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LOA Reach Consortium

Frequently Asked Questions (FAQs)

Over the past year, the Lower Olefins and Aromatics (LOA) REACH Consortium and the LOA Services Team have received a large number of questions on all aspects of the workings of the Consortium. These questions have come from potential Consortium members and members of the SIEFs of the LOA substances via our website, email, and during the Webinars that we ran in May 2009. The enquires concern how the Consortium works in relation to all the complexities that REACH presents.

This compilation of questions and basic answers is an attempt to bring together those most frequently asked of us, so that they can act as a reference set. We hope it will provide you with some basic answers to the questions that you might have. They will be updated on a regular basis.

The questions are arranged in categories in the following order and are numbered for easy reference:

MEMBERSHIP
REGISTRATION
DOSSIER
SUBSTANCES COVERED
CATEGORIES
LEAD REGISTRANTS
LETTER OF ACCESS
EXPOSURE AND USE
SIEFs

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IMPORTANT NOTE TO REVIEW BEFORE READING THIS FAQs DOCUMENT

The answers to the questions addressed in this document are for general informational purposes only. The information provided is based on the LOA REACH Consortium’s current understanding and knowledge. Note, however, that the information provided is subject to change and should not be used for making decisions. You should regularly check the relevant law, regulations, guidelines, and other relevant documents. The members of the LOA Consortium and of the LOA REACH Services Team do not accept any liability or responsibility for any error or omission in this document. ******************************************************************************************

MEMBERSHIP

Membership Q1: How do I become a member of the Consortium?
A: The process for becoming a new LOA REACH Consortium member is described in detail on the LOA web site under the New Members tab.

Membership Q2: How much does it cost to enter into the Consortium?
A: The membership fee charged to date is about EUR121,000. This initial membership fee is intended to finance operational and technical activities. In the budget mechanism of LOA, operational budget items (project management, legal, financial) are shared between all members. Development of the technical content of dossiers is shared between members with an interest in the specific substance. Consequently, membership costs will eventually vary dependent upon the interests of the Consortium member. New members pay exactly the same initial membership fees that the existing members have paid. It is not anticipated that any additional fees will be charged for the remainder of 2009 for the majority of the Consortium members. Because this fee is intended to cover the costs of the Consortium, there is no discount possible. Additional information on budget will be provided after the Confidentiality Agreement is signed in the New joiners process.

Membership Q3: Do I have to be in the EU to be a LOA REACH Consortium member?
A: No, the current LOA membership includes worldwide non-EU manufacturers.

Membership Q4: Is there a deadline for joining the LOA REACH Consortium?
A: Yes, the LOA REACH Consortium will close the member admission process as of December 31, 2009.

Membership Q5: Will late joining increase the membership fee?
A: There is no increase in the membership fee for later joiners. The principle is that all Consortium members pay the same overall fee irrespective of when they join. If in the future we decide to have a late joining fee, we will publish it on the LOA public website (www.loa-reach.com).

Membership Q6: Can an Only Representative join the Consortium?
A: As an Only Representative, you cannot join the Consortium. Only manufacturers or importers can become Members of the LOA REACH Consortium; however, they do not need to be in the EU - our membership encompasses companies that are worldwide. In exceptional cases, upon specific approval, agents of non-EU manufacturers can join.

Membership Q7: Being an Only Representative (OR) Company representing a non-EU manufacturer, who will sign the “Confidentiality Agreement” and “Accession Agreement”? Also, who will be able to participate in the LOA Consortium meetings on behalf of the manufacturer?
A: Only the manufacturer (not the Only Representative) may join the Consortium and sign the agreements. However, the Member is free to choose its representative, either within or outside its own company to attend the meetings. Therefore the Member can appoint a person from the OR company as its representative.

Membership Q8: Would you please compare the benefits of Consortium membership to simply purchasing the Letter of Access?
A: Each company will have to make its own decision in light of its own circumstances. In very general terms, the more substances a company has in LOA, the more cost effective Consortium membership appears. However, many companies with only a few substances have also joined the Consortium to be close to the decisions in the consortium and increase the level of business certainty on registration issues.

