Scivera Safer Chemistry Standard Overview v1 (November 2021)

Scivera Safer Chemistry Standard – version 1 (November 2021)

Introduction

The overall Scivera Safer Chemistry screening, scoring, and certification process for a chemical product is a weighted-average of the Screened Chemistry scores for each Ingredient and Applicable Impurity* present in the finished chemical product.

The Scivera Safer Chemistry scoring rules includes a component scoring structure for Ingredients and Applicable Impurities is is separated into three Sections:

1. Priority Chemical List Check (determined by Product Category)
2. Chemical Hazard Assessment Result
3. Priority Supplemental Endpoint Check (determined by Product Category)

During the scoring process for each Ingredient or Applicable Impurity in a chemical formulation, the component scores are added together to derive the Ingredient’s or Impurity’s Scivera Safer Chemistry score.

Once a score is established for each Ingredient and Applicable Impurity in a formulation, the formulation overall receives a Scivera Safer Chemistry score based on a weighted average of each Ingredient’s and Applicable Impurity’s Scivera Safer Chemistry score.

*See Rules 2 and 3 in Step 1 below for scope definition of Ingredients and Applicable Impurities.

Step 0 :: Declare and confirm that no banned substances are present in the finished chemical formulation

Chemical manufacturer provides required documentation that no banned substances or restricted substances are present in the finished formulation as Ingredients or as Impurities above threshold limits (if applicable).

If finished formulation is free of any banned or restricted substances (above threshold limits), the formulation advances to Step 1 below.

Presence of banned or restricted substances (above threshold) ends Scivera Safer Chemistry evaluation.

Step 1 :: Confidential Full Formulation Disclosure (CFFD)

Chemical manufacturer provides full formulation disclosure to Scivera (or another authorized assessor) under confidentiality/non-disclosure agreement. If sub-suppliers provide proprietary components for the formulation, the assessor engages sub-supplier(s) using SciveraLENS® to gather full formulation disclosure of component(s) under confidentiality/non-disclosure agreement with sub-supplier.

CFFD Requirements for your formulated product including all raw materials. By chemical and concentration:
1. All intentional ingredients at any concentration (“Ingredient”)

2. Any impurities present in the finished formulation at concentration ≥100 ppm (0.01%) (“Applicable Impurity”)

3. Any chemicals present as impurities at any detectable concentration and also listed on the ZDHC MRSL v2.0 (“Applicable Impurity”)

4. Supporting documentation for 1-3 above, including:
(i) Technical Data Sheet (TDS) for finished chemical product
(ii) Safety Data Sheet (SDS) for finished chemical product
(iii) SDS for each component and/or raw material sourced for the finished chemical product
(iv) Chemical formulations containing polymers require completion of the Polymer Data Detail Form by polymer component supplier(s)
(v) Chemical formulations containing dyes or pigments require supporting color ingredient and impurity data by color component supplier(s)
(vi) Test reports from a qualified analytical laboratory for the applicable restricted substances based on product category, etc.

In some cases, the Scivera Safer Chemistry CFFD data collection process requires engagement with a chemical company’s component chemical and/or raw material supplier(s)—and in some cases their sub-suppliers—to gather required ingredient and impurity information. Scivera regularly executes confidentiality and non-disclosure agreements with upstream suppliers to collect this component information. This step protects the sub-suppliers’ confidential product information, while providing the necessary ingredient and impurity data for the requesting chemical company’s Screened Chemistry certification process.

Step 2 :: Priority Chemical List Screen

Based on the applicable product category, use the indicated list(s) for the list screen step: 

Step 3 :: Positive Chemical List Screen

Screen all ingredients and applicable impurities against the following Positive Chemical Lists:

U.S. EPA Safer Chemical Ingredients List (SCIL):

• Full Green Circles = 30 points
• Half Green Circles = 25 points
• Yellow Triangle = 20 points

If the ingredients or applicable impurities are present on any SCIL, then score that ingredient or impurity as noted above.

Step 4 :: Chemical Hazard Assessment

Any ingredient or applicable impurity that is not a SCIL chemical must have accepted Chemical hazard Assessment (CHA) completed. For any SCIL chemical present in the formulation, the Screened Chemistry certificate applicant can elect to have a CHA completed for the SCIL chemical. 

Scivera GHS+ Chemical Hazard Assessment Scores:

• Scivera GHS+ Hazard Category Green = 45 Points
• Scivera GHS+ Hazard Category Green/Yellow = 35 Points
• Scivera GHS+ Hazard Category Yellow = 25 points
• Scivera GHS+ Hazard Category Gray = 0 points
• Scivera GHS+ Hazard Category Red = Overall formulation score is capped at 0

Based on the resulting Chemical Hazard Assessment result, apply the corresponding score to the ingredient or impurity for the Preferred Chemical List Check OR Chemical Hazard Assessment Component.

