The Transition period on ZDHC Gateway, that started on 1st January 2023 which closed on 31st October 2023.
Since 1st November 2023 only products according to the new ZDHC MRSL V3.1 and the related latest ZDHC Conformance Guidance can be uploaded.
The following changes have taken place on the ZDHC Gateway:
- The ZDHC Gateway only hosts ZDHC MRSL conformant chemical products with proof of conformance and thus only ZDHC MRSL Level 1,2,3.
- A new product status “Expired” has been introduced. An “Expired” product is a chemical product with an expired ZDHC MRSL Conformance certificate. A product that is expired will still be visible (published) on the ZDHC Gateway for eight weeks, so the formulator has time to re-certify the chemical product. Once the eight weeks have passed, the chemical product gets unpublished if there is no new ZDHC MRSL Conformance certification.
- Uploading Safety Data Sheets (SDS) for all ZDHC MRSL Conformant products is mandatory.
- Products that have been certified against ZDHC MRSL V3.1 can be uploaded and published on the ZDHC Gateway.
- Products that have been certified against ZDHC MRSL V2.0 can be uploaded and published on the ZDHC Gateway until 31st October 2023.
The transition period has now come to an end. The following changes have been made;
- Since 1st November 2023 products certified against MRSL V2.0 cannot be uploaded and published on the ZDHC Gateway.
- Products only certified against the ZDHC MRSL V2.0 and not against the ZDHC MRSL V3.1 were moved to a ‘Expired’ public status for eight weeks. Now these products have been automatically unpublished and not visible on the ZDHC Gateway, until a new valid ZDHC MRSL V3.1 certification has been uploaded.
- The Performance InCheck Report showed ZDHC MRSL V2.0 certified products until 31st May 2024. Only products certified against ZDHC MRSL V3.0 or V3.1 are now shown on the Performance Incheck Report.
A review of the SDS should be done by the ZDHC Approved MRSL Certifier to check the following:
- Any intentional addition in the formulation of a substance listed in the ZDHC MRSL V3.1 or listed under the ZDHC MRSL Archived List. This can be done by reviewing the information given in Section 3 of a GHS conformant SDS on the hazardous ingredients, using the CAS numbers declared by the formulator therein, and checking in the ZDHC MRSL.
- Correct name of the product and the formulator name through the details given in Section 1 of the SDS to issue the final certification.
- Any physical hazards (flammable, combustible, etc.) mentioned in Section 2 of the SDS to ensure safe storage and handling of the sample in the laboratory.
- Chemical stability and reactivity information is given in Section 10 of the SDS.
- Information on toxicological parameters in Section 11 of the SDS, such as skin/eye irritation/corrosion/ damage or acute oral or dermal toxicity, to ensure the use of proper PPE when handling the chemical sample in the laboratory for testing.
- Information on ecotoxicological parameters in Section 12 of the SDS for disposal considerations of the chemical sample
The ZDHC MRSL Conformance Guidance document V2.0 requires evaluation of the capability of a formulator “to produce a technical data sheet for detailing optimum application conditions of the finished product for all defined end uses and indications of any applications that the formulation should not be used for (in case where this is available)”. This means that the formulator should have capability and resources to incorporate sufficient technical and suitable application knowledge to assist textile and leather producers to fulfil their requirements, with any specific information on conditions of use or limitations of application. This information should be given preferably via Technical Data Sheets or through e-mail or verbal communication.
A screening methodology is recommended to support the decision on analytical testing of a chemical sample for ZDHC MRSL risks. Annex A - Smart Testing Grid in the ZDHC MRSL Conformance Guidance V2.1 document should be used as the guidance for analytical testing by the ZDHC Approved MRSL certifier. However, wherever there is a requirement to confirm MRSL substances (other than those given in Appendix A-Smart Testing Grid) to support the professional judgment of the ZDHC Approved MRSL certifier, screening methodology can be used. The final certification for ZDHC MRSL Level 1 conformance must be based on analytical testing of the chemical sample.
Section 4.7 of the ZDHC MRSL Conformance Guidance V2.1 document gives details on screening methods that can be followed by a laboratory. However, these are for guidance only, and laboratories can develop their own approach to screening methodology.
As a formulator, if you need only ZDHC MRSL Level 1 certification, you will need to get your products tested with a ZDHC approved MRSL Level 1 Certifier. However, in case you are able to demonstrate that you have adopted the principles of analytical evaluation for ZDHC MRSL conformance in your formulation facility/facilities (either in-house or outsourced) as part of your management system, you need not certify all your products for ZDHC MRSL Level 1 and directly approach for ZDHC MRSL Level 2 or 3.
