Manufacturers and distributors of all sizes face rising challenges as a result of increasing globalization in the marketplace and changing international regulatory initiatives. The Regulation for Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) addresses the production and use of chemical substances and their potential impacts on both human health and the environment.
When considering compliance with REACH, most companies think only of the EU. However, other countries are implementing REACH-like regulations. Korea’s REACH-like regulation came into effect in 2016. Turkey’s will be in effect in 2017.
For companies with European production or distribution of chemical substances, and companies that import into Europe, REACH significantly increases the complexity of maintaining compliance.
EU REACH is the 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 June 1st, 2007, the regulation will be implemented in phases spanning a period of more than ten years with the final provision to be met in 2018.
In Korea, the REACH-like regulation became effective in 2016. The first impact is that annual reporting of all chemicals imported or manufactured greater than 1,000 kg in 2015 must be reported by June 30, 2016. The annual reporting requirement continues for future years and will always be due by June 30th of the next year. Chemicals not listed on the Korean Existing Chemical Inventory (KECI) will always require prior submission of a notification to the Korean government and be included in the annual report regardless of volume.
Under the Korean regulations, chemicals included in a company’s annual report that are listed on the Priority Existing Chemicals (PEC) list will also require registration starting in 2020. Registrants will be required to work together, as in the EU, to collect the required data. Assignment of “Lead Registrants” is in process for all PEC chemicals.
In addition to registration in 2020, Chemical Safety Reports (CSRs) will be required for all PEC chemicals on a company’s annual report. CSRs are required to be submitted starting in 2017 based on volume ranges.
Define Your REACH Role
In Europe, non-EU manufacturers should understand the registration obligations of any EU importers they work with and help them meet the pre-registration deadline. If registration is required, they should be prepared to support the registration by having the hazard assessment/EU classification ready with up-to-date European MSDS / SDSs.
EU manufacturers/importers/distributors should decide which substances to register and when. They should also consider substitution of Substances of Very High Concern (SVHCs). Downstream users in Europe should inform suppliers of use and also consider replacing SVHCs with less hazardous substances wherever possible.
Non-Korean manufactures are in the best position to support annual reporting requirements for their importers. Their partners in Korea may require documentation that chemicals supplied to them from non-Korean manufacturers have been reported and/or the required registrations are in process.
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 thoroughly understand the EU and Korean regulatory environment and are well-versed in data and information as it relates to global EH&S regulations.
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, and REACH is no exception. 3E Company offers a unique combination of services that can help companies with the preparation process and with ongoing compliance.
Substance Information Management
Ariel® chemical and regulatory content fuels all of the REACH support that 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 and Korea 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 for chemicals on the lists. Access to existing IUCLID 5 substance dossiers is also available for EU REACH. For chemicals in Korea, Ariel WebInsight can be used to determine if a chemical is listed on the PEC list and therefore requires registration and a CSR.
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 EU REACH requirements.
Supply Chain Compliance
REACH requires communication up and down the supply chain. 3ESC® Supply Chain Solutions enable the collection, validation, enrichment and contextualization of supplier data required for continuous REACH and REACH SVHC supply chain compliance.
At 3E we can leverage our global supplier network to quickly identify critical REACH contacts within your supply chain. Our experienced, in-house obtainment team reaches deep into your supplier base for supplier and product level data. The data is securely stored in 3ESC’s industry-leading online platform and can feed into your ERP system.
3ESC’s REACH compliance program equips your organization to quickly respond to and fulfill REACH requests from your downstream customers. 3ESC also supplements the existing list of SVHC chemicals, as provided by Ariel WebInsight, by integrating new and proposed SVHC chemicals into the 3ESC Regulatory Monitoring notification system. 3E can also provide regulatory consulting services as needed. At a fraction of the cost of managing the program in-house, your organization can leverage 3ESC to launch your REACH compliance program today.
Pre-registration and Registration Support
REACH Impact Analysis Using 3E Online®
For EU REACH, establishing which category individual substances in your chemical inventory fall into—whether manufactured within the EU, imported into the EU or purchased from a supplier within the EU—can be a challenge without 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 a 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, which can then be used to communicate with your suppliers.
Outsourced REACH 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. 3E's team can act as a third party representative or refer your company to a partner that can serve as an Only Representative.
Authoring, Producing and Distributing Extended MSDS / SDSs
Outsourced Authoring Services
As companies consider the impact of REACH on their MSDS / SDSs for updates and/or new MSDS / 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 MSDS / 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 need to effectively manage the complexities of issuing REACH-compliant MSDS / SDSs, 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 provides a built-in interface that imports key data elements from IUCLID5 in order to facilitate the classification of materials and authoring of compliant MSDS / SDS documents and labels. REACHsync includes the import of physical and chemical properties, toxicological and ecological data, CLP Classification as well as DSD/DPD classification. Future interfaces will also include the adoption of the ESCom XML exchange standard which allows customers to share and exchange ES information for their products authored with the EuPhraC library.
Downstream Supply Chain Communication: SDS Distribution Services
3E Company offers a variety of products and services to ensure that REACH-compliant MSDS / SDSs are published, distributed and retrieved by downstream users, resulting in cost savings, increased efficiency and improved compliance.