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Update of the IR&CSA Guidance Chapter R.

12 (Use Descriptor System) - Summary of comments and ECHA responses

Source Topic Comment Response


1 BASF Document "Remove the reference to industrial or professional setting from most of the process ok
history categories"
2 BASF Contents Deleted, except appendices (?) New table of contents, tables, figures will be
generated
3 BASF R.12.1 "Each registrant is also obliged to include a brief general description of all identified uses ok
in his Technical Dossier (see chapter 3.5 of IUCLID) and in Section 2 of the CSR. The
brief general description of use can also be based on the descriptor system in this
guidance"- Good to mention this explicitly!
4 BASF Table R.12.1 "Preparation category"changed to chemical product category- Comment (B3) Changed to text streamlined
be consistent with text on page 8
5 BASF Table R.12.1 "Mono-material"- Does the AC only describe mono-material articles? What does mono- Wording rephrased to make it more clear.
material mean in this respect?
8 UBA Table R.12.1 What is meant with the phrase "No link to exposure estimation tool"? No default values Footnote 4 added and text in table R.12-1 adapted.
available, not possible to select in ECETOC TRA? And what is the conclusion of that?
Expert judgement necessary, no tier 1 estimation possible? Please explain in more detail the
meaning and consequences.
1 UBA R.12.3.1 Please explain the necessity of the SU for sector of end-uses. If there is "no link" to tools The use descriptions does not only aim to identify
for exposure estimation, what is SU for sector of end-uses for? What does it trigger? Every suitable entries for Tier1 exposure estimation tools,
user will use this descriptor in an individual way. In a workshop we had lately with but also aims to form the title of an exposure
stakeholders from industry, these questions arised. scenario in a standardised way, and to communicate
on uses in a harmonised way. The SU may support
such communication. The example in section 12.3.1
may illustrate this.

2 UBA Figure R.12-1 Paint (PC 9a) instead of Paint (PC 9) adapted
3 UBA Appendix R.12-1 When splitting SU please delete SU8 and SU9 from the sector of end-uses Based on the comments received we identified that
the split leads to major confusion and is not really
needed. Thus we merged the two tables again and
clearly state in the guidance that the sector only
related to "uses" of a substance to be registered , but
not to its manufacture.

4 UBA Appendix R.12- PC Market sectors by preparations - no link to exposure estimation tool? For example the Footnote 4 added and text in table R.12-1 adapted.
2.1 selection of PC12 fertilizers has no link to exposure estimation? How is this possible? What
do you mean? What does the selection of PC 12 trigger? Form environmental perspective it
should trigger emissions to environment, and thus should somehow be connected to
exposure estimation tools
5 UBA Appendix R.12- Numbering of subgroups necessary The Appendix 12-2.2 is still under discussion with
2.2 ECETOC. In order to make the list of product
subcategories and article subcategories consistent
we removed the numbering from both lists. These
subcategories are entries to the TRA and not part of
the use descriptor system.

6 UBA Appendix R.12-3 PROC 26 can be described with PROC5 and PROC 8a and is therefore not necessary. We agree, this would be possible. We do not know
Please explain the reasons why EUROMETAUX found it more
appropriate to create a new category. We have
forwarded the question and received the answer that
the conditions are so particular for metals that this
category is needed.

7 UBA Appendix R.12- please check listing of AC 9 Has been included into paper articles, AC has been
5.1, R.12-5.2 deleted as a separate entry.
8 UBA Appendix R12- AC5*. What is * for? Has been removed.
5.2
9 UBA Appendix R.12-6 please explain closer, what are the characteristics for AC32 and AC36 The two products contain substances that are
intended to be released on use to create a smell.
1 CEFIC Appendix R.12-1 The medical industry request use descriptors for their sector: SoU: manufacturing of We have extended the SoU list only if there was
medical devices,SoU medical use on humans,PC: medical devices some evidence that the sector plays a major role as
an end-user of chemicals. We dont see this here.

2 CEFIC Appendix R.12-1 It needs to be crystal clear that there is no new Use Descriptor ‘Main sector of use’. The In order to avoid confusion and unnecessary
current wording, and in particular the table of appendix R12.1 are misleading and may be complexity we have moved this back to the previous
interpreted as such. approach, and have instead clarified the guidance.

3 CEFIC Appendix R.12- Idem with the Product Sub-categories. ECHA needs to make clear that the PC sub- In our view, this is clear. No action taken. However
2.2 categories are not a new Use Descriptor. the purpose of Appendix 12-2.2 is now explained in
the main text under section 12.3.2
4 CEFIC R.12.2 Is “descriptor” referring to e.g. a certain SU like SU 12 or is it referring to the genus SU? Terminology has been streamlined.
The same for the descriptor category.
5 CEFIC R.12.1 We need more clarification on the inclusion of information on use in the section 3.5 of A more elegant solution than re-typing is of cause
IUCLID5. If there is a CSR attached, are companies really obliged to re-type again all the desirable. Yes: The identified uses to be reported in
Use Descriptors in this section? IUCLID (based on Annex VI of REACH) are to be
consistent with the titles of the exposure scenario
(legal requirement, see Annex 1, section 5.1.1) and
the identified uses reported under section 2.2 of the
CSR. Since "identified uses" only emerge from the
assessment, for dangerous substances the IUCLID
information results from the CSR and not visa versa.
We have included a section on how to apply the use
descriptor system for reporting in IUSES (see
R.12.5).

