ATOUT CHIMIE has been carrying out REACH registration dossiers for over 12 years, and notably supports lead registrants (or LEAD registrants) in sharing data and costs within the joint submission and management of letters of access (LoA ).
CONTEXT OF COST AND DATA SHARING IN REACH REGISTRATION
REACH registration obligation: Since June 1, 2008, companies manufacturing or importing chemical substances into the European Union in quantities equal to or greater than 1 tonne per year are required to register them under REACH. To do this, hazard and exposure data must be generated on the substance in question.
The same substance must be registered jointly, by a group of industrialists called the Substance Information Exchange Forum (FEIS or SIEF for Substance Information Exchange Forum) whose objectives are to harmonize information for the same substance on the European market, to avoid the repetition of tests, in particular those on vertebrate animals and to share the costs between manufacturers.
In certain more complex cases, another type of collaborative structure can be proposed, for example a “consortium” (in particular to pool information relating to families of similar substances) or a “cooperation”.
A SIEF agreement - or consortium agreement / cooperation agreement depending on the type of structure chosen - documents the sharing of data on REACH requirements, within SIEF to share information and costs between manufacturers and importers, and sometimes allow the participation of data holders (eg downstream users). The letter of access (or LoA for letter of access) paid to the lead registrant allows access to common data and to join the joint submission (or JS for joint submission).
In accordance with the REACH Regulation, existing registrants and / or potential registrants must make every effort to reach an agreement on data sharing and ensure that the costs of sharing the required information are established in a fair, transparent manner. and non-discriminatory. (Regulation 2016/0: implementing act on data sharing).
ATOUT CHIMIE, through its ATOUT REACH service, supports you during this process in order to make your job easier and to allow you to better manage this data sharing, in accordance with the recommendations of the authorities and while preserving the interests of each.
ATOUT REACH OFFERS THE FOLLOWING SERVICES FOR THE MANAGEMENT OF LETTERS OF ACCESS OVER THE LONG TERM:
|step of collaboration||Detail|
Preparation of cost / data sharing material
Communication with pre-SIEF members
Contract management and the LoA
Coordination of the following tasks between the pre-SIEF member and the lead registrant:
LoA managed by ATOUT CHIMIE
The lead registrants of the following substances have entrusted us with the management of the corresponding SIEFs
|Substance name||ec number||cas number||type||Joint submission tonnage band|
|Poplar, ext||281-681-3||84012-37-3||FULL (annex III)||1-10T (annex III)|
|Batilol/ 3-(octadecyloxy) propane-1,2-diol||208-847-7||544-62-7||FULL||10-100T|
|Methyl 2-[(2-methylundecylidene)amino] benzoate||267-104-8||FULL||1-10T|
|Reaction mass of linolenate methyl and linoleate methyl and oleate methyl||907-284-3||FULL||1-10T|
|Cresoxyacetate d'ethyle||266-554-2||INTERMEDIATE under SCC||<1000T|
|1,3- dimethylbut-3-enyl isobutyrate||279-399-0||80118-06-5||FULL||1-10T|
|Hydrogenated decyl olive oil esters||924-579-2||FULL||1-10T|
|Hydrogenated Cetyl Olive Oil Esters||921-980-4||FULL||1-10T|
|Hydrogenated Stearyl Olive Oil Ester||921-548-5||FULL||1-10T|
|Olive oil decyl esters||948-056-3||FULL||1-10T|
|Extract obtained from powder of Theobroma cacao (Malvaceae) by co-extraction with ethanol and propylene glycol||947-962-6||FULL||10-100T|
|[(2H)oxy](2H (deuterium oxide))||232-148-9||7789-20-0||FULL||1-10T|
For more information, see the ECHA website: registration dossier