License

You must register in order to access the MeClas tool and all supporting information. A short description of the Terms of conditions can be downloaded. The manual gives an idea on the basic functionalities of MeClas.

News

IMPORTANT NOTE

7 May 2018: This MeClas version 4.5 is currently the old version (will only temporarily remain available). You are recommended to use the new MeClas version 5.0 (available later this week). In case of questions or issues, don’t hesitate to contact helpdesk@meclas.eu.

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Frequently Asked Questions about MeClas

Introductory answers to frequently asked questions are offered about technical and general issues. Click on a subject heading below to view questions and answers relating to your selection. Links throughout the answers will guide you to further information on our website or from other sources. Should you have any further questions, please consult our contact page.

About MECLAS

1. How can MeClas be defined in one sentence?
2. Why was MeClas set up?
3. Where can I find MeClas?
4. How does MeClas work?
5. What are the basic principles behind MeClas?
6. How safe is MeClas?
7. Can I check more than 5 complex mixtures with MeClas?
8. What are the main differences between MeClas and other classification tools? What is the added value of MeClas?

Use of MeClas

9. How can Consortia and companies work together on classification?
10. MeClas exist in two license formats: full and free. What are the differences between those tow types of licenses? 
11. What are the costs related to both licences?
12. How is MeClas governed?
13. Do I have to change my SDS or Labels as soon as MeClas reviews a classification?
14. Do I need MeClas if my company already has in-house SDS/classification software?
15. Can the “self-classifications” be toggled off, in view of current difficulties with M factors and self-classifications?
16. What if the RAC was to decide upon/change a classification for an Annex VI substance?
17. What should be done with TDP and bio-elution data required for the MeClas Tier 2
18. Why can't we enter TDP data for metal powders, and only for massives?
19. MeClas populates all of the TDP columns with values of 100 %. Why was this done if in many cases there is no data?
20. How come the classification is different from the metal classification if we design a metal substance with 100% of one metal?

MeClas database of classifications and Ecotoxicity Reference Values (ERV)

21. How are new data taken into account under MeClas for substances listed in Annex VI?
22. How is MeClas updated?
23. When and how will the toxicity reference data be screened for quality?
24. How was the self-classification for lead compounds determined?
25. Which classification is considered in MeClas when a substance has both a self-classification and an Annex VI classification?
26. Where can the sources of the classifications, used for the various substances, be identified (self, Annex VI).
27. Has a full licence member free access to individual ERV's and TRV's submitted by consortia, or are they protected in MeCLAS.
28. What to do if no ERV is submitted for available as yet for certain consortia
29. Could MeClas signal which kinds of data are available, with a contact point?


How can MeClas be defined in one sentence
The MeClas tool allows classifying complex inorganic materials like ores and concentrates, complex intermediates, alloys or UVCBs, recognizing the specific properties and assessment techniques for inorganics, using the most updated information on toxicity references and self classifications available

 

Why was MeClas set up

Hazard identification and classification of complex inorganic materials, companies, consortia and commodities often faced significant but common difficulties, including the following:

 

MeClas was set up in order to address those difficulties, aiming at facilitating the exchange of information, improving efficiency, adequacy and consistency of the generated classifications through collective action. It also provides a common system to ensure the quality and confidentiality of proprietary data

 

Where can I find MeClas
MeClas is available on www.meclas.eu. You will have to register in order to access the MeClas tool and all supporting information. Registered users will be notified on license conditions. A completed license agreement can be send to info@meclas.eu.

 

How does MeClas work
MeClas proposes a tiered and inorganic specific approach, allowing refinement of the classification in accordance with the availability of data. The tiers are shown here below:

MeClas has a core block, which includes Toxicity and Ecotoxicity Reference Values (ERV and TRV), forming its basis with the classification rulings. Those ERV and TRV values are provided by the data owners (e.g. consortia or companies), and a system has been set up in MECLAS to both ensure confidentiality for proprietary information and quality control of the provided values. MECLAS has a two-layer structure:

 

How can Consortia and companies work together on classification
MeClas allows for a smoothly cooperation between Consortia and Companies by the use of Reference materials, i.e.:


What are the basic principles behind MeClas
MeClas is governed by a number of principles and it is expected that all licence holders of the model agree to these principles when buying licence rights to the MeClas tool:

 

MeClas exist in two license formats: full and free. What are the differences between those two types of licenses

Restricted MeClas access is free to metal industry, but access is limited composing 5 reference compositions and to modifying (an unlimited number of) reference materials entries for company-specific materials.

