We often get requests from our clients from outside of EU to “simply transcribe” their original Safety Data Sheets (SDS) to the format used in the European Union. Usually these SDS contain components (substances) marked as “trade secret”.
Why did I put the “simply transcribe” in quotation marks? Because it is usually not as simple as that. Why? Let’s take look.
The format of the SDS in the EU is determined by the REACH regulation (REGULATION (EC) No 1907/2006), namely the COMMISSION REGULATION (EU) 2020/878.
Now comes the excerpt from the legislation where it is specified exactly, which of the substances as part of the mixture, need to be stated in section 3.2 of the SDS.
This part requires a bit of legal language. If you find such language confusing, you can simply jump down to the end of the article, where I give the short summary.
Let’s now look at two possibilities stated in the aforementioned regulation.
1. case: if the mixture is classified as hazardous according to CLP regulation (Regulation (EC) No 1272/2008).
For a mixture meeting the criteria for classification in accordance with Regulation (EC) No 1272/2008, the following substances (see also Table 1.1) shall be indicated, together with their concentration or concentration range in the mixture:
(a) substances presenting a health or environmental hazard within the meaning of Regulation (EC) No 1272/2008, if those substances are present in concentrations equal to or greater than the lowest of any of the following:
(i) the generic cut-off values set out in Table 1.1 of Annex I to Regulation (EC) No 1272/2008;
(ii) the generic concentration limits given in parts 3 to 5 of Annex I to Regulation (EC) No 1272/2008, taking into account the concentrations specified in the notes to certain tables in part 3 in relation to the obligation to make available a safety data sheet for the mixture upon request, and for aspiration hazard (Section 3.10 of Annex I to Regulation (EC) No 1272/2008) ≥ 1 %;
(iii) the specific concentration limits given in Part 3 of Annex VI to Regulation (EC) No 1272/2008;
(iv) if a M-factor has been given in Part 3 of Annex VI to Regulation (EC) No 1272/2008, the generic cut-off value in Table 1.1 of Annex I to that Regulation, adjusted using the calculation set out in Section 4.1 of Annex I to that Regulation;
(v) the specific concentration limits provided to the classification and labelling inventory established under Regulation (EC) No 1272/2008;
(vi) one tenth of the specific concentration limit for a substance classified as skin sensitiser or respiratory sensitiser with a specific concentration limit;
(vii) the concentration limits set out in Annex II to Regulation (EC) No 1272/2008;
(viii) if an M-factor has been provided to the classification and labelling inventory established under Regulation
(EC) No 1272/2008, the generic cut-off value in Table 1.1 of Annex I to that Regulation, adjusted using the calculation set out in Section 4.1 of Annex I to that Regulation;
(b) substances for which there are Union workplace exposure limits which are not already included under point (a);
(c) provided that the concentration of an individual substance is equal to or greater than 0,1 %, substances that meet any of the following criteria:
— substances that are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII,
— substances included in the list established in accordance with Article 59(1) for reasons other than the hazards referred to in point (a) of this subsection such as endocrine disrupting properties,
— substances identified as having endocrine disrupting properties in accordance with the criteria set out in Delegated Regulation (EU) 2017/2100 or Regulation (EU) 2018/605.
Table 1.1
List of hazard classes, hazard categories and concentration limits for which a substance shall be listed as a substance in a mixture in subsection 3.2.1
| Hazard class and category | Concentration limit (%) |
|---|---|
| Acute toxicity, category 1, 2 and 3 | ≥ 0,1 |
| Acute toxicity, category 4 | ≥ 1 |
| Skin corrosion/irritation, category 1, categories 1A, 1B, 1C and category 2 | ≥ 1 |
| Serious damage to eyes/eye irritation, category 1 and 2 | ≥ 1 |
| Respiratory sensitizer category 1 or category 1B | ≥ 0,1 |
| Respiratory sensitizer category 1A | ≥ 0,01 |
| Skin sensitizer category 1 or category 1B | ≥ 0,1 |
| Skin sensitizer category 1A | ≥ 0,01 |
| Germ cell mutagenicity category 1A and 1B | ≥ 0,1 |
| Germ cell mutagenicity category 2 | ≥ 1 |
| Carcinogenicity category 1A, 1B and 2 | ≥ 0,1 |
| Reproductive toxicity, category 1A, 1B, 2 and effects on or via lactation | ≥ 0,1 |
| Specific target organ toxicity (STOT) – single exposure, category 1, 2 and 3 | ≥ 1 |
| Specific target organ toxicity (STOT) – repeated exposure, category 1 and 2 | ≥ 1 |
| Aspiration toxicity | ≥ 1 |
| Hazardous to the aquatic environment – Acute, category 1 | ≥ 0,1 |
| Hazardous to the aquatic environment – Chronic, category 1 | ≥ 0,1 |
| Hazardous to the aquatic environment – Chronic, category 2, 3 and 4 | ≥ 1 |
| Hazardous for the ozone layer | ≥ 0,1 |
Here comes the second case, for mixtures, that are not classified as hazardous.