Membership Q9: Please differentiate the various informational LOA websites and identify those that require passwords.
A: The LOA REACH Consortium uses several systems to manage and communicate about its work.

  • LOA REACH Consortium Public Web site (www.loa-reach.com): An open external web site that provides general information on the Consortium, its objectives and scope, the procedures for joining, the list of current members and substances, updates on the SIEFs managed by the Consortium, and events held by the Consortium.
  • LOA Consortium Extranet: An internal web site that provides details of meetings (agenda, minutes, other materials) and members (contact information), etc. It is also used for setting up meetings, sending out information to the various groups, and for storing documents relevant to the LOA Consortium activities. This site is password -protected but is open to all Members who have joined the Consortium.
  • IUCLID: An electronic tool that stores information used to build REACH registration dossiers. The LOA instance of IUCLID is password -protected but is open to all Members who have joined the Consortium.
  • REACHsuite: An electronic management and storage system built to help the LOA Consortium run both the technical activities of the Consortium and also the SIEFs. The majority of the information on REACHsuite is password protected but is open to all Members who have joined the Consortium. Certain SIEF pages of the site are also password-protected but are open to all SIEF Members; if you are a SIEF member and your contact information is up to date in the ECHA REACH IT system, you should have received a user name and password for the SIEF pages related to your substances of interest.

Membership Q10: What are the obligations for LOA members (e.g., participation in meetings, chemical / toxicological expertise)?
A: Members are expected to participate in the operational or technical processes that have been set up within the Consortium. Members are also encouraged to participate in the General Assembly meetings (all members, twice a year). All Members are included on the distribution lists for the technical information at various stages. Members of the Technical Steering Committee are expected to contribute their ideas and energies to help make the LOA Consortium successful.

Membership Q11: Are there any plans so far on creating a category of “Associate Members” as described in Article VI.4.2 on the powers of the Executive Committee?
A: There is currently no plan to create a category of Associate Members.

 

REGISTRATION

Registration Q1: Where can I find more information about ECHA regulations and compliance?
A: ECHA Guidance documents are available for download at either the ECHA website (see http://guidance.echa.europa.eu/guidance_en.htm) or at the EU Bookshop (see http://bookshop.europa.eu). In the EU bookshop, you can either conduct a ‘QuickSearch’ for the documents on the right side menu or view all available ECHA documents with the help of the left side menu: Browse / By author / Community Agencies (the second last one from the bottom) / ECHA (by expanding the structural content) / and then click on the hyperlinked numbers. The documents can be downloaded as PDF files free of charge.

Registration Q2: Can I modify my deadline for registration in the REACH IT system if I’d made a mistake in estimating it according to the tonnage band?
A: When you sign up within the REACH IT system, you provide a deadline but this date can currently be revised within the system. Note, however, that this is subject to the functionality of the REACH IT system, which is separate from the LOA Consortium.

Registration Q3: Is there any substantial difference between a "substance" (REACH Art. 6-1) and the "monomer substance" (Art. 6-3)? A: Practically, you cannot register as a monomer. You register as a substance with the use "monomer." LOA companies are using this shorthand – registration as a monomer – to show that it’s only use is as a monomer. This restricts some information needs and also makes later exposure assessments easier due to the assumptions made. The REACH Regulation and the ECHA Guidance should be consulted for further information on this issue.

Registration Q4: As an importer of polymers containing monomers supported by LOA, could you please clarify the process to ensure REACH compliance?
A: The monomers in the polymers are substances subject to registration under REACH. Thus, as an importer of polymers containing monomers, you must ensure that the monomers, unless exempt, are registered in accordance with the REACH Regulation.

Registration Q5: Outside Europe, we import an ethylene-propene polymer. We do not produce the polymer or the monomer. I import the polymer and then I mix it with other raw materials, without modifying its chemical composition. My customers (downstream users) don't change the chemical composition. Can we use your data for our registration? To register the monomers that constitute my imported polymer, what kind of information do I need for the "individual" part of dossier? Does it suffice to provide the name and CAS/EINECS no. of monomers?
A: The monomers in the polymer you import are subject to REACH registration. As an importer, you are required to register if the 1 tonne per year threshold is exceeded and no exemption applies. The LOA REACH Consortium will produce dossiers on ethylene and propene, including use as a monomer. If you are willing to share in the cost of these dossiers, you can have access to them for REACH registration purposes.

