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safety data sheet
PREAMBLE: REACH - Registration, Evaluation, Authorisation and Restriction of Chemicals [go to this PREAMBLE]
... (57) As the existing safety data sheet is already being used as a communication tool within the supply chain of substances and preparations, it is appropriate to develop it further and make it an integral part of the system established by this
Regulation. ...
... (58) In order to have a chain of responsibilities, downstream users should be responsible for assessing the risks arising from their uses of substances if those uses are not covered by a safety data sheet received from their suppliers, unless the downstream user concerned takes more protective measures than those recommended by his supplier or unless his supplier was not required to assess those risks or provide him with information on those risks. For the same reason, downstream users should manage the risks arising from their uses of substances. In addition, it is appropriate that any producer or importer of an article containing a substance of very high concern should provide sufficient information to allow safe use of such
an article. ...
... (60) For enforcement and evaluation purposes, downstream users of substances should be required to report to the Agency certain basic information if their use is outside the conditions of the exposure scenario detailed in the safety data sheet communicated by their original manufacturer or importer and to keep such reported information up-to-date. ...
ARTICLE-8: Only representative of a non-Community manufacturer [go to this ARTICLE]
... 2. The representative shall also comply with all other obligations of importers under this Regulation. To this end, he shall have a sufficient background in the practical handling of substances and the information related to them and, without prejudice to Article 36, shall keep available and up-to-date information on quantities imported and customers sold to, as well as information on
the supply of the latest update of the safety data sheet referred to in Article 31. ...
ARTICLE-22: Further duties of registrants [go to this ARTICLE]
... (e) new knowledge of the risks of the substance to human health and/or the environment of which he may reasonably be
expected to have become aware which leads to changes in the safety data sheet or the chemical safety report; ...
ARTICLE-31: Requirements for safety data sheets [go to this ARTICLE]
... 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: ...
... 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. ...
... 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. ...
... 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: ...
... 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. ...
... 6. The safety data sheet shall be dated and shall contain the following headings: ...
... 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 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). ...
... 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: ...
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 [go to this ARTICLE]
... 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: ...
ARTICLE-34: Duty to communicate information on substances and preparations up the supply chain [go to this ARTICLE]
... (b) any other information that might call into question the appropriateness of the risk management measures identified
in a safety data sheet supplied to him, which shall be communicated only for identified uses. ...
ARTICLE-37: Downstream user chemical safety assessments and duty to identify, apply and recommend risk reduction measures [go to this ARTICLE]
... 4. A downstream user of a substance on its own or in a preparation shall prepare a chemical safety report in accordance
with Annex XII for any use outside the conditions described in an exposure scenario or if appropriate a use and exposure category communicated to him in a safety data sheet or for any use his supplier advises against. ...
... (a) a safety data sheet is not required to be communicated with the substance or preparation in accordance with Article 31; ...
... (d) the downstream user implements or recommends an exposure scenario which includes as a minimum the conditions described in the exposure scenario communicated to him in the safety data sheet; ...
... (a) the safety data sheet(s) supplied to him; ...
... 6. Where a downstream user does not prepare a chemical safety report in accordance with paragraph 4(c), he shall consider
the use(s) of the substance and identify and apply any appropriate risk management measures needed to ensure that the risks
to human health and the environment are adequately controlled. Where necessary, this information shall be included in any
safety data sheet prepared by him. ...
ARTICLE-39: Application of downstream user obligations [go to this ARTICLE]
... 1. Downstream users shall be required to comply with the requirements of Article 37 at the latest 12 months after receiving a registration number communicated to them by their suppliers in a safety data sheet. ...
... 2. Downstream users shall be required to comply with the requirements of Article 38 at the latest six months after receiving a registration number communicated to them by their suppliers in a safety data sheet. ...
ARTICLE-119: Electronic public access [go to this ARTICLE]
... (d) information, other than that listed in paragraph 1, contained in the safety data sheet; ...
