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Webinar

October 2, 2018 | Written by GreenSoft Technology, Inc.

Register Now for EU Medical Devices Regulation Webinar

Get prepared for the new European Medical Devices Regulation (EU MDR) coming in 2020

Medical-devices-EU-MDROn Wednesday, November 14 we'll be hosting a webinar about one of the most popular compliance topics in the industry: the new medical devices regulation coming out of the European Union.

Compliance with the EU MDR becomes mandatory for medical device producers in May 2020. The regulation changes how medical devices are defined, how devices are classified for risk, and creates a new labeling system. The regulation also includes certain substance content requirements.

GreenSoft's Senior Manager of Product Support, Randy Flinders, will be hosting a free educational webinar to teach you everything you need to know to ensure your company will be ready when EU MDR comes into effect.

Learn your responsibilities and requirements as a medical device product or parts manufacturer, and make sure your company is complying with updated version of the regulation (formerly EU Medical Device Directive).

Space is limited, so reserve your spot today! Register Now. 

Plus, learn more about GreenSoft's EU MDR data services online.

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Conference

September 21, 2018 | Written by GreenSoft Technology, Inc.

Compliance Events Coming Up in Silicon Valley, San Francisco and London

Learn about EU MDR, EU RoHS, EU REACH, CA Prop 65 and more at one of our upcoming events

event-logosWe'll be visiting three cities coming up this fall to talk about regulations and compliance solutions.

Join us at the RMI Annual Conference in Silicon Valley, the Chemical Watch Chemicals Management for Electronics and Electricals USA 2018 Conference in San Francisco, or the RINA EEE/Edif ERA Electrical and Electronic Equipment and the Environment Conference in London!

Visit our Events page to see our full schedule.

RMI Annual Conference on Conflict Minerals

We're headed back to Silicon Valley for the 10th annual RMI Annual Conference on conflict minerals on October 31 through November 1.

Formerly known as CFSI, the RMI organization creates the Conflict Minerals Reporting Template (CMRT) to help companies share data across the supply chain. The conference brings together experts from industry, governments, and civil society for a 2 day program on responsible mineral supply chains.

We'll be exhibiting our Conflict Minerals Data Services, Smelter or Refiner (SOR) Validation services, and GreenData Manager software Conflict Minerals Module. Registration and more information on the conference can be found online.

Chemical Watch Conference: Chemicals Management for Electronics and Electricals USA 2018

Held in San Francisco, CA on November 8-9, this new event by Chemical Watch will feature talks from expert industry speakers, informative panel discussions and the opportunity to network with important figures in the world of chemicals management for electronics and electricals.

Randy Flinders, Sr. Product Support Manager for GreenSoft, will be giving a presentation on the new European Medical Devices Regulation (EU MDR) at the conference. There will also be presentations on EU RoHS, EU REACH, and CA Prop 65. Don't miss this great educational event! Registration and more information can be found online.

RINA EEE/Edif ERA Electrical and Electronic Equipment and the Environment Conference

We'll be wrapping up our fall events with a trip to London on November 14-15 for the Electrical and Electronic Equipment and the Environment Conference.

Presented by the Edif/RINA group, this conference on environmental regulations for manufacturers, importers and distributors is a leading compliance event in Europe. Now in its 20th year, the conference focuses on responsible sourcing in supply chains and environmental regulations affecting the design, manufacture and disposal of electrical and electronic equipment.

We'll be exhibiting our EU RoHS and EU REACH data services and GreenData Manager software solutions at the event. Stop on by to learn more! Registration and more information on the event is available online.

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EU Medical Devices Regulation (MDR)

August 20, 2018 | Written by GreenSoft Technology, Inc.

Get Ready for the New EU Medical Devices Regulation

Compliance with New EU Medical Devices Regulation (EU MDR) Becomes Mandatory in May 2020

Medical-devices-EU-MDRA new European regulation for medical devices is coming into effect in 2020.

