REACH (the Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals), a European Union (EU) law that took effect on June 1, 2007, is designed to streamline and improve the regulation of chemicals in the EU. For example, it requires industries to use a classification and labelling system to create Safety Data Sheets (SDSs) to communicate information about the environmental and health risks of the chemicals they sell, import, export or distribute so that people, including workers, can safely use products containing these chemicals.
Why should Canadian companies care about a European law? Because REACH applies to not only manufacturers and importers located in the EU but also manufacturers that make their products available to consumers in the EU. So if your company sells, exports or distributes any of the designated chemicals or chemical mixtures in Europe, it must comply with REACH. This article explains what Canadian EHS coordinators need to know about SDS requirements to keep their companies in compliance with REACH.
REACH SAFETY DATA SHEET TEMPLACE: Download a REACH-compliant SDS template that you can use to create such SDSs for chemicals your company sells, distributes or exports to the EU.
HOW TO COMPLY
The box on page X explains how the REACH law works and who and what it covers. Safety coordinators need to know about the SDS requirements. Specifically, there are five questions you need to be to answer to ensure your company’s compliance:
1. When Is an SDS Required?
The basic rule is that suppliers of substances and preparations, including manufacturers, must provide an SDS to their customers when supplying a designated dangerous substance or preparation. Suppliers must also provide an SDS when supplying substances that are classified as persistent, bio-accumulative and toxic (PBT) or very persistent and very bio-accumulative (vPvB), or preparations containing such substances.
2. What Information Must the SDS Include?
The information provided in an SDS must be consistent with that given in a chemical safety report, when one is required. When is a chemical safety report required? All manufacturers and importers of chemicals must identify and manage the risks linked to the substances they manufacture and market. But they don’t all have to prepare chemical safety reports. If manufacturers and importers produce or import substances in quantities greater than or equal to 10 tonnes/year, then they must perform chemical safety assessments to determine and demonstrate the safe use of a substance and include that information in a chemical safety report. They must also register with the ECHA and provide that report.
Insider Says: Exposure scenarios are used to assess the exposure to chemicals of humans and the environment and to identify the appropriate risk management measures. When exposure scenarios are developed as a result of conducting a chemical safety assessment, those scenarios must be attached to the SDS and passed down the supply chain. By doing so, the supplier informs his customer of the risk management measures that are implemented or recommended for safe use of the substance.
3. What Is the Appropriate Format for an SDS?
An SDS has to be supplied in the official languages of the countries in the EU in which the substance or preparation is placed on the market. The SDS should use a “16-point” format, based on GHS recommendations, that has the following headings:
1. Identification of the substance/mixture and the company/undertaking;
2. Hazard identification/assessment;
3. Composition/information on ingredients;
4. First aid measures;
5. Fire fighting measures;
6. Accidental release measures;
7. Handling and storage;
8. Exposure controls/PPE;
9. Physical and chemical properties;
10. Stability and reactivity;
11. Toxicological information;
12. Ecological information;
13. Disposal considerations;
14. Transport information;
15. Regulatory information; and
16. Other information.
REACH SAFETY DATA SHEET TEMPLATE: Download a REACH-compliant SDS template that you can use to create such SDSs for chemicals your company sells in or exports to the EU.
4. When Must an SDS Be Updated?
An SDS must be updated if:
- New data become available on hazards or which may affect the risk management measures;
- The substance’s classification is new or revised;
- An authorisation is granted or refused; or
- A restriction is imposed.
Any new or revised classification, including any changes of specific concentration
limits or M-factors for substances, should be included in Sections 2, 3 and 15. The full
text of a new hazard statement should go in Section 16. You’ll also need to review the other sections of your SDS to ensure they’re consistent with the information on which the new or revised classification is based.
Example: You may have generated or identified new information about the physical, health or environmental hazards of your substance or mixture as part of the classification process. So review the information provided in Sections 9, 11 and 12
and include any appropriate new or updated information.
5. What Is the Deadline for Compliance with SDS Requirements?
There are two key deadlines for meeting SDS requirements:
- Dec. 1, 2010: After this date, all sections of required SDSs must be completed. When a company doesn’t have the necessary information for a section, it must state in the SDS that this information isn’t available; and
- June 1, 2015: All SDSs must be updated or rewritten to include information on mixtures.
For substances or mixtures that don’t require reclassification under the REACH process, existing SDSs will be valid until Nov. 30, 2012 for substances and May 31, 2017 for mixtures.
Complying with Canadian OHS and environmental laws is complicated enough. But for many companies, compliance obligations don’t stop at the border. Canadian companies may also have to comply with the OHS and environmental laws of other countries, especially if they sell or export hazardous substances to those countries. REACH is an example of a foreign law that impacts Canadian companies that sell certain chemicals or chemical mixtures to members of the EU. Although ensuring compliance with REACH’s requirements may seem like yet another burden for EHS coordinators, the good news is that some of the requirements, such as those for SDSs, are similar to requirements your company is already fulfilling.
WHAT THE LAW SAYS
REACH replaces about 40 laws across the EU. Some related laws, such as OHS laws for workers handling chemicals, haven’t been replaced by REACH and so continue to apply. The law also created the European Chemicals Agency (ECHA) to centrally coordinate and implement the overall process.
REACH applies to approximately 30,000 “substances”—that is, chemical elements and their compounds in their natural state or obtained by any manufacturing process. If two or more substances are mixed together forming a mixture or a solution, the term “preparation” is used. There are a few exceptions to the REACH requirements, including radioactive substances, waste and polymers. A few substances are exempted from some of the requirements when other equivalent legislation applies, such as substances used in medicinal products.
One of the key steps in the REACH process is communication in the supply chain. Suppliers of substances must pass on information on the health, safety and environmental properties and safe use of their chemicals to their downstream users through an SDS or other means. The communication requirements of REACH ensure that not only manufacturers and importers but also downstream users have enough information to use chemical substances safely. Downstream users may be:
- Formulators of preparations, such as paints, glues, detergents, plastics or rubbers;
- Users of chemicals, such as oils, lubricants and antifoams, in industrial processes;
- Professional users, such as car repair shops and cleaners; or
- Producers of items, such as electronic components, computers, toys or cars.
Distributors and consumers aren’t considered downstream users under REACH. But distributors must ensure that safety information is provided with the substances they sell and pass on relevant information within the supply chain.
Annex II of REACH spells out the requirements for SDS preparation and dictates when an SDS is needed, the language, formatting, etc. The REACH requirements for SDSs are modeled on—but not necessarily identical to—the second revision of the Globally Harmonised System of Classification and Labelling of Chemicals (GHS). (For more on the GHS, see Insider, May 2009, p. 1.)