ARTICLE-I: GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS [go to this ARTICLE]
... If the substance is placed on the market, the relevant exposure scenario(s), including the risk management measures and operational conditions shall be included in an annex to the safety data sheet in accordance with Annex II. ...
... 0.9. Where information is not necessary in accordance with Annex XI, this fact shall be stated under the appropriate heading of the chemical safety report and a reference shall be made to the
justification in the technical dossier. The fact that no information is required shall also be stated in the safety data sheet. ...
... 0.10. In relation to particular effects, such as ozone depletion, photochemical ozone creation potential, strong odour
and tainting, for which the procedures set out in Sections 1 to 6 are impracticable, the risks associated with such effects
shall be assessed on a case-by-case basis and the manufacturer or importer shall include a full description and justification of such assessments in the chemical safety report and summarised in the safety data sheet. ...
... 0.13. Part A of the chemical safety report shall include a declaration that the risk management measures outlined in
the relevant exposure scenarios for the manufacturer's or importer's own use(s) are implemented by the manufacturer or importer and that those exposure scenarios for the identified uses are communicated to distributors and downstream users in the safety data sheet(s). ...
... 1.0.4. The first three steps shall be undertaken for every effect for which information is available and shall be recorded
under the relevant section of the Chemical Safety Report and where required and in accordance with Article 31, summarised in the Safety Data Sheet under headings 2 and 11. ...
... 1.0.6. Step 4 of the human health hazard assessment shall be undertaken by integrating the results from the first three
steps and shall be included under the relevant heading of the Chemical Safety Report and summarised in the Safety Data Sheet under heading 8.1. ...
... 2.3. The assessment of each effect shall be presented under the relevant heading of the Chemical Safety Report (Section
7) and where required and in accordance with Article 31, summarised in the Safety Data Sheet under headings 2 and 9. ...
... 3.0.2. The environmental hazard assessment shall consider the potential effects on the environment, comprising the (1)
aquatic (including sediment), (2) terrestrial and (3) atmospheric compartments, including the potential effects that may occur
(4) via food-chain accumulation. In addition, the potential effects on the (5) microbiological activity of sewage treatment
systems shall be considered. The assessment of the effects on each of these five environmental spheres shall be presented
under the relevant heading of the Chemical Safety Report (Section 7) and where required and in accordance with Article 31, summarised in the Safety Data Sheet under headings 2 and 12. ...
... 3.0.3. For any environmental sphere, for which no effect information is available, the relevant section of the chemical
safety report shall contain the sentence: "This information is not available". The justification, including reference to any
literature research carried out, shall be included in the technical dossier. For any environmental sphere for which information
is available, but the manufacturer or importer believes that it is not necessary to conduct the hazard assessment, the manufacturer or importer shall present a justification, with reference to pertinent information, under the relevant heading of the Chemical Safety
Report (Section 7) and where required and in accordance with Article 31, summarised in the Safety Data Sheet under heading 12. ...
... The assessment shall also be summarised in the Safety Data Sheet under heading 12. ...
... Where required and in accordance with Article 31, the exposure scenario shall also be included in an annex to the Safety Data Sheet. ...
... 5.1.1. Exposure scenarios as described in Sections 0.7 and 0.8 shall be generated. Exposure scenarios are the core of
the process to carry out a chemical safety assessment. The chemical safety assessment process may be iterative. The first
assessment will be based on the required minimum and all available hazard information and on the exposure estimation that
corresponds to the initial assumptions about the operating conditions and risk management measures (an initial exposure scenario). If the initial assumptions lead to a risk characterisation indicating that risks to human health and the environment are
not adequately controlled, then it is necessary to carry out an iterative process with amendment of one or a number of factors
in hazard or exposure assessment with the aim to demonstrate adequate control. The refinement of hazard assessment may require
generation of additional hazard information. The refinement of exposure assessment may involve appropriate alteration of the
operational conditions or risk management measures in the exposure scenario or more precise exposure estimation. The exposure scenario, resulting from the final iteration (a final exposure scenario), shall be included in the chemical safety report and attached to the safety data sheet in accordance with Article 31. ...
