Screened Chemistry Certification using SciveraLENS

About Screened Chemistry

SciveraLENS supports many certifications, including Screened Chemistry. Screened Chemistry is a process used by several global apparel brands (including Levi Strauss & Co) to score chemical formulations for presence on various restricted substances lists and preferred substance lists as well as on critical underlying human and environmental health characteristics.

The Screened Chemistry Program marks an important milestone in consumer product brands’ and suppliers’ chemical management efforts. Conventional list screening for basic regulatory compliance and restricted substance list control are no longer sufficient for achieving best practices in sustainable chemistry. It is now cost-effective, practical, and highly valuable to go beyond these basic steps to understand and select better chemicals for processes and products using comprehensive human and environmental health characteristics.

Because Screening Chemistry assessments include both a list screening and hazard assessment for each chemical in a formulation, doing this work manually can be time-consuming and expensive. Fortunately, SciveraLENS supports the Screening Chemistry Program and makes scoring and certification fast and cost-effective.

Screened Chemistry is different from other certification programs as, unlike testing, list screening, or site audit programs, Screened Chemistry requires:

• Full transparency into the chemicals used in product and process chemistry, going beyond SDSs and other incomplete disclosure efforts. To participate in the Screened Chemistry program, you are being asked to work with your suppliers to discover and understand the chemicals used in your products at each step in the supply chain.
• Toxicological assessments for each CAS RN, providing information about human and environmental health. The goal is to reduce the use of hazardous substances across the supply chain not just because they are regulated or restricted but because they could negatively impact humans (your workers, your consumers) and the ecosystem and encourage using safer alternatives.

Screened Chemistry Scores can range from 0 to +50 for individual chemicals and formulations overall. The higher the Screened Chemistry score, the more preferred the chemistry. Our internal Toxicology team generates chemical-level Screened Chemistry scores to help SciveraLENS subscribers understand how individual ingredient selection will impact a product’s overall Screened Chemistry score.

Confidential Full Formulation Disclosure Requirements for Screened Chemistry

To submit your Screened Chemistry certificate request, you must ensure that you have gathered all the required information so we can proceed with the assessment, scoring, and certification process.

Confidential Full Formulation Disclosure (CFFD) is a requirement for the Screened Chemistry program, and it is the applicant’s responsibility to obtain this information. Communicating with your supplier(s) about the importance of their cooperation in responding to product requests is vital to expediting the certification process. Without sub-supplier cooperation and CFFD, product requests will be cancelled.

Confidential Full Formulation Disclosure (including sub-supplier formulations) (by chemical and concentration)

• All intentionally added chemicals at any concentration
• Any impurities (e.g., residuals, by-products, etc.) present in the final formulation at 100 ppm (0.01%) or greater
• Any chemicals present as impurities at any concentration listed on the current version of the ZDHC MRSL.

Please be sure you can obtain this information before proceeding.

Preparation for Screened Chemistry

To pursue Screened Chemistry certification with SciveraLENS, you must ensure that you have an active SciveraLENS subscription and a Certificate Review Package.

As a reminder, you must ensure you meet all disclosure requirements for each product you want scored and certified.

To better prepare:

1. Review your readiness checklist and make sure you have all the required documents
2. Prepare your suppliers to look for a SciveraLENS request. You may share the checklists and disclosure requirements with them ahead of time to ensure they can also meet them.

There are fees associated with each Screened Chemistry submission. These will be deducted as needed from your prepaid Certification Review package.

• Chemical Verification fee: To complete a verified chemical hazard assessment on unverified chemicals (indicated by a missing checkmark in the verified column). All chemicals in a product must be verified before a product can be certified.
• Review and Certification fee: Upon submission, our team will add your request to our queue to begin the review process. This fee is non-refundable. If you have not met the disclosure requirements or fail to respond to communication or requests for information, your request will be canceled, and your review fee will be forfeited.
  • If you want an EIM score, it can be added at no additional cost if done with Screened Chemistry Certification. The complimentary EIM score option must be selected during your initial form submission.

Certification Review (CR) packages can be used for EIM scoring, Screened Chemistry certification, and Chemical Hazard Assessment needs.

Building your Formulation

You will be building a bill of substances for each product to include:

1. Each sourced material in your product. These should be entered as requests
2. Individual CAS RNs that make up the rest of your product. These will be entered first as CAS RNs.

