1 February 2018, CIRS and ECHA had a two-hour meeting after the stakeholders’ day. Mr. Christel Schilliger-Musset, Director of Registration and other experts attended the meeting. During the meeting, CIRS consulted ECHA on some frequently asked questions under REACH.
1). Q: As a LR, how can I submit my registration dossier if I cannot complete all the tests before the registration deadline?
A: DGG already gave suggestions on this issue. Below is the link to the DGG suggestions:
LRs can inform ECHA of the ongoing studies and the estimated completion date through DCG. It is even better if LRs can submit explanations provided by the laboratory as a proof. After ECHA accepts it LRs are allowed to submit registration dossiers prior to the given registration deadline (LRs must confirm when all the tests will be completed as the dossier update deadline granted by ECHA is depending on the completion date). When LRs acquire the testing results, they can update their registration dossiers before the deadline granted by ECHA. Afterwards, co-registrants are approved to submit their co-registrations. However, before the updated dossier submitted with complete studies, LR and co-registrants will not acquire the registration number. As an alternative way, the submission number is valid, which can be used to certify that the registration dossier has been submitted. Enterprises can still trade with others by using the submission number after the May 31 registration deadline.
2). Q: As a member of joint submission, what can we do if LR can not complete the registration before the registration deadline?
A. If the LR is not aware
of DCG suggestions, potential co-registrants can suggest LR to prepare relevant
documents and contact ECHA through DCG.
3) Q: What can be done if the studies in LR dossier are not satisfied?
A: There are two options: 1. If a potential co-registrant has his own data, he can submit the registration dossier as a opt-out way; 2.Otherwise, he can make a request to ECHA together with other potential co-registrants to asking ECHA to revoke the LR identity and elect a new one.
4). Q: Quantitative tests cannot be carried out for most of the UVCB substances or highly insoluble substance, how can I submit the inquiry and registration?
A: These substances must
be analyzed case by case. Enterprises are suggested to submit all the available
analytical reports for the inquiry. If possible, with a statement issued by the
lab explaining why the tests can’t be performed. ECHA will give detailed
suggestions to the enterprise after receiving the inquiry
5). Q:A tech- company (company with intellectual property rights) entrusted an OEM located outside EU to manufacture the products, is it possible for tech-company to apply complete the registration?
A: The OEM shall entrust an OR to register the
substances. In order to ensure the interest of the tech-company, tech-companies
are suggested to draft a contract with the OEM so as to restrict the use of
REACH registration number by the OEM.
6). Q: LR completed a low-volume registration, however, a potential co-registrant (Company A) intends to apply for a high-volume registration. Can you give us some suggestions on this issue?
A: If the LR is not willing to transfer the LR to Company A, then Company A may launch a new survey to all the pre-SIEF members asking if other potential co-registrants agree that Company A act as LR. If other members agree, the LR shall transfer the LR to Company A; Otherwise, Company A can require the LR to update the registration to cover the tonnage band of Company .n this circumstance, Company A shall cover all the relevant expense about the update including studies fee and administrative fee..
7). Q: Some LOA prices are extremely high, will ECHA consider set a range for the data fee and administrative fee?
A: It is quite a good suggestion. ECHA may consider accept this suggestion in the future.
8) Q: Will ECHA consider open REACH-IT in non-workdays?
A: ECHA is considering open the REACH-IT in non-workdays. So enterprises
may submit their registration dossiers at weekends in the future.
9) Q: Questions regarding the payment of administrative fee
A: After the registration dossier is
submitted and the business rule passed, an invoice will be sent to the company.
TCC will also be carried out at the same time. If the company fails the TCC
manual check, there is only one chance for the company to update the
registration dossier. The administrative fee will paid in vain if the updated
registration dossier still fails the TCC manual check. That is to say, if the
company still intends to submit its dossier, it shall pay the administrative
again. For this reason, relevant companies must make sure that they have passed
the TCC before they pay the administrative fee to ECHA.
10). Q: When will the existing individual dossier subject to joint submission?
A: Currently, joint
submission is not mandatory for intermediates. However, it is only a matter of
time before the joint submission become mandatory. It is suggested that
enterprise shall prepare in advance.
11). Q: What kinds of parameters must be shown in the registration dossier in terms of nano material registration?
A: Some basic parameters, including length, area and property of the nano material must be shown in the registration dossier. Besides, surface treatment is also very important. When it comes to nano material registration, it is necessary to confirm with the company whether the surface treated has been processed.
12) Q. Can you please tell us something about SME examination?
A: If ECHA found the applicants do not fulfill the SME requirements, they must not only make up cost difference but also pay extra administrative fee (SME examination fee) to ECHA, then their registration number will be maintained. If applicants are not willing to make up the differences, ECHA will revoke the registration number. However, even if the registration number is revoked, applicants still need to pay the extra administrative fee. ECHA strongly recommends ORs must verify whether the representing company fulfills the SME requirements.
13). What are the punishments if the SCC intermediates are not satisfied with strictly controlled conditions?
A: On-site inspection for the SCC intermediates is implemented by the member state competent authority of the imported country. If the SCC intermediates fails the competent authority will require the importer to update the registration dossier within a certain period. Besides, the member state may implement extra punishments as well (not decided yet).
14). Q: Can you tell us something about the 12-year data protection term?
A: Data (excluding data
acquired through non-experimental methods such as QSAR and Read-across) are applied
free of charge 12 years after LR submitted the registration dossiers to ECHA.
That is to say, the LOA fee may be reduced since 2021.
15). Q: As far as we know, the data requirements of some substances will be strengthened. Can you please tell us some specific substances?
A: The European Commission temporarily decided that the data requirements will be strengthened in the following circumstances:
1. CMR Substances in volumes of 1-10t/y; CSR may be required as well;
2. More data may be required for general substances in volumes of 1-10t/y; and
3. Polymers of concern. The European Commission will publish a detailed criteria of
polymer of concern. If a polymer belongs to polymers of concern, then the
polymer itself shall get registered; even if the monomer or other reactants have
16). Q: If LR registered a substancein1-10 ton/y, and the substance is not classified based on the provided studies, is it possible that co-registrant purchase the physicochemical data only in accordance with Annex III of REACH regulation?