The preparation of safety data sheets is an essential process to ensure that all users of chemicals have all the data necessary for the safe handling of substances. Material Safety Data Sheets (MSDS) are prepared both for individual chemical substances and for substances in mixtures or products.
The preparation of safety data sheets includes detailed information about the regulatory framework for the control of the chemical used in the workplace or the chemical in the mixture. This document is important to both employers and employees as it provides information on hazards to the safety and health of workers and hazards to the environment, as well as recommendations on safety measures.
The preparation of safety data sheets is regulated in Annex II of the REACH Regulation, which was approved by Regulation (EU) No. 2020/878. This regulation defines the format and content of the safety data sheet, which is applicable in Lithuania and other EU member states.
Who must have and submit safety data sheets
The supplier of the substance or mixture must submit the MSDS in the following cases:
When a chemical substance or mixture is classified as dangerous according to Regulation (EC) No. 1272/2008 (CLP).
When the substance is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to the criteria set out in Annex XIII of the REACH Regulation.
When a chemical is included in the candidate list of chemicals to be authorised.
Also, at the request of the recipient (buyer), the supplier must submit an MSDS when the mixture is not classified as dangerous, but it contains:
At least one chemical substance hazardous to human health or the environment, whose concentration in the non-gaseous mixture is equal to or greater than 1 percent. by mass, and in the gaseous mixture — equal to or greater than 0.2 percent. volume.
At least one chemical that is persistent, bioaccumulative and toxic (PBT) or very persistent and bioaccumulative (vPvB) according to the criteria set out in Annex XIII of the REACH Regulation, and whose concentration in the non-gaseous mixture is equal to or greater than 0.1%. masses.
When a chemical substance is included in the candidate list of chemicals to be authorized, and whose concentration in the non-gaseous mixture is equal to or greater than 0.1 percent. masses.
A chemical substance for which the limit value of exposure in the working environment has been determined in the EU (and Lithuania).
The preparation of safety data sheets also covers products for which deviations from the labeling requirements are allowed under the provisions of paragraph 1.3 of Annex I of the CLP Regulation, such as gas cylinders for propane, butane or liquefied petroleum gas.
When is the safety data sheet available
Article 31(8) of REACH states: "The safety data sheet shall be provided free of charge in writing or electronically no later than the date on which the substance or mixture is submitted for the first time."
The preparation of safety data sheets also includes the methods of their presentation. The safety data sheet can be provided in paper form, for example by sending a letter, together with the product, or by fax or electronically, for example by email.
The European Chemicals Agency points out that the word "provided" in this context implies an unequivocal obligation on the part of the supplier to actually provide the safety data sheet (and any mandatory updates to it), rather than passively arranging access, for example on the Internet, or delivering it to the recipient upon request. The mere publication of a copy of the safety data sheet (or its update) on the website does not constitute the requirement to provide it.
When a safety data sheet is provided for the first delivery of a substance or mixture to a specific recipient, another copy of the safety data sheet does not need to be delivered to the same recipient if the safety data sheet has not been changed. The preparation of safety data sheets requires that the MSDS be provided in the official language of the Member State where the substance or mixture is placed on the market. The safety data sheet is available free of charge in written or electronic form.
When the safety data sheet is updated
Suppliers of chemicals and mixtures shall immediately update the safety data sheet in the following cases:
Immediately after new information that may affect risk management measures or new information about hazards becomes known.
If authorization has been granted or denied.
If restrictions have been imposed.
A new version of the MSDS marked "Revised: (date)" is provided free of charge in writing or electronically to all previous recipients to whom the substance or mixture has been supplied in the past 12 months. After registration of the substance, updates include the registration number and, if applicable, the exposure scenario.
If a company has registered more than 10 t of a chemical substance according to the REACH regulation, an exposure scenario must be prepared in addition to the safety data sheet. Such a safety data sheet is called an extended safety data sheet.
Attention! From 2021 January 1 all safety data sheets must be prepared and updated in accordance with Regulation (EU) no. 2020/878 requirements.
Structure (contents) of the safety data sheet
The preparation of safety data sheets also includes their structure. The content (structure) of safety data sheets is determined by Article 31.6 of the REACH Regulation. It specifies the sections and sub-sections of the safety data sheet. The safety data sheet must consist of 16 sections, each section must have sub-headings (except for section 3, where only sub-headings 3.1 or 3.2 (sub-sections) are sufficient as required for the relevant substance or mixture). When preparing a safety data sheet, it is mandatory to complete all sections and subsections by recording all the necessary information as specified in Annex II of the REACH Regulation (or Annex of Regulation (EU) No. 2020/878).
Preparation and updating of safety data sheets for chemicals and mixtures according to the latest requirements of REACH and CLP regulations. We ensure that your documents always meet regulatory standards.
Professional translation of safety data sheets from English. Our translations are carried out by chemical specialists, so you can be sure that the phrases and terms used will meet all legal requirements. In addition, we supplement the translations with necessary information according to the legal acts of the Republic of Lithuania.
Preparation of extended safety data sheets after substance registration. Our team will ensure that all your documents are complete and meet all requirements.
Adaptation of safety data sheets from foreign languages. We ensure that your documents are adapted to the local market and meet all requirements.
Verification of compliance of safety data sheets with REACH and CLP regulations. Our specialists will carefully review your documents and ensure that they meet all requirements.
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