Keep in mind, as you are building your formulation and sending your requests, you are responsible for including all information needed to meet the CFFD requirements:

• Confidential Full Formulation Disclosure (including sub-supplier formulations) (by chemical and concentration)
  • All intentionally added chemicals at any concentration
  • Any impurities (e.g., residuals, byproducts, etc.) present in the final formulation at 100 ppm (0.01%) or greater
  • Any chemicals present as impurities at any concentration listed on the current version of the ZDHC MRSL.

To get started, log into your SciveraLENS account and create a Formulation for each product you want scored.

• Go to the All Formulations tab in the menu on the left-hand side of the screen.
• Click the green “+” to create a new Formulation.

• Select BOS Builder

• Name your Formulation. The Formulation name should be the product name you would like scored.

• Click the Save and Continue button.

• On the Add CAS RNs screen, you must enter the chemical ingredient (by CAS RN) and concentration information for each chemical ingredient in your product.

1. 1. Concentrations should be entered as a decimal. For example, if a chemical concentration is 80%, you will enter 0.80 in the concentration field.
   2. Click the green “+” button to add rows.
   3. This should include the CAS RNs you input into your product. In a later step, you will have the option to request information from your suppliers for any sourced formulations, products, mixtures, components, etc.

• Click Save.
• In Step 3, “Add Formulation,” you can Send a Request for any supplier formulations included in your product or link existing formulations in your SciveraLENS account.
  1. To gather information from a supplier, you can initiate a request directly through SciveraLENS. Select the green “+” button to begin the request process. Select “New Request” and this screen will appear.
• Here are some quick tips when filling out the request form:

1. 1. Request Name should be the name of your supplier’s product or formulation you are requesting from your supplier.
   2. Enter a message for your supplier about your request. Below is an example message you can use for Screened Chemistry Requests:
      “Dear (Contact Name), We are working on certifying one of our products that contains (Supplier Product Name) for Screened Chemistry (required by several fashion and apparel brands). As part of the certification requirements, we must disclose all ingredients and impurities in our product, including those we source from our suppliers, to meet the Confidential Full Formulation Disclosure requirements. Please provide the requested information using the SciveraLENS system. SciveraLENS will allow you to provide us with the required information without disclosing confidential ingredient information. All data are kept in confidence by Scivera. Using the Scivera tool to enter your information is free for the first five product shares then you will need to upgrade to a paid SciveraLENS account to keep responding to product requests. As you enter this information into SciveraLENS, we recommend using BOS Builder, allowing you to select, identify, and attach additional information required for the Screened Chemistry assessment process. The required fields include SCIL Function (if applicable), Designation, Type, and Concentration amount for each chemical in your formulation. Please include a product-level safety data sheet with your formulation and complete the polymer form for any polymers or ethoxylated alcohols. If you have questions about ingredient and impurity disclosure requirements for Screened Chemistry, please let me know, or feel free to contact the team at Scivera sustainablechemistry.support@enhesa.com
   3. Concentration is the concentration of the supplier’s formulation within your product.
   4. Select the checkbox indicating your request is for Certification and choose Screened Chemistry (and EIM Option 3 if applicable).
      By selecting this check box as part of the request process, your suppliers will receive system guidance on the required fields. We have added a review screen before completing a response so suppliers can confirm that they have met 100% ingredient and impurity disclosure, completed all required fields for SCIL function, designation, type, and others, and attached any required documentation.
   5. Once you have sent the request to your supplier, your supplier will receive the request via email to the address you entered in the formulation Request Form. The email will guide your supplier on creating a login for a free SciveraLENS data-entry account (if they do not already have one). With a free SciveraLENS data-entry account, users can share up to five times; after five shares, users will need to upgrade to a paid account. Suppliers can enter their formulation information, send their own requests as needed, and share the completed formulation with you in redacted form meaning CAS RNs and chemical names will be hidden from their share to protect proprietary information.

• On Step 4, “Assign Supporting Documents”, upload a PDF of the product SDS, TDS, and testing documents. Click the Upload File button for each individual file.
• Click the Continue button.
• On Step 5, “Assign Lists for Screening”, you can search through the lists available in SciveraLENS and select those that interest you. This step will tell the system which list(s) you want to screen your chemicals against. We have preselected lists needed for Screened Chemistry scoring, so this step is optional.
• Click the Submit button to complete your Formulation.

Manage your Requests in SciveraLENS

All requests are tracked and managed directly in your SciveraLENS account. To view your sent requests and track progress, click on the Sent Requests menu item. Here, you can view the status of a request or update your requests as needed.