 

DOSSIER

Dossier Q1: What is covered by the dossier that LOA will provide?
A: For the dossiers, LOA will provide the following, which will address all the information requirements of REACH Annexes VII to X:

  • Agreed Classification and labelling
  • IUCLID Sections 4 -13, which include:
4. Physical and chemical properties
5. Environmental fate and pathways
6. Ecotoxicological information
7. Toxicological information
8. Analytical methods
9. Residues in food and feedings stuffs
10. Effectiveness against target organisms
11. Guidance on safe use
12. Literature search
13. Assessment reports
  • Common elements of the extended Safety Data Sheet (eSDS), including exposure scenarios for full dossiers
  • Chemical Safety Reports (CSR Part B) for full dossiers

 In addition, LOA is currently preparing guidance for Consortium and SIEF Members for IUCLID Sections 1-3, which covers the company-specific information, as follows: 1. General Information (substance id, composition), 2. Classification and Labelling, and 3. Manufacturing, Use and exposure. Registrants will have to input the information themselves and also provide any specific aspects (e.g., proprietary uses) in the CSR. The Consortium will endeavour to obtain full rights to grant data access to the full joint registration dossier required for REACH registration, including optional elements (the CSR, guidance on safe use, etc.), but excluding, of course, all elements that must be submitted individually.

In addition to data required at the highest tonnage level, we will also provide access to the Chemical Safety Report. The dossier will cover the major uses and related Exposure Scenarios, but in some instances, where the use is either specialised or proprietary, additional information and data may need to be added by an individual registrant. With respect to studies provided by the Consortium’s Members, the Consortium Agreement provides that third parties may be granted access. With respect to studies provided by third parties, the Consortium will seek the right to grant access to third party REACH registrants. Of course, we may not always succeed in securing such rights. In any event, we will indicate clearly the scope of the data access we are offering.

 

Dossier Q2: What is the difference between what is provided for a full versus an intermediate dossier?
A: The REACH regulation lays out the differences for on site and transported intermediates at different tonnages. These are reduced requirements (see Article 17(2)(d), REACH Regulation). However, for the majority of substances, LOA will produce full dossiers that will support a substance registration. LOA will offer a reduced price for the dossier to support an intermediate registration. The main difference is likely to be in the letter of access and the right to which the dossier may be used, rather than the actual text. However it should be noted that for one or two substances, LOA will only produce a dossiers to support registration as an intermediate. You are advised to review this aspect on the SIEF reporting pages of the specific substance.

Dossier Q3: Will the CSR be completely available for reading for every joint registrant? Will it be possible to get access to the CSR if a company intends to register jointly but not at highest tonnage level?
A: We intend to make parts of the CSR available for review by SIEF members. SIEF members will be required to sign a confidentiality, non-disclosure, and non-use agreement.

Dossier Q4: Will information obtained be presented in IUCLID 5 format including all required data as endpoints, robust summary (if necessary), etc.?
A: Yes, the information will be presented in IUCLID 5 format.

Dossier Q5: What is different between the dossier that LOA will provide to the Members who are part of the Consortium and those who purchase a dossier via a letter of access?
A: Nothing, there will be no difference in the dossier. Consortium members are also SIEF members. What is provided to the Consortium members is the same as what is provided to the SIEF members outside the Consortium who purchase a letter of access.

Dossier Q6: What about benzene? I received a cost letter saying that LOA would not produce a full dossier for this substance.
A: Because of the intentions of the Consortium Members, the benzene dossier will only support registration as an intermediate However, because benzene is such a data rich substance, it will address all the information requirements of REACH Annexes VII to X and this information will also be presented in the Chemical Safety Assessment. Exposure scenarios and a Chemical Safety Report will not be developed. SIEF members who want to submit a registration dossier as a substance will need to add to the LOA dossier and assessment with their own use information, exposure scenarios and risk characterisation.