... The final exposure scenario shall be presented under the relevant heading of the chemical safety report, and included in an annex to the safety data sheet, using an appropriate short title giving a brief general description of the use, consistent with those given in Section 3.5
of Annex VI. Exposure scenarios shall cover any manufacture in the Community and all identified uses. ...
... 5.2.1. The exposure shall be estimated for each exposure scenario developed and shall be presented under the relevant heading of the Chemical Safety Report and where required and in accordance
with Article 31, summarised in an annex to the safety data sheet. The exposure estimation entails three elements: (1) emission estimation; (2) assessment of chemical fate and pathways; and
(3) estimation of exposure levels. ...
ARTICLE-II: GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS [go to this ARTICLE]
... This Annex sets out the requirements for a Safety Data Sheet that is provided for a substance or a preparation in accordance with Article 31. The Safety Data Sheet provides a mechanism for transmitting appropriate safety information on classified substances and preparations, including information from the relevant Chemical Safety Report(s) down the supply chain to the immediate downstream user(s). The information provided in the Safety Data Sheet shall be consistent with the information in the Chemical Safety Report, where one is required. Where a Chemical Safety Report
has been performed, the relevant exposure scenario(s) shall be placed into an annex of the Safety Data Sheet, to make reference to them under the relevant headings of the Safety Data Sheet easier. ...
... This Annex sets out the requirements for a Safety Data Sheet that is provided for a substance or a preparation in accordance with Article 31. The Safety Data Sheet provides a mechanism for transmitting appropriate safety information on classified substances and preparations, including information from the relevant Chemical Safety Report(s) down the supply chain to the immediate downstream user(s). The information provided in the Safety Data Sheet shall be consistent with the information in the Chemical Safety Report, where one is required. Where a Chemical Safety Report
has been performed, the relevant exposure scenario(s) shall be placed into an annex of the Safety Data Sheet, to make reference to them under the relevant headings of the Safety Data Sheet easier. ...
... This Annex sets out the requirements for a Safety Data Sheet that is provided for a substance or a preparation in accordance with Article 31. The Safety Data Sheet provides a mechanism for transmitting appropriate safety information on classified substances and preparations, including information from the relevant Chemical Safety Report(s) down the supply chain to the immediate downstream user(s). The information provided in the Safety Data Sheet shall be consistent with the information in the Chemical Safety Report, where one is required. Where a Chemical Safety Report
has been performed, the relevant exposure scenario(s) shall be placed into an annex of the Safety Data Sheet, to make reference to them under the relevant headings of the Safety Data Sheet easier. ...
... This Annex sets out the requirements for a Safety Data Sheet that is provided for a substance or a preparation in accordance with Article 31. The Safety Data Sheet provides a mechanism for transmitting appropriate safety information on classified substances and preparations, including information from the relevant Chemical Safety Report(s) down the supply chain to the immediate downstream user(s). The information provided in the Safety Data Sheet shall be consistent with the information in the Chemical Safety Report, where one is required. Where a Chemical Safety Report
has been performed, the relevant exposure scenario(s) shall be placed into an annex of the Safety Data Sheet, to make reference to them under the relevant headings of the Safety Data Sheet easier. ...
... This Annex sets out the requirements for a Safety Data Sheet that is provided for a substance or a preparation in accordance with Article 31. The Safety Data Sheet provides a mechanism for transmitting appropriate safety information on classified substances and preparations, including information from the relevant Chemical Safety Report(s) down the supply chain to the immediate downstream user(s). The information provided in the Safety Data Sheet shall be consistent with the information in the Chemical Safety Report, where one is required. Where a Chemical Safety Report
has been performed, the relevant exposure scenario(s) shall be placed into an annex of the Safety Data Sheet, to make reference to them under the relevant headings of the Safety Data Sheet easier. ...
... The information provided by Safety Data Sheets shall also meet the requirements set out in Directive 98/24/EC on the
protection of the health and safety of workers from the risks related to chemical agents at work. In particular, the Safety Data Sheet shall enable the employer to determine whether any hazardous chemical agents are present in the workplace, and to assess
any risk to the health and safety of workers arising from their use. ...