We will send automated reminders for each request. A “Remind” button lets you send additional reminders to a supplier if needed on a specific request.

When your suppliers respond to your request, you will be notified via email and can log into your SciveraLENS account to view their responses. For Requests generated as part of a Formulation as outlined above, the results will be imported into your Formulation automatically upon completion. You can view the assessment results as part of your detailed assessment view while maintaining any redaction set by your supplier.

Preview your Screened Chemistry forecast score

Once you have completed your Formulation, you can view our assessment results for each CAS RN. In addition, you will have access to our Screened Chemistry dashboard, which was designed to provide you with a preview of your Screened Chemistry score. While your score cannot be confirmed until it passes our Toxicology team’s review, this dashboard can help you identify if you have any problematic chemicals that need replacing or if some of the chemicals need additional assessment before submitting for review.

Understanding the Screened Chemistry Dashboard in SciveraLENS

When you click on a formulation, you can view your assessment results and the Screened Chemistry Dashboard for that formulation (let us know if you don’t see it!). At the top of your screen, you’ll notice that several tabs are available, including a Screened Chemistry v3 tab, a Summary tab, and a Details tab.

The Screened Chemistry v3 Dashboard provides a detailed view of how we assess your chemicals for Screening. You can review the current Screened Chemistry version 3 rules here.

Screened Chemistry considers for each chemical:

• List screening results against relevant lists (like the ZDHC MRSL)
• Chemical Hazard Assessment results looking at the impact of each chemical on humans and the environment

The list screening results are broken down into three columns:

• PCL 1 (This includes the ZDHC MRSL)
• PCL 2 (This includes the AFIRM RSL and ChemSec SIN List)
• SCIL (This includes the US EPA Safer Chemical Ingredient List)

Our hazard assessment score is summarized in the Hazard Category (HC) column. You’ll also see a column for the assessment’s verification status (V), the Dermal Sensitization (DS) assessments, and then a scoring column (SC).

List Scoring

Your chemicals are screened against several Screened Chemistry Priority Lists, including the most current versions of the ZDHC MRSL, AFIRM RSL, and ChemSec SIN List—grey triangle lists.

• If one or more ingredients or applicable impurities are present on the ZDHC MRSL (PCL 1 on the dashboard) and are above the stated concentration threshold for the chemical, the formulation receives a Screened Chemistry score of red “c” that is equivalent to capping the Screened Chemistry product score to 0.
• If no ingredients or applicable impurities are present on the ZDHC MRSL but one or more are present on either the AFIRM RSL or the ChemSec SIN List (PCL 2 on the dashboard), the chemical receives a score of -5 for the Priority Chemical List Check component.
• If a chemical is listed as a SCIL chemical, SCIL scores will depend on function.

Hazard Assessment Scoring

Hazard assessments examine in depth how chemicals impact humans and the environment. Our team of toxicologists examines 24 endpoints or criteria to determine whether a chemical poses a high, moderate, or low hazard for a particular endpoint. Our hazard assessment process is consistent with chemical screening frameworks like UNECE GHS, US EPA Safer Choice, and GreenScreen for Safer Chemicals. We review a few more endpoints and information, so we added the “+” in our GHS+ Hazard Assessment Framework.

What sources of information are used to determine hazard?

Our toxicologists focus on three main components when conducting a hazard assessment.

1. Our toxicologists first review authoritative lists to identify problematic chemicals.
2. Second, we gather data on each of the 24 endpoints we focus on using authoritative resources like:
   • European Chemicals Agency (ECHA)
   • US Environmental Protection Agency (EPA)
   • US National Institutes of Health National Library of Medicine (NIH NLM)
   • National Toxicology Program
   • WHO International Agency for Research on Cancer (IARC)
   • Academic Journals
   • Many others
3. When conclusive data is unavailable, we sometimes use modeling platforms (like OECD QSAR Toolbox, UP EPA EpiSuite/EcoSAR/PBTProfiler, etc.) to close data gaps.

Using this information, we’ll create a summary assessment to guide you on whether a chemical is a high, moderate, or low hazard for each of the 24 endpoints.