Dossier Q7: Who is preparing the dossiers and how will they get access to all the information that is needed?
A: The LOA REACH Consortium brings together industry leaders, with all of their technical resources, and is assisted by a team of technical experts with many years of experience in the petrochemical industry. Thus, the Consortium has access to the best available technical information, including proprietary studies from leading petrochemicals companies both within and outside Europe. The registration dossier is prepared based on the principles of sound science, technical judgment, and cost-effectiveness.

Dossier Q8: Is it possible that the dossier will contain only a handful of (four to ten) literature data points?
A: The goal of REACH LOA is to find and document the best data around. If we have the best data and it meets the requirements, the quantity of literature is less important.

 

SUBSTANCES COVERED

Substances Q1: Where can I find the list of substances covered by the Consortium?
A: The list of substances is on the LOA REACH Consortium web site under the LOA Substances tab.

Substances Q2: What if I have a substance or reaction mass that is not on the LOA list currently?
A: At this time, we are not planning on taking on any new substances within the LOA Consortium unless it is a stream that fits into one of the existing categories, or all the components of the reaction mass are currently covered under LOA. Please note that if a substance does not fit into an existing category or is not already on the LOA list of substances, we can not accept it as part of the LOA REACH Consortium work process.

Substances Q3: I don't see pentane or hexane on the list of substances – are they covered by LOA?
A: No, CAS numbers 109-66-0, pentane, and 110-54-3, hexane, are both covered by the Hydrocarbon Solvents Producers Association (HSPA) and not by LOA.

Substances Q4: Is ethylbenzene covered by LOA? What about styrene?
A: No, CAS numbers 100-41-4, ethylbenzene, and 100-42-4, styrene, are both covered by the Styrene Producers Association (SPA) and not by LOA.

Substances Q5: I saw methane in the list of the substances covered by the LOA REACH Consortium but we thought that this substance was exempted from REACH as being "natural." Is there any way to confirm that it is not exempted and that the LOA REACH consortium is taking care of its registration? Our methane is generated (by distillation) from natural gasoline and we do handle it as a not isolated intermediate as well.
A: We understand that methane produced naturally (i.e., from gas fields, cows) would be exempt but producing methane by chemical synthesis it would still need to be registered, despite it being produced from natural gasoline. This also applies to a number of fuel gases. However, as LOA is not an advisory group on REACH for members or non-members, you need to decide on your own course of action.

Substances Q6: In which LOA category is isoprene contained?
A: A separate dossier for isoprene (CAS number 78-79-5) is being developed by LOA which is not part of a category; however, information on this substance will be used for categories (i.e., C5 non-cyclics category, resin oils & cyclic dienes) with streams containing more than 0.1 percent isoprene.

Substances Q7: Do you cover reaction masses within LOA? I am specifically interested in the reaction mass of ethylbenzene and xylene and do not see it on the substance list on the web site?
A: We are still resolving how to incorporate reaction masses into the current process. We will very likely cover several reaction masses, but the process has not yet been finalised (especially for the reaction mass of ethylbenezene and xylene, since we do not cover ethylbenzene within LOA). Based on the current interest from our Members, we intend to cover reaction masses that have been pre-registered by our Members and include substances which are completely managed within LOA, as follows:

  • Reaction mass of butene-2 and n-butane
  • Reaction mass of propene and propane
  • Reaction mass of toluene and benzene
  • Reaction mass of methane and hydrogen
In addition, we have a number of Members with reaction masses that include some substances which are managed within LOA and others that are outside LOA (e.g., the reaction mass of xylenes and ethylbenzene). We have discussed this within the LOA Technical Steering Committee, and it was agreed that for the reaction masses that are covered between various groups, we should discuss them individually with members to decide on an approach and determine what data are needed on a case-by-case basis. For the reaction mass of xylenes and ethylbenzene, one of current LOA members is also the lead company for ethylbenzene in the Styrene Producers Association and is helping to facilitate the cooperation between the two groups; therefore it is very likely that LOA will produce a dossier for this reaction mass with the Ethylbenzene REACH Consortium. Any data access rights to ethylbenzene would also need to be considered as well as data access rights for xylene and we have not yet worked out the detail on this process. It is most likely that we will complete the work on xylene (and ethyl benzene) before we put together a joint dossier for the reaction mass.