6 CEFIC Appendix R.12-1 SU 21 and SU 22 seem to be reversed has been corrected

7 CEFIC Table R.12.1 Table R.12.1, page 9: PC is now preparation category instead of product category. This is Has been streamlined across the document.
confusing

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8 CEFIC R.12.3.3 Page 11 R.12.3.3 last paragraph: The creation of new use descritors should be discouraged We think, that the text is strong enough. However
to the maximum and as agreed in the CSAT consultation meeting only after approval of there may be reasons why a sector assumes that an
ECHA. The text of this paragraph could be stronger to emphaisze that. additional category is needed. ECHA will not
"approve" but possibly propose a category in a
guidance update.
9 CEFIC Table R.12.6 Table R.12-6, AC39: reference 18 is missing has been corrected
10 CEFIC Appendix R.12- It would be helpful if subcategories get a sub code like done for AC subcategories The Appendix 12-2.2 is still under discussion with
2.2 ECETOC. In order to make the list of product
subcategories and article subcategories consistent
we removed the numbering from both lists. These
subcategories are entries to the TRA and not part of
the use descriptor system.

11 CEFIC Appendix R.12- ERC’s: some segmentation water/air has been disappeared (ERC4. ERC8A, ERC8D, This has not disappeared but is still contained in
4.1 ERC10B, ERC11B). It was useful in order to distinguish process which lead mainly to Guidance R.16. However we felt that the release
emission into water iso air. factors should not occurr in the use descriptor list, in
order to ensure a consistent presentation across all
the five lists.
12 CEFIC Appendix R.12-1 R.12.1, page 18: Some SU’s appear in part 1 and part 2 of the table: SU8,9 should they be This is no relevant anymore, since we went back to
deleted in part 2? one table. Based on the comments received we
identified that the split leads to major confusion and
is not really needed. Thus we merged the two tables
again and clearly state in the guidance that the
sector only related to "uses" of a substance to be
registered , but not to manufacture.

13 CEFIC Appendix R.12-3 R.12.3, page 23: PROC 21 the inclusion “substance in form of massive metal” is a bit revised.
confusing as this refers to non-metal articles as well. Perhaps it would be better to include
the metal example in the explanation column.
14 CEFIC Appendix R.12-3 R12.3, page 24: PROC 22 why was industrial setting added here, while it was deleted in For this PROC, the TRA does not allow a choice
most other PROC’s between industrial or not industrial, its is only
industrial.
15 CEFIC Appendix R.12-3 R12.3, page 24: PROC 24 like in PROC 21 “massive metals” was added in the first column, revised.
while this may refer to other materials as well. Again suggest to move the reference to
massive metals to the explanatory column.
16 CEFIC Appendix R.12- R12.4.1, page 25: ERC 5 has been expanded to substances remaining in an article that have example has been included.
4.1 been used as processing aids in an earlier life stage. This needs more explanation as to when
this might be an issue.
17 CEFIC Appendix R.12- R12.4.1 page 25: ERC 7 The last sentence: no intended contact with product produced was clarification added.
4.1 added. This seems rather related to human exposure and should if this is the case be deleted
again for the environmental category.
18 CEFIC Appendix R.12- R12.5.1, page 29: AC12-2 was deleted. As the exposure migt be quite different with indoor Since outdoor and indoor use can be concluded from
5.1 and outdoor use, 12-2 seems useful and reinsertion should be considered. the ERC anyway, this differentiation is not needed
at AC level.
19 CEFIC Appendix R.12- R.12.3.5: includes a reference to the TARIC system as an alternative to the Article The text clearly says that this is not an alternative
5.1 Categories. Again, we should minimise the use of alternative lists. but could be used if more detailed description of an
article is needed. The AC list is now systematically
referenced to the TARIC system.

20 CEFIC R.12.3.4 R.12.3.4, top page 12, last bullit: The substance is meant to act as a processing aid and as No, here we really talk about the process, but of
such is released from the process mixture(…) or the chemical product (…) cause the source of the release is the chemical
product used as a processing aid.
21 CEFIC Table R.12-2 ...or use of a substance as a processing aid (ERC4)- Comment: This needs to be added in Has been added.
(CEPE) line with our own mapping . It also is a more relevant to the exposure pattern identified
across.
CEFIC Table R.12-2 "Use in closed batch process(PROC 3). Mixing and blending in batch process(multistage Further steps (substance transfers) included
(CEPE) and/or significant contact (PROC5)"-Comment: This section is far too simplified . It deals
only with a couple of examples of one step in the overall manufacturing process

