REACH Inquiries process - Article 26
Article 26 Inquiries under REACH for Registration of new (non phase-in) substances.
From the inception of REACH, it has been very clear that importance is given to avoiding duplicate animal testing and to prevent (or reduce the risk) of performing unnecessary animal studies when making a new registration an ‘Inquiry' is needed. This is explained in Article 26 of the Regulation. The REACH Inquiry is needed before registration where there is no valid pre-registration and therefore applies to substances that are:
- Non phase-in (ie. not on EINECS, not a valid 'no-longer polymer' or has no other valid reason to make a late pre-registration)
First supply is greater than the phase-in tonnage band (100 tonnes per annum) or is CMR Cat 1a/1b.
Article 26 describes the process by which a potential registrant of a non-phase in substance (ie ‘new' substance not subject to phase-in) provides ECHA with details of the new substance. By doing this, ECHA can check if other data have been submitted or if other organisations are working on a test programme. When other data are available, both parties will be expected to contact each other and work on a data share agreement to avoid duplication of animal testing.
The data requirements for an Inquiry are limited to chemical analysis (presented using section 1.2 and 1.4 of IUCLID 6) and these reports need to be attached to confirm the chemical identity.
The key requirements are to provide sufficient analytical information to identify the substance and for ECHA to be able to use that data to compare with other Inquiries or Registrations. There is also some ‘intelligent' assessment of the data to see if there are opportunities for ‘read-across' with other substances.
For all analytical reports, it is essential to include details of the sample used (source, batch number, certificate of analysis etc), details of the testing laboratory and date, the methods followed, types of equipment etc. This report needs to be added to the IUCLID dossier file in Section 1.4.
The purpose is to provide evidence for the identity of the substance by spectral analysis, typically IR, UV-Vis, NMR or MS. Even in cases where it is not possible to interpret the results fully, the spectra will at least provide a ‘fingerprint' for future reference. Although not essential in all cases, it is recommended that if checking the UV-Vis spectra of a water soluble material, evaluation should be at three pH levels.
Chromatography and other analysis
A number of qualitative and quantitative methods can be used to confirm identity and purity, including (HP)LC, GC, MS, X-Ray diffraction etc. The analysis must be sufficient to demonstrate that the substance you are registering is equivalent to the material previously tested.
Evaluation of Inquiries
It is worth noting that a large proportion of Inquiries are rejected by ECHA and other than procedural issues, the reason for rejection is typically a failure for the analysis data to meet the demands set by ECHA.
It is therefore important to ensure high quality analysis is performed and reported in a way that helps ECHA make comparison with past registrations; for instance, if it is known that an original Notification under NONS (ie considered Registered) or early Registration under REACH was supported with specific types of analysis, provide analysis data using the same methods and conditions. Guidance on this is available in the technical guidance documents, but rejections to date have included some of the following points:
• UV-Vis not covering a wide enough range of wavelengths
• Chromatography not continued for long enough after main peak to confirm if other minor constituents are present or not
• HPLC conditions not appropriate for substance (eg pH of buffer does not match known dissociation properties.
• Wrong type of NMR used (eg when one of carbon, phosphorous or hydrogen is not the most most appropriate)
• Poorly defined conditions for inorganic analysis that does not enable the method to be repeated.
• The substance not being named to IUPAC standards or the name not corresponding to details given in analysis.
These do not include the large number of rejections that were made as methods were not included or because the quality of the work failed to confirm the identity.
To conclude, it is important to not only get the science correct to confirm identity (structure, isomers, molecular weight etc), but to follow standardised methods to allow repeatability. It is also important to complete the forms correctly and ensure that the submission passes the ‘completeness' check - more on this with the other types of dossier.
If successful, the submitter will receive details of who has already Registered the substance (if indeed it has been previously Registered (or Notified under NONS) or a statement confirming that there has been no known submission of animal data for this substance.
