What is the transition period from the ZDHC MRSL V2.0 / ZDHC Conformance Guidance V1.1 to the new ZDHC MRSL V3.1 / ZDHC Conformance Guidance V2.0 on the ZDHC Gateway?
The transition period on the ZDHC Gateway started 1st January 2023 and ends on 31st October 2023. In this transition period, the products can still be verified according to both ZDHC MRSL versions (2.0 and 3.1). After 1st November 2023 only products according to the new ZDHC MRSL V3.1 and the related ZDHC Conformance Guidance V2.0 can be uploaded.
What are the key changes on the ZDHC Gateway from the transition period which started on 1st January 2023?
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. The “Registered” product status will disappear.
- 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 Once the eight weeks have passed, the chemical product gets unpublished if there is no new ZDHC MRSL Conformance certification.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.
- If there is a certification for both ZDHC MRSL (2.0 and 3.1), the certification for ZDHC MRSL 3.1 prevails.
- Product visibility of the prevailing certification in the ChemCheck report and in the Performance InCheck Report.
What will be the key changes on the ZDHC Gateway at the end of the transition period on 31st October 2023?
The following changes will take place on the ZDHC Gateway from 1st November 2023 onwards:
- From 1st November 2023 products certified against MRSL V2.0 cannot be uploaded and published on the ZDHC Gateway.
- If by 1st November a product has been only certified against ZDHC MRSL V2.0 and not against ZDHC MRSL V3.1, it will be moved to an “Expired” public product status for eight weeks. If the product is not re-certified against ZDHC MRSL V3.1 within eight weeks the product will be automatically unpublished and not be visible on the ZDHC Gateway, until a new valid ZDHC MRSL V3.1 certification has been uploaded.
- The Performance InCheck Report will still show ZDHC MRSL V2.0 certified products until 31st May 2024.
Why is a document review of the SDS required? Which aspects of an SDS are to be reviewed? What are the expected outcomes of the SDS review?
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
As part of implementing a chemical management system, what are the requirements for a Technical Data Sheet to be incorporated by a formulator?
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.
Is screening of a formulation for MRSL substances mandatory? Or can a test laboratory only perform analytical testing to issue the certification?
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 V2.0 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 Annex 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.
What is the screening methodology to be followed by a laboratory?
Section 4.7 of the ZDHC MRSL Conformance Guidance V2.0 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.
If a certification body does not have screening/testing of a formulation as part of its certification methodology, but only an ingredient or document review, does it qualify as a ZDHC MRSL V3.1 certifier?
The ZDHC MRSL Conformance Level 1, as per the ZDHC MRSL Conformance Guidance V2.0 requires analytical testing as a criteria to certify a product for Level 1 conformance. A certification standard or body applying for ZDHC MRSL Level 1 conformance must include analytical testing in its protocol.
Do I need to test all my chemical formulations for ZDHC MRSL Level 1 before I move to higher levels of conformance?
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.
Is it required for a chemical formulator to get a ZDHC MRSL Level 1 certification before applying for the higher ZDHC MRSL conformance levels?
The ZDHC MRSL Conformance Guidance V2.0 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.
For ZDHC MRSL Level 2 and Level 3 certification, what are the requirements for meeting the principles for testing at MRSL conformance level 1?
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.
Does a chemical formulator have to re-certify products to the ZDHC MRSL V3.1 even if the certification for a chemical product for ZDHC MRSL V2.0 is valid?
The implementation of the ZDHC MRSL V3.1 and ZDHC Conformance V2.0 has a transition period until 1st November 2023. After this period, only ZDHC MRSL V3.1 certified products will be accepted in the ZDHC Gateway and all valid ZDHC MRSL V2.0 products will be archived. Hence, even if a product certified for ZDHC MRSL V2.0 validity is ongoing, the formulator will have to re-certify the product to the ZDHC MRSL V3.1 at the appropriate ZDHC MRSL conformance level as per the ZDHC MRSL Conformance Guidance V2.0 criteria. After verification by the ZDHC Approved MRSL the certificate must be uploaded and published on the ZDHC Gateway.