For a mixture not meeting the criteria for classification in accordance with Regulation (EC) No 1272/2008, substances present in an individual concentration equal to or greater than the following concentrations shall be indicated, together with their concentration or concentration range:
(a) 1 % by weight in non-gaseous mixtures and 0,2 % by volume in gaseous mixtures for:
(i) substances which present a health or environmental hazard within the meaning of Regulation (EC) No 1272/2008; or
(ii) substances for which Union workplace exposure limits have been assigned;
(b) 0,1 % by weight for substances that meet any of the following criteria:
— substances that are persistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XIII,
— substances that are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII,
— substances included in the list established in accordance with Article 59(1) for reasons other than the hazards referred to in point (a) of this subsection such as endocrine disrupting properties;
— identified as having endocrine disrupting properties in accordance with the criteria set out in Delegated Regulation (EU) 2017/2100 or Regulation (EU) 2018/605;
(c) 0,1 % of a substance classified as skin sensitiser category 1 or 1B, respiratory sensitiser category 1 or 1B, or carcinogenic category 2;
(d) 0,01 % of a substance classified as skin sensitiser category 1A or respiratory sensitiser category 1A;
(e) one tenth of the specific concentration limit for a substance classified as skin sensitiser or respiratory sensitiser with a specific concentration limit;
(f) 0,1 % of a substance classified as toxic to reproduction categories 1A, 1B or 2, or with effects on or via lactation.
For the substances indicated in subsection 3.2:
— the classification of the substance according to Regulation (EC) No 1272/2008, including the hazard class(es) and category code(s) as provided in Table 1.1 of Annex VI to that Regulation as well as the hazard statements and supplemental hazard statements, shall be provided. The hazard statements and the supplemental hazard statements do not need to be written out in full in this subsection; their codes shall be sufficient. In cases where they are not written out in full, reference shall be made to section 16, where the full text of each relevant hazard statement shall be listed. If the substance does not meet the classification criteria, the reason for indicating the substance in subsection 3.2 shall be described, such as “non-classified vPvB substance” or “substance with a Union workplace exposure limit”.
— the specific concentration limit, the M-factor and the acute toxicity estimate for the substance in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or as determined in accordance with Annex I to that Regulation shall be indicated, if available.
— if the substance as used in the mixture is in nanoform and is as such registered or addressed by the downstream user chemical safety report, the particle characteristics that specify the nanoform, as described in Annex VI, shall be indicated. If the substance as used in the mixture is in nanoform but is not registered or addressed by the downstream user chemical safety report, the particle characteristics which have impact on the safety of the mixture, shall be provided.
For the substances indicated in subsection 3.2 the name and, if available, the registration number, as assigned under Article 20(3) of this Regulation, shall be given.
Without affecting the obligations of downstream users laid down in Article 39 of this Regulation, the part of the registration number referring to the individual registrant of a joint submission may be omitted by the supplier of the mixture provided that:
(a) this supplier assumes the responsibility to provide the full registration number upon request for enforcement purposes or, if the full registration number is not available to him, to forward the request to his supplier, in line with point (b); and
(b) this supplier provides the full registration number to the Member State authority responsible for enforcement (hereinafter referred to as the enforcement authority) within seven days upon request, received either directly from the enforcement authority or forwarded by his recipient, or, if the full registration number is not available to him, this supplier shall forward the request to his supplier within seven days upon request and at the same time inform the enforcement authority thereof.
The EC number, if available, shall be given in accordance with Regulation (EC) No 1272/2008. The CAS number, if available, and the IUPAC name, if available, may also be given.
For substances indicated in this subsection by means of an alternative chemical name in accordance with Article 24 of Regulation (EC) No 1272/2008, the registration number, EC number and other precise chemical identifiers are not necessary.
If you have skipped the legislation part, you can read on here below. If you had the time and have managed to read through all of it, well done!
So basically, every substance needs to be stated in section 3.2 of the SDS, if the criteria are fulfilled. Therefore, it is not possible to claim confidentiality on certain components if the REACH regulation demands for them to be visible on the Safety Data Sheet.
There is only one option of claiming confidentiality – if your substance has an approved alternative chemical name in accordance with Article 24 of Regulation (EC) No 1272/2008.
Experience shows that with chemicals which are labelled as irritant (or even hazardous for the environment) the secrecy of the chemical name can be claimed. It should be noted that this cannot be performed arbitrarily.
In this case, an application must be sent to the European Chemicals Agency and obtain the permission to do so. A fee must be paid. The fees are prescribed in the Commission Regulation (EU) No 440/2010. For example, standard fee for an alternative chemical name of a substance in up to five mixtures costs 4000 €. Additionally, fee for use of alternative chemical name per 10 additional mixtures costs another 500 €.
In the procedure, the company must demonstrate that the disclosure of the chemical identity of the substance on the label or the Safety Data Sheet could jeopardize the confidential nature of their activity, particularly their intellectual property. If you get the approval of use of alternative chemical name, then you able to use that name in the SDS without additional identifiers.
I hope I was successful at giving you a glimpse at why the task of “transcribing” the SDS from other regions to EU SDS is not as simple as it may seem at first glance. If you need assistance with the creation of your SDS for the EU/EEA region, write us at info@bens-consulting.eu.
Back to posts
