To achieve compliance with the European Union’s Registration, Evaluation and Authorization of Chemicals (REACH), it is essential that you follow these steps:
1 Understand REACH requirements
Published on December 18, 2006, EU REACH Regulation (EC) No.1907/2006 sets out new requirements for the control of chemicals throughout the EU. While some provisions went into effect on June 1, 2007, the regulation is being implemented in phases over ten years.
REACH affects all companies with European production or distribution of chemical substances, as well as all companies that import into Europe. In order to comply with REACH and with the new EU Globally Harmonized System of Classification and Labeling of Chemicals (GHS) Regulation, companies need to: identify / categorize substances and tracking volumes (substance information management); register substances; update material safety data sheets and produce extended (M)SDS; communicate up and down the supply chain — identifying and describing uses of the substances and distributing REACH-compliant (M) SDSs; check if any substances are restricted or require authorization; and classify substances and submit information to the European Chemicals Agency (ECHA).
Import into or manufacture in Europe is not allowed if the manufacturer or importer does not register (for substances above one ton). The fact that another company has registered the same substance is not sufficient. Registration must be done by each manufacturer and importer.
Since the pre-registration deadline has passed, registration must happen immediately unless import or manufacture has not taken place in the past. The ECHA Web site states: “Late pre-registration does not apply to companies that failed to meet the preregistration deadline of 1 December 2008 for their substances. These companies cannot continue producing or importing the substances until they have submitted a full registration dossier.”
2 Develop an accurate inventory
Under REACH, obtaining and maintaining raw material safety data sheets (SDS) and the full composition of mixtures helps companies establish which category (manufactured within the EU, imported into the EU or purchased from a supplier within the EU) individual substances fall into. Companies must also identify each substance’s tonnage and current classification.
3 Conduct annual master inventories
A master inventory should be conducted annually in each specific location/department. Each purchase or disposal must be tracked and the inventory updated regularly. Environmental Health and Safety (EHS) supervisors should have pre-purchase review and approval rights for any new product or chemical. Inventories from separate locations within an organization should be rolled into a corporate-level inventory to ensure consistency in process and purchasing.
The location of each product or chemical must be recorded along with the container size and quantity of the material, the name of the product or chemical, the name of the company that made the product or chemical and any manufacturer’s part numbers or descriptions. This basic data will enable EHS staff to match the item to an MSDS, thus providing the critical data needed for reporting and exposures.
4 Determine impact analysis
Once you have a chemical inventory, establish which category individual substances fall into (manufactured within the EU, imported into the EU or purchased from a supplier within the EU). Convert information about the full composition of mixtures into information at the substance level. For manufacturers who need to create a list of substances in their product inventory that are either exempt or require registration, this impact analysis is critical. Manufacturers must check the REACH lists and compare the lists against their product inventory to identify which substances are affected.
5 Track substance volume
The volume in which the substances are used is also part of the requirement. By tracking the volume for each mixture, manufacturers can de-formulate any product/mixture and show the tonnage and classification for each substance. The manufacturer needs an accurate, at-a-glance view of which substances may be affected and the associated registration deadlines based on REACH tonnage bands.
6 Ensure supply chain communication
For downstream chemical end-users, an important aspect of REACH is ensuring that products/substances used in your facilities are registered by the manufacturer/ importer. If the supplier of a substance has not registered the substance, or does not intend to register it for your specific use, you will need to locate an alternate source of this material. Downstream users should generate and review reports with lists of substances by product and manufacturer and the required use.
7 Match substances to MSDSs
Once an accurate inventory is obtained, each item should be associated with a manufacturer-specific MSDS. To do this, the company should contact suppliers for the appropriate MSDS for each country in the appropriate languages.
Manufacturers must write accurate and compliant MSDSs for their manufactured products. For higher volume substances, they must attach an exposure scenario for each substance in the chemical product or mixture that describes how it can be used safely, with no risk, for the intended use. They must also ensure that their management system can accommodate the newly formatted MSDSs and must train employees to interpret them.
8 Streamline the process
To use an electronic MSDS management or inventory- building tool, look for a solution that supports your REACH-compliance efforts; offers easy, step-by-step instructions; allows users to build an inventory of MSDSs specific to multiple individual locations; allows users to update, add, or delete products from their catalog; lets users run reports and provides real-time materials inventories in both summary and detail format; and lets you create and add custom fields.
