Safety data sheet (SDS)

Ekotox Centers are providing consultancy services and customers support in the area of EU chemicals legislation – REACH Registration, Only Representative, REACH Authorisation, REACH/CLP Screening, Safety Data Sheets, Legal Compliance Services, PCN and UFI services and more.

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Safety data sheet (SDS)

  • substances must be classified only according to CLP;
  • the mixtures must be classified, labeled and packaged only according to CLP;
  • substances and mixtures in safety data sheets must be classificated according to CLP.
  • Commission Regulation (EU) 2019/957 of 11 June 2019
  • Commission Regulation (EU) 2019/1691 of 9 October 2019
  • Commission Regulation (EU) 2020/171 of 6 February 2020
  • Commission Regulation (EU) 2020/507 of 7 April 2020
  • Commission Regulation (EU) 2020/878 of 18 June 2020
  • Commission Regulation (EU) 2020/1149 of 3 August 2020.

Ekotox Centers offers preparation of Safety Data Sheets and revisions under REACH/CLP in most of EU languages.

All safety data sheets provided after 31 December 2022 have to be in the format according to Regulation (EU) 2020/878.

It is recommended that the new format, as set out in Regulation (EU) 2020/878, is adopted, as soon as practicable, to ensure that all SDSs comply by the 31 December 2022 deadline.

The CLP Regulation was adopted by the European Parliament and the Council in December 2008. The purpose of CLP is to ensure a high level of protection of human health and the environment as well as the free movement of substances, mixtures and certain articles.

The CLP Regulation applies the terminology, evaluation principles and criteria of the GHS (Globally Harmonised System), and includes the provisions on the classification & labelling inventory from Regulation (EC) No 1907/2006 (REACH Regulation).

All safety data sheets provided after 31 December 2022 have to be in the format according to Regulation (EU) 2020/878. It is recommended that the new format, as set out in Regulation (EU) 2020/878, is adopted, as soon as practicable, to ensure that all SDSs comply by the 31 December 2022 deadline.

SAFETY DATA SHEETS – REACH requirements

  • Article 31

Requirements for safety data sheets

1. The supplier of a substance or a preparation shall provide the recipient of the substance or preparation with a safety data sheet compiled in accordance with Annex II:

(a) where a substance or preparation meets the criteria for classification as dangerous in accordance with Directives 67/548/EEC or 1999/45/EC; or

(b) where a substance is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII; or

(c) where a substance is included in the list established in accordance with Article 59(1) for reasons other than those referred to in points (a) and (b).

2. Any actor in the supply chain who is required, under Articles 14 or 37, to carry out a chemical safety assessment for a substance shall ensure that the information in the safety data sheet is consistent with the information in this assessment. If the safety data sheet is developed for a preparation and the actor in the supply chain has prepared a chemical safety assessment for that preparation, it is sufficient if the information in the safety data sheet is consistent with the chemical safety report for the preparation instead of with the chemical safety report for each substance in the preparation.

3. The supplier shall provide the recipient at his request with a safety data sheet compiled in accordance with Annex II, where a preparation does not meet the criteria for classification as dangerous in accordance with Articles 5, 6 and 7 of Directive 1999/45/EC, but contains:

(a) in an individual concentration of ≥ 1 % by weight for nongaseous preparations and ≥ 0,2 % by volume for gaseous preparations at least one substance posing human health or environmental hazards; or

(b) in an individual concentration of ≥ 0,1 % by weight for non-gaseous preparations at least one substance that is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII or has been included for reasons other than those referred to in point (a) in the list established in accordance with Article 59(1); or

(c) a substance for which there are Community workplace exposure limits.

4. The safety data sheet need not be supplied where dangerous substances or preparations offered or sold to the general public are provided with sufficient information to enable users to take the necessary measures as regards the protection of human health, safety and the environment, unless requested by

a downstream user or distributor.

5. The safety data sheet shall be supplied in an official language of the Member State(s) where the substance or preparation is placed on the market, unless the Member State(s) concerned provide otherwise.

What has changed?

Transitional provision to implement the latest version of Annex II to REACH

In accordance with Article 2 of Regulation (EU) 2020/878, safety data sheets compiled in accordance with Regulation (EC) No 1907/2006, as amended by Commission Regulation (EU) 2015/830, can continue to be used until 31 December 2022.

This is without prejudice to the obligation to update the safety data sheets in accordance with Article 31(9) of Regulation (EC) No 1907/2006, and to the cases where the Unique Formula Identifier (UFI) is added to safety data sheets as provided for in section 5 of Part A of Annex VIII to Regulation (EC) No 1272/2008 (CLP).