The full MeClas License allows Consortia, Companies, etc. to use all the features of the MECLAS program and they have a seat in the MeClas Steering Committe.

Free MeClas License owners can modify Reference materials’ classifications for own purposes based on metal elemental concentrations and create up to five new reference samples or change the Speciation, Mineralogy, Transformation dissolution or Bio-elution information/corrections applied. The free license owner needs to be part of metal industry.

 

What are the costs related to both licences
The fees for MeClas are set as follows (all costs are exclusive of VAT, if relevant):

 

How is MeClas governed
A Steering Group overviews the progress and advises and decides on priorities for the next year. Every full licence holder of MeClas is considered as a Steering Committee member. A steering meeting, defining guidance and priorities, will be organised twice a year.

 

How are new data taken into account under MeClas for substances listed in Annex VI
MeClas is in line with the CLP requirements and applies in addition new scientifically valid toxicity reference value when these would warrant a higher classification level. MECLAS has therefore built in two decision levels in this respect :

 

 

How safe is MeClas
MeClas works with unique passwords. A unique password is provided for reference substances.

 

Can I check more than 5 complex mixtures with MeClas
Yes. The limit of 5 materials relates to the number of Reference materials (e.g. matte, speiss, flue dust,…) that can be introduced with the free license, stored at the same time. However, within this group of 5 entries, all users can ‘play and assess classifications’ for as many materials they would like to check. If need so, more reference materials can be included when the user becomes a full license holder.

A Reference material/substance is recognized by its speciation and dissolution kinetics (e.g. Transformation dissolution results) (if used). A new reference material entry is required as soon as a complete new speciation profile or new Transformation dissolution evidence needs to be entered.

 

How is MeClas updated
MECLAS updates the ecotoxicity reference values after a quality screening. These new data are subsequently included in the Reference materials database (the core block) and all existing Reference materials can/will be automatically updated using this new info. Reported joint self classifications (agreed by sector/Consortium) and updates of Annex VI are also included as soon as made available to MeClas. These updates are accessible for both full and free MeClas License holders ensuring the hazard classification remains up to date for as far as MeClas was informed about these new references.

 

 

When and how will the toxicity reference data be screened for quality
MeClas starts from the data provided by the metal REACH Consortia or the ECHA dissemination database and in exceptional cases from literature reviews. The Consortia data should be in line with the REACH or CLP data quality criteria and the check will therefore be focussed to a check of compliance with the ruling. This does not apply to those data sets that were reviewed under the ESR and where the toxicity reference was already fixed by this program and no new evidence was provided in the Consortia reports. Alternatively, Klimisch criteria are applied to literature data sets not covered by Consortia reviews. Only Klimisch 1 and 2 data are included unless none are available. In such case the reference point will be marked as “limited evidence of lower quality”.

Do I have to change my SDS or Labels as soon as MeClas reviews a classification
MeClas provides hazard assessments to the best and most recent knowledge level possible. It is up to the user to decide when and how he uses the outcome of the MECLAS classification for downstream obligations like SDS, labels and others, as a function of the law and national/permit requirements.

 

 

Do I need MeClas if my company already has in-house SDS/classification software
MeClas and existing in-house SDS/classification software should be seen as complementary tools. MeClas has deliberately no SDS generation or labelling functionalities to avoid overlap. Existing in-house SDS/Classification software typically does not have the latest self-classifications/ERV/TRV values nor specific metal related issues such as elemental versus mineralogical/species analysis and TDP and bio-elution calculation modules. Experience has shown that differences between MeClas and other classification software tools are usually caused by more recent self-classifications in MeClas.