CEFIC Table R.12-2 "Dying and finishing of textiles, leather or paper:"- Comment: powder coating of metal Example has been removed
(CEPE) articles is not a dipping or pouring operation, so is inappropiate to use as an example in this
cell.
CEFIC Table R.12-2 "Printing operations"-Comment:including this activity is misleading , as it is not mentioned Example has been removed
(CEPE) in the rest of the row, and it is a totally different process from that described-SU 3/ERC 4
and 5)
CEFIC Table R.12-2 "Low energy spreading such as rolling ,brushing (PROC10). Wide dispersive professional Outdoor uses have not been incuded (see scope of
(CEPE) use (ERC8C)-Comment: ERC8a,b,d and f, see CEPE Professional application Descriptor of the example in the intro text to the table)
use table. Note: if include industrial applications, such as printing, then need to add ERC 4
and 5)
CEFIC Table R.12-2 "Mixing of solids and liquids in batch formulation of coatings,cleaners,plastic Example has been converted into textile dyes
(CEPE) compounds,dyestuffs"-Comment:as far as I am concerned,dyestuff is a substance and is
inappropiate to include here.
22 CEFIC R.12.4.2 R12.4.2, page 15: Second line: please replace coating by paint to be consistent with term done
used elsewhere in the guide.
23 CEFIC Table R.12-3 Which sectors of the formulating- Comment: [brackets not needed, as PC9 de facto is a Chemicals deleted. Formulating remains to make
(CEPE) formulating sector] industry[“chemical” is an inappropriate term to apply to formulators. clear that this question does not address end use
Formulators are users of chemicals, not manufacturers of chemicals, which the term sectors. We don’t understand the last comment. In
suggests. Also changes here now line up with description in ERC 2 (page 25] buy the order to streamline the terminology in the guidance
substance? In which categories of mixtures [see my comment on page 12]is it used? we talk of consumer products. Definition is
provided in section 12.2.

CEFIC Table R.12-3 In which consumer preparations is the substance used? What are the broad environmental It’s a pigment, thus only 8a applies.
(CEPE) characteristics of these uses? PC9- Comment:ERC8a,c,d/f [see CEPE consumer Descriptor
of Use table]
24 CEFIC Figure R.12-1 Figure R.12-1: Structure of the descriptor system exemplified for a pigment: The PROCs Figure has been deleted and replaced by a more
and ERCs in this table need to be updated in line with the proposed changes in the tables generic figure in section 12.5.
and text above
25 CEFIC Appendix R.12- Appendix 12.2.2: PC 9b: delete removers, This category looks to be incorrectly located – it PC list and relation to subcategories has been
2.2 has nothing to do with “fillers or putties” – and note that it is more appropriately located in revised in dialogue with ECETOC.
PC 10]
26 CEFIC R.12.1 First paragraph: It has other purposes: mapping the supply chain for environmental Reference to Article 37 has been included
assessment, allowing the DU to report uses in a language that the M/I can directly translate
into ES, etc. Third paragraph: a reference to Article 37(2) and the right of DU to report uses
is missing.
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27 CEFIC R.12.3.1 R12.3.1, Sector of use: . Please add after first paragraph: They are important to the assessor Included.
as they help direct the exposure assessment (selecting the appropriate tools).

28 CEFIC R.12.3.1 R12.3.1, please add at end of section: In some cases, the PC better describes the market These are two different types of information and
sector than the SU. In such a case, the user may consider that the main user group SU and cannot really replace each other, however they can
the PC is the best way to describe the market sector. be used in a complementary way. But this is not
specific for SU and PC. Thus, no action taken.

29 CEFIC R.12.3.1 "Appendix R.12-2 provides a pick-list of preparation [mixture] categories[1]. The categories Additions
listed in the
have
leftbeen
handmade,
column
either
are in
meant
section
to structure
12.3.2 the market of a substance accord
or in Appendix 12-3.1

It will, for example, make a difference in terms of exposure whether a substance (e.g.
solvent) is used in air care products (PC3) or in cleaning products (PC35).
For consumer uses that are assessed using the TRA, it is important to select the PC in the
second column, as far as possible (for example, sodium hypochlorite acting as a disinfectant
in a cleaning product: PC35 is probably the best descriptor in comparison to PC8 because
the function of the substance as a disinfectant has no impact on the exposure calculation;
the formulation has to assessed and authorised under the Biocide Products Directive
anyway. In addition, PC8 is not included in the TRA consumers so it would not help the
assessor to report PC8).

Based on in-house knowledge and possibly additional information from customers, the M/I
assigns the type of end-use preparations in which the substance is known to be used. Uses
the manufacturer is not aware of, for example supplied through distributors or a longer
chain of formulators, may be communicated to him from downstream during the REACH
implementation process. Several DU associations have mapped the main sector uses and
published tables of uses on their websites: this is also a useful reference for the M/I.

30 CEFIC R.12.3.3 R.12.3.3, last note at end of section: This note is generally applicable; not only to PROC. It done
should be moved upfront, e.g. end of R12.2
31 CEFIC R.12.3.4 R.12.3.4, last bullet first section: processing aid, It would be worth mentioning that done
“processing” in this wording does not only refer to chemicals used in processes in
production facilities, but is a general term that may also apply to consumer uses (the
surfactant example).
32 CEFIC R.12.3.5 R 12.5: please consider to add :
A paragraph on the TRA sub-product categories and sub-article categories would be reference included
worthwhile as an addendum, or in Appendix 12-2.2
It should advise M/I to closely consider which sub-PC applies (exposure levels vary reference included
considerably e.g. in a spray that can be inhaled or in a liquid). It should also advise the DU
who reports uses to mention the sub-PC.
33 CEFIC Appendix R.12- Appendix 12.2.2: It seems that part of the table missing here (incl sub-PC of PC35). corrected
2.2
34 CEFIC Table R.12.1 Table R 12.1: What is meant with mono-material, article mostly contain many different Text has been clarified.
substances. Are the “multi-materials” not considered here?
35 CEFIC Appendix R.12-1 Appendix R12.1: SU 9: SU 8,9 are given in the main user group and also with different The approach has been revised, and SU is not used
description in the sectors of end-use. This is confusing and the naming for the sectors of used for manufacture of the registered substance
end-user could be e.g. SU 8a, SU 9al anymore. Thus it really refers only to uses.