... The information in the Safety Data Sheet shall be written in a clear and concise manner. The Safety Data Sheet shall be prepared by a competent person who shall take into account the specific needs of the user audience, as far as it
is known. Persons placing substances and preparations on the market shall ensure that competent persons have received appropriate training, including refresher
training. ...
... The information in the Safety Data Sheet shall be written in a clear and concise manner. The Safety Data Sheet shall be prepared by a competent person who shall take into account the specific needs of the user audience, as far as it
is known. Persons placing substances and preparations on the market shall ensure that competent persons have received appropriate training, including refresher
training. ...
... For preparations not classified as dangerous, but for which a Safety Data Sheet is required according to Article 31, proportionate information shall be provided under each heading. ...
... Give the date of issue of the Safety Data Sheet on the first page. When a safety data sheet has been revised, the changes shall be brought to the attention of the recipient and identify it as "Revision: (date)". ...
... Give the date of issue of the Safety Data Sheet on the first page. When a safety data sheet has been revised, the changes shall be brought to the attention of the recipient and identify it as "Revision: (date)". ...
... Where a Chemical Safety Report is required, the Safety Data Sheet shall contain information on all the identified uses relevant to the recipient of the Safety Data Sheet. This information shall be consistent with the identified uses and exposure scenarios set out in the annex to the Safety Data Sheet. ...
... Where a Chemical Safety Report is required, the Safety Data Sheet shall contain information on all the identified uses relevant to the recipient of the Safety Data Sheet. This information shall be consistent with the identified uses and exposure scenarios set out in the annex to the Safety Data Sheet. ...
... Where a Chemical Safety Report is required, the Safety Data Sheet shall contain information on all the identified uses relevant to the recipient of the Safety Data Sheet. This information shall be consistent with the identified uses and exposure scenarios set out in the annex to the Safety Data Sheet. ...
... Identify the person responsible for placing the substance or preparation on the market within the Community, whether
it is the manufacturer, importer or distributor. Give the full address and telephone number of this person as well as the e-mail address of the competent
person responsible for the Safety Data Sheet. ...
... Where a chemical safety report or a registration is required, the information in this section shall be consistent with the information given, for the identified uses and
exposure scenarios set out in the annex to the Safety Data Sheet. ...
... Where a Chemical Safety Report is required, the relevant DNELs and PNECs for the substance shall be given for the exposure
scenarios set out in the annex to the Safety Data Sheet. ...
... For preparations, it is useful to provide values for those constituent substances which are required to be listed in the Safety Data Sheet according to heading 3. ...
... For the purposes of this document exposure control means the full range of specific risk management measures to be taken
during use in order to minimise worker and environmental exposure. Where a chemical safety report is required, a summary of
the risk management measures shall be given in Section 8 of the Safety Data Sheet for the identified uses set out in the Safety Data Sheet. ...
... For the purposes of this document exposure control means the full range of specific risk management measures to be taken
during use in order to minimise worker and environmental exposure. Where a chemical safety report is required, a summary of
the risk management measures shall be given in Section 8 of the Safety Data Sheet for the identified uses set out in the Safety Data Sheet. ...
... Where a chemical safety report is required, a summary of the risk management measures that adequately control exposure
of the environment to the substance shall be given for the exposure scenarios set out in the annex to the Safety Data Sheet. ...
... Ensure that information relevant to the environment is provided under other headings of the Safety Data Sheet, especially advice for controlled release, accidental release measures, transport and disposal considerations under headings
6, 7, 13, 14 and 15. ...
... Where a Chemical Safety Report is required, the information on the waste management measures that adequately control
exposure of humans and the environment to the substance shall be consistent with the exposure scenarios set out in the annex
to the Safety Data Sheet. ...
... If the substance or preparation covered by this safety data sheet is the subject of specific provisions in relation to protection of man or the environment at Community level (e.g. authorisations
given under Title VII or restrictions under Title VIII) these provisions shall, as far as is possible, be stated. ...
