Expert Q&A: James Calder on SDSs

Inside Cosmeceuticals conducted a Q&A with James Calder, manager for the global regulatory services group at Intertek, regarding safety data sheets (SDSs) for substances registered under REACH in order to ensure compliance with Regulation (EU) No. 453/2010.

IC: As of Dec. 1, 2010 Annex II of REACH replaced by Annex I of Regulation (EU) No 453/2010. What changes were made to the layout and content of Safety Data Sheets (SDS)?  What is staying the same?

A: The overall layout of SDS stays the same. There are some detail changes in content of SDS that are listed as follow: identification of substance or mixture and company; hazards identification; composition & information on ingredients; handling and storage; exposure controls/personal protection (If CSR is required); Section 11, 12: toxicological information and ecological information; and regulatory information.

IC: What do these changes mean for companies in the supply chain?

A: Although REACH required SDS needed to be available as of June 2007—but after CLP regulation took place—Annex II of REACH replaced by Annex I of regulation (EU) No 453/2010 and products will need to be reclassified under the new CLP (classification, labeling and packaging ) regulations in a transitional period starting December 2010.

IC: What is an Exposure Scenario?

A: Exposure scenarios are a set of conditions that describe how a substance can be safely handled to control exposure to human health and the environment. This includes operational conditions (e.g., the duration and frequency of use or the amount used, the process temperature or the pH) and necessary risk management measures (e.g., local exhaust ventilation or a certain type of glove, waste water and gas treatment). Exposure scenarios need to be developed to cover all “identified uses" of the substance/mixture in each step of the supply chain to ensure the risks from the uses of the substance/mixture are adequately controlled for every actor in the supply chain (e.g., manufacturer, importer and downstream users). An exposure scenario is required for substances that are manufactured or imported in quantities of 10 tonnes or more per year, and are classified as dangerous or as PBT/vPvB (persistent, bioaccumulative or toxic/or very[vPvB]).There is more information on exposure senarios below.

IC: Who is affected by these changes?

A: Each actor in the supply chain. In other words, any supplier, whether it is a manufacturer, importer, only representative, downstream user or distributor shall update their SDS according to the Annex I of Regulation (EU) No 453/2010, whenever is applicable.

IC: What substances apply to the extended Safety Data Sheet (eSDS), i.e., an updated SDS? 

A: A substance that requires a chemical safety assessment (CSA) and chemical safety report (CSR; more than 10 tones/year) and is classified as hazardous under CLP guidelines; or a substance of very high concern (SVHC) in a concentration greater than or equal to 0.01 percent w/w; or PBT/vPvB apply to the eSDS (some hazards are exempt, i.e., flammable liquids. Details can found in Article 58 of CLP).

A more in-depth summary is included below:

First and foremost, each customer will need to understand whether their product is a substance, a mixture or an article because this will determine timelines and data required in the SDS.

SDS requirements under the following circumstances:  

When “you" supply (import) a substance or a mixture at or before the first delivery that is:

• (a) substance or a mixture that is classified as dangerous under Dangerous Substances Directive 67/548/EEC or Dangerous Preparations Directive, 1999/45/EC or classified as hazardous under the CLP Regulation (EC) No 1272/2008; or
• (b) a substance that is PBT or vPvB as defined in Annex XIII of REACH; or 
• (c) a substance that included in the European Chemicals Agency’s Candidate List of SVHC for reasons other than (a) and (b) given here.

When you are a supplier (importer) and your customer requests:

• (a) a substance posing human-health or environmental hazards in an individual concentration of greater than or equal to 1 percent by weight for mixtures that are solid or liquids (i.e., non-gaseous mixtures) or greater than or equal to 0.2 percent by volume for gaseous mixtures; or
• (b) a substance that is PBT or vPvB in an individual concentration of greater than or equal to .1 percent by weight for mixtures that are solid or liquids (i.e., non-gaseous mixtures); or
• (c) a substance on the Candidate List of SVHC (for reasons other than those listed above), in an individual concentration of greater than or equal to 0.1 percent by weight for non-gaseous mixtures; or
• (d) a substance for which there are Europe-wide workplace exposure limits. If you are a supplier to EU countries other than the U.K., then you may need to supply a SDS for substances or mixtures that are not classified as dangerous where they have relevant national workplace exposure limit values.

When you are a supplier of a product listed as a “special case" in paragraph 1.3 of Annex 1 of the CLP Regulation (EC) No 1272/2008 for which there are unique labeling criteria,  e.g., gas containers intended for propane, butane or liquefied petroleum gas.

The SDS will need to be updated immediately if:

1. A registration number is required to be added;
2. The “identified use(s)" and “uses advised against" are identified and added;
3. Exposure scenarios, including any risk management measures, should be added when available. The information in the SDS should be consistent with the information in the CSR for that substance or mixture, if a CSA for the mixture is available;
4. The DNEL (derived no effect level) or PNEC (predicted no effect concentration) is available for hazardous substances from Dec. 1, 2010 and for hazardous mixtures from Dec. 1, 2015;
5. New hazard information or information that may affect the risk management measures becomes available, if the CLP regulation changes the classification, once an authorization under REACH is granted or refused, or once a restriction under REACH has been imposed.

Exposure Scenarios (from CRS) shall be annexed to SDS after REACH registration is completed. 

Exposure Scenario (ES) means the set of conditions, including operational conditions and risk management measures, that describe how the substance is manufactured or used during its life-cycle, and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment.

Note 1: eSDS is only required for substances that are sold in quantities of more than 10 tonnes per year and are classified as dangerous.

Note 2: eSDS could reach hundreds of pages. When customers receive an eSDS, they will need to identify the relevant ES(s) for their own particular uses. If their uses are not covered, they will need to develop their own ESs.

The changes of SDSs are outlined as below:

    1.  Section 1: Identification of substance or mixture and company:

• Registration No. is required (when available);
• Identified uses of the substance/mixture is added;
• Email address of competent person is needed;

    2.  Section 2: Hazards identification: 

• Distinguish between mixtures that are and are not hazardous;
• Mention other hazards that do not result in classification (e.g., dustiness, ozone depletion);
• Classification as in Title V CLP and DSD(see note);

    3.  Section 3: Composition & information on ingredients:

• All substances classified as hazardous or those with ELVs or PBT/vPvB need to be reported;

    4.  Section 7: Handling and storage:

• Where CSR required, information to be consistent with ES;
• Under "Handling" include measures to protect environment;
• New section on "Specific uses";

    5.  Section 8: Exposure controls/personal protection (If CSR is required):

• DNELs and PNECs for substance shall be provided;
• Summary of Risk Management Measures(RMM) shall included for identified uses as set out in ES;

     6.  Section 11, 12: Toxicological information and Ecological information:

• Summaries of toxic tests and ecological tests need to be provided;

    7.  Section 15: Regulatory information:

• Indicate if CSA has been carried out;
• Indicate if substance subject to authorization/restriction;

    8.  Section 16: Other information:

• Full text of R phrases (hazard statements) to be listed;
• Upon revision, indicate information added/deleted/revised.

Note: From Dec. 1, 2010, until June 1, 2015, substance shall be classified in accordance with both 67/548/EEC(DSD) and CLP regulation.