 

Substances Q8: How will the SIEF work if we have a reaction mass that LOA will cover? Who will coordinate the sameness check between all those different pre-registrations?
A: The LOA REACH Consortium will state clearly what substance is covered by it so that other SIEF members can determine whether their substances are the same.

Substances Q9: Has the Consortium already agreed on criteria regarding the qualities (purities) of the substances which will be dealt with in the joined dossier?
A: LOA is currently working on this aspect and will describe the purities on the SIEF pages as we progress. Much of what we will support will be driven by the existing data on the various substances – i.e., what has been tested previously. To a great extent, this tends to be what is already in general commerce. We believe that we will cover substances that fall within the mono-constituent 80/ 20 rule. For streams, we are covering those that fall within the definitions of the various LOA categories.

Substances Q10: Are there any qualities (specs with certain impurities) the LOA will not cover?
A: As above, LOA will be preparing dossiers on what has been general commerce. If you have products with specific impurities that will affect the classification and labelling – or drive any specific health effects – then these may be out of scope, or you would need to add them to the dossier yourself. If you are just producing substances that are used by a number of people, in similar processes and conditions to others, this will likely not be an issue.

 

CATEGORIES

Categories Q1: Where can I find the descriptions of the categories for LOA?
A: At present, we have brief descriptions of each of the categories for LOA on the public Web site under LOA Substances/Categories. The category justification that will expand on these descriptions is now being developed based on the analysis of the composition of the streams received from the current Consortium members.

Categories Q2: What kind of documentation will you use to provide evidence of the sound decision(s)/assessment on grouping and test methods?
A: We are writing a category justification document that will address all pertinent endpoints. This document will explicitly explain grouping and testing methods and be shared on the SIEF pages when completed.

 

LEAD REGISTRANTS

Lead Registrants Q1: How were the Lead Registrants selected or appointed?
A: A current Consortium Member was proposed as the Lead Registrant. Following ECHA guidance, the nominations were published on the LOA SIEF pages, with a two-week period to allow SIEF members to comment on the nomination. When no objections were received, the Lead Registrants were officially nominated to ECHA and their status changed on the SIEF pages.

Lead Registrants Q2: Which dossier will be appreciated as valid by ECHA if two Lead Registrants each submit one? Do you allow the possibility that such an event can occur?
A: We are do not wish to see this occur and will work to reduce the chances of this happening, as it will cause confusion and additional costs for those involved.

 

LETTER OF ACCESS

Letter of Access Q1: Would you please compare the benefits of Consortium membership to simply purchasing the Letter of Access?
A: See question 8 under MEMBERSHIP.

Letter of Access Q2: How were the costs for the Letter of Access derived?
A: The amounts charged by the Consortium for letters of access are intended to strike a fair balance, in a non-discriminatory way, between the interests of all SIEF members, whether they are members of the Consortium or not. Costs for letters of access were based on the total costs the Consortium expects to incur in generating the dossiers, together with an estimate of the number of Consortium members and other SIEF members who are expected to source the dossiers from the Consortium. To reduce complexity and administrative cost for all potential registrants, the Consortium provides a simple three-tier cost structure in which access to a dossier for the majority of substances covered by the LOA REACH Consortium will be charged at one of three cost levels (EUR 5,000, 10,000 or 20,000), with a 50% discount for an intermediate dossier, reflecting the reduced data requirements for intermediates.

Letter of Access Q3: Obtaining a Letter of Access as a SIEF member requires payment based on a contribution to the cost of technical work and the data required for the tonnage band. Are there any other costs, such as a contribution to the cost of the CSA?
A: No, there are no other costs. Our pricing model is intended to be simple and transparent.

Letter of Access Q4: Why are the costs for the Letter of Access so inexpensive?
A: As described above, the costs for each Letter of Access were derived using the estimate of the number of Consortium members and other SIEF members who are expected to source the dossiers from the Consortium. In many cases, the number of Consortium and interested SIEF members was large and thus the cost of the dossier was low.