36 CEFIC Appendix R.12- Appendix R12 5.2: no explanation for the asterix used asterix removed
5.2
37 CEFIC R.12.3.4 R 12.3.4 Last paragraph, page 12: SPERCs should be mentioned at least in a footnote to SPERCs are now addressed in the text
make the link to ECETOC TRA and to introduce them in an official document showing
“approval” of this approach by ECHA.
1 Specific Environmental Release Categories (SPERCs) are being developed by industry to
refine the emissions estimates provided by the Environmental Release Categories for the
exposure assessments.
38 CEFIC R.12.5 R 12.5, page 17: Please add for the first 3 items and for the item “Service life by workers” Has been included as examples, however in a
the corresponding SUs. This is needed for the exposure assessment and its refinement. slightly modified form for articles handled by
Exposure information is different for the same PROC if it refers to professional or industrial workers, since this is no use under REACH.
use.
Please correct the 2. paragraph accordingly: “Assignment of the market sector is useful to Text has been rephrased to bring it closer to the
derive exposure estimation.” proposed text.
39 CEFIC R.12.1 Page 8: For downstream users it would be more efficient essential to receive standardised ok
exposure scenarios
40 CEFIC R.12.2 Page 9: consumer preparationproduct/article categories ok
46 CEFIC Appendix R.12-1 Document History and R.12.3.1 Sector of use [SU] and Appendix R.12-1 The approach has been completely revised. SU only
refers to uses, not to manufacture anymore. See
The approach to separate the SU’s into two blocks, Main User Group and Sector of End – above
Use, could give the impression that two separate use descriptors exist. As this is not really
the case, we suggest to have the MUG’s and Sector of End Uses listed in one single table
(only one block) and to flag
§ Manufacturers of chemical substances [SU 8, 9, 14],
§ Mixing and blending chemicals (formulators) to produce preparations
(mixtures) [SU 10]
§ Industrial end-users [SU 3]
§ Professional end-users [SU 22]
§ Consumers [SU 21],
which are relevant when using estimation tools, as mandatory MUG’s. This could be done
in a similar way as it is practiced for the PC’s in appendix R.12-2.1, where some of the
PC’s have been flagged as a preparation category matching the entry of the TRA exposure
estimation tool (TRA consumer).
47 CEFIC R.12.3.4 R.12.3.4 last sentence: This is now explained in more detail in section
Replace 12.5.1 of the guidance. However it will not always
“For all uses an ERC should be assigned.” by “For all uses during each LCS, an ERC be the case that only 1 ERC is applicable per life
should be assigned." This change could add clarification that for multiple PROC’s the same cycle stage.
ERC applies.
48 CEFIC Table R.12-3 Table R.12-3: done
In the 2nd question “Which processes are applied during mixing/formulation of substance?”,
PROOC 8 is indicated as category, should be either PROC 8a or PROC 8b

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49 CEFIC R.12.5 R.12.5: No.
In the section “Service life by workers: Assign an article category (AC), a process category
(PROC) and an environmental release category (ERC)” we wonder how this should be
addressed in a risk assessment. Is it intended to add the exposure derived from the
consumer assessment (AC) to the exposure predicted via the worker assessment (PROC)?

50 CEFIC Appendix R.12- PC10 and PC12 should be flagged relevant for TRA consumer PC list and the relation to subcategories has been
2.1 revised in dialogue with ECETOC. All PC for
which exposure estimates can be generated with the
TRA are listed in Appendix R.12-2.2. PC 10 has
been deleted, since this category was largely
overlapping with other categories.

51 CEFIC R.12.3 Page 9-13, general explanations on descriptors: This has been clarified in the text.
1. I am missing an order how to do the use mapping with the specific descriptors. For
example, the PCs. The text starts with the descriptors, follows with free text field and than
to UCN codes. It should be the same priority in the explanation part, starting with the
descriptors itself, additional codes and finally free text. Otherwise it might be confusing.
This mixing is as well with other part of the guidance in the same manner.

2. Reading the explanations, it seems that additional codes instead of the descriptors and
even free text might be a common choice. From a harmonization and IT point of view, the
use of additional codes might be already critical, the use of free words should be clearly
described as the last possibility.
52 CEFIC Appendix R.12-3 Appendix R.12-3: descriptors for process categories:
PROC 8a: Sampling, loading, filling, transfer, dumping, bagging in non-dedicated facilities, We assume, that PROC 8b is not the only category
including maintenance activities. Exposure related to dust, vapour, aerosols or spillage, and that may be considered to reflect maintenance
cleaning of equipment to be expected. conditions. Thus no action taken.
53 CEFIC Appendix R.12-3 Appendix R.12-3: descriptors for process categories:
PROC 8b: Sampling, loading, filling, transfer, dumping, bagging in dedicated facilities, We assume, that PROC 8b is not the only category
including maintenance activities. Exposure related to dust, vapour, aerosols or spillage, and that may be considered to reflect maintenance
cleaning of equipment to be expected. conditions. Thus no action taken.
54 CEFIC Appendix R.12- Can a PC, production of gas mixtures be added? PC does not relate to production but to certain
2.1 products. So what products are meant here (fuel,
laboratory needs, medical needs, …). No action
taken.
55 CEFIC Appendix R.12-3 Can a PROC transfilling gas be added? (gas into another container, gas cylinder, Dewars, This may be useful in future but needs some further
bundles, drums etc) explanation that this is not covered in any of the
other PROCs.
56 CEFIC Appendix R.12-3 Page 11: PROC xyz, no guidance how to use this descriptor is given Has been removed.