In May 2017, the EU Commission published the Medical Devices Regulation (MDR). The regulation becomes mandatory for medical device producers as of May 26, 2020.

The EU MDR replaces the previous Medical Device Directive (EU MDD) and Active Implantable Medical Device Directive.

EU MDR changes how medical devices are defined, how devices are classified for risk, and creates a new labeling system. The regulation also includes certain substance content requirements.

Under the new EU MDR, medical devices cannot contain substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR 1A/1B) or endocrine-disrupting substances (EDS) in amounts over 0.1% w/w without justification. The use of latex, as well as substances of human or animal origin, must also be declared if present.

Get Help With Substance Data

Our EU MDR Data Services provide you with the substance data you need to enable your product to be submitted to the UDI database, and evaluated by a notified body for approval, while freeing up your time to focus on other elements of the product approval process.

As part of our EU MDR Data Services, we will collect substance data from your suppliers on your behalf, and check it against the lists of applicable CMR 1A/1B and endocrine-disrupting substances addressed under the EU MDR, using our powerful, purpose-built GreenData Manager compliance software.

We can even collect information on the presence of animal and human derived materials, as well as latex, as required by the EU MDR.

Contact us to get started. Or visit our website to learn more. Plus, don't miss our EU MDR webinar in November!

 

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EU RoHS

July 26, 2018 | Written by GreenSoft Technology, Inc.

RoHS-2 Exemptions List for RoHS-2 Compliance Now Available

Available to Download: EU RoHS-2 Exemptions List

eu-rohs

Under Annexes III and IV of the EU RoHS-2 Directive, producers of electronic equipment may be permitted to apply exemptions to substances restriction thresholds for certain specific uses and applications.

GreenSoft has compiled a complete exemption list in a single Excel file of all the current valid EU RoHS-2 exemptions for easy reference. Download the EU RoHS-2 exemptions list here.

These exemptions are updated regularly as some expire and others are renewed. While the European Commission website provides information on exemption updates, there is no compiled list of all current valid exemptions easily accessible to the environmental product compliance industry.

GreenSoft has maintained a compiled list of valid EU RoHS-2 exemptions in order to perform EU RoHS Data Services for our customers and to keep our GreenData Manager software up-to-date, and now we are offering this list to the public for download.

Download the compiled list of current EU RoHS-2 exemptions here. 

GreenSoft Keeps Track of RoHS-2 Exemptions So You Don’t Have To

Updates and exemptions to regulations occur regularly. With the status and timing of exemption extensions unknown, compliance can be a continually moving target.

Affected companies using parts or materials that utilize expiring exemptions should immediately begin finding replacements and phasing out the use of those parts or materials.

GreenSoft can help with this process, including the sourcing of replacement parts. We can help you collect the substance data on your parts and format the data to meet the due diligence and documentation requirements of RoHS-2 and EN 50581. Learn more about our RoHS-2 Services or contact us today to get started!

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EU RoHS Exemptions Timeline Update

EU RoHS Exemptions Updates: European Commission announces target adoption dates expected in third quarter 2024 for critical EU RoHS exemptions for electronics manufacturers

California Proposition 65

July 25, 2018 | Written by GreenSoft Technology, Inc.

Changes to California Prop 65 Coming in August 2018

Changes to CA Prop 65 Warning Labels Effective August 30, 2018

prop-65New amendments to CA Prop 65 are coming into effect on August 30, 2018. The amendments affect the Clear and Reasonable Warnings section of the regulation.

The changes come due to the adoption of amendments to the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) that were approved by the California Office of Administrative Law on August 30, 2016.

