TMH Requirement Overview:
The Transparent Material Health Imperative requires that manufacturers demonstrate that their product meets an adequate level of health through conducting an assessment of the substances in the product inventory.
There are two pathways to achieve this:
- Preapproved Program Pathway: Demonstrate that the product has achieved one of the pre-approved material health certifications outlined in the documentation requirements, and that certification is valid at the time of LPC Certification.
- LPC Transparent Material Health Pathway: Engage an approved third party Material Health Assessor (MHA) to conduct a review of a minimum of 95% of material ingredients represented on their valid Third Party Verified Declare label and demonstrate that there is no significant risk of exposure to the manufacturer, installer or end-user of the product (process outlined here) by working to eliminate all BM-1 chemicals (Carcinogens, Mutagens and Reprotoxics or Persistent, Bioaccumulative Toxics) in their product’s formulation. The percentage of product assessed is represented on the LPC Label.
Recertification Requirements:
Certification under LPC is valid for 3 years, at which time, the manufacturer must demonstrate maintenance or improvement on any of the areas identified in their initial certification to maintain their status.
The two different pathways outlined in the certification requirements therefore have two different recertification processes:
- Pathway 1: Preapproved Assessment Results
For the manufacturer to continue to pursue the pre-approved program pathway at recertification (3 years after certification), their certification for that program must continue to be valid at an approved level, or higher at the time of recertification.
- Pathway 2: LPC Transparent Material Health Pathway
Those manufacturers who pursue the pathway outlined in the Transparent Material Health Guide must work with the approved Material Health Assessor leading up to recertification to demonstrate that their product meets any continuous improvement requirements.
As noted above, initial certification allows 5% of the product to be unassessed (100% of the product is still required to be inventoried and show Red List compliance per the Red List Imperative). By recertification, the manufacturer should have worked with the MHA to assess the remaining 5% of the product to achieve 100% assessed at a 100 ppm threshold. If they are unable to assess the remaining 5% they may request to use HH-00X Continuous Improvement for Assessment.
Current TMH Imperative assessments are generally conducted using the GreenScreen® Methodology as well as other screening methodologies that are outlined in the Transparent Material Health Guide. GreenScreen assessments are valid for 5 years, though the LPC Certification period is only 3 years at a time.
The focus of recertification for this Imperative is on optimization, conducting additional assessments, and addressing any changes to the product’s formulation, not on redoing work that is still valid. The timing of components is as follows:
- Recertification takes place every 3 years for LPC
- GreenScreen® Assessments are valid for 5 years
- Declare labels (Third Party Verified) are renewed every 1 year
As the Third Party Verified (3PV) Declare label renews each year and requires verification of backup documentation from the supply chain, it provides an accurate annual picture of what, if any, material ingredient changes or material suppliers have occurred pertinent to the TMH review, and identifies if any new substances are present in the final product requiring review at the time of recertification in 3 years. However, any completed GreenScreen chemical screens have a lifespan of 5 years and should only be revisited when they expire.
Manufacturers are therefore not required to re-review any chemicals assessed at certification, when they recertify (after 3 years) as this falls within the 5 year chemical screen shelf life timeline. Manufacturers will be required to confirm whether their product formulation (BOM) and material suppliers have changed since the formulation’s last review. This BOM and their statement will be confirmed through comparison of their 3PV Declare label to the existing review. Recertification under the Material Health Imperative can only proceed after the product has renewed its Third Party Verified Declare Label for that current year and all information has been verified.
At recertification, the MHA must only:
- assess new substances that have been added to the formulation since the last review,
- repeat reviews for any polymeric substances that are being sourced from different suppliers than that of the previous review
- assess new substances that are added to the review under the requirement to assess the additional 5%.
The MHA is required to revisit any chemical assessments made over 5 or more years ago and determine whether they are still valid or whether they require updates (new GreenScreen® or confirming previously obtained polymer data and updating the relevant polymer screens if needed). Therefore, by the second recertification, at six years, the chemical screens present under the TMH report will no longer be valid and may need to be updated based on a review per the discretion of the MHA. If a substance has been recently reviewed by that MHA’s firm and they are confident that the results of that assessment stand, the MHA should take that into account and focus efforts on new substances or truly out-of-date reviews.
Continuous Improvement:
The TMH report under LPC, and other pre-approved programs, often mandate corrective actions and/or continuous improvement that should be addressed by recertification.
While the standard asks manufacturers to assess the final 5% by weight of their products, use of the pre-approved program pathway allows manufacturers to sit at a level of 95% assessed. ILFI encourages all manufacturers to pursue 100% assessment of their products to ensure safety for those who interact with their products. However, for manufacturers pursuing the LPC Transparent Material Health Pathway, ILFI has created RL-020 Assessment Continuous Improvement that relieves them of the absolute need to reach 100% after 3 years. ILFI intends to remove this exception over time, but first seeks to identify more cost-effective pathways that are market-driven to build the business case for achievement.
