Questions and Answers

GLOBALLY HARMONIZED SYSTEM OF CLASSIFICATION AND LABELLING OF CHEMICALS (GHS). Fifth revised edition, UNITED NATIONS, 2013, PART 1 INTRODUCTION, CHAPTER 1.5 HAZARD COMMUNICATION: SAFETY DATA SHEETS (SDS), 1.5.1 The role of the safety data sheets (SDS) in the harmonized system:

1.5.1.1 The SDS should provide comprehensive information about a substance or mixture for use in workplace chemical control regulatory frameworks. Both employers and workers use it as a source of information about hazards, including environmental hazards, and to obtain advice on safety precautions. The information acts as a reference source for the management of hazardous chemicals in the workplace. The SDS is product related and, usually, is not able to provide specific information that is relevant for any given workplace where the product may finally be used, although where products have specialized end uses the SDS information may be more workplace-specific. The information therefore enables the employer (a) to develop an active programme of worker protection measures, including training, which is specific to the individual workplace; and (b) to consider any measures which may be necessary to protect the environment.

1.5.1.2 In addition, the SDS provides an important source of information for other target audiences in the GHS. So certain elements of information may be used by those involved with the transport of dangerous goods, emergency responders (including poison centers), those involved in the professional use of pesticides and consumers. However, these audiences receive additional information from a variety of other sources such as the UN Recommendations on the Transport of Dangerous Goods, Model Regulations document and package inserts for consumers and will continue to do so. The introduction of a harmonized labelling system therefore, is not intended to affect the primary use of the SDS which is for workplace users.

REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, TITLE IV INFORMATION IN THE SUPPLY CHAIN, Article 31 Requirements for safety data sheets

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

а) where a substance or mixture meets the criteria for classification as hazardous in accordance with Regulation (EC) No 1272/2008;

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).

REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, TITLE IV INFORMATION IN THE SUPPLY CHAIN, Article 31 Requirements for safety data sheets

3.The supplier shall provide the recipient at his request with a safety data sheet compiled in accordance with Annex II, where a mixture does not meet the criteria for classification as hazardous in accordance with Titles I and II of Regulation (EC) No 1272/2008, but contains:

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

(b) in an individual concentration of ≥ 0,1 % by weight for non-gaseous mixtures at least one substance that is carcinogenic category 2 or toxic to reproduction category 1A, 1B and 2, skin sensitiser category 1, respiratory sensitiser category 1, or has effects on or via lactation or is persistent, bioaccumulative and toxic (PBT) in accordance with the criteria set out in Annex XIII or very persistent and very bioaccumulative (vPvB) 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.

REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, TITLE I GENERAL ISSUES, CHAPTER 2 Definitions and general provision, Article 3 Definitions

32. supplier of a substance or a mixture: means any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a mixture, or a mixture;

REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, TITLE IV INFORMATION IN THE SUPPLY CHAIN, Article 31 Requirements for safety data sheets

where:

13. downstream user: means any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. A re-importer exempted pursuant to Article 2(7)(c) shall be regarded as a downstream user;

14. distributor: means any natural or legal person established within the Community, including a retailer, who only stores and places on the market a substance, on its own or in a mixture, for third parties;

Guidance on the compilation of safety data sheets, Version 3.1 November 2015, 2.2 Responsibility for the content of an SDS

Where there is a chain of supply, the requirements of REACH in relation to the provision of safety data sheets apply at each stage of the supply chain. The initial responsibility for drawing up the safety data sheet falls on the manufacturer, importer or only representative who should anticipate, so far as it is reasonably practicable, the uses to which the substance or mixture may be put. Actors further down the supply chain should also provide a safety data sheet, drawing on, checking the adequacy of, and adding to, the information provided by their suppliers to cater for the specific needs of their customers. In all cases, suppliers of a substance or a mixture which requires a safety data sheet have the responsibility for its contents, even though they may not have prepared the safety data sheet themselves. In such cases, the information provided by their suppliers is clearly a useful and relevant source of information for them to use when compiling their own safety data sheets. However, they will remain responsible for the accuracy of the information on the safety data sheets they provide (this also applies to SDSs distributed in languages other than the original language of compilation).

REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, TITLE IV INFORMATION IN THE SUPPLY CHAIN, Article 31 Requirements for safety data sheets

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.

REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, TITLE I GENERAL ISSUES, CHAPTER 1 Aim, scope and application, Article 2 Application

6. The provisions of Title IV shall not apply to the following mixtures in the finished state, intended for the final user:

(a) medicinal products for human or veterinary use, within the scope of Regulation (EC) No 726/2004 and Directive 2001/82/EC and as defined in Directive 2001/83/EC;

(b) cosmetic products as defined in Directive 76/768/EEC;

(c) medical devices which are invasive or used in direct physical contact with the human body in so far as Community measures lay down provisions for the classification and labelling of dangerous substances and mixtures which ensure the same level of information provision and protection as Directive 1999/45/EC;

(d) food or feedingstuffs in accordance with Regulation (EC) No 178/2002 including use:

I. as a food additive in foodstuffs within the scope of Directive 89/107/EEC;

II. as a flavouring in foodstuffs within the scope of Directive 88/388/EEC and Decision 1999/217/EC;

III. as an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003;

IV. in animal nutrition within the scope of Directive 82/471/EEC.

Guidance on the compilation of safety data sheets, Version 3.1 November 2015, 2.21 Possible compilation of an SDS for substances and mixtures even when not legally required

From marketing and/or logistical aspects it may in certain cases be useful for suppliers to have SDS available for all substances and mixtures, including those for which there is no legal obligation to provide an SDS. In such cases it may be desirable to indicate in the document that the substance or mixture does not legally require an SDS to avoid unnecessary compliance and conformity issues arising.