The new changes will require affected businesses to:

  • Make warnings more visible (due to the use of the familiar exclamation point
    symbol for most warnings)
  • State that the product or the location can expose them to a listed chemical (as
    opposed to the current general practice of simply warning of the presence of a
    chemical)
  • Identify at least one listed chemical to which they would be exposed

Additionally, affected businesses must provide the URL for an OEHHA web site which will provide more information about listed chemicals, and provide for warnings in non-English languages in instances where product labeling contains information in alternative languages or at locations where signs are posted in those language.

prop-65-label
An example of the CA Prop 65 Clear and Reasonable Warning label before and after the August 2018 amendments.

In the past, many businesses required to comply with CA Prop 65 would simply affix the general CA Prop 65 warning label to their products or post it within their business locations whether or not the business was certain of the chemical exposure risk level in order to mitigate the company's liability risk for not adhering to the regulation. The goal of the new amendment is to curb this practice and provide more detailed and accurate information to the California public regarding chemical exposure risk.

GreenSoft Helps Collect Chemical Information For CA Prop 65 Compliance

The new amendments will require affected businesses to have detailed knowledge of the chemicals that their products or business locations contain and expose to the public in California. In order to know which chemicals are exposed to the public, a business must collect substance data on the products that it sells to the public in California or the products that it uses within its California business locations.

As part of our CA Prop 65 Data Services, we will collect substance data from your suppliers on your behalf, and check it against the list of chemicals regulated under CA Prop 65 using our powerful, purpose-built GreenData Manager compliance software.

This will provide you with the data you need to show compliance with the new amendments to CA Prop 65 while freeing up your time to focus on your original business goals of making and selling products instead of complying with detailed regulations.

Learn more about our CA Prop 65 Data Services and GreenData Manager software, or contact us online or at (323) 254-5961 today.

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Webinar

July 16, 2018 | Written by GreenSoft Technology, Inc.

Green Compliance 201 Webinar Available On-Demand

View the Green Compliance 201: Best Practices for Complying with EU REACH, RoHS, CA Prop 65 and Other Global Regulations Webinar

green-compliance-101On July 10, we hosted part 2 of our Green Compliance webinar series. Green Compliance 201 covered the best practices for compliance with global regulations such as EU REACH, RoHS, CA Prop 65 and more.

This webinar expanded on our popular Green Compliance 101 webinar held in May. You can view both webinars online in our Webinar Archive.

Green Compliance 201 covered a range of topics including:

  • Establishing a product compliance plan
  • Types of compliance documents
  • Data collection strategies
  • Resolving fabricated (drawing based) parts
  • EN 50581 and its requirements
  • Strategies for reducing sustaining costs

We'll be hosting more webinars in the future. Sign up to be notified when registration opens for our next webinar.

To learn more about the compliance solutions discussed in the webinar, contact us online or call +1-323-254-5961 to receive a personalized recommendation on how GreenSoft can help your company with environmental product compliance.

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GreenData Manager (GDM) Software

June 29, 2018 | Written by GreenSoft Technology, Inc.

GDM-EM: Environmental Compliance and Project Management Tool Now Available for Wide Release

GreenSoft's GreenData Manager Escalation Manager Project Management Tool is Now Available for Wide Release

GDM-EM-logoGreenData Manager Escalation Manager (GDM-EM) is a cloud-based project management tool that enables communication between your engineers and GreenSoft's engineers to manage escalated issues on your product compliance project.

GreenSoft has offered GDM-EM to few select customers for over a year, and we are excited to announce that GDM-EM is now available for wide release.

GDM-EM promotes the completeness of data collection and speeds up the time for resolving escalated issues by providing a centralized project management hub.

When you have multiple team members working on your project, GDM-EM makes it easy to share work, manage tasks, and resolve project issues.

GDM-EM compliments Hosted GDM and GDM Browser Edition of GreenSoft’s award-winning GreenData Manager software and GreenSoft’s data collection and validation services.

