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This information is needed to verify the composition of your substance and to ensure that the chemical identifiers, such as IUPAC name or CAS number, are appropriate.
ECHA requires, as a minimum, ultra-violet (UV), infra-red (IR) and nuclear magnetic resonance (NMR) spectra (Annex VI section 2.3.5, REACH). You can also provide a mass spectrum in place of an NMR spectrum. For some substances, this information is not sufficient or appropriate and, in such cases, you need to provide other types of spectral data. For example, in the case of inorganic substances, X-ray diffraction (XRD), X-ray fluorescence (XRF) or atomic absorption spectroscopy (AAS) are likely to be more appropriate techniques.
No. ECHA protects the confidentiality of the analytical information submitted by (potential) registrants.
An acceptable justification should be based on technical feasibility or scientific necessity, meaning robust scientific argumentation.
Yes. The sum of the typical concentrations of each constituent should add up to 100 %.
When preparing your dossier to be submitted to ECHA, we recommend that you also read the following documents:
- Guidance for identification and naming of substances under REACH and CLP: http://echa.europa.eu/documents/10162/13643/substance_id_en.pdf
- The relevant Submission Manuals at: http://echa.europa.eu/manuals
- Question and answers on Substance Identification http://echa.europa.eu/support/qas-support/qas
- Question and answers on Inquiry http://echa.europa.eu/support/qas-support/qas
Yes. Ionic substances in an aqueous solution are exempted from registration only if:
- All starting substances (salts, acids and bases) of the aqueous solution are registered;
- None of the salts in the aqueous solution is isolated from the solution; and
- The salts remain in their ionic form in the solution.
In this particular case, the third condition is not fulfilled, since the salts do not remain in their ionic form in the complex. Therefore, this exemption does not apply and the complex would be subject to registration. This case is discussed in Attachment 1 ‘Ionic Mixtures' of the Guidance document to Annex V.
Complexes consisting of chelated ions must be registered if they are themselves manufactured, imported or placed on the market. However, there are different exemptions in Annex V which could be considered, for example if the complex results from a chelating agent functioning as intended (‘substances which are not themselves manufactured, imported or placed on the market and which result from a chemical reaction that occurs when: (a) a [...] chelating agent [...] functions as intended').
For the purpose of registration, hydrates of a substance and the anhydrous substance are regarded as the same. If the anhydrous substance is registered by the manufacturer/ importer, and if a company uses that substance to manufacture the hydrated substance, this company is regarded as a downstream user. Therefore, the respective registration dossier must include the necessary information for the anhydrous and the hydrated substance occurring within the supply chain, i.e. the chemical safety assessment with exposure assessments and risk characterisations of hydrated substances and the water-free substance. This information needs to be communicated along the supply chain in safety data sheets which should include all the necessary facts, e.g. exposure scenarios and identified uses for the water-free as well as the hydrated substance which occur within the supply chain. The registration number of the registered anhydrous substance must be specified in section 1 of the SDS. The provisions foreseen for downstream users according to Articles 37 and 38 can be implemented for both the hydrates of a substance and the anhydrous substance.
Registrants need to take into account in their CSA the potential implications of specific forms of the substance on downstream uses, in particular when the form is changed during downstream use.
Yes. To confirm the presence of the ions, you need to provide analytical data for the identification and quantification of each ion.
Configurational isomers (e.g. enantiomers, diastereoisomers, regioisomers) are regarded as different constituents. Therefore your substance may only be regarded as a mono-constituent substance if one specific isomeric form is present at a concentration of at least 80%.
Provided your well-defined substance consists of all possible stereo isomeric forms as the main constituents of that substance, you can identify your substance in IUCLID section 1.1 using only the IUPAC name of the substance without specifying the stereochemistry. However you should still identify your substance as a multi-constituent substance. Information on the identity and concentration of each of the individual stereoisomers should be reported in IUCLID section 1.2.
When your substance contains impurities that you are unable to identify, you need to create a generic reference substance for them in IUCLID. In the reference substance, you need to state the following:
- "unknown impurities" in the IUPAC name field; and
- the number and the individual concentration range of each unknown impurity in the remarks field.