57 CEFIC R.12.1 p.8: Other functions have been added in the text.
"This guidance therefore provides a system of use descriptors to allow the building of short
titles for exposure scenarios. Such short titles are meant to flag the scope and applicability
of an ES"
Comment: It has other purposes: mapping the supply chain for environmental assessment,
allowing the DU to report uses in a language that the M/I can directly translate into ES, etc.
58 CEFIC R.12.2 p.9: Has been streamlined.
"The same applies to consumer preparation/article categories and environmental release
categories."
Comment: Should be “product/article categories, as this refers to PC”
59 CEFIC R.12.3.1 p.10: The SU is not meant to describe the market sector at
The discussion of SU selection might be completed by adding the following: all. Thus proposal not included.
“In some cases, the PC better describes the market sector than the SU. In such a case, the
user may consider that the main user group SU and the PC is the best way to describe the
market sector. “
60 CEFIC R.12.3.2 p.11: has been added
"Uses the manufacturer is not aware of, for example supplied through distributors or a
longer chain of formulators, may be communicated to him from downstream during the
REACH implementation process". Comment: Several DU associations have mapped the
main sector uses and published tables of uses on their websites: this is also a useful
reference for the M/I.
61 CEFIC R.12.5 p.17: has been added
A paragraph on the TRA sub-product categories and sub-article categories would be
worthwhile as an addendum, or in Appendix 12-2.2
It should advise M/I to closely consider which sub-PC applies (exposure levels vary
considerably e.g. in a spray that can be inhaled or in a liquid). It should also advise the DU
who reports uses to mention the sub-PC.
62 CEFIC Appendix 12-2.2 p.21: has been added
The table on page 21 (Appendix 12-2.2) is incomplete. In order to be aligned with the
Consumer TRA, the product subcategories listed in the last row (PC35) should also include:
Cleaners, liquids (all purpose cleaners, sanitary products, floor cleaners, glass cleaners,
carpet cleaners, metal cleaners)
Cleaners, trigger sprays (all purpose cleaners, sanitary products, glass cleaners)
1 EXXON R.12.3.3 Free text fields are allowed as an alternative to the Use Descriptors. Use of free text fields has been removed
MOBIL should be discouraged since they are inconsistent with harmonisation. For example, the
free text Process Category "PROCxyz" could lead to a proliferation of processes that are
already covered by the listed process categories.
2 EXXON Figure R.12-1 The examples (Figures R.12-1 and R.12-2) of the structure of the descriptor system (page Use reporting in IUCLID will be updated in
MOBIL 16) are not consistent with the IUCLID5 Guidance and support document "How to report IUCLID 5 to make it consistent with the CSA Tool,
identified uses for REACH in IUCLID 5.0" (July 2008, v1.0). For example, in the figures, and to allow for use reporting in IUCLID and CSR
the "top level" use descriptor is the Preparation Category, whereas in IUCLID 5.0, the "top chapter 2 consistent with the exposure scenario
level" use descriptor is the Process Code. titles.
3 EXXON Appendix R..12- Clarify that the splitting of the Sector of Use descriptor into two blocks (Main User Groups Approach has been changed back to one table. See
MOBIL 1 and Sector of End-Use) is not creating a new Use Descriptor. The two tables in Appendix above.
R.12-1 may be misleading.
4 EXXON Appendix R.12- Clarify that the Product Category sub-categories are not a new Use Descriptor. Should be clear from how the text is now phrased.
MOBIL 2.2

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5 EXXON R.12.3.4 p. 11, Section R.12.3.4 first sentence mentions six aspects relevant from the environmental Whole section has been rephrased to make it more
MOBIL perspective, but then does not list six aspects in numerical order (while interjecting three reader friendly.
possibilities regarding intended technical fate). Listing the six aspects as a group (or
rewording the first sentence) would make the guidance easier to understand. Example of
rewording the first sentence: Environmental release categories [ERC] characterize a use
based on the intended technical fate (purpose) of the substance and the general conditions
of use.