The ZDHC MRSL Conformance Guidance V2.1 clearly outlines the criteria to be fulfilled for each ZDHC MRSL level. The principles of Level 1 are included in Level 2, and the principles of Levels 1 and 2 are included in Level 3. This means that if a formulator feels that they can satisfy the criteria of Level 2, they can directly apply for ZDHC MRSL Level 2 conformance with the ZDHC Approved MRSL certifier for that conformance level. Similarly, if a formulator feels that they can satisfy the criteria of Level 3, they can directly apply for ZDHC MRSL Level 3 conformance with the ZDHC Approved MRSL certifier for that conformance level and get the ZDHC MRSL Level 3 certification for their products.
In the case of formulations eligible for a MRSL Level 2 or Level 3 conformance directly, compliance with the principles of analytical testing is achieved through the ZDHC approved MRSL certifier’s assessment of the chemical management system at the formulator during the on-site visit. This assessment will include the evaluation of the formulator’s testing regime and their ability to provide sufficient and reliable information on the conformance of the final commercial formulations to ZDHC MRSL V3.1.
The implementation of the ZDHC MRSL V3.1 and ZDHC Conformance Guidance V2.1 had a transition period up to 1st November 2023. After this time, Only ZDHC MRSL V3.1 certified products have been accepted in the ZDHC Gateway and all valid ZDHC MRSL V2.0 products have been archived. Hence, even if a product certified for ZDHC MRSL V2.0 validity is ongoing, the formulator must re-certify the product to the ZDHC MRSL V3.1 at the appropriate ZDHC MRSL Conformance Level as per the ZDHC MRSL Conformance Guidance V2.1 criteria. After verification by the ZDHC Approved MRSL Certifier, the certificate must be uploaded and published on the ZDHC Gateway.
No, a re-testing is not needed as the ZDHC MRSL V3.1 just replaces the previous V3.0 due to some minor changes that needed to be reflected and all V3.0 certificates remain valid.
The ZDHC Approved MRSL certifier should check the following:
- Is there any new ingredient that is listed in the ZDHC MRSL or in the ZDHC MRSL Archived List as detailed in Section 3 of the SDS by the formulator?
- Is there any impact on ZDHC MRSL risks as per Annex A- Smart Testing Grid due to the change of ingredients in the formulation?
- Can such MRSL risks be confirmed through screening or will it require analytical testing?
- Does the formulation need to be tested for only an additional specific ZDHC MRSL group/ substance based on the changes in the formulation?
Based on information obtained from the above checks, the ZDHC Approved MRSL certifier can perform the activities required to re-certify the formulation. The validity depends on the policy of the ZDHC Approved MRSL certifier. However, during the validity period, in case of a revision in the ZDHC MRSL version, the formulation should be re-certified to the latest ZDHC MRSL version by the ZDHC Approved MRSL certifier before the end of the transition period for implementation of the new ZDHC MRSL version.
Principally, all formulation sites should be evaluated for Level 2 or Level 3 criteria through an on-site audit. However, if this is a challenge due to any practical reasons, the ZDHC Approved MRSL Certifier may use their discretion and professional judgment to do an onsite audit of at least one main (major) formulation site and assess the other sites through online technology and document review to confirm the implementation of the Level 2 and 3 criteria at the other formulation sites.
Formulations whose validity for ZDHC MRSL Conformance Level 1, 2 or 3 have expired will be placed in the “Expired” category on the ZDHC Gateway. “Expired” formulations are not considered as a ZDHC MRSL Conformance Level. Such chemical products will be placed under the “Expired’ category for eight weeks on the ZDHC Gateway. After eight weeks, the chemical product is set back to the private 'products’ tab in the formulator’s account on the ZDHC Gateway. The formulator will be able to publish the product and make it visible under the product tab in their profile in ZDHC Gateway only if they re-certify the product with a ZDHC Approved MRSL Certifier at the appropriate ZDHC MRSL Conformance Level. The formulators whose products are nearing the expiry date will be notified via email or through the bell icon on the ZDHC Gateway six weeks in advance.
ZDHC MRSL V3.1 is the official ZDHC MRSL now and the ZDHC MRSL V3.0 is no longer valid.