GDM-EM provides:

  • Access for multiple concurrent users with secure login ID and password.
  • Email notifications when new issues are posted at the Escalation Manager database.
  • Workflow based processing –workflow token is circulated between GreenSoft engineers and your engineers until the issues are resolved.
  • Quick access to escalated issues based on escalated categories or other criteria such as manufacturer name, manufacturer part number, etc.
  • Ability to assign issues to users and change assignments until the task is resolved.
  • Bulk resolution abilities for issues from the same category or the same manufacturer.
  • Ability to save reference documents and assign them to escalated issues.

Existing GreenSoft customers can contact their Project Manager to learn more about GDM-EM. For those who are not yet GreenSoft customers, contact us online to learn more or call +1-323-254-5961 today!

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EU REACH

June 28, 2018 | Written by GreenSoft Technology, Inc.

10 New Substances Added to EU REACH SVHC Candidate List

Addition of 10 Substances Brings EU REACH SVHC Candidate List to 191 Substances

EU-REACHYesterday, the European Chemicals Agency (ECHA) announced the addition of 10 substances to the EU REACH Substances of Very High Concern (SVHC) Candidate List. The SVHC Candidate List now contains 191 substances.

Eight substances were added to the SVHC Candidate List on June 27, 2018:

SUBSTANCE NAME EC NUMBER CAS NUMBER INTRINSIC PROPERTY(IES) REFERRED TO IN ARTICLE 57 EXAMPLES OF USE(S)
Octamethylcyclotetrasiloxane (D4) 209-136-7 556-67-2 PBT (Article 57d) vPvB (Article 57e) Used in washing and cleaning products, polishes and waxes and cosmetics and personal care products.
Decamethylcyclopentasiloxane (D5) 208-764-9 541-02-6 PBT (Article 57d) vPvB (Article 57e) Used in washing and cleaning products, polishes and waxes, cosmetics and personal care products, textile treatment products and dyes.
Dodecamethylcyclohexasiloxane (D6) 208-762-8 540-97-6 PBT (Article 57d) vPvB (Article 57e) Used in washing and cleaning products, polishes and waxes, cosmetics and personal care products.
Lead 231-100-4 7439-92-1 Toxic for reproduction (Article 57c) Used in metals, welding and soldering products, metal surface treatment products, and polymers.
Disodium octaborate 234-541-0 12008-41-2 Toxic for reproduction (Article 57c) Used in anti-freeze products, heat transfer fluids, lubricants and greases, and washing and cleaning products.
Benzo[ghi]perylene 205-883-8 191-24-2 PBT (Article 57d) vPvB (Article 57e) Not registered under REACH. Normally not produced intentionally but rather occurs as a constituent or impurity in other substances.
Terphenyl hydrogenated 262-967-7 61788-32-7 vPvB (Article 57e) Used as a plastic additive, solvent, in coatings/inks, in adhesives and sealants, and heat transfer fluids.
Ethylenediamine (EDA) 203-468-6 107-15-3 Respiratory sensitising properties (Article 57(f) - human health) Used in adhesives and sealants, coating products, fillers, putties, plasters, modelling clay, pH regulators and water treatment products.

Two further substances were also added to the list on April 13, 2018, but were announced yesterday in the combined news release for all 10 of these new additions. These two substances were identified as SVHCs by the European Commission due to their respiratory sensitising properties and toxic for reproduction and endocrine-disrupting properties, respectively.

SUBSTANCE NAME EC NUMBER CAS NUMBER INTRINSIC PROPERTY(IES) REFERRED TO IN ARTICLE 57 EXAMPLES OF USE(S)
Benzene-1,2,4-tricarboxylic acid 1,2 anhydride (trimellitic anhydride) (TMA) 209-008-0 552-30-7 Respiratory sensitising properties (Article 57(f) - human health) Used in the manufacture of esters and polymers.
Dicyclohexyl phthalate (DCHP) 201-545-9 84-61-7

Toxic for reproduction (Article 57c)

Endocrine disrupting properties (Article 57(f) - human health)

 Used in plastisol, PVC, rubber and plastic articles. A further use is also as a phlegmatiser and dispersing agent for formulations of organic peroxides.

