Volete cercare la domanda e risposta pertinente nella vostra lingua? Basta cambiare la lingua nel menu a tendina in alto.
- The risk management measures for the identified uses with regard to human health and the environment are to be summarised in section 8 (and 7). This includes consumer related measures communicated to a downstream user producing consumer preparation or articles. Also the relevant Derived No-Effect Levels (DNELs) and Predicted No-Effect Concentrations (PNECs) should be presented here.
- The information on physicochemical properties, toxicology and eco-toxicology in the SDS is to be updated in line with the information requirements of Annex VI to XI of the REACH Regulation.
- The results of the PBT and vPvB assessment are to be presented in section 12.
- The information on uses advised against in section 16 of the SDS may need to be updated depending on the outcome of the manufacturer's Chemicals Safety Assessment (CSA).
- Where Exposure Scenarios (ES) are developed as a result of conducting a chemical safety assessment in accordance with Article 14 of the REACH Regulation they must be annexed to the SDS and thereby be appropriately passed down the supply chain. The information on uses of the substance in section 1.2 of the SDS must be consistent with the short titles of the ES in the annex, indicating which uses are covered by the ES.
- Since REACH includes a requirement to include the waste disposal considerations into the manufacturer's chemicals safety assessment, section 13 of the SDS may need to be updated with substance specific waste management advice as contained in the ES.
According to Article 31(5) of the REACH Regulation, the safety data sheet (SDS) shall be supplied in an official language of the Member State(s) where the substance or mixture is placed on the market, unless the Member State(s) concerned provide otherwise. Placing on the market means supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market (Article 3(12) of the REACH Regulation).
The above also applies to exposure scenarios, which are a part of an SDS. A document listing the languages required for safety data sheets and labels within the EU is available at http://echa.europa.eu/documents/10162/13562/languages_required_for_labels_and_sds_en.pdf
For a substance or mixture requiring a Safety Data Sheet (SDS) according to Article 31 of the REACH Regulation, Annex II of REACH requires that the registration number assigned in accordance with Article 20 of REACH be given in the SDS when it is available. Article 31(9) of REACH gives specific occasions on which an updated SDS should be supplied without delay. Receipt of a registration number per se is not listed as one of these occasions. However as the assignment of a registration number is of major potential interest to downstream users of the substance it may be recommendable to send existing customers an updated SDS either immediately or on the next supply of the substance or of a mixture containing it. The SDS should of course be updated to incorporate the registration number(s) for customers who are going to receive the substance or mixture for the first time. Note in particular that the final sentence of Article 31(9) requires that "any updates following registration shall contain the registration number". Please note that there are detailed provisions in Regulation (EU) No 453/2010 amending Annex II to the REACH Regulation regarding when the part of the registration number referring to the individual registrant of a joint submission (the last four digits of the original full registration number) may be omitted by a supplier who is a distributor or a downstream user.
Similarly, Article 32(1)(a) of REACH indicates that when registration numbers have to be communicated to customers according to Article 32 (Communication duties for substances and mixtures not requiring an SDS) the registration number, if available, should be supplied. The occasions on which an update without delay is required are given in Article 32(3) of REACH. Again, receipt of a registration number per se is not listed as one of these occasions. For similar reasons it may be deemed to be desirable to nonetheless send updated information. Note again that the last sentence of Article 32(3) of REACH also requires that "any updates following registration shall contain the registration number". Further guidance can be found in section 6.1.2-'Provide other information to customers' in the Guidance on Registration available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach.
The provisions of Articles 31 and 32 of REACH apply irrespectively of whether the relevant registration deadline is still to come or has already elapsed.
There is no obligation under REACH for suppliers of substances and mixtures meeting the criteria in Article 31 to provide a SDS to their non-EU customers. Article 31(1) refers to "recipients of the substance or mixture". Article 3(34) of REACH defines a "recipient of a substance or a mixture" as being downstream user or a distributor being supplied with a substance or a mixture. Both downstream users and distributors are, in line with their respective definitions in Article 3(13) and 3(14), natural or legal persons established within the Community. The obligation of Article 31 of REACH to provide an SDS therefore applies only to the recipients of the substance or mixture established in the EU.
However, it is notable that the obligation to provide a REACH compliant SDS to non-EU customers, in the context of export, may arise pursuant to other pieces of legislation. For example, Article 16(3) of Regulation (EC) No 689/2008 concerning the export and import of dangerous chemicals, implementing the Rotterdam Convention within the EU, requires companies exporting certain hazardous chemicals within the scope of this Regulation to provide a REACH compliant SDS when exporting them outside the EU.