 

What are the main differences between MeClas and other classification tools? What is the added value of MeClas
In order to clarify the differences between the existing available classification tools, a short comparison was made here below between:


The following parameters/functionalities were compared:

 

 

How was the self-classification for lead compounds determined
Short justification for self-classification for carcinogenicity in regards to lead compounds (exerpt from lead monoxide REACH dossier).
Given the large doses of soluble lead compounds required to induce tumors in animals, only compounds with significant bioavailability will likely elicit a carcinogenic response. The bioavailability of most high production volume lead compounds is not known, but the sparingly soluble nature of some of the compounds under consideration does not equate with limited bioavailability under the acidic conditions of the stomach. For example, both lead oxide and lead carbonate exhibit high bioavailability in animal feeding studies and when tested in in vitro gastric simulation systems. While not all lead compounds may exhibit high bioavailability, extension of Category 3 R40 (DSD or Carc. 2 (CLP)) classification to most inorganic lead compounds can be considered.

 

Which classification is considered in MeClas when a substance has both a self-classification and an Annex VI classification?
It was recalled that the business rules require MeClas to function within the legal boundaries, and therefore uses the Annex VI classifications for the EU framework and, if these are lacking, uses reported self-classifications. In the case of an Annex VI entry, lower self-classifications are currently not accepted by the regulator, while stricter ones are.

 

Can the ““self-classifications” be toggled off, in view of current difficulties with M factors and self-classifications
Some licence holders would like a distinction to be made between considering or not considering self-classifications. According to DG ENV and ECHA, it is assumed that you know the self-classifications as soon as the inventory becomes public, and must then update without undue delay (3-6 months). The “on and off toggle” is most probably not required on a long-term basis within the EU, but until such time as the inventory becomes public it would have relevance. Moreover, toggling of Annex 1 and only using self-classification is relevant for non-EU countries.
It would be feasible to introduce such a toggling on/off system, but that this would constitute a software investment. It was agreed to assess timing, costs and difficulties

 

 

What if the RAC (Risk Assessment Committee) was to decide upon/change a classification for an Annex VI substance?
MECLAS would have to be updated at the moment of publication of the ATP. MECLAS would consequently stick to the formal legal conclusion so as to ensure acceptance/use of the tool.

 

 

What should be done with TDP and bio-elution data required for the MeClas Tier 2
It is up to the data owner to decide who has access to these data. MeClas will not take on ownership of data. However, differences in data availability may generate inconsistent classifications.

 

 

Why can't we enter TDP data for metal powders, and only for massives
You can enter TDP data for metal powders in the same field of the TDP data for the massives. To determine the Tier 2 classification the amount of each metal released is compared to the ERV values of those metals. Since the ERV values for massive and metal powder are equal, the same field can be used to enter the metal powder TDP data.

 

MeClas populates all of the bioelution columns with values of 100 %. Why was this done if in many cases there is no data
TDP percentages were automatically set to 100 % to avoid an underestimation of the classification result (= worst case assumption). If the field should be left blank then no transformation/dissolution factor is assumed and thus would probably lead to an underestimation of the classification. If the metal TDP was measured then the input value in the TDP column must be manually changed.

 

 

How come the classification is different from the metal classification if we design a metal substance with 100% of one metal?
MeClas is a tool to classify inorganic mixtures and is therefore using the CLP mixture rules to derive the classification. Therefore, when metals are contributing to other endpoints then their own classified endpoints, it is possible this results in a more severe classification.

 

Where can the sources of the classifications, used for the various substances, be identified (self, Annex VI).
This was already considered by adding a column in the pdf output that stipulates whether it is Annex VI and self-classification, but will further facilitate source tracking in MeClas. This ‘traceability’ will become even more important when applied to other classification systems.

 

Has a full licence member free access to individual ERV's and TRV's submitted by consortia, or are they protected in MeClas
While used for the classification calculation, these data remain protected even when they are integrated in MeClas. It was also recalled that data used for classification could not be claimed as confidential and will become visible via the dissemination website.

 

What to do if no ERV is submitted for available as yet for certain consortia
A provisional value could be used, but this should be flagged.
It should therefore be discussed whether the list of ERVs/TRVs can be made publicly available. It was agreed to re-contact all registered parties and ask the consortia to declare ERVs/TRVs in one or another table format.

 

Could MeClas signal which kinds of data are available, with a contact point
There are some companies that did not have any REACH obligations but that did have CLP obligations. As such, SIEF did not inform these companies what data were available. We suggest to contact the relevant consortium through the Eurometaux REACH metals gateway