For more information on the addition of these substances, view ECHA's news release online. The full list of 191 SVHC Candidate List substances can be viewed here. The last prior addition to the REACH SVHC Candidate List was in January 2018.

GreenSoft Can Help Ensure Your Company is in Compliance with REACH

GreenSoft helps companies manage REACH compliance with a process that includes data collection, data validation, and report generation. We can also help with sourcing replacement parts for non-compliance parts, or recommending replacement suppliers for non-compliant or non-responsive suppliers. Learn more about our REACH compliance services here or get started with a FREE Risk Analysis/BOM Scrub.

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EU RoHS

June 20, 2018 | Written by GreenSoft Technology, Inc.

Critical Updates to EU RoHS-2 Exemptions

Multiple RoHS-2 Exemptions Extended or Redefined

eu-rohsSeveral exemptions under the EU RoHS-2 regulation have been updated or extended by the European Commission.

On May 18, the European Commission updated and published the following exemptions in the EU Official Journal:

Exemption Description Link
Exemption 6(a) Extended and Redefined.  Newly created exemption 6(a)-I has been implemented.   New definitions become mandatory on July 1, 2019.  (Commission Delegated Directive (EU) 2018/739) Link
Exemption 6(b) Extended and Redefined. Due to this change, new exemptions 6(b)-I, and 6(b)-II have been implemented. The new exemption definitions become mandatory on July 1, 2019. (Commission Delegated Directive (EU) 2018/740) Link
Exemption 6(c) Extended until July 21, 2021 for most categories, July 21, 2023 for category 8 in-vitro devices, and July 21, 2024 for category 9 and 11 devices. The new exemption definitions become mandatory on July 1, 2019.  (Commission Delegated Directive (EU) 2018/741) Link
Exemption 7(a) Extended until July 21, 2021 for most categories, July 21, 2023 for category 8 in-vitro devices, and July 21, 2024 for category 9 and 11 devices. The new exemption definitions become mandatory on July 1, 2019. (Commission Delegated Directive (EU) 2018/742) Link
Exemption 7(c)-I Extended until July 21, 2021 for most categories, July 21, 2023 for category 8 in-vitro devices, and July 21, 2024 for category 9 and 11 devices. The new exemption definitions become mandatory on July 1, 2019. (Commission Delegated Directive (EU) 2018/736) Link
Exemption 24 Extended until July 21, 2021 for most categories, July 21, 2023 for category 8 in-vitro devices, and July 21, 2024 for category 9 and 11 devices. The new exemption definitions become mandatory on July 1, 2019.  (Commission Delegated Directive (EU) 2018/737) Link
Exemption 34 Extended until July 21, 2021 for most categories, July 21, 2023 for category 8 in-vitro devices, and July 21, 2024 for category 9 and 11 devices. The new exemption definitions become mandatory on July 1, 2019. (Commission Delegated Directive (EU) 2018/738) Link

These updates follow the update of Exemption 39(a), which was published to the EU Official Journal on October 31, 2017:

Exemption Description Link
Exemption 39(a) Expires October 31, 2019. (Commission Delegated Directive (EU) 2017/1975) Link

Producers relying on these exemptions to demonstrate compliance to the EU RoHS-2 regulation should review these changes for impacts to the compliance status of affected products.

The last prior set of exemption extensions/updates, known as "Pack 7," was announced in June 2017. A detailed explanation of exemptions can be found in our blog from January 2017. View the EU RoHS-2 website with exemption updates online here.

GreenSoft Keeps Track of RoHS-2 Exemptions So You Don’t Have To

Updates and exemptions to regulations occur regularly. With the status and timing of exemption extensions unknown, compliance can be a continually moving target.

Affected companies using parts or materials that utilize expiring exemptions should immediately begin finding replacements and phasing out the use of those parts or materials.