No, it is not. Regarding section 2 of the SDS, either the full wording of the hazard classes or the hazard class and category code(s) may be used. If the full wording is used, it needs to be in the language of the SDS. If the hazard class and category code(s) are used, it is important to note that the abbreviations given for each hazard class are actually codes which cannot be translated. The codes must thus remain as they are given in Annexes VI and VII to CLP. If codes, other abbreviations and acronyms are used, their full text and explanation must be given in section 16 of the SDS, in the language of the SDS.
For mixtures, the codes as given in Annexes VI and VII to CLP can be used in section 3.2.3. Again, section 16 needs to contain the full wording.
No, manufacturers or importers do not have the obligation to inform downstream users that they have submitted a notification to the C&L Inventory. Furthermore, there is no need for downstream users to receive confirmation from upstream suppliers that substances have been notified to the C&L Inventory in order to continue the use of the substances in their own products. Similar to the REACH pre-registration number, the C&L notification number is for internal use for the importer/manufacturer as receipt/proof of notification. It does not need to be communicated to the DU/distributor.
A notification number cannot be considered as an identifier according to Article 18 CLP and it is not the inventory reference number published in the C&L Inventory.
Substances e.g. pre-registered, inquired or notified to the C&L Inventory with only a CAS number or without any numerical identifier are automatically assigned a list number. In contrast to the EINECS, ELINCS and NLP entries, the list numbers and the list inventory are not based on a legal act or requirement, and they have not been published in the Official Journal of the European Union. Therefore, the list numbers do not have the same significance as EC numbers but have only the numerical format in common. Most importantly, the vast majority of list numbers and their connected substance identification have never been checked for correctness, validity or whether the conventions outlined in the Guidance for Identification and naming of substances under REACH have been kept.
Therefore, industry is advised not to use list numbers in their documents.
However, when a supplier wishes to include a list number on a document, e.g. Safety Data Sheet, it shall be clearly indicated that this number is not an EC number and has no legal significance.
Distributors/formulators can truncate the registration number (omit the last four digits) of their suppliers' registration numbers in the SDS in accordance with points 1.1 and 3.2.4 of Annex II of REACH.
The first part of the registration number is the same for a given substance if the registrants have jointly submitted their registrations. Therefore, only one truncated registration number needs to be included. However, if a registrant has not registered in the context of the joint submission, this registration number is different. Therefore, all relevant (truncated) registration numbers should be mentioned in the SDS.
For registered substances for which a Chemical Safety Report (CSR) is required, the information appearing in section 1.2 of the SDS needs to be in line with the identified uses in the CSR (under REACH, the definition of use goes beyond the chemical function) and the Exposure Scenario (ES) annexed to the SDS. Intuitive ES titles can be reported in section 1.2. When the use descriptor system is used in the ES, it is advised that, in section 1.2, the uses of the substance are described in a generic wording while remaining consistent with that of the use descriptor system. Reporting the use descriptor codes in section 1.2 is not recommended as it may lead to lengthy lists. The Process and Product Categories in the use descriptor system can be used as an indication.
For registered substances for which a CSR is not required (between 1-10 tonnes/year), substances not yet registered or not subject to registration (e.g. below 1 tonne/year or listed in Annex IV or V) and mixtures, the intended uses known to the supplier need to be indicated, with a brief description of what the substance or mixture is intended to do, such as "flame retardant in textile fibres", "antioxidant in paints, cosmetics, detergents", etc.
For downstream users in a supply chain who must generate their own safety data sheets for products procured from within the EEA, the main source of information should be the supplier. Using information from the supplier will ensure that any specific, detailed information is reviewed and included as appropriate.
In addition, use may be made of publicly available information that is not restricted by copyright or any confidentiality protections. It should be noted that, as stated in ECHA's legal notice, reproduction or further distribution of the information from the registration dossiers may be subject to copyright protection and that the use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Moreover, the legal notice emphasises that the Agency cannot guarantee the correctness of the information in the databases and REACH does not permit the Agency to make modifications to the data provided by the owner(s) of the respective information.
It should be noted that the supplier of the Safety Data Sheet is responsible for the accuracy of its contents in all cases.
Where an Exposure Scenario (ES) is developed as a result of conducting a chemical safety assessment as required by Article 14 or 37(4) of the REACH Regulation, it must be annexed to the safety data sheet (SDS), provided it is relevant for the customer.
According to Article 31(9) a supplier shall update his SDS without delay as soon as new information which may affect the risk management measures or new information on hazards becomes available. An ES is considered to be such new information, which normally triggers the need to update a SDS as soon as it becomes available. The SDS with annexed ES resulting from this update has to be provided without delay to all customers who have been supplied with the particular substance or mixture within the preceding 12 months. This provision applies since the entry into force of the REACH Regulation and irrespectively of whether the substances are registered or not.