6 EXXON R.12.4.2 p. 15, Section R.12.4.2, first paragraph: table references are incorrect. Change from Table done
MOBIL R.12-2 to Table R.12-3.
7 EXXON Appendix R.12-1 The NACE codes listed in Appendix r.12-1 should include the letter designator, e.g., "10, included
MOBIL 11" should be "C10,11", "86" should be "Q86".
8 EXXON General Need to update ECHA's Chemical Safety Report (CSR) Template to incorporate will be done
MOBIL Environmental Release Category (ERC) Use Descriptor
9 EXXON General It seems the IUCLID5 Guidance and support document "How to report identified uses for Agree that this duplication is not ideal, however the
MOBIL REACH in IUCLID 5.0" (July 2008, v1.0) will need to be updated to include ERCs, since legislation requires i) the identified uses to be
ERCs characterize a use from the environmental perspective. Will IUCLID 5.0 need to be reported in IUCLID and ii) the identified uses being
modified to include ERCs in the Identified Uses section 3.5? An alternative approach consistent with the titles of the exposure scenarios.
which would reduce effort by all would be to consider eliminating the duplicative Since the CSR is meant to be a stand-alone
requirement for the use descriptor coding in both section 3.5 of the dossier and Part A document, also here the identified uses need to be
Section 2.2 of the CSR. described. ECHA's CSA tool may in future (not first
version) include a functionality to export the
identified uses from the CSR into IUCLID.

1 BFR General The Term TRA-consumer is not explained. From the information on page 12 I assume that Explanation incorporated in footnote 4.
the ECETOC TRA tool is mentioned.
2 BFR General In addition, it seems that the current draft of the descriptor system has been adjusted to the The article pick-list (AC) and the preparation pick
ECETOC TRA the reason for which is not clear. The ECETOC TRA is representing only list (PC) include more entries than addressed in the
one tool for exposure assessments among others, e.g. ConsExpo. The category pick lists are TRA for consumers. The SU and ERC is completely
only partly harmonized with the TRA and practical experiences with this new tool are still independent from the TRA. So in general, we cant
to be gathered. The document should be opened to further development Therefore the see the point here. Based on the comments received
ECHA documents should provide the standards for exposure assessment and not a single from KEMI, EUROFER and BfR we have
tool like ECETOC TRA nevertheless increased the internal consistency of
the AC-list (mostly material based, closely fitted to
the TARIC classification, using the so-far
subcategories only as examples but not as defined
categories ).

3 BFR Contents R 12.3: “five” descriptors (not six). A list of Tables and Figures would be helpful ok, included
4 R.12.1 1. The purpose of the guidance is “…. to map out all the uses of his substance. Such a The pick-lists do not aim for completeness. If a
mapping of uses within a market sector can often be reused for different substances, or can registrant sees that his use cannot be described
even be collectively created by several manufacturers/importers. It is therefore important to based on the available pick lists he is requested to
standardise the mapping of uses and to enable linking to exposure scenarios "I conclude add a new category, making use of the NACE, the
from this sentence that almost all uses of the substances shall be addressed, by a TARIC or the UCN system. There is no 1:1 link
standardised procedure/approach and to link the uses with exposure scenarios. I conclude between uses and exposure scenarios since the brief
that these exposure scenarios should also be standardised. On this background, the use description of uses based on the use descriptor
descriptor system should contain a selection of at least almost all of the uses. The descriptor system, does not include all information needed to
system should therefore be checked for completeness. It would be also be helpful if each derive a (standard) exposure scenario. Thus we took
use is linked to a short title characterising a standard scenario. no action here.

Consumer uses are described by SU (sector of use) and PC (product categories) and AC Clarification has been added in section 12.3.5
(article categories). It is not clear whether the use of the latter is workers or consumer use
(or both) and should be pointed out.:
5 BFR Table R.12.1 The abbreviation “PC” is sometimes used for “chemical product categories” and sometimes Has been streamlined.
for “preparation categories”. This should be clarified
6 BFR Table R.12.1 Table 12-1 and Appendix 12-5.1 are not consistent. From Table 12-1 I deduce, that the Table 12.1 has been adapted to the revision of the
TRA does not offer exposure estimation for articles, if they are not mono-material. In AC Pick list.
Appendix R 12 5-1 article categories matching the entry of “an exposure estimation tool”
which is the TRA are mentioned
7 BFR Table R.12.1 In the second para it is said that the categories (of products) mentioned are the essential Sentence has been rephrased. The coverage and the
ones. This should be checked by comparison with other internationally used product level of detail has not been changed for the update
category systems, published e.g. by WHO/IPCS, OECD, or by others. As we deal here with (except for the ERC). In the revision of the AC list,
consumer use, it could also be extremely helpful to compare the categories with poison we went back to the more broad categories (so-far
centre product classifications and the respective numbers of accidents. subcategories only examples anymore), in order to
avoid the notion of completeness. We have taken no
further action here.

8 BFR R.12.3.2 The uses listed under “others” should be checked from time to time to become included into We hope that this can be done based on the IUCLID
the fixed use descriptor list. data.

9 BFR R.12.3.2 It should be noted in the header of the SU list of end uses that these are only applicable for Disagree. The SU is not related to exposure at all.
workers exposure and not for consumer exposure. However, use of the substance in one of the sectors
can lead to exposure of workers at workplace (while
article production) and to consumer (during service
life of the article).
10 BFR Appendix R.12-1 In the former R12 document SU 21 is Private household (=general public =consumer). In Mistake has been corrected
the new draft it is SU 22, and SU 21 is professional uses (public domain)

11 BFR Appendix R.12-1 Mentioning the TRA-consumers (please see general comments) raises the question for other The OC and RMM described in an exposure
tools. In chapter R 15 a number of scenarios is given as examples that should be also scenario need to be linked to an exposure estimate
considered here. Other tools are available e.g. the ConsExpo tool for consumer exposure and risk characterisation. Since the different models
estimation. Also other internationally available documents pro-vide standard scenarios e.g. for tier 1 estimates are driven by different
US-EPA documents, exposure guidance's and calculation tools. determinants (= OC/RMM) it is hardly possible to
In order to fulfil the recommendation from page 8 (here point 1) it should be con-cluded generate standard ES independent from the exposure
that a series of standard scenarios must be worked out, independently from existing tools. estimation model applied. Thus, we see of cause the
usefulness of other tools and the registrants may
want to use them.

