The Requirement

Manufacturers and distributors of all sizes increasingly face challenges that result from globalization in the marketplace and changing international regulatory initiatives. For companies with European production or distribution of chemical substances, and companies that import into Europe, REACH significantly increases the complexity of maintaining compliance.

REACH (Registration, Evaluation and Authorization of Chemicals) is the EU regulatory framework for managing chemical substances in Europe. The long-awaited EU REACH Regulation (EC) No.1907/2006 was published on the 18th of December, 2006—setting out new requirements for the control of chemicals throughout the EU. While some provisions came into force on 1st of June, 2007, the regulation will be implemented in phases, spanning a period of more than 10 years with the final provision to be met in 2018.

Companies with European production or distribution of chemical substances and companies that import into Europe are affected by REACH and should go through several steps to comply with REACH, many of which 3E Company can support:

• Identify / Categorize Substances and Track Volumes (Substance Information Management)
• Pre-register
• Register
  • Participate in SIEFs
• Update Material Safety Data Sheets
  • Produce Extended (M)SDS
• Communicate up and down the supply chain
  • Identify and describe uses of the substances
  • Distribute REACH-compliant (M)SDSs
• Check if any substances are restricted or would require authorization
• Classify substances and submit information to the European Chemicals Agency (ECHA )

Define Your REACH Role

Non-EU manufacturers should understand the registration obligations of any EU importers they work with and help them to not miss the pre-registration deadline. If registration is required, they should be prepared to support the registration by having the hazard assessment/EU classification ready and up-to-date European (M)SDSs.

EU Manufacturers/Importers/Distributors should decide which substances to register and when. They should also consider substitution of most hazardous substances. Downstream Users in Europe should inform suppliers of use and also consider substituting the most hazardous substances with less hazardous substances wherever possible.

How 3E Company Can Help

REACH Compliance is no simple task. Companies are likely to seek assistance from a number of consultants and/or service providers throughout various adoption and implementation phases. There is no single "REACH Solution" that can be purchased that takes care of all aspects of REACH; however, companies that are impacted by REACH should seek assistance from providers who are well-versed in data and information as it relates to global EH&S regulations and who thoroughly understand the EU regulatory environment.

3E Company has spent more than two decades helping customers understand chemical, regulatory and compliance management. Data, information and professional expertise are at the very core of all the products and services we deliver. REACH is no exception. 3E Company offers a unique combination of tools and services that can help companies with the preparation process and with on-going compliance thereafter. As the regulation is adopted and implemented, 3E Company’s products and services will evolve to meet the demands of the market.

Substance Information Management

Ariel™ chemical and regulatory data fuels all the REACH support 3E Company offers. Ariel Content consists of a massive, aggregated collection of lists, legislation and compliance guides for regulated chemicals throughout the world at multiple levels of jurisdiction, including REACH. Lists of chemicals and substances will continue to be included as they are published by ECHA as well as physical, chemical, toxicological and eco-toxicological data as it is submitted and accumulated. The text of the regulation as well as REACH lists of chemical substances are available in Ariel WebInsight™, our online chemical regulatory compliance reference tool. Ariel REACH content can be used to categorize and identify substances, identify exemptions and as lists are published, search if a chemical is on a list or not. Access to existing IUCLID 4 substance dossiers is available as well and IUCLID 5 information will be included when possible.

Ariel data also includes multilingual phrases, which can be integrated into corporate systems, such as SAP® EHS Management. In-house authors can use the Ariel Multilingual ES (Exposure Scenario) Phrase Library to create eSDSs (Extended Safety Data Sheets) to meet REACH requirements.

Pre-registration and Registration Support

REACH Impact Analysis Using 3E Online®

Establishing which category individual substances in your chemical inventory fall into--manufactured within the EU, imported into the EU or purchased from a supplier within the EU-- can be a challenge if you don’t have a way to 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, the RegImpact module within 3E Online can help. It accesses the REACH lists maintained by Ariel WebInsight to enable users to compare the lists against their product inventory to identify which substances are impacted.

