Letter of Access
i2a hereby outlines the option of a Letter of Access (LoA) for intending registrants of the antimony substances covered by i2a that prefer NOT to become Full Reach member of i2a.
A LoA will grant you a 'permission to refer' to the technical dossier of a substance for the specific purpose of making your REACH registration if you prefer NOT to become member of i2a.
The LoA option does not involve ownership of any data or studies produced or obtained by i2a, and it does not allow the company access to view or to use these data/studies. In contrast to full i2a membership, the LoA option also means that no additional help can be expected from the i2a secretariat (for example during substance registration).
Available to whom?
A LoA is sold per legal entity and per substance and REACH dossiers are currently available for antimony metal, diantimony trioxide, sodium hexahydroxoantimonate, sodium antimonate (A), antimony pentoxide, antimony trisulfide, diantimony tris (ethylene glycolate) and antimony trichloride.
We offer 1 year free membership to i2a if you buy access to our REACH data via a LoA. You are allowed to participate to our meetings and get to know the other major antimony players. You won’t have voting right though. You are put on our distribution lists and get first-hand information on the EHS topics we are working on. We hope to persuade you of the benefits of i2a membership during that year. If you don’t want to prolong your membership; all you need to do is send a letter to the i2a secretariat by end November of that year saying that you step out again.
The 8 substances have been successfully REACH registered as a Joint Submission and access is offered to additional registrants.
Via grouping, a distinction has been made between Sb(V) and Sb(III) substances. Read across has been used whenever possible to avoid unnecessary (animal) testing. Furthermore, all exposure scenarios in all dossiers show SAFE use for both human health and environment.
There was a EU Risk Assessment Report on diantimony trioxide
peer reviewed by all EU Member States and finalized in May 2008. The report was later that year reviewed and accepted by OECD experts under the SIAP
program. The REACH dossiers are largely based on.
Further data will continue to be developed in the future where needed.
i2a is also helping its members with REACH-like systems, like e.g. Korean REACH. For more information: please contact i2a.
What is included in the Letter of Access?
- Access to the Chemical Safety Report (CSR) for a Substance registered at or above 10 tonnes/y by the Lead Registrant;
- Access to a valid security token granted by ECHA to the Lead Registrant which shall enable the company to participate in the joint submission of the Registration Dossier;
- The right to participate in the Joint Submission;
- The right to refer to the Dossier for the sole purpose of supporting the company’s registration in accordance with the REACH Regulation;
- Agreed classification and labelling.
What shall the company buying a Letter of Access provide to i2a?
- The names of all Affiliates to which the rights conferred by the LoA shall exclusively apply.
- In case of an Only Representative (OR): the full name of the non-European company and its Affiliates for which this LoA will be used.
- The average annual tonnage per substance produced in or imported into the EU (by each Affiliate in the three calendar years prior to the date of signature of the LoA Agreement).
If a Company requests a LoA close to the registration deadline, the obligations of i2a shall only be obligations of best effort (and not an obligation of result). Neither i2a nor the Lead Registrant can be held liable for the Company failing to meet its registration deadline in this case.
Cost of membership compared to Letter of Acces (LoA) cost
The price of a LoA charged initially by i2a may not be the total cost. In case the REACH Dossier needs to be significantly updated, companies that buy a LoA will have to pay their fair share of the costs at the moment the LoA is bought. A significant update can be, among others, the inclusion of new scientific data, the inclusion of new exposure scenarios or updating existing ones, extra costs associated with external consultancy during the evaluation of the Dossier by a Member State etc.
The board of i2a will decide whether or not the update is required and whether or not the companies that bought the LoA will be charged additionally for this.
In 2018, i2a will partially refund payments received from LoA-applicants in the unlikely case that their total sum exceeds the actual investment costs to an extent that must be deemed unreasonable or abusive within the meaning of the applicable competition laws.
Please contact i2a for the latest membership fee and LoA cost.
We encourage companies to go for the membership option.
Advantages of i2a membership
- i2a offers its members help with preparing the company specific IUCLID file (i.e. sections 1, 3 and 11)
- i2a offers its members an on-site visit by a member of the i2a secretariat to assist with the actual REACH registration.
- i2a provides its members a template for the Safety Data Sheet for antimony metal, diantimony trioxide, sodium hexahydroxoantimonate, antimony trisulfide, sodium antimonate (A), diantimony tris(ethylene glycolate) and diantimony pentoxide .
- The i2a membership fee is based on the total worldwide tonnage of all antimony substances of all your legal entities.
- i2a members have voting right (influence/direct REACH dossiers and the work done by i2a).
- i2a acts as a helpdesk for REACH-related questions.
- Members get answers to all their EHS and regulatory questions, not just EU-REACH.
- The data, owned and gathered by i2a, are used for worldwide (regulatory) purposes, not just for EU-REACH.
- i2a is a non-profit association. The more companies join i2a, the less each individual member pays.
If you are interested in becoming i2a member or if you prefer the option of buying a LoA, please contact us at firstname.lastname@example.org