Letter of Access Q5: Where do I find the cost for the Letter of Access for my substance of interest?
A: The Letter of Access costs are posted on the substance-specific SIEF pages for the LOA Consortium. Please note that this is a password-protected site; if you are a SIEF member and your contact information is up to date in the ECHA IT system, you will have received a user name and password for the site. If you have any problems accessing the SIEF pages for your substances, please contact the LOA SIEF Manager by emailing her at sief.manager@loa-reach.com. If possible, please include your UUID number in the email.

Letter of Access Q6: What is the deadline for purchasing a Letter of Access?
A: There is no deadline at this time for purchasing a Letter of Access; however it is important to note that the LOA Consortium will only guarantee the costs that were circulated for the 2010 registration. The Letters of Access will be available beyond this date, but are not guaranteed at this price beyond 2010.

Letter of Access Q7: I need to register by 2018. Can I wait until nearer that date before purchasing a Letter of Access?
A: Yes, Letters of Access will be available beyond 2010 but LOA does not guarantee the current price beyond 2010.

Letter of Access Q8: Is the proposed cost for the Letter of Access the same for all tonnage bands?
A: Yes, the current costs of Letters of Access for the LOA Consortium extend to registration in all of the tonnage bands, but the costs are only valid for purchase for the 2010 registration deadline. The Consortium splits the costs for substance vs. intermediate registration, but not for tonnage bands as most who are registering in 2010 have >1000 t/y. The LOA Consortium will offer Letters of Access after the 2010 registration deadline, but the costs that were recently provided are not guaranteed (they may change for the 2013 and 2018 registration deadlines).

Letter of Access Q9: When do you estimate companies will get Letters of Access for their substances of interest, and how we can be sure that it will cover everything what is necessary for 2010?
A: There is currently no set date that has been established for when the Letters of Access will be available to SIEF members, however, a timeline of both technical items and dossier delivery will be posted timely for each substance on the LOA SIEF pages. Please note that this is a password-protected site; if you are a SIEF member and your contact information is up to date in the ECHA IT system, you should have received a user name and password for the site.

Letter of Access Q10: Is the cost that was provided for each substance for the Letter of Access the cost of dossier that LOA will provide to me for registering REACH?
A: Yes, this is the cost of the dossier that will be provided. For more information on what is included in the dossier, please see the DOSSIER section.

Letter of Access Q11: Will the purchase of a Letter of Access enable the data to be used for regulation purposes other from REACH?
A: No, the purchase of a Letter of Access will only apply to REACH regulatory requirements.

Letter of Access Q12: Will a Letter of Access be available for specific endpoints and tonnage bands or will we need to purchase a Letter for the entire dossier? What if a potential registrant only needs data of the lowest tonnage level (Annex VII) or does not need a CSR: does he still need to pay the full sum (5000, 10000 or 20000) as for the highest tonnage dossier?
A: At this stage, there will be two options for obtaining data access – one for a full dossier and the other for an intermediate dossier. There are no differences for the tonnage bands as the dossiers have all been developed for the highest tonnage band. As noted above, the cost of Letter of Access for registration in 2013 and 2018 has not yet been determined.

Letter of Access Q13: Is there a cost reduction for a Letter of Access relating to monomers i.e., polymer import? You mentioned half price for intermediates. How are "monomers" going to be evaluated for costs? Will they be discounted for registration of monomers in imported polymers?
A: No, monomers are treated like full substances (not as intermediates) under REACH, and there is no basis for differentiating between imported and domestically produced monomers for this purpose.

Letter of Access Q14: Upon purchasing a Letter of Access, are we entitled to see and use the testing data to build our own CSR?
A: Yes, you will receive the IUCLID file with information for Sections 4-13 and you may use that data to build your own CSR.

Letter of Access Q15: For what kind of documents is it necessary to buy Letter of Access?
A: The LOA REACH Consortium provides access to full substance or intermediate dossiers. In the near future, there will be an established set of data access rights.

Letter of Access Q16: If I have several very similar substances, can I purchase a single Letter of Access to cover them all? What if I have the same substance for different legal entities?
A: You must buy a Letter of Access for each substance (even if two or more substances are in the same category) and for each legal entity involved. Where LOA produces joint dossiers for categories of substances, the cost basis for those efforts will be spread more broadly in the interest of all SIEF members.