In addition the typical concentration and concentration range of the unknown impurities has to be provided.
An illustrative example on how to report unknown impurities in IUCLID can be found in section 9.4.2 of the manual How to prepare registration and PPORD dossiers, which is available at: http://echa.europa.eu/manuals
Yes. You need to report concentration ranges (i.e. both minimum and maximum values) for each constituent. These should be representative of the substance as manufactured/imported and you can take them from, for example, certified specification limits that often form part of a certificate of analysis (CoA). It is important that the concentration ranges are realistic and do not cover different substances.
REACH-IT will provide you with a list number once your registration passes the business rules. You will be able to download this automatically created EC entry as an i6z file from REACH-IT. You will be requested to assign this list number when submitting any update of your registration.
You must report the chemical name of your UVCB substance in the ‘IUPAC name' field of IUCLID Section 1.1. You can find the naming conventions for deriving the chemical name of UVCB substances in Chapter 4.3 of the Guidance for identification and naming of substances under REACH and CLP. An example of a chemical name for UVCB substances is "Oligomerisation reaction products of formaldehyde and phenol".
You must report the chemical name of your multi-constituent substance in the ‘IUPAC name' field of IUCLID Section 1.1. The generic format for the chemical name is "Reaction mass of" followed by the name of each main constituent separated by "and". In principle, the name of the main constituents should follow the IUPAC rules. An example of a chemical name for multi-constituent substances is "Reaction mass of ethylbenzene and m-xylene and o-xylene".
You should normally report each individual isomer and their typical, upper and lower concentration levels separately in IUCLID Section 1.2.
As a deviation, you may report the isomers under one entry in IUCLID Section 1.2. This approach may be considered appropriate when the isomers are present as a racemic mixture or when the number of isomers is large. In that situation, you should do the following:
- Specify the overall typical, upper and lower concentration level of isomers covered by the entry in the relevant IUCLID Section 1.2 fields;
- Indicate the relative ratio of isomers in the "Remarks" field in the repeatable block for that entry. If the relative ratio of isomers varies, you will need to report it in the form of a range;
- Indicate that specific isomers have not been reported separately in the "Justification for deviations" field.
Yes. The manufacturing process description is one of the identifiers for UVCB substances. The information should be included in the "Description" field of IUCLID Section 1.2. The description generally consists of the following:
- Identity and ratio of starting materials;
- Description of the relevant manufacturing steps in the order they occur;
- The relevant operating parameters applied to control the composition (e.g. temperature, pressure, solvent, catalysis type…);
- Details on any extraction/isolation/purification step.
In addition, you can also report the reaction schemes or process workflows to complement the description of the manufacturing process as an attachment under the "Attached description" heading of IUCLID Section 1.2.
No. The "Legal entity composition of the substance" should only be used to report compositions of the substance on its own that you manufacture or import. For instance, if your substance is formulated with a solvent upon manufacturing, you should only report the composition of the substance without the solvent as "Legal entity composition of the substance".
If your substance is only made available as a component of a mixture, the "legal entity composition of the substance" to be reported should still be for the substance on its own.
You should not confuse a mixture with a multi-constituent substance or a UVCB substance. Under REACH and CLP, a mixture is obtained by blending two or more substances without a chemical reaction. Substances within a mixture should be registered separately. A multi-constituent substance or a UVCB substance is normally the result of a chemical reaction. A multi-constituent substance or a UVCB substance should be registered as such.
You should proceed as follows:
- Assign the reference substance for the anhydrous substance and select the corresponding type of substance (mono-constituent, multi-constituent or UVCB) in Section 1.1.
- For technical reasons, report the composition of the anhydrous substance as the first composition with the composition type "Legal entity composition of the substance" in Section 1.2.
- If you manufacture or import the anhydrous substance, you should report the composition of that substance as the first composition.
