eFirma Doradztwo i Szkolenia
ul. Jasna 18A/19
phone: +48 605 328 922
Safety Data Sheets are the primary tool used in REACH, ensuring the flow of information in the supply chain to initiate the necessary measures to ensure safety and protection of human health and the environment.
Requirements for safety data sheets are described in Title IV of the information in the supply chain of the REACH Regulation, while the guidelines for their preparation are described in Annex II to the Regulation. MSDS contain information about the hazards of a substance or mixture, as well as information on recommended risk management measures necessary to adequately control risks to health and the environment.
In accordance with Article. 31 of the REACH supplier of a substance or mixture to the recipient of the MSDS in the official language of the Member State in which the substance or mixture is marketed, prepared in accordance with Annex II in cases where:
the substance or preparation meets the criteria for classification as dangerous according to Directive 67/548/EEC or Directive 1999/45/EC,
the substance is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) in accordance with the criteria set out in Annex XIII,
the substance is on the list for eventual inclusion in Annex XIV (Annex XIV – List of substances subject to authorization).
In accordance with the provisions of REACH Safety Data Sheet must also prepare for preparations not classified according to the criteria for classification as dangerous (and provide the recipient at his request), but including:
a) in an individual concentration of at least 1% by weight. preparations for gaseous and at least 0.2% vol. for preparations gaseous substance posing a threat to human health or the environment, or
b) in an individual concentration of at least 0.1 wt%. in the case of preparations not gaseous at least one substance that is a PBT or vPvB, or has been included in the list of substances subject to authorization for reasons other than those specified in point. a), or
? a substance for which there are Community maximum residue levels in the workplace.
Suppliers are required to update the data sheets:
? there is new information that might affect the risk management measures or new information about threats,
? permission is granted for specific directions of use for substances
? For use restrictions in trade or use.
New document, which in some cases will have to be attached to the sheet as the exposure scenarios.
It contains a set of conditions that describe how or used during its life-cycle and how the manufacturer or importer controls the exposure of humans and the environment or how it recommends downstream users to this control.
Exposure scenarios have to be included as an attachment to the MSDS for these substances for which a chemical safety assessment and chemical safety report. In this case, the information contained in the SDS must be consistent with the information contained in the CSA.
The chemical safety report is required for all substances subject to registration if the registrant manufactures or imports such a substance in quantities of 10 tonnes per year.
In some cases, a chemical safety report must also be made by downstream users. A downstream user of a substance on its own or in a mixture of chemical safety report for any use outside the conditions described in the exposure scenario communicated to him in the Charter of the characteristics or for any use his supplier advises against. In this case, a chemical safety report must be made when the downstream user uses the substance or mixture in a total quantity greater than 1 tonne per year.
In accordance with Commission Regulation (EU) No. 453/2010 amending Annex II of REACH for substances that will be marketed from 1 December 2010. should draw up a new data sheet, including the provisions of Annex I to Regulation No 453/2010.
From that date, apply a double classification of a substance – in accordance with Directive 67/548/EEC and Regulation (EC) No 1272/2008 (CLP). These substances are packaged and labeled in accordance with CLP.
For substances placed on the market before 1 December 2010. That need not be re-labeled or packaged, safety data sheet does not need to be replaced by a new card drawn up under the new rules, 1 December 2012.
From 1 June 2015 all substances and mixtures should be classified according to Regulation (EC) No 1272/2008 (CLP).
We also recommend:
1. Development of the Information Card Technical Specification as a form of promotion, advertising leaflets, part of the directory information of each company – use it to the company should submit a property, the parameters of your product and reach effectively described in summary form to the client
2. Translation to Polish based on the original Technical Information Sheets/Specifications of the manufacturer