Letter of Access Q17: Will it be possible to see data prior to purchasing a Letter of Access?
A: A contractual relationship will be created to show data to those who would like to do so before making a commitment to the purchase of a Letter of Access.

Letter of Access Q18: During the Webinar in May it was stated that the CSR would cover 'common agreed uses'. Will the SIEF members opting for the Letter of Access route be able to contribute to the determination of the uses to be included (e.g., will imported polymers be included for propene & ethylene)?
A: The CSR will cover the commonly agreed uses form all the Consortium members. Considering that there are now over 35 members it is very likely that all the common uses of LOA substances will be covered in the dossiers and the CSR. SIEF members who have specific and unusual uses will be able to use their data in the CSR to support their own risk characterisation (when required) for these uses.

Letter of Access Q19: We have the right to use some data made in the U.S. by a consortium. Shall we pay a reduced fee for a Letter of Access that considers the data already owned by us?
A: No, the LOA REACH Consortium offers only two options: full substance dossier or intermediate dossier. The fees of these dossiers will be exactly the same under all circumstances. You will appreciate that with so many companies involved to deviate from a simple structure would make the whole process very difficult to manage.

 

EXPOSURE AND USE

Exposure Q1: Did LOA already decide about applications and exposure scenarios per each substance which will be covered by the joined dossier?
A: We are currently developing the exposure scenarios and uses that will be supported in the dossier. In general, these will be the normal industry uses of each substance. If a company has very specific uses that they wish to keep confidential, then they are likely to have to do these aspects themselves. Obviously companies inside the Consortium will be able to influence this process to a much greater degree than those outside.

Exposure Q2: Who will decide which exposures will be included in the registration (i.e., general exposures)?
A: These decisions will be made by the LOA REACH Consortium. Specifically the Technical Steering Committee with input from the whole membership.

Exposure Q3: As a member of the Consortium, would we be allowed to put forward identified uses for substances to be included in the CSA/CSR?
A: Yes, member companies will be able to (and are encouraged to) put forward identified uses. LOA will attempt to cover general uses by means of Generic Exposure Scenarios in the first instance. If this is not completely successful, Specific Exposure Scenarios will be developed by LOA in cooperation with the interested companies for those additional uses supported by the Consortium. Where a single company has a unique proprietary use, or has confidentiality issues with certain uses, then the company will be responsible for generating any additional Exposure Scenarios and customising their own dossier based on that provided by LOA.

Exposure Q4: Could you help us in how to communicate an exposure scenario to the Consortium so it can be considered as a general use?
A: No, only the Consortium members can participate in this activity. You can contact an individual member that serves as your supplier.

Exposure Q5: When and how will SIEF members be informed of which exposures are included in the registration? Is it possible to see your general exposure scenario for every single substance?
A: Solicitations and decisions regarding exposures will be posted to SIEF pages and you will have access to view the information as long as you are a member of that SIEF. Establishing exposure scenarios is a work in progress.

Exposure Q6: Has a generic exposure scenario been developed for ethylene? Which exposure scenarios/uses will be covered? Will the Consortium also consider special uses of ethylene beyond those involved in the aromatics industry (e.g., uses of ethylene as a polymer)?
A: Exposure scenarios are developed one by one, per substance, as specifically as possible. The decisions are confined to the established Industry Normal Processes. Information regarding exposures will be posted to SIEF pages when they are available. For ethylene, production and use as a monomer - both in production of polymer and the end use of the polymer - will be considered by LOA.

Exposure Q7: When do we have to define the application in which the substance is used? Will you be able to manage the exposure scenario for very specific application?
A: The whole approach of devising the appropriate Exposure Scenarios will be to use the most generic one possible for any given application. Very specific applications are likely to be a minority activity and may not be supported by the Consortium. Consequently, companies will need to devise their own exposure scenarios and risk characterisations, if required, and enter them into the chemical safety report.

Exposure Q8: As SIEF members, would you like us to send you "our" uses of our substance?
A: If this step is required, we will announce it through the SIEF pages for the specific substance.