For textile chemical products that contain one or more polymer component(s), use the following for scoring: 

Polymer-specific Scoring Rules:

• Screened Chemistry Acceptable: Meets US EPA Safer Choice Polymer Criteria (and additionally does not contain monomers with CMR-PBT or non-CMR/PBT hazards at >0.1%) = 35 points
• Screened Chemistry Not Acceptable (Low Priority): Doesn’t Meet US EPA Safer Choice Polymer Criteria due to other endpoint (but not CMR/PBT related) OR contains monomer with non-CMR/PBT hazards at >0.1% – Potential Weight Score = 25 points
• Screened Chemistry Not Acceptable (High Priority): CMR, PBT (monomer and polymer) doesn’t Meet US EPA Safer Choice Polymer Criteria due to CMR/PBT OR contains residual monomer with CMR/PBT hazards at ≥1000 ppm (0.1%).

The presence of a Not Acceptable CMR/PBT High Priority ingredient at any % composition in the formulation will result in an automatic reduction of the overall formulation score to 10 points.

See also the Special Rules for Polymer Formulation Ingredient and Applicable Impurity Disclosure and Scoring section below for more detail.

Step 5 :: Dermal Sensitization Score

For each ingredient or applicable impurity, assess for Dermal Sensitization Hazard. Based on result, apply the corresponding score:

Low Hazard for Dermal Sensitization = 5 points
Moderate Hazard for Dermal Sensitization = 0 points
Insufficient Data to Determine Dermal Sensitization Hazard = -5 points
High Hazard for Dermal Sensitization = -10 points

Step 6 :: Calculate the chemical-level Screened Chemistry Score

Once a Screened Chemistry Score has been assigned to each of the three scoring components (ie Priority Chemical List Check, Preferred Chemical List Check OR Chemical Hazard Assessment, and Dermal Sensitization Check) add the three scores together to determine the overall Screened Chemistry Score for the Ingredient or Applicable Impurity.

Step 7 :: Calculate formulation-level Screened Chemistry Score

Once a chemical-level Screened Chemistry Score has been assigned to each ingredient and applicable impurity in the finished formulation, calculate a weighted-average score for the formulation by multiplying each ingredient and applicable impurity score by its concentration in the finished formulation and then add all values for an overall Screened Chemistry Score.

EXAMPLE CALCULATION

Chemical name :: Screened Chemistry Score :: Concentration :: Weighted SC Score

Ingredient 1 :: 40 :: 80% :: 32

Ingredient 2 :: 20 :: 19% :: 3.8

Impurity 3 :: 15 :: 1% :: 0.15

Total Screened Chemistry Score :: 35.95

NOTES and CLARIFICATIONS

Special Rules for Polymer Formulation Ingredient and Applicable Impurity Disclosure and Scoring

Complete disclosure of polymers, including polymeric oligomers, catalysts, cross-linkers, residual monomers, etc. Polymeric residual monomers present at concentrations greater than or equal to 1,000 ppm (0.1%) in the polymer component formulation, or 100 ppm in the Finished Chemical Formulation must be disclosed. 

Intentionally added polymers must have adequate disclosure, including all residual monomers at or above 0.1% (1,000 ppm) in the polymer Ingredient and all other Applicable Impurities. The overall score for a polymer will be capped at the lowest score for any residual monomer at or above 1,000 ppm (0.1%) in the polymer. For polymer assessments, the Service Provider must provide sufficient detail on how polymer assessments are performed. This must be clearly articulated in the Finished Chemical Formulation report so that the basis of the polymer’s hazard classification is clear. 

For polymeric ingredients, residual monomers have a screening threshold requirement of 1,000 ppm (0.1%) for each monomer at the polymer level. The overall score for the polymer will be capped at the lowest score for any residual monomer at or above 1,000 ppm in the polymer.  All polymer-specific Applicable Impurities have a threshold of 100 ppm (0.01%) at the Finished Chemical Formulation level for Chemical Formulation Hazard Scoring. 

Special Rules for Colorant (Dye or Pigment) Formulation Ingredient and Applicable Impurity Disclosure and Scoring

Chemical Hazard Scoring strives for complete disclosure of colorant Ingredients and their Applicable Impurities. Ideally, with impurity disclosure ≥100 ppm, or ≥1,000 ppm if accompanied by colorant-specific analytical testing.

If the finished colorant formulation does not include all impurities present at or above 1,000 ppm (0.1%), the colorant formulation cannot be scored. 

If an impurity related to a dye/pigment ingredient is listed on the ZDHC MRSL v2 (or most current version) AND is present in the formulation at a concentration greater than 100 ppm but less than the concentration limit published in the ZDHC MRSL v2 (or most current version), the MRSL-listed impurity is screened but not scored. The remaining Ingredients and Applicable Impurities are screened and scored, but the maximum score for the formulation is capped at 20. If full formulation scoring (not including the screened MRSL-listed impurity) results in a score lower than 20, then the lower score is used.

If the finished colorant formulation does not include all Applicable Impurities present at or above 100 ppm, it can be scored if it is accompanied by consistent analytical testing that adheres to the ZDHC MRSL v2 (or most current version) in additional to full formulation screening; however, the formulation score is capped at 20. The formulation must meet the ZDHC MRSL v2 (or most current version) conformance limit.  If full formulation scoring results in a score lower than 20, then the lower score is used.

Special Rules for Additional Test Data Requirements

The Service Provider may request additional test data for any other chemical that is present on the MRSL, or to confirm 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.