitate communication between competitors.
There are many ways to manage consortia depending on your expectations and relationship with competitors. And sums of money involved often worth handling with experts.