Ongoing Inventory Management and Volume Tracking Using 3E Online

Substance identification is only one piece of the REACH puzzle. The volume in which the substances are used is part of the requirement as well. By maintaining the mixture information within 3E Online®, manufacturers can utilize the REACH module to upload volume information into the application and produce reports that will de-formulate any product/mixture that is exported to, or manufactured in the EU, and show the tonnage and classification for each substance. The report provides an accurate, at-a-glance view of which substances may be impacted by REACH and the associated registration deadlines based on the various REACH tonnage bands.

Supply Chain Communication using 3E Online

If you are a downstream user, another important aspect of REACH is ensuring that the product/substance that is used within your facility will be registered by the Manufacturer/Importer. If your supplier of a particular substance you use in your products has not registered the substance, or does not intend on registering it for your specific use, you will need to locate an alternate source of material. 3E Online enables you to track these products and their associated uses. Downstream Users Reports provide a list of substances by product and manufacturer and your required use. This information can then be used to communicate with your suppliers.

Outsourced REACH Registration Services

3E Company employs industry professionals well versed in many areas of EH&S compliance, including REACH and GHS. The team can work collaboratively with a company to submit and collect data for late pre-registration, including the identification of substances to determine possible authorization requirements.

Third Party Representative Services

3E Company can act as a third party representative to EU companies for late pre-registration to prepare the documentation and help clients understand the process. As a third party representative, we act and participate on the company’s behalf in SIEFs (Substance Information Exchange Forums). This is helpful for companies who want to keep the fact that they use certain substances in their products confidential from competitors. 3E Company is listed on the pre-registration, protecting the company from disclosing their name during the registration process. Complying with REACH is ultimately the company’s responsibility, but 3E Company can provide valuable guidance to meet the complex requirements. 3E Company does not perform any work with the technical guidance document, or develop Chemical Safety Reports, but has established partnerships with consultancies to which we can refer you.

Non-EU companies must assign an Only Representative, which acts as the EU company importing the substances into the EU. If your company needs an Only Representative, 3E Company can refer you to one of our partners.

Authoring, Producing and Distributing Extended (M)SDSs

Outsourced Authoring Services

As companies consider the impact of REACH on their (M)SDSs for updates and/or new (M)SDSs, 3E Outsourced Authoring Services can alleviate some of the burden so that internal EH&S resources are able to focus on other aspects of REACH. 3E can support the additional information requirements for the Extended Safety Data Sheets as required by REACH. They can even author Exposure Scenarios for pure substances and components within a mixture for inclusion as a separate document, or attached to and integrated within part of the European eSDS. 3E's own multi-lingual staff create, analyze and manage globally compliant (M)SDSs, product label content and hazardous materials transportation documents covering regulatory and language requirements for dozens of countries, including EU members.

For in-house Authoring Staff: MSDgen

For companies with in-house EH&S staff that needs to effectively manage the complexities of issuing REACH-compliant (M)SDS, our MSDgen enterprise authoring software system can help. MSDgen stores registration details and automatically recognizes exemption status based on the data retrieved from the regulatory data content source (Ariel). MSDgen also enables authoring of the required Exposure Scenarios, which specify the conditions under which the substance or preparation can be used safely, for uses that have been identified. The system has powerful features that leverage data for multiple uses, enabling significant increased efficiency and productivity of authoring staff.

MSDgen’s REACHsync™ mechanism enables the user to export data into a IUCLID5 compatible file format. Information residing in MSDgen may be transferred to the local IUCLID5 database for subsequent uploading to REACH-IT. This includes physical and chemical properties, toxicological and ecological data. In addition, data residing in IUCLID5 may be transferred to MSDgen for inclusion on the (M)SDS.

Downstream Supply Chain Communication: (M)SDS Distribution

3E Company offers a variety of products and services to ensure that REACH-compliant (M)SDSs are published, distributed, and retrieved by downstream users, resulting in cost savings, increased efficiency and improved compliance.

Still don't know where to start?

3E Company can help identify specific responsibilities and establish an action plan for your company to execute. Contact us today.

Each of 3E's services comes with a variety of options and enhancement modules that can be integrated into the leading EH&S systems, custom systems, or configured based on a customer's EH&S information management needs. Contact us for more information today.