Endpoints

As a SciveraLENS subscriber, you can access our Insight table and view the individual assessments and summary scores for each of the 24 endpoints. You’ll notice that at the top of the table is a row for each endpoint with the endpoint abbreviation. Some of these endpoints are marked with capital letters. These are considered “Core” endpoints and include:

Human Health Core Endpoints:

• Carcinogenicity — Does the chemical have a high potential to cause cancer in humans or other mammals?
• Mutagenicity — Does the chemical have a high potential to cause genetic mutations in humans or other mammals?
• Developmental Toxicity — Does the chemical have a high potential to cause developmental defects in unborn or young humans or other mammals?
• Reproductive Toxicity—Does the chemical have a high potential to damage the reproductive systems of humans or other mammals?

Environmental Health Core Endpoints:

• Persistence — Does the chemical stay persistent in the environment (i.e., it is not readily biodegradable)?
• Bioaccumulation — Does the chemical accumulate in the tissue of mammals or other living creatures?
• Acute Aquatic Toxicity—Does the chemical have a high potential to kill aquatic life if present in water for a short period of time?
• Chronic Aquatic Toxicity—Does the chemical have the potential to kill aquatic life if it is present in water for a long period of time?

Core Endpoints carry greater weight in categorizing a chemical for overall hazard and are used when calculating the SciveraLENS Hazard Category result. Supplemental endpoints are also used in the Hazard Category calculation.

Dermal Sensitization Endpoint:
Dermal Sensitization: This column shows a colored stoplight representing our GHS+ Assessment results for the dermal sensitization endpoint.

Human and Environmental Health Screen Results:

SciveraLENS uses an easy-to-understand “traffic light” system for communicating assessment results for human and environmental health attributes of specific endpoints and for a chemical overall.

A solid green, yellow, red, or black light indicates sufficient authoritative or experimental evidence for an unequivocal hazard assessment.

When half of the light is gray, this indicates limited evidence is currently available for the endpoint and that our toxicology team has used systems such as modeling software, quantitative structural activity relationship (“QSAR”) methods, or expert judgment to complete the assessment.

Green is good. Green lights signal an overall assessment of a chemical or a specific human or environmental health endpoint that shows evidence of low hazard.

 Yellow is acceptable. Yellow lights signal an overall assessment of a chemical or a specific human or environmental health endpoint that shows evidence of moderate hazard.

 Red indicates concern. Red lights signal an overall assessment of a chemical or a specific human or environmental health endpoint that shows evidence of high hazard.

 Black indicates high concern. Black lights signal an overall assessment of a chemical or a specific human or environmental health endpoint that shows evidence of high hazard.

 Light blue signals that the endpoint does not show concern for the designated endpoint based only on list evidence.

 The light blue and gray light indicates an endpoint or chemical that does not show list evidence of concern, but after additional work by our toxicology team, we are not able to conclude an assessment. The data are currently not sufficient for an assessment.

Hazard Category (for each chemical)

The Hazard Category (HC) score is based on an algorithm SciveraLENS created. Based on standard hazard assessment guidelines, it weights certain endpoints over others to give a summary view of the chemistry.

The Summary Line will show the highest or maximum HC score.

Verified

The Verified column indicates that the SciveraLENS toxicology team has confirmed the HC rating. If a chemical has been fully verified, it will be indicated with a check mark. If the check mark is missing from the verified column, additional work is still needed to determine the hazard rating. All chemicals must be verified to proceed with Screened Chemistry certification. There is a fee to complete the verification process for unverified chemicals, and it is charged out of your Certification Review package.

Screened Chemistry Score (Product)

The Screened Chemistry score for a product comes from a weighted average of each chemical’s Screened Chemistry score. Here is a category breakdown for a product’s Screened Chemistry score.

• Products with scores of 35-50 are “Preferred Finished Chemical Formulation”
• Products with scores of 20-34 are “Acceptable Finished Chemical Formulation” products
• Products with scores of 0-19 are classified as “Phase Out” products and will not receive a Screened Chemistry certificate.

Submit your Product for Screened Chemistry Certification

When you are ready to submit your product for review, click on the ellipses menu for that Formulation and select “Services/ Certificates”.

You will be directed to the Screened Chemistry Certification Request form, which will be pre-populated with the data from your Formulation.

The system will provide prompts and guidance to help ensure that you have met all disclosure requirements before submitting your request form.

Use the guided prompts to fill in the Certificate request form for each product. The company and product names must be written exactly as you would like them entered on your certificate.

Each chemical must be listed as an ingredient or impurity. Concentration must be entered as a decimal, and your total must equal at least 1 (100%). You must also include the SCIL function for each chemical, if applicable.