The ZDHC MRSL V3.1 is valid until a new version of ZDHC MRSL is launched by ZDHC. The transition period is always included.
The ZDHC MRSL V3.1 has been updated in response to queries from stakeholders and after discussion with the MRSL Council. The document has been updated to reflect changes in supplier guidance, formulation limits, and in the note about the testing procedure for specific substances.
The different updates are as follows:
- O-Phenylphenol (+salts) (CAS No. 90-43-7)
- The supplier guidance for the ‘leather applicability’ of this substance in the category ‘1B. Anti-microbials and biocides’ have been amended to:
"Use is permitted for chemical preservation for transportation and storage of raw hides as well as tanned semi-finished products (wet-white, wet-blue). Chemical preservation of coated or uncoated finished leather shall not be permitted."
- It is also permitted as an 'in-can preservative’ in leather chemical formulations under the BPR PT6 up to the formulation limit of 5000 mg/kg.
2. Chlorophenols
To provide clarity to test laboratories and prevent misleading results, a ‘Note on testing’ is added in the introductory text of ‘1E. Chlorophenol’ category:
"If monochlorophenols or dichlorophenols are identified in a sample prepared for evaluation of chlorophenols using KOH extraction, the results should be confirmed in accordance with Annex C of DIN-50009."
When certifying a sample for the ZDHC MRSL V3.1, how does a laboratory distinguish between a leather finishing formulation and any other general formulation for leather applicability?
The term ‘leather finishing’ can be defined as the finishing which determines the appearance and properties of the final surface of the leather. This covers not only colouring, waterproofing, and wax dressings but also mechanical processing stages such as ironing and embossing of the leather. Typically in the first step of leather finishing, finishing agents are applied to cover the grain defects. Next, the base coat, which forms the base for the leather design, is applied. Finally, leathers are finished with a top coat to support the manufacturer's visual and physical specifications. The final colouring is also applied to the topcoat, which levels the colour of the leather.
Out of all the leather finishing agent categories listed in the ZDHC Gateway, only the following leather
finishing categories are granted this exception of formulation limit of 5000 mg/kg:
- Cellulose derivatives (base coat, top coat, etc.)
- Compounds
- Cross-linkers (finishing)
- Matting agents - inorganic
- Matting agents - organic
- Patent leather
- Protein binders
- Resins
- Stucco
- Transfer coating
- In ZDHC MRSL V3.1, the formulation limit for cresol (all isomers) under organic solvents is given as 500 mg/kg for textile, leather, and polymers. This has created some confusion amongst stakeholders as to whether this is the overall limit or a limit for each isomer. To clarify, we continue with the ZDHC MRSL V2.0 limits, i.e. the formulation limit for individual cresol isomers (o-cresol, m-cresol and p-cresol) is 500 mg/kg each. The sum of all these isomers should not exceed 1500 mg/kg.
- In the case of xylenes, however, the sum of all isomers (o-xylene, m-xylene, p-xylene) should not exceed 500 mg/kg.
- TiO2 is classified as a carcinogen following Delegated Regulation (EU) 2020/2017 by ECHA. According to this, the substance TiO2 must be classified as a carcinogen (if inhaled) (Carc. 2, H351 (inhalation)) when supplied on its own or in mixtures, where the substance or mixture contains 1% (w/w) or more TiO2 particles with an aerodynamic diameter ≤10 μm. You can find more details on this classification here.
- The ZDHC MRSL V3.1 restriction only applies to "solid mixtures" of TiO2 which are in “powder form”.
- This restriction does not apply to the chemical formulations which are liquid mixtures, emulsions, or pastes that contain TiO2 and have the proper GHS/CLP classification, these are allowed for use.
- The 'formulation limit’ criteria for powder formulation is that, the proportion of TiO2 particles with an aerodynamic diameter of ≤10 μm should not exceed 1% (w/w) in that powder formulation.
- To meet the ZDHC MRSL conformance criteria of such powder formulations, the chemical formulator must provide particle size analysis of TiO2 to the ZDHC Approved MRSL Certifier.
- Where a formulation meets the criteria detailed above ZDHC Approved MRSL Certifiers are responsible for providing the final ZDHC MRSL conformance certificate, approving such formulations.
- Whether the formulations containing TiO2 meet the criteria detailed above or not will be decided by the ZDHC Approved MRSL Certifier based on the declaration provided by the formulators. If needed, certifiers can ask for or perform the particle size analysis tests on the sample as well.