This website is intended to provide some general information on the Consortium, its objectives and scope, the substances which were registered in 2010, costs of letters of access for those substances and instructions on how to join any of the SIEFs currently managed by the LOA REACH Consortium.
Lower Olefins and Aromatics Reach Consortium vzw
c/o Penman Consulting bvba, Avenue des Arts 10, 1210 Sint Josse ten Noode, Brussels, Belgium
Phone +32 2 305 0698
Managing Director: Mike Penman, c/o email@example.com
SIEF Manager: firstname.lastname@example.org
Project Officer: email@example.com
General Enquires: firstname.lastname@example.org
This compilation of questions and 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.
The questions are arranged in categories in the following order and are numbered for easy reference:
If you still have a question please email us at email@example.com
Important note to review before reading this faqs documentThe 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.
Registration Q1: Where can I find more information about ECHA regulations and compliance?
Registration Q2: Can I modify my deadline for registration in the REACH IT system if I made a mistake in estimating it according to the tonnage band?
Answer: 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)?
Answer: 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?
Answer: 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?
Answer: 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 Q1: What is covered by the dossier that LOA will provide?
Answer: For the dossiers, LOA will provide the following, which will address all the information requirements of REACH Annexes VII to X:
In addition, LOA prepared guidance for Consortium and SIEF Members for IUCLID Sections 1-3, which covers the company-specific information, as follows:
Registrants will have to input the information themselves and also provide any specific aspects (e.g., proprietary uses) in the CSR. The Consortium endeavoured 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.
Dossier Q2: What is the difference between what is provided for a full dossier versus an intermediate dossier?
Answer: 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 only produced 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?
Answer: 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.?
Answer: Yes, the information will be presented in the most recent IUCLID 5 format and updated as necessary.
Dossier Q5: LOA only produced an intermediate dossier for Benzene. Why was this?
Answer: An intermediate dossier for Benzene was all that was required by the LOA REACH Consortium Members in 2010. Therefore the benzene dossier produced will only support registration as an intermediate. However, because benzene is such a data rich substance, it does address all the information requirements of REACH Annexes VII to X and this information is also presented in the Chemical Safety Assessment. Exposure scenarios and a Chemical Safety Report were 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 Q6: How can I find out who the lead registrant is for a particular substance?
Answer: All information is held on our SIEF Portal, please log in with your details or contact the SIEF Manager by email at firstname.lastname@example.org
Letter of Access Q7: How were the costs for the Letter of Access derived in 2010?
Answer: The amounts charged by the Consortium for letters of access were 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. In 2010, costs for letters of access were based on the total costs the Consortium expected to incur in generating the dossiers, together with an estimate of the number of Consortium members and other SIEF members who were expected to purchase letters of access. To reduce complexity and administrative cost for all potential registrants, the LOA REACH Consortium provided letters of access to a ‘full’ dossier ie. All tonnage bands were covered and an ‘Intermediate’ dossier to cover registration of a substance as an intermediate only. The cost for an intermediate dossier was set at approximately 50% of the cost of a full dossier to reflect the reduced data requirements for intermediates.
The LOA REACH Consortium has not plan to reimburse co-registrants in the future and this is why the letter of access costs were set at low prices.
In 2014 the LOA Executive Committee decided to reduce the cost of full dossiers by 50% for SIEF members who wished to register at tonnage bands up to 100 tpa.
Letter of Access Q8: 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?
Answer: No, there are no other costs. Our pricing model is intended to be simple and transparent.
Letter of Access Q9: Why are the costs for the Letter of Access so inexpensive?
Answer: 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 Q10: Where do I find the cost for the Letter of Access for my substance of interest?
Answer: 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 email at email@example.com If possible, please include your UUID number in the email.
Letter of Access Q11: I need to register by 2018. Can I wait until nearer that date before purchasing a Letter of Access?
Answer: Yes however please note that the letter of access process can take between 1 and 3 weeks to complete. SIEF members are encouraged to ensure that they purchase their data early to avoid complications and delays immediately before the deadline. In addition, the LOA Executive Committee has decided to charge an additional €1,000 per dossier from 1st January 2018 so SIEF members are advised to purchase their letter of access before this date to take advantage of the current price reduction and to reduce workload at busy times.
Letter of Access Q12: Will the purchase of a Letter of Access enable the data to be used for regulation purposes other from REACH?
Answer: No, the purchase of a Letter of Access will only apply to REACH regulatory requirements.
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?
Answer: 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?
Answer: 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: 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?
Answer: 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 Q16: Will it be possible to see data prior to purchasing a Letter of Access?
Answer: It is possible to view the dossier via our Brussels office by special arrangement. Please contact firstname.lastname@example.org
Letter of Access Q17: What Uses are covered by LOA REACH Consortium dossiers?
Answer: You can view the Uses covered by logging in to the SIEF Portal. The CSR covers the commonly agreed uses from all the Consortium members. Considering that there are now over 35 members it is very likely that all the common uses of LOA substances are 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.
Substances Q1: Where can I find the list of substances covered by the Consortium?
Answer: The list of substances is on this website on the ‘Letters of Access’ page.
Substances Q2: Did the LOA REACH Consortium produce a dossier for pentane or hexane?
Answer: No, CAS 109-66-0 pentane and CAS 110-54-3 hexane are both covered by the Hydrocarbon Solvents Producers Association (HSPA). Please contact them for assistance.
Substances Q3: Did the LOA REACH Consortium produce a dossier for ethylbenzene or styrene?
Answer: No, CAS 100-41-4 ethylbenzene and CAS 100-42-4 styrene are both covered by the Styrene Producers Association (SPA). Please contact them for assistance.
Substances Q4: Is registration for methane required by REACH or is methane exempt as a ‘natural’ substance?
Answer: We understand that methane produced naturally (i.e., from gas fields, cows) would be exempt. However, any production of methane by chemical synthesis will need a REACH registration, 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, companies will need to decide on their own course of action.
SIEFs Q1: Which SIEFs are managed by the LOA REACH Consortium?
Answer: LOA manages the SIEFs only for the substances that are included on the LOA substance list. You can download a full list of all substances and costs for letters of access on the Letters of Access page.
SIEFs Q2: What is the cost of SIEF management for the SIEF members?
Answer: 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?
Answer: Information has been posted and will be updated as necessary 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: Who will be the leader of SIEF in LOA SIEF?
Answer: 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.