Comparable MIMs Approach

General Annex VIII CLP Description of the product (mixture) exact concentration or concentration ranges of substances and/or mixtures in mixtures MIMs generic product identifiers

General Annex VIII CLP Downstream users defining products (mixtures) by substance concentration ranges can exchange substance and MIMs suppliers, as long as the submitted concentration range does not change, without the need to update the submission or to create new UFIs. When using MIMs, this requires exact knowledge of the composition of the MIMs, which in practice is not given. Downstream users defining products (mixtures) by MIM concentration ranges cannot. In this case each combination of MIMs is considered an individual mixture, requiring an individual UFI. An exchange of a MIM by a comparable MIM requires a submission update and a new UFI.

The MIM Problem Topping up of silos  separation of delivery batches not possible MIMs are mixed in the silos  targeted, detailed UFI distinction is not possible

Appointed bodies / poison centres Preferences Appointed bodies / poison centres Prefer knowing the composition of mixtures by substances rather than by MIM, as it safes valuable time that is needed to compile the the detailed information of a MIM (which in itself can contain one or more MIMs) and identify the substances contained in a mixture and their concentration ranges. Downstream users Prefer submitting substance based compositions as it provides greater flexibility and greater confidentiality. However, in general they lack the necessary information.

Comparable MIMs Approach Component Downstream user can define a group of MIMs that are interchangeable within a component of his product (mixture) while delivering the same technical performance know the classification for health and physical hazards for each of the MIMs used know the components of each MIM used as well as their concentration ranges, as indicated in chapter 3 of the respective SDS do not know the composition of MIM in the necessary detail to determine the composition of substances in accordance with the criteria of Annex VIII, CLP MIM1 MIM2 MIM3

Comparable MIMs Approach Component Appointed bodies know everything downstream users of MIMs know know from the preceding MIM submissions further the composition of MIMs in accordance with the criteria of Annex VIII (more precise than in SDS) know the composition of the mixture can determine from the composition of the mixture and the detailed composition of the contained MIMs the concentration ranges of contained substances can verify if the determined composition ranges of each substance meet the conditions for product to be submitted as one mixture (one UFI) or several mixtures MIM1 MIM2 MIM3

Verification of comparability of MIMs – Step 1 Component Downstream user indicates for relevant mixture component the MIMs that are interchangeable and therefore comparable (e.g. by indicating several UFIs for the same mixture component) As a pre-condition for the submission of a group of comparable MIMs all MIMs within the group must have the same classification for health and physical hazards, indicate in section 3 of the safety data sheets (according Annex II of Regulation (EC) No 1907/2006) the same components with similar concentration ranges, belong to the same product category as referred to in Section 3.4 of Part A and be used within the mixture inside the same concentration range according section 3.4 of Part B. MIM1 MIM2 MIM3

Verification of comparability of MIMs – Step 2 Component Appointed body operates a software with access to the data base, which automatically verifies if the information for all listed comparable MIMs has been submitted (is available) and determines from the existing information the min/max substance concentration within a group of comparable MIMs MIM1 MIM2 MIM3 “Group of comparable MIMs”

Verification of comparability of MIMs – Step 3 Appointed body (automatically, via Software) Determines the substance composition of the submitted mixture, based on the substance composition of the “Group of comparable MIMs” and their submitted concentration in the mixture Component 1 Component 2 Component 3 “Group of comp. MIM1” “Group of comp. MIM2” “Group of comp. MIM3” min X1 % – max X1 % min X2 % – max X2 % min X3 % – max X3 % Final (submitted) mixture

Verification of comparability of MIMs – Step 4 Appointed body (automatically, via Software) Verifies if the composition ranges of each substance meet the conditions for the product to be submitted as one mixture (one UFI) Final (submitted) mixture CR1 CR2 CR3 CR4 CR5 CR6 CR 7 Do all comparable MIMs within one group contain the same relevant substances? Do all Concentrations ranges comply with Table 1 respective Table 2? YES -> Submission admitted with one UFI NO -> Submission not accepted

Conclusions The proposal… seems to be good, but we don’t yet know how much it will reduce the problem is currently the (only and therefore) best available is complex and not easy to understand requires the support from appointed bodies and Member States needs to be “sold”