If Notified under NONS, the ‘lead registrant' will not have the full REACH registration for you to access. It is possible to take the old NONS submission using the SNIF software and convert to IUCLID using a free downloadable tool, but this generally turns out a mess that needs sorting to get the IUCLID dossier complete. It is perhaps easier to manually enter data.
If the first registrant only provides access to the minimum vertebrate animal data, the other data gaps will need to be completed through testing, modelling etc. Either way, once all the data end-points are covered, it is necessary to complete the CSR and other parts of the registration.
It is worth attempting to obtain as much data from the first registrant as possible (a robust summary if available would be a minimum in the future); even if this costs more to purchase access, sharing data will in the long term save time and money. Agreement on the value of data is a commercial process.
12 year rule
If the data was submitted under NONS more than 12 years before the Inquiry, there is no need to obtain permission to use the data from the first registrant and no need to pay compensation for access.
In the future, ECHA will provide the new registrant with the robust summary to allow the new registrant to prepare the dossier with CSR and correct classification and labelling. Unfortunately, old NONS submissions did not include a robust summary and ECHA have to provide simple summaries of key data end-points. Experience has shown that this is barely adequate. It is also worth noting that Notifications made more than 10 years ago may have certain key data end-points missing and the data set may not be complete. In these cases, new testing may be necessary.
Once the data has been provided by ECHA, IUCLID can be completed and a ‘normal' registration prepared to include Exposure Scenarios, CSR and other supporting documents.
The Inquiry process is not easy and many have failed. It can also take a considerable amount of time to complete (some have been several months) and even when the data has been provided, there is still work involved in preparing the chemical safety report, exposure scenarios and other supporting registration documents. Remember that the objective is not to save industry time and money, but to prevent duplicate animal testing.
Denehurst Chemical Safety Ltd - Inquiry for REACH
An Inquiry is needed if a non-phase in substance is to be registered (ie not on EINECS or not fullfilling other criteria for phase in) and since May 2017, when the late pre-registration facility finished, all substances not originally pre-registered.
The mechanics of this process, using IUCLID 6 is not difficult, but getting the analysis details correct is a challenge and many Inquiries fail at first attempt.
Help can be provided by Denehurst to assess the quality of analysis data and examples of reporting format can be provided on request.
Note : Inquiries will be possible through REACH IT directly without using IUCLID.
IUCLID and the Inquiry
The free IUCLID software from ECHA is used to prepare an Inquiry. Only parts of Section 1 need to be completed together with some administration details in Section 14.
Section 1 relates to details of the registrant and substance identity. The most important part is to ensure that the analysis information attached as a report(s) in Section 1.4 provides sufficient analysis information by way of spectroscopy and chromatography or other suitable methods (eg for inorganic substances or metal complexes) to confirm the identity used in Section 1.1 and 1.2.
If the substance is new and no EC number or CAS number is available, this is not a problem and the software will ask for full chemical identity, including structures, to be created as a new reference substance. An EC number will be assigned on acceptance of the Inquiry; this may match an existing substance (EC number starting 2 or 3) or may match a substance registered under the pre-REACH NONS process (EC number starting 4) or may have been previously considered a polymer (no-longer polymer with EC number 5). Most likely, an 'emergency' EC number starting 6 or a brand-new confirmed number starting with a 9 will be assigned.
Section 14 of IUCLID will only appear if the dossier type selection is for an Inquiry (the dossier type selection is a tab at the top of the left-hand part of the screen). In Section 14, you need to right-click to create a new entry.
The normal type of Inquiry (where late pre-registration is not possible) is a 'Type 1 Inquiry' which means you do not need the explanation as to why you had been supplying already or details of tonnage changes etc.
For most registrations, there will be a data requirement and the box with a poorly worded question about data requirements will be 'yes'. Failure to answer 'yes' or'no' will cause a business rules failure in the final dossier. If yes, you then need to select which data endpoints you need.
More help can be provided if needed
For more information on IUCLID
A short guide to PPORD including a suggested template for the justification of a PPORD is provided on the linked page