Page 5
12 BFR Appendix R.12-1 In para 5 the explanation is not consistent with the appendix. Appendix R.12-5 consists of Text has been refined.
two different lists: R12-5.1 and R12-5.2. The explanation should be adapted.

13 BFR R.12.3.5 The list of product categories seem to be incomplete. Incompleteness is also due to the TRA Completeness is not the aim of this. The PC list
scenarios. covers many more products than addressed in the
ECETOC TRA, so we have taken no action here.

14 BFR Appendix R.12- 15. Table 12-2-2: The main categories are inconsistent with the subcategories. For ex- PC list and the relation to subcategories has been
2.1 ample, one major category is “Coatings and Paints, Thinners” The list of subcategories does revised in dialogue with ECETOC. All PC for
not list any thinner or coating. What about removers? which exposure estimates can be generated with the
Additionally “finger paint, face paint” is also mentioned on the main category “Artists TRA are listed in Appendix R.12-2.2.
supply, hobby preparations”.

15 BFR Appendix 12-2.2 PC 35 (washing and cleaning products” only consider Laundry and dish washing products”, Regarding PC we corrected the copy/paste mistake
Too specific, what about other cleaning products, e.g. oven cleaners, drain cleaners, in the draft guidance. PC list and the relation to
bathroom cleaners? If the TRA is used, then the subcategories should also be taken into subcategories has been revised in dialogue with
consideration. In the ConsExpo product database 7 subcategories are mentioned that should ECETOC. All PC for which exposure estimates can
be included. In the EXCEL sheet of the new TRA draft also some subcategories are listed be generated with the TRA are listed in Appendix
that should be matched with ConsExpo categories. It should also be mentioned in this list of R.12-2.2. PC 10 has been deleted, since this
product categories how the products are used, e.g. as aerosol. category was largely overlapping with other
categories.

16 BFR Appendix 12-2.2 17. It should be noted whether the articles listed are intended for consumer use or not. Does Indeed, articles can be handled by consumers and
mentioning the TRA tool mean that the other products are not consumer prod-ucts? The list workers. Clearly, the list has been built up from the
5.1 is hard to read and not well structured. The first category mixes up different main consumer perspective, but also some articles have
classes and sub classes of articles which make it very complex and in-consistent. For been included of particular relevance workers. To
example, toys are mentioned under metal products, plastic products, and wood and generally split between workers and consumer
furniture. This makes it very hard to built standard scenarios which are driven by the kind related articles is hardly possible. In order to make
of use, and not the type of product. This list should be made trans-parent and best use of the standardisation approaches available
understandable. It could be helpful to separate consumer use from work-ers use, for which and in line with the general structure of the list
the list is obviously aimed. agreed in 2008, we revised the list to make it more
transparent and more closely related to the TARIC
system.

17 BFR Appendix R.12- The list R12-5.1 is based on the older version of R12 (not TRA) and links to TRA are This has now been adapted as far as useful.
5.1 completed where appropriate. R 12-5.1 combines Article categories from R12-5.1 with However again: The use descriptor list does not aim
subcategories from the TRA. However, the categories from the older R12 do not fit exactly to mirror the input parameters of the available tier 1
with the categories and subcategories from the TRA, which makes the lists difficult to read. tools 1:1.

18 BFR Appendix R.12- Appendix R12-5.2: AC5-1 fits two Subcategories. AC11-1 an AC11-2 have the same removed. Same wording to be clarified with
5.1 wording. The signs * and AC13-1_n are not explained. ECETOC
19 BFR Appendix R.12- The category codes in tables R12-5-1 and R12-5.2 do not fit, which leads to confusion. The Table R.12-5.1 includes now systematic reference to
5.1 categories in table R12-5-2 which are taken from the TRA are incomplete, e.g. the category TRA entries.
AC 5.2 is missing. The tables R 12-5-1 and R12 5-2 should be merged to attain
consistency.
20 BFR Appendix R.12- Sometimes very heterogeneous categories, from diapers to table cloth. Such category is not As said before, it is not the intention that the use
5.1 applicable to create standard scenarios. description relates 1:1 to an exposure scenario.

21 BFR Appendix R.12- The apparent classification is obviously a compromise of different competing interests. The We do not exactly understand what you mean here
5.1 product classification approach seems hard to be used and needs major revision. A clear AC or PC. We think that all issues are already
concept for structuring is needed. addressed above.
1 CONCA Appendix R.12- There is currently no ERC for the distribution stage. This would be useful to address Agree, we will check. May be included into a future
WE 4.1 loading and unloading into ships/barges, tanks and road/rail tankers. update.
1 EUROFE R.12.3.1 While the revised approach is welcomed as an improvement on the current text, there is the
R potential for confusion with regard to the use of a substance on its own, in preparations and
in articles. For example, iron is a metal (SU 14 applies), while steel is an alloy (a
formulation) and, thus, steel should be assigned to SU 10. However, NACE code 24.10
covers the “Manufacture of basic iron and steel and of ferroalloys”. This anomaly needs to
be resolved.