 

SIEFs

SIEFs Q1: What SIEFs does LOA cover?
A: LOA manages the SIEFs only for the substances that are included on the LOA substance list. See SUBSTANCES COVERED.

SIEFs Q2: What is the cost of SIEF management for the SIEF members?
A: There is no direct cost to SIEF members. The cost is part of the management cost of the Consortium to be incurred by Consortium members. To ensure the fullest possible participation, we do not request SIEF members to contribute to the cost.

SIEFs Q3: Can you provide me with regular updates on the progress of the SIEFs for my substances?
A: Information has been posted and will be regularly updated on the substance-specific SIEF pages for the LOA Consortium. If you are a SIEF member and your contact information is up to date in the ECHA IT system, you will have received a user name and password for the site. You can check the SIEF pages for information on the sameness discussion, proprietary data, survey results, classification & labelling, use & exposure, and the availability of the dossier. In addition, communications will be sent out as needed to announce the posting of critical new information.

SIEFs Q4: According to the “one substance, one registration” (OSOR) principle of REACH, how will it be managed if a SIEF member does not want to join the Consortium but is willing to register? Will the costs for data access increase?
A: If a SIEF member does not obtain access to the Consortium’s data, it will need to secure data access through other means or develop its own registration dossier, which may well involve very substantial cost.

SIEFs Q5: What is the difference between LOA SIEF and Reach SIEF?
A: These are not official terms. There is only one SIEF per substance. LOA manages the SIEFs for the substances it covers.

SIEFs Q6: Who will be the leader of SIEF in LOA SIEF?
A: The Lead Registrant Company has been appointed within the SIEF and is the leader within the SIEF. For LOA will the LOA REACH Services Team takes on this role and performs all the administrative tasks and attends to the smooth running of all SIEFs within the LOA remit on behalf of the Lead Registrant Company.

SIEFs Q7: What is the role of the SIEF Formation Facilitator (SFF)?
A: SFFs have a role in the formation of SIEFs. However, Lead Registrants have now been appointed and have taken the lead in the SIEFs. Therefore, SFFs no longer have a role.

SIEFs Q8: What is your relationship with Ecomundo, who I believe it the SSF for ethylene? Have you communicated with them?
A: The LOA REACH Consortium services team has written to the company, but had no reply. LOA does not plan to work with Ecomundo.

SIEFs Q9: For some substances under the scope of LOA, SFF is a consultant. These SFFs sent us some surveys on SIEF activity, sameness profiles, etc. Do you have any contacts with them (e.g., Ecomundo, B-Lands Consulting) and share information with them?
A: The LOA REACH Consortium was set up by the major industrial companies in Europe and is fully established as a Consortium with a robust budget for SIEF Management. Therefore the LOA REACH Consortium will not need to share information with or have any ongoing contact with consultancies who are offering SIEF services. However, as you would expect, the LOA Services Team has strived to make contact with groups and to be as open as possible. In general we have had no response to our enquiries.

SIEFs Q10: We received an invitation from SIEF-IT to participate in the SIEF for one of our substances. Does LOA support this communication tool for data sharing concerning the registration of substances?
A: No, the LOA Consortium will not be using SIEF-IT as we have our own system for SIEF Management.

SIEFs Q11: What should I do if I was not able to respond to the first LOA online survey that was distributed in February 2009 regarding my company’s registration intentions?
A: Although the online survey closed in March, we can update our system manually with your details and intentions. If you provide the following information to our SIEF Manager (sief.manager@loa-reach.com), we will update our systems: substance name(s) your UUID number, and the appropriate Cefic code (1 – Leading, 2-Involved, 3-Passive, 4-Dormant) for your company within the specific SIEF.

SIEFs Q12: We can check number of pre-registrants of each substance through ECHA REACH-IT, but could you disclose number of participants of each SIEF as of today?
A: You can view all the SIEF participants in REACH IT.

SIEFs Q13: How is LOA working if there is a read-across possibility with another SIEF Consortium and it owns literature access rights and data, what would be the way to act? Would LOAT be open to a merge with SIEFs of non-LOAT substances if needed?
A: We will look for opportunities for read-across, but are unlikely to merge with other SIEFs.