... - list of relevant R phrases. Write out the full text of any R phrases referred to under headings 2 and 3 of the Safety Data Sheet, ...
... - sources of key data used to compile the Safety Data Sheet. ...
... For a revised Safety Data Sheet, indicate clearly the information, which has been added, deleted or revised (unless this has been indicated elsewhere). ...
ARTICLE-VI: INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10 [go to this ARTICLE]
... 3.7. Uses advised against (see Safety Data Sheet heading 16) ...
... This information shall be consistent with that in the Safety Data Sheet, where such a Safety Data Sheet is required according to Article 31. ...
... This information shall be consistent with that in the Safety Data Sheet, where such a Safety Data Sheet is required according to Article 31. ...
... 5.1. First-aid measures (Safety Data Sheet heading 4) ...
... 5.2. Fire-fighting measures (Safety Data Sheet heading 5) ...
... 5.3. Accidental release measures (Safety Data Sheet heading 6) ...
... 5.4. Handling and storage (Safety Data Sheet heading 7) ...
... 5.5. Transport information (Safety Data Sheet heading 14) ...
... 5.6. Exposure controls/personal protection (Safety Data Sheet heading 8) ...
... 5.7. Stability and reactivity (Safety Data Sheet heading 10) ...
... 5.8.1. Disposal considerations (Safety Data Sheet heading 13) ...
ARTICLE-XII: GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS [go to this ARTICLE]
... The purpose of this Annex is to set out how downstream users are to assess and document that the risks arising from the substance(s) they use are adequately controlled during their use
for a use not covered by the Safety Data Sheet supplied to them and that other users further down the supply chain can adequately control the risks. The assessment shall cover the life-cycle of the substance, from its receipt by the
downstream user, for his own uses and for his identified uses further down the supply chain. The assessment shall consider the use of the substance on its own, in a preparation or in an article. ...
... The downstream user shall develop exposure scenarios for uses not covered in a Safety Data Sheet supplied to him in accordance with Section 5 of Annex I. ...
... If the downstream user considers the hazard and PBT assessments reported in the Safety Data Sheet supplied to him to be appropriate, then no further hazard assessment or PBT and vPvB assessment is necessary. In this case he shall use the relevant information reported by the supplier for the risk characterisation. This shall be stated in the Chemical Safety Report. ...
... If the downstream user considers the assessments reported in the Safety Data Sheet supplied to him to be inappropriate, then he shall carry out the relevant assessments in accordance with Sections 1 to 4 of Annex I as appropriate to him. ...
... On completion of any additional testing, the downstream user shall revise the Chemical Safety Report, and his Safety Data Sheet if he is required to prepare one, as appropriate. ...
... A risk characterisation shall be carried out for each new exposure scenario as prescribed in Section 6 of Annex I. The risk characterisation shall be presented under the relevant heading of the Chemical Safety Report and summarised in
the Safety Data Sheet under the relevant heading(s). ...
ARTICLE-FOOTNOTES: List of Footnotes [go to this ARTICLE]
... [58] Where the person responsible for placing the preparation on the market can demonstrate that the disclosure in the
safety data sheet of the chemical identity of a substance which is exclusively classified as irritant with the exception of those assigned
R41 or irritant in combination with one or more of the properties mentioned in point 2.3.4 of Article 10 of Directive 1999/45/EC,
or harmful or harmful in combination with one or more of the properties mentioned in point 2.3.4 of Article 10 of Directive
1999/45/EC presenting acute lethal effects alone, will put at risk the confidential nature of his intellectual property, he
may, in accordance with the provisions of Part B of Annex VI to Directive 1999/45/EC, refer to that substance either by means
of a name that identifies the most important functional chemical groups, or by means of an alternative name. ...
... [61] This information cannot be given for the preparation because it is substance specific. It should therefore be given,
where available and appropriate, for each constituent substance in the preparation which is required to be listed in the Safety Data Sheet according to the rules under Section 3 of this Annex. ...