Does a chemical formulator have to re-certify products for ZDHC MRSL Level 1 if the ZDHC Approved MRSL Certifier approved for the ZDHC MRSL Conformance Guidance V3.1 is the same as the current certificate?
Yes, products certified for ZDHC MRSL Level 1 for ZDHC MRSL V2.0 will have to be re-certified for ZDHC MRSL V3.1 and the new ZDHC MRSL Level 1 even if the ZDHC Approved MRSL certifier is the same as for the current certificate.
If there are changes in the formulation during the validity period of the certificate issued by the ZDHC Approved MRSLCertifier, what guidelines should be followed for re-certification? What will be the validity of such a re-certified formulation?
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.
If a chemical formulator has multiple formulation sites, is it required that all the sites are audited on-site for ZDHC MRSL Level 2 or Level 3 certification by the ZDHC Approved MRSL Certifier?
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.
What are “Expired” products? How and when will I get communication for my products that are “Expired” in the ZDHC Gateway? What is the process of publishing them with the renewed ZDHC MRSL conformance certificate?
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.
Is the ZDHC MRSL V3.0 still valid after ZDHC MRSL V3.1 got published?
ZDHC MRSL V3.1 is the official ZDHC MRSL now and the ZDHC MRSL V3.0 is no longer valid.
How long will the ZDHC MRSL V3.1 be 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.
What are the changes from the ZDHC MRSL V3.0 published in November 2022 to the ZDHC MRSL V3.1 published in April 2023?
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.
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."
How does a laboratory interpret the total boron test findings by ICP to certify a formulation containing the ZDHC MRSL listed boron-containing substances for ZDHC MRSL conformance?
The ZDHC MRSL V3.1 document lists the following boron-containing substances and related test methods:
The formulation limits for boron-containing flame retardant substances is 250 mg/kg, and for other/miscellaneous substances i.e. borate, zinc salt and perboric acid, sodium salt is 1000 mg/kg). The presence of these substances is through results for total elemental boron performed by “methanol, extraction, ICP” or “acid digestion, ICP”, which determines the ‘total boron’ content.
In case total boron is determined by the laboratory, they should take the following steps to certify the formulation for the boron-containing substances listed in the ZDHC MRSL V3.1:
- Discuss with the chemical formulator on the application/use of the formulation to determine the possibility of a boron-based substance in the formulation.
- Get proper ingredient information based on SDS or any other document review or consultation with the chemical formulator.
- Based on this information, the interpretation of total boron can be done through the mathematical calculation for the relevant boron-based ingredient in the formulation.
For example, if the content of boron determined by ICP is 150 mg/kg and the ingredient in the formulation is confirmed as boric acid (flame retardant finish), then the content of boric acid
(H3BO3) in the formulation can be deduced as follows:
Content of boric acid (H3BO3 ) = 150 mg/kg X 61.84 (molecular weight of boric acid)
10.81 (atomic weight of boron)
= 858.1 mg/kg
Since the result as per the calculation is above the MRSL limit value of 250 mg/kg, the formulation does not conform to the ZDHC MRSL V3.1. A laboratory should develop its methodology for calculations for each boron-based substance.
Under the ‘Glycols/Glycol Ethers’ category of ZDHC MRSL V3.1, for ‘leather applicability’ of ‘2-Methoxypropyl acetate (CAS No. 70657-70-4)’, there is a general formulation limit of 50 mg/kg and a formulation limit of 1000 mg/kg specifically for ‘leather finishing formulations'.
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.)
- Cross-linkers (finishing)
- Matting agents - inorganic
- Matting agents - organic
- Patent leather
- Protein binders
- Transfer coating
In ZDHC MRSL V3.1, how does a ZDHC Signatory Approved Solution Provider/ZDHC-Approved laboratory interpret the formulation limits for cresol, xylene, and their respective isomers?
- 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.
Titanium dioxide (TiO2) is restricted in the ZDHC MRSL V3.1. Please provide more details on the restriction conditions, types of chemical formulations to be considered, formulation limit, and conformance requirements.
- 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.