Where the information in an ES that becomes available does not affect the risk management measures and the ES contains no new information on hazards, the SDS does of course not have to be updated.
Yes, if the conditions of Article 31(1) of the REACH Regulation are fulfilled, the supplier of a biocidal product that is a substance or a mixture must provide the recipient with a safety data sheet.
When a formulator produces a biocidal product, the relevant safety measures (or restrictions on use) indicated in the product authorisation should be communicated down the supply chain (with the SDS, where required).
An active substance which is either approved under the BPR at EU level or part of the BPR Review Programme, is considered as registered under REACH only for the use in a biocidal product.
There is no requirement to attach an exposure scenario to the SDS for the active substance used in a biocidal product. REACH exposure scenarios may, nevertheless, be received for co-formulants in the biocidal product. The formulator needs to take into account the relevant information in these exposure scenarios in the SDS, where required.
(See also BPR Q&A 908).
Yes, the SDS format can be used. Suppliers, who do not have to supply an SDS may be obliged to provide certain information in accordance with Article 32 of the REACH Regulation or they may chose to provide a SDS on a voluntary basis. They may use the SDS format to provide such information. In such cases, it is recommended that it is clearly stated that the SDS is not provided pursuant to Article 31 of REACH, but to facilitate the communication of information.
The suppliers of a substance or a mixture may also choose to provide information in the safety data sheet format even if they are not obliged to provide any information under Articles 31 or 32 under REACH. In this case, they should also clarify that the SDS is not provided pursuant to Article 31 of REACH, and then explain why they provide it.Among possible solutions would be the addition to the relevant SDS of a phrase such as ‘A safety data sheet is not required for this product under Article 31 of REACH’.
Yes it can if the information provided in the SDS fulfills the requirements of Annex II of REACH for each of those substances or mixtures. However, this condition can only be fulfilled in cases of minor variations of a substance or a mixture, for example for minor concentration changes of impurities or components, due to which the hazard profile does not change. A single SDS cannot be used for totally different substances or mixtures.
While it is not legally required under Annex II of the REACH Regulation to include EUH statements for substances in a mixture in section 3.2 of the SDS, it would be advisable and good practice to include those substances assigned a physical and health property as set out in Part 1 of Annex II and Table 1.2 of Annex VII as these were translated from risk phrases assigned under Directive 67/548/EEC e.g. EUH032. Furthermore, it would also be advisable and good practice to include these EUH statements in Section 2.1 and 2.2 of the SDS. For other EU hazard statements it is only necessary to include them in Section 2.2 of the SDS.
Note: COM may need to consider including provision for EU hazard statements relating to supplemental hazard information taken over from Directive 67/548/EEC in the next update of Annex II of REACH.
Yes, you do. The obligation to mention any European or national occupational exposure limits (OELs) is not connected to the physical form or to the classification of the mixture, or even to the fact that the mixture can be considered as a special mixture. Where an OEL exists for any constituent substances, you must indicate these in Section 8 of the safety data sheet (SDS).
An SDS must enable employers 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.
It should also be taken into account that a user might use the paste in a way that it undergoes further processing.
According to Article 119(2)(d) of the REACH Regulation, ECHA has to make the information which is contained in the safety data sheet, and which is not already disseminated under other articles of REACH1 available over the internet, unless the registrant successfully claims confidentiality. Since a copy of the safety data sheet document as such is not part of the data
submitted to ECHA, it has been determined which information has to be listed in both the safety data sheet (as set out in Annex II of REACH) and the registration dossier (as set out in Article 10 and Annexes I and VI of REACH). Information meeting both criteria that is not already disseminated for other reasons (in accordance with Article 119 of REACH) is considered
to be “safety data sheet information”.
- registration number;
- registrant name;
- life cycle description and uses advised against information;
- exposure scenario elements;
- result of the PBT (Persistent, Bioaccumulative and Toxic chemicals) and vPvB (very Persistent and very Bioaccumulative) assessment;
- indication of whether a chemical safety assessment (CSA) was performed.
In the questions that follow, it will be explained in detail which data is concerned and how the data can be claimed confidential in IUCLID 5.4.
Safety data sheet information is disseminated from all registration dossiers, whether the substance requires a safety data sheet or not, unless claimed confidential. It should be stressed that confidentiality needs to be claimed separately for each item, using the confidentiality flags in the IUCLID dossier. In dossiers for substances which do not require a safety data sheet, it is deemed that the registrant ‘volunteers’ the safety data sheet information for publication if the information is not claimed confidential.