Until 31 December 2022, all safety data sheets provided after 1st January 2021, including new and updated safety data sheets, can be provided in the current format according to Regulation (EU) 2015/830 or in the new format according to Regulation (EU) 2020/878, including the following scenarios:
• No change to safety data sheet

• Small change to safety data sheets not within scope of Article 31(9)

• Update to safety data sheets within the scope of Article 31(9) or introducing the UFI

• New safety data sheets authored for the first time after 1st January 2021

UFI & PCN

The harmonisation of information requirements means that the existing national requirements across the EU have been replaced by one set of information requirements and one format of data submission, the Poison Centres Notification (PCN) format.

Some information requirements may be new compared to previous obligations that applied at national level. You may need to generate new information or adjust the existing information to the PCN format.

UFI

UFI

The unique formula identifier (UFI) is a new submission requirement and a new label element that is described in detail in step 4. An example of a UFI in the correct format is YV9K-3J9A-G209-C2T7. The UFI establishes a unequivocal link between the information you provide on a mixture through the notification and the corresponding product placed on the market, which helps ensure that the appropriate emergency health response is quickly identified in the event of an incident.

The full chemical composition of the mixture will be required. That means that you must indicate the exact concentrations or concentration ranges for hazardous and non-hazardous components. This is more than the information usually present in a safety data sheet.

The classification and labelling for the final mixture/product is required – in addition to this, the classification information of both the substance and mixture in mixture (MiM) components (including the substances contained in the MiM as well) will also need to be provided.

Toxicological information for the mixture will need to be provided. This information will need to be provided as free text, and is normally available in section 11 of a safety data sheet.

A product category must be assigned to the product based on its main intended use – for example, dishwashing detergent, adhesive, decorative paint – in accordance with the European product categorisation system (EuPCS).

All submissions must also include information identifying the submitter, the product (e.g. trade name, packaging, colour) and whether the mixture has consumer, professional or industrial uses.

7. Any actor in the supply chain who is required to prepare a chemical safety report according to Articles 14 or 37 shall place the relevant exposure scenarios (including use and exposure categories where appropriate) in an annex to the safety data sheet covering identified uses and including specific conditions resulting from the application of Section 3 of Annex XI.

Any downstream user shall include relevant exposure scenarios, and use other relevant information, from the safety data sheet supplied to him when compiling his own safety data sheet for identified uses.

Any distributor shall pass on relevant exposure scenarios, and use other relevant information, from the safety data sheet supplied to him when compiling his own safety data sheet for uses for which he has passed on information according to Article 37(2).

8. A safety data sheet shall be provided free of charge on paper or electronically.

9. Suppliers shall update the safety data sheet without delay on the following occasions:

(a) as soon as new information which may affect the risk management measures, or new information on hazards becomes available;

(b) once an authorisation has been granted or refused;

(c) once a restriction has been imposed.

The new, dated version of the information, identified as ‘Revision: (date)’, shall be provided free of charge on paper or electronically to all former recipients to whom they have supplied the substance or preparation within the preceding 12 months. Any updates following registration shall include the registration number.

  • Article 32

Duty to communicate information down the supply chain for substances on their own or in preparations for which a safety data sheet is not required

1. Any supplier of a substance on its own or in a preparation who does not have to supply a safety data sheet in accordance with Article 31 shall provide the recipient with the following information:

(a) the registration number(s) referred to in Article 20(3), if available, for any substances for which information is communicated under points (b), (c) or (d) of this paragraph;

(b) if the substance is subject to authorisation and details of any authorisation granted or denied under Title VII in this supply chain;

(c) details of any restriction imposed under Title VIII;

(d) any other available and relevant information about the substance that is necessary to enable appropriate risk management measures to be identified and applied including specific conditions resulting from the application of Section 3 of Annex XI.

2. The information referred to in paragraph 1 shall be communicated free of charge on paper or electronically at the latest at the time of the first delivery of a substance on its own or in a preparation after 1 June 2007.

3. Suppliers shall update this information without delay on the following occasions:

(a) as soon as new information which may affect the risk management measures, or new information on hazards becomes available;

(b) once an authorisation has been granted or refused;

(c) once a restriction has been imposed.

EKOTOX CENTERS are providing consultancy services and customers support – Safety Data Sheets authoring, revisions, complex management, Legal Compliance Services, PCN and UFI services and more.

Safety Data Sheet