- If you do not manufacture or import the anhydrous substance, you will still need to report a composition corresponding to the anhydrous substance as the first composition in Section 1.2. In this case, we recommend you to report a theoretical composition where the reference substance for the anhydrous substance is reported at a typical concentration of 100 % (w/w). Select "Legal entity composition of the substance" as the type of composition. In the "Description" field, indicate that the reported composition is theoretical. In the "Justification for deviation" field, indicate the following: "This composition is neither manufactured nor imported. It is only reported for technical reasons because the derogation for the registration of hydrates is applied".
- Report all other relevant compositions, including the composition of the different hydrates that are covered by the registration. For the compositions referring to hydrates, indicate "Hydrate covered by the registration of the anhydrous substance" in the "Justification for deviation" field. The ‘Type of composition' of the reported hydrate compositions should be ‘legal entity composition of the substance'.
You should provide sufficient analytical information to verify the identity of the monomer you register. The analyses typically consist of spectral and chromatographic data and a chromatogram of the original monomer or other substance used in the manufacture of the polymer. For further information, please consult Q&A 72 agreed with national helpdesks.
No. You should provide sufficient information in IUCLID Section 1.4 to identify the monomer to be registered.
If you encounter difficulties in getting hold of the information from the non-EEA manufacturer/supplier of the polymer, you may consider one of the following options:
- Propose to the non-EEA manufacturer of the polymer that they appoint an only representative (OR) in accordance with Article 8 of the REACH Regulation;
- Identify the non-EEA manufacturer of the monomer and request the analytical information directly from them;
- If an OR has already been appointed by the non-EU manufacturer, propose to that OR to take on the legal responsibility envisaged in Article 8 of REACH for the polymer importers (see also Q&A 834).
You may also consider any relevant scientific method to fulfil this information requirement. Should you consider information that is not limited to analytical data on the original monomer, we recommend you follow a clear and transparent approach carefully documented when reporting the information in IUCLID Section 1.4 of your registration.
No. The chemical name alone does not include all the process circumstances determining the composition of the UVCB substance and therefore its identity. For further details on the information expected to be reported on the manufacturing process of UVCB substances, please consult the Q&A 1199.
You first need to define which information on the manufacturing process is relevant for the identification of the UVCB substance. The Q&A 1199 will assist you deciding on which information on the manufacturing process matters for the identification of your UVCB substance.
The more you know about the composition of the UVCB substance, the less you will be dependent on the manufacturing process to identify your substance. For instance, you may not need to specify the ratio of reactants used to manufacture the substance if you can define the reaction yield and the content in residual starting materials from the compositional information. Beware that in this case you will still need to explain why some elements of the manufacturing process expected to be submitted are not provided, as indicated in Q&A 1318.
If the missing information on the manufacturing process prevents you from identifying the substance and the non-EEA manufacturer does not share this information directly with you, you may propose to the non-EEA manufacturer of the UVCB substance that they appoint an only representative (OR) in accordance with Article 8 of the REACH Regulation.
You need to provide all the relevant information on the manufacturing process in IUCLID section 1.2 as instructed in the Q&A 1199. If you consider that some of the information is not relevant, you need to clearly explain why this information is not included in the same field where the manufacturing process description is provided (i.e. in the ‘Description’ field of IUCLID Section 1.2).
No. The manufacturing process description is necessary to circumvent the limitations of identifying UVCB substances by their composition only. You therefore need to provide both types of information (composition and manufacturing process description) in IUCLID section 1.2. For further information on how to report the manufacturing process description and the composition of UVCB substance, please refer the Q&A 1199 and chapter 9.4.2 of the manual ‘How to prepare registration and PPORD dossiers’ available on the ECHA website: https://echa.europa.eu/manuals.
No. ECHA will not disseminate the manufacturing process description reported by registrants in compositions of the type ’legal entity composition of the substance’ in IUCLID section 1.2. This concerns both the information reported in the field ‘Description’ and any document included as ‘Attached description’.
Lead registrants need to additionally provide generic information on the manufacturing process of the jointly registered UVCB substance in the section 1.2 field ‘Description’ in compositions of the type ‘boundary composition of the substance’. This information will be displayed on the REACH-IT Joint submission page for the members of that joint submission to see.