The information is disseminated on the ECHA website in the section on Registered Substances, at http://echa.europa.eu/web/guest/information-on-chemicals/registered-substances.
Confidentiality claims on safety data sheet information are only charged if the substance requires a safety data sheet. The fee for confidentiality claims on safety data sheet information is detailed in Annex IV of the Fee regulation. The fee is charged only once per registration, regardless of the number of confidentiality claims on some or all of the specific items of SDS information. If the fee has been charged once, subsequently placed confidentiality claims on safety data sheet information will not be charged anymore. However, a specific justification for each of the types of information claimed confidential is still required.
It should be noted that confidentiality claims on the PBT assessment (section 2.3), on exposure scenarios and local assessment (section 3.7.1), and on whether a CSA was performed (section 13) are invoiced if the substance requires a safety data sheet and the registrant submits a CSR. As an example, if in a joint submission the lead registrant provides the CSR on behalf of the members, only the lead will be invoiced for the before mentioned specific sections (i.e. provided that in the member dossier it is indicated that the CSR is submitted by the lead on behalf of the member). If a member individually submits the CSR, they will be charged for all potential SDS confidentiality claims (including sections 2.3, 3.7.1 and 13) as described above.
If the substance does not require a safety data sheet, it is deemed that the confidentiality claim indicates that the registrant does not volunteer the publication of the information, and no fee is charged for keeping this information confidential. Registrants can verify whether they will be charged for a confidentiality claim on safety data sheet information using the Fee Calculation plug-in in IUCLID (see also question 11 below). Confidentiality claim on safety data sheet information for monomers
According to the REACH Regulation polymers are exempted from registration. However monomer substances have to be registered under certain circumstances. A safety data sheet is needed for the monomer substance if it meets the relevant hazard criteria and it is placed on the European market. A safety data sheet for monomer substances is not required in the following situations:
1) When the monomer is only imported as part of a polymer (as such or in a mixture).
2) When the monomer is synthesized into the polymer directly by the manufacturer.
Consequently, a fee does not apply in these cases even if the safety data sheet related information is claimed confidential. In all other cases, a safety data sheet would be required for the monomer, as it will be made available from the manufacturer to a third party, and a fee would apply if the confidentiality on the safety data sheet is claimed.
In the case you as a registrant receive an invoice for a confidentiality claim on safety data sheet information for a monomer which is covered by the situations described above, please contact ECHA Helpdesk (http://echa.europa.eu/web/guest/contact) explaining your situation. ECHA will analyse your case and provide you with instructions on how to proceed. The same applies for other substance(s) in the form of monomeric units and chemically bound substance(s).
You do not need to indicate whether the substance requires a safety data sheet. REACH-IT will determine this and consequently whether a confidentiality claim needs to be invoiced or not. For determining whether the substance requires a safety data sheet, REACH-IT is verifying in the registration dossier if the conditions set out in Article 31 of REACH are met:
- the substance is classified as hazardous according to the CLP Regulation2; and/or
- the substance is PBT or vPvB; and/or
- the substance is listed on the candidate list;
- and it concerns a full registration or a registration for a transported isolated intermediate.
Relevant information concerning the dissemination of the safety data sheet information can be found in the manual on Dissemination and confidentiality under the REACH Regulation at: https://echa.europa.eu/manuals.
The technical annexes to the manual are detailed with screenshots of the entire registration dossier on which information will be disseminated. The manual also gives instructions on how to write justifications for confidentiality requests.
ECHA has also developed a series of IUCLID plug-ins to help registrants preparing their dossiers. These plug-ins are available in IUCLID 6 software. Relevant plug-ins concerning the dissemination of safety data sheet information are:
- the Dissemination IUCLID plug-in, which simulates which information from the registration will be made available on the ECHA website.
- the Fee Calculation IUCLID plug-in, which allows registrants to verify whether they will be charged for a confidentiality claim on safety data sheet information and calculates all fees associated to a registration.
There can be several reasons why the SDS for a substance does not include exposure scenarios:
- Substance is not registered yet;
- Substance is registered below 10 tonnes per year;
- Substance is registered as an intermediate;
- The SDS is provided on a voluntary basis;
- The SDS is required, but the registrant was not obliged to carry out an exposure assessment according to Article 14(4) REACH;
If the SDS you receive is for a mixture containing one or more registered substances, the reason you did not receive exposure scenarios could be that the relevant information from the exposure scenario is incorporated in the main body of the SDS or in an annex for the mixture (also called SUMI, Safe Use of Mixture Information).
Follow the safety advice in the SDS unless it is inappropriate. In such an event, you are obliged to inform your supplier of the reason why you consider their advice to be inappropriate. Contact your supplier if you think that an exposure scenario should have been provided.