Attempt to demystify the new ZDHC level 3 conformance requirements for chemical formulators
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Attempt to demystify the new ZDHC level 3 conformance requirements for chemical formulators

The zero discharge of hazardous chemicals (ZDHC) program released the version 3.0 of the manufacturing restricted substances list (MRSL) and the conformance guidance version 2.0 document on 1st November’ 2022. These two documents contain many changes compared to their previous versions.

Among other changes, one change in the conformance guidance document that is seen to be a big ask from most of the textile auxiliary chemical formulators; is a review of the chemical hazard assessment (CHA) capability of the companies, desirous of achieving the highest level (Level 3) of ZDHC conformance.

At a recently held webinar last week by the ZDHC India office on the above issue, the prevailing confusion manifested itself in the form of questions like;

  • Whether a read-across data will be accepted for satisfying the toxicological information of the formulation in section 11 of the safety data sheet (SDS)?
  • Will a list of toxicologists be made available by ZDHC,
  • Will testing have to be done for satisfying the information requirements; specifically of Section 11 and 12 of SDS, etc.

It is important for the formulators to start putting in place the following; to adhere to the requirements of the CHA:

1.     Formulators will need to put in place a document that contains the hazard classification details of all the raw materials present in all the formulations that a company proposes to take up for Level 3 ZDHC conformance.

2.     In addition, hazard classification details of all the formulations will also have to be properly documented applying the principles of globally harmonized system (GHS) for classification and labelling of hazardous chemical mixtures/formulations.

3.     Having SDS of each raw material in records and seeking the chemical identity of the raw material from their suppliers (wherever lacking) in terms of correct CAS No or standard chemical nomenclature.

4.     Access to EU REACH Candidate list, Annex XIV and Annex XVII of EU REACH regulation, and other hazardous lists.

5.     Company to identify safer alternatives for high hazard chemicals and to demonstrate successfully reformulation, wherever applicable.

6.     Knowledge of Safer Chemical Ingredients List (SCIL) of United States Environment Protection Agency (US EPA).

7.     Competence in SDS authoring as per the statutory requirements of various countries.

Companies should read the conformance guidance version 2.0 for more details. This document at no place indicates the need for testing; since testing (confirming to test guidelines); can prove to be cost-prohibitive and time consuming. 

Interesting as it may sound, companies have been provided with the option of either putting in place the above competencies at their manufacturing facility/company office or outsourcing these specialized requirements to consultants. A word of caution here, if sub-contracting the CHA part to consultants seems to be a better option. There is a dearth of professionals in India possessing the above capabilities and hence companies must exercise due diligence and verification before outsourcing this very critical aspect to consultants.

Chitralekha Datta

Global Chemical Regulatory Consultant

2y

Truly, it needs a lot of expertise to perform appropriate hazard assessment specially for mixture in mixture auxiliary products 

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