Attach your supporting documentation

• ZDHC Analytical Testing (see below)
• Supporting documentation
  • Product-level Safety Data Sheet (SDS) and Technical Data Sheet (TDS)
    • Your supplier must upload a product SDS when completing their request
• Chemical-level SDS
• When applicable, polymer and ethoxylated alcohol assessment data collection form (must be filled out by supplier)

The ZDHC Analytical Testing requirements for Screened Chemistry include:

• Testing must be completed by a third-party lab verified by ZDHC. A list of ZDHC-accredited labs and service providers is available here.
• The analytical testing reports must show conformance with the current version of ZDHC MRSL, requiring metals testing at a minimum (arsenic, cadmium, mercury, lead, chromium VI, and colorant-specific metals listed on the ZDHC MRSL). Accredited labs can provide testing requirements based on your product type.
• Testing must be completed less than one year prior to the effective date of the Screened Chemistry certification.
• Our team may request additional test data for any other chemical that is present on the MRSL or to confirm the accuracy of the Confidential Full Formulation Disclosure. This is entirely up to the Service Provider, and if the Applicant or their Component Supplier does not oblige, the Finished Chemical Formulation cannot be assessed.

Select “Save and continue editing” on your Certification Request Form as needed throughout the process to prevent data loss. You can return to the form to make additional edits before submission.

Submit

Once you are ready to submit your Certification Request, select Submit for Review and Certification. This will notify our toxicology team to begin reviewing your product submission.

Once all requirements have been met and all chemicals in the product have been verified, the process usually takes 4-6 weeks. Our Toxicology team will review your formulation and assessment results, generate a Screened Chemistry (and EIM, if requested) Certificate for each product, and send it to you.

Tracking your Certificate Progress in SciveraLENS

You can track progress in your Certificates panel as we work through your Certificate request(s). At the top of your screen, you’ll see one of the following statuses:

• “Pending Review” – Our team has not yet reviewed your submission.
• “Preliminary Review” – Our team has begun reviewing your submission.
• “Updates Requested” – We need more information from you. Your submission is now unlocked, so you can update your submission form as needed so we can complete our assessment.
• “Feedback Requested” – We need more information from you. Please respond accordingly.
• “Preparing Certificate”—Our team is assessing and scoring your product. Your certificate will be ready soon.
• “Certificate Delivered” – Your product certification is complete.

Communicating with our team

Our team will use the messaging feature at the bottom of your certificate request form to communicate additional updates, questions, etc., with you. Please ensure that you pay attention to these messages and respond accordingly to avoid any delay in processing your request.

If you have questions, use the messaging feature at the bottom of your Certificate form or email us at sustainablechemistry.support@enhesa.com.

Renewing your Products for Screened Chemistry

Screened Chemistry certifications are valid for three years. We will alert users when their product certifications are about to expire. Still, we recommend tracking your renewal timeline for each product based on the expiration date included in your score report.

To renew your Screened Chemistry certification, you must have an active SciveraLENS subscription and a Certificate Review Package.

Unused spots in your Certificate Review Package do not expire if you maintain an active SciveraLENS subscription. If you are unsure how many CR package spots you have left, you can contact our support team and purchase more before submitting the product for renewal.

When we renew your Screened Chemistry certificate, our Toxicology team will do a complete review, just as we did for your initial score. You must ensure that the formulation is current, that any changes are accurately reflected, and that all documentation is updated.

To submit your previously certified product for a review, please follow these steps:

1. Login to your SciveraLENS account.
2. Click on “Completed Certificates” from the left-hand menu to be brought to a list of your previously scored and certified products.
3. Find the product name you want to submit for renewal review.
4. To the right of the product name, click the three-dot icon to select “View Formulation.”
5. If there are any updates to your formulation since this product was last scored or you need to upload updated supporting documentation, please select the three-dot icon at the top right-hand corner of your dashboard view to select “Manage/Edit” and make any needed changes.
6. You will be taken to the “Certificate and Scoring Request Form.”
7. Complete the form with all required fields and verify the accuracy of your data entry. Update your product-level documentation.
8. To submit your request for review, please click “Submit for Review and Certification.”
9. Any missing requirements will be highlighted in red, and you cannot “Submit for Review and Certification” until all requirements have been fulfilled.

You can also create a new Formulation to submit for review if needed. This can be a good option if you want to keep a record of your Formulation changes over time.