Contact Details and FAQ
Contact details
Lower Olefins and Aromatic vzw
c/o Penman Consulting BV, Rue du Trône 108, 1050, Brussels, Belgium
Phone +32 (0) 2 403 7239
Managing Director: Tim Kilpatrick project.officer@loa-reach.com
JSG Manager: jsg.manager@penmanconsulting.com
Project Officer: project.officer@loa-reach.com
General Enquires: info@loa-reach.com
Data Protection: For GDPR and other data protection details, please see the GDPR statement on the Penman Consulting website.
FAQs
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 info@loa-reach.com
Important note to review before reading the FAQs
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 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.
1. Questions and Answers about Registration
Registration Q1: Where can I find more information about ECHA regulations and compliance?
Answer: ECHA Guidance documents are available for download at:
ECHA website: http://guidance.echa.europa.eu/guidance_en.htm
EU Publications: http://publications.europa.eu/en/home
Registration Q2: 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 Q3: 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 Q4: 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.
2. Questions and Answers about LOA REACH Consortium Dossiers / Letters of Access
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:
Agreed Classification and labelling
IUCLID Sections 4 -13, which include:
Physical and chemical properties
Environmental fate and pathways
Ecotoxicological information
Toxicological information
Analytical methods
Residues in food and feedings stuffs
Effectiveness against target organisms
Guidance on safe use
Literature search
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 prepared guidance for Consortium and JSG Members for IUCLID Sections 1-3, which covers the company-specific information, as follows:
General Information (substance id, composition)
Classification and Labelling
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 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 JSG 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 JSG members. JSG members will be required to sign a confidentiality, non-disclosure, and non-use agreement.
Dossier Q4: Will information obtained be presented in IUCLID 6 format including all required data as endpoints, robust summary (if necessary), etc.?
Answer: Yes, the information will be presented in the most recent IUCLID 6 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. JSG members who want to submit a registration dossier as a substance will need to add to the LOA dossier providing 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 JSG Portal, please log in with your details or contact the JSG Manager by email at JSG.manager@loa-reach.com
Letter of Access Q7: 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 JSG pages for the LOA Consortium. Please note that this is a password-protected site; if you are a JSG 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 JSG pages for your substances, please contact the LOA JSG Manager by email at JSG.manager@loa-reach.com If possible, please include your UUID and REACH Registration number in the email.
Letter of Access Q8: Will the purchase of a Letter of Access enable the data to be used for regulation purposes other than EU REACH?
Answer: No, the purchase of a Letter of Access will only apply to EU REACH regulatory requirements.
Letter of Access Q9: 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 Q10: 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 Q11: 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 JSG members.
Letter of Access Q12: 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 jsg.manager@loa-reach.com
Letter of Access Q13: What Uses are covered by LOA REACH Consortium dossiers?
Answer: You can view the Uses covered by logging in to the JSG Portal. The CSR covers the commonly agreed uses from all the Consortium members provided to the LOA REACH Services Team during the Uses and Tonnage Surveys. JSG 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.
3. Questions and Answers about LOA REACH Consortium JSGs
JSGs Q1: Which JSGs are managed by the LOA REACH Consortium?
Answer: LOA manages the JSGs 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.
JSGs Q2: Can you provide me with regular updates on the progress of the JSGs for my substances?
Answer: Information has been posted and will be updated as necessary on the substance-specific JSG pages for the LOA REACH Consortium. If you are a JSG 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 JSG 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.
JSGs Q3: Who will be the leader of JSG in LOA JSG?
Answer: The Lead Registrant has been appointed within the JSG and is the leader within the JSG. For LOA the LOA REACH Services Team takes on this role and performs all the administrative tasks and attends to the smooth running of all JSGs within the LOA remit on behalf of the Lead Registrant.