Accueil  .  Management of access letters for REACH registration dossiers

reach registration files:
Management of access letters (LOA)

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
  • Pre-SIEF survey to identify interested entities
  • Calculation of the costs of the letter of access (LoA): list and evaluation of studies and their reliability, rules for cost sharing and distribution
  • Learning and validation of cost / data sharing by the lead registrant
  • SIEF agreement proposal (and / or consortium agreement, cooperation agreement) and letter of access
Communication with pre-SIEF members
  • Communication to present data and cost sharing conditions to all pre-SIEF members
  • Sending of the SIEF agreement (and / or consortium agreement, cooperation agreement), sending of the list and evaluation of studies as well as the distribution of costs upon request of interested members
  • Response to members' questions
Contract management and the LoA 

Coordination of the following tasks between the pre-SIEF member and the lead registrant:

  • Signature of the SIEF agreement (and / or consortium agreement, cooperation agreement)
  • Billing, payment and signing of access letter fees
  • Generation and sending of the joint submission file (name of joint submission and token, and possibly chemical safety report (or CSR for Chemical Safety Report), IUCLID reference substance, etc.)
SIEF monitoring
  • Monitoring of the evolution of the SIEF and possible reimbursements
  • Answers to SIEF members on request

 

 

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
 Hydrogenated lecithines 295-786-7 92128-87-5  FULL 10-100T
 Sodium Undec-10-enoate 222-264-8 3398-33-2  FULL 1-10T
 Diethylacetal heliotropine 254-956-0    FULL 1-10T
 Acetate piperonyle 206-312-5    FULL 1-10T
 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
4-tert-butylcyclohexanone 202-678-5 98-53-3  FULL 1-10T
5-methyl-2-(1-methylvinyl) cyclohexan-1-ol 232-102-8 7786-67-6  FULL 1-10T
Diethyl tartrate 201-783-3 87-91-2  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
1,3-dioxane, 2-(3,3-dimethyl-1-cyclohexan-1-yl)-2,5,5-trimethyl 815-500-1 1853175-99-1   FULL 1-10T
[(2H)oxy](2H (deuterium oxide)) 232-148-9 7789-20-0  FULL 1-10T
 di[(2H3)methyl] sulphoxide 218-617-0 2206-27-1  FULL 1-10T
2,6,10,15,19,23- hexamethyltetracosane  203-825-6 111-01-3  FULL 100-1000T

 

For more information, see the ECHA website: registration dossier

Need personalized support for your letters of access?

Contact us at: info@atoutchimie.eu