GreenSoft can help with this process, including the sourcing of replacement parts. We can help you collect the substance data on your parts and format the data to meet the due diligence and documentation requirements of RoHS-2 and EN 50581. Learn more about our RoHS-2 Services or contact us today to get started!

 
 

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EU RoHS Exemptions Timeline Update

EU RoHS Exemptions Updates: European Commission announces target adoption dates expected in third quarter 2024 for critical EU RoHS exemptions for electronics manufacturers

Webinar

June 18, 2018 | Written by GreenSoft Technology, Inc.

Registration Open for Green Compliance 201 Webinar

Learn How to Comply with Environmental Product Regulations

green-compliance-201Next month we're hosting part two of our popular Green Compliance webinar series.

Green Compliance 201 will provide the specifics on how to comply with global product regulations such as EU REACH, EU RoHS, CA Prop 65, China RoHS and more.

Expanding on the Green Compliance 101 webinar, the Green Compliance 201 webinar will cover topics including:

  • Establishing a product compliance plan
  • Types of compliance documents
  • Data collection strategies
  • Resolving fabricated (drawing based) parts
  • EN 50581 and its requirements
  • Strategies for reducing sustaining costs

GreenSoft's Senior Manager of Product Support, Randy Flinders, will host this free informational webinar, and will answer audience questions during the Q&A section at the end of the session.

Space is limited, so reserve your spot today!

Tuesday, July 10, 2018

Registration for this event is now closed. View a recording of the webinar in our Webinar Archive.

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California Proposition 65

June 13, 2018 | Written by GreenSoft Technology, Inc.

New Substance Added to CA Prop 65 Chemical List

TRIM® VX Added to List of Chemicals Known to the State of California to Cause Cancer

prop-65

The California Office of Environmental Health Hazard Assessment (OEHHA) has added a new substance to the list of chemicals known to be harmful under The Safe Drinking Water and Toxic Enforcement Act of 1986, known as CA Prop 65.

TRIM® VX, a soluble oil coolant designed for heavy-duty machine operations, has been added to the list of chemicals known to the State of California to cause cancer under CA Prop 65. The addition is effective May 25, 2018.

The OEHHA news release on this addition is available to read online, and the list of all chemicals regulated under CA Prop 65 can be downloaded here.

GreenSoft provides data services for CA Prop 65 and our GreenData Manager software includes CA Prop 65 as one of the regulations built into the software. Contact us to learn more about how we can help your company comply with CA Prop 65.

 

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Conflict Minerals

June 11, 2018 | Written by GreenSoft Technology, Inc.

New Version CMRT 5.11 for Conflict Minerals Reporting Released

Conflict Minerals Reporting Template (CMRT) Version 5.11 Released

In April, the Responsible Minerals Initiative (RMI) released an updated Conflict Minerals Reporting Template (CMRT) version: CMRT 5.11.

Major changes to CMRT 5.11 include:

  • Corrections to all bugs and errors
    • Update to ISO country, state and province lists
  • Enhancements which do not conflict with IPC-1755
  • Updates to the Smelter Reference List and Standard Smelter List
  • Name changes to reflect the organization's rebrand

CMRT forms are updated and released twice per year by the Responsible Minerals Initiative (RMI) organization, formerly known as the Conflict-Free Sourcing Initiative (CFSI).The next CMRT version is anticipated to be released in November 2018. The last prior update was version 5.10 in December 2017.

CMRT 5.11 can be downloaded from the RMI website here.

Get Help With Your CMRT Collection and Conflict Minerals Compliance

For customers using GreenSoft’s Conflict Minerals data services to perform Reasonable Country of Origin Inquiry (RCOI), our data services team will use CMRT 5.11 for data collection going forward.

For customers using our GreenData Manager software Conflict Minerals Module, our software development team has prepared the software for the use of CMRT 5.11 as part of our most recent software update.

If you are not yet a GreenSoft customer, contact us today to learn about our Conflict Minerals data services and software and we’ll provide you with a free Risk Analysis!

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