2 EUROFE Appendix R.12-1 Furthermore, although AC codes are provided for a wide range of products (e.g. AC1-1 Alloys have been assigned to SU14 and excluded
R passenger cars and motor cycles), NACE sections D, E, F, G, H, I, K, M and P are not from SU10. Reasoning: Keep consistency with
assigned in Appendix R.12-1 in terms of uses. Nevertheless, chemicals, plastic metals and NACE system. Regarding the technical process,
alloys are used, for example, in the production of passenger vehicles as well as in the alloy production is fundamentally different from
vehicles themselves (articles). Thus, Appendix R.12-1 would seem to be inconsistent with mixing chemical substances or preparations.
the narrative in R.12.2 (The use descriptor system). In order to both redress this imbalance
and to aid the description of uses within technical dossiers, it is recommended that NACE
code sections D E, F, G, H, I, K, M, O, P and NACE codes 84.22 (defence activities), 84.25
(fire services activities), 90.02 (museum activities), 90.03 (Operation of historical sites and
buildings and similar visitor attractions), 91.04 (botanical and zoological gardens and
nature reserves activities), 93 (sports activities and amusement and recreation activities), 95
(repair of computers and personal and household goods), 96.01 [washing and (dry-)cleaning
of textile and fur products], 96.02 (hairdressing and other beauty treatment) and 96.04
[physical well-being activities (e.g. saunas, swimming pools, etc)] are assigned to SU 0-2.

3 EUROFE Appendix R.12-3 While these descriptions may be helpful for assessment tools (e.g. ECOTOC TRA), their We are not sure whether we have completely
R value as a communication tool is questionable. In order to be meaningful to downstream understood the proposal. However: The categories
users (who are generally far removed from the intricacies of risk assessment), the examples to describe the Sector of Use can be used for two
and explanations need to make extensive use of industry-related terms. In this respect, many purposes: i) describe the sector of end-use (last
terms do not currently relate to the metal industry. "use" in the meaning of REACH before a substance
enters into an article matrix or a waste [-water, -air]
stream. ii) describe the life cycle stage on which an
activity with the substance takes place. The listed
categories only list the manufacturing sector and a
few services in order not to overload the descriptor
list. Where a registrant finds it useful or necessary to
describe a sector of end-use in more detail he is
advised to make use of the corresponding NACE
entry under "other".

Page 6
4 EUROFE R.12.3.5 This is the inherent nature of all "generic guidance".
R Thus it is up to the sector organisation to support
their membership to apply the use descriptor system
The application of AC represents the most difficult of these concepts to fully comprehend. in a correct ways, and to propose additional
Especially, as the opening sentence of R.12.3.5 states “For dangerous substances processed categories where the existing lists are insufficient.
into articles, the manufacturer or importer of the substance may find it necessary to specify Often, it may be useful first to describe the uses in
which types of articles are covered in the CSA and the ESs”. Yet REACH definition of an sector related language and then to assign the
exposure scenario refers to “how the substance is manufactured or used during its life- generic categories.
cycle”, which implies that the CSA covers all identified uses and that must include a record
of the uses and their assessment.
5 EUROFE Appendix R.12- While these descriptions may be helpful for assessment tools (e.g. ECOTOC TRA), their Correct. According to Annex 1 also the subsequent
R 5.1 value as a communication tool is questionable. Especially, as the structure of Appendix life cycle stages are to be included into the exposure
R12-5.1 appears to be rather haphazard and inconsistent with a strange mixture of product assessment.
specific and material specific categories. Material specific categories seem to be limited to
only 3 or 4 options (e.g. Metal products: cutlery, cooking utensils, pots, pans; Metal
products: toys; Metal products: furniture). Why select these metal products, which
incidentally are not listed amongst the consumer items in Appendix R.12-5.2? Is the
description “Metal products: cutlery, cooking utensils, pots, pans” intended to be indicative
Furthermore, there appears to be no recognition that humans are exposed to articles in The Appendix 12-5.1 has been revised, indicating
industrial, professional and consumer situations. Indeed, the same article may be used in all that all the mentioned article types are indicative
three exposure categories (e.g. cameras, craft knives/scalpels, bolts/screws/nuts and other and not definitive (or exhaustive).
fasteners).
This is now systematically addressed, however the
Stainless steel may provide a helpful illustration of the complexity of the uses of metals and focus of the specifically mentioned articles is still
alloys, where the initial mapping of uses (covering its production, further processing, uses on consumer relevant articles. However through
in articles and their associated exposures) consisted of 160 pages of information. This level referencing to the TARIC system it is made clear
of detail will, of course, be refined and condensed into a manageable format for the various that also articles can be described which are
substance technical dossiers with the aid of this guidance. It is, therefore, extremely exclusively used by workers.
important that this guidance is formulated in comprehensive and user-friendly manner.
Especially, as it serves the dual purpose of assisting exposure assessments and as a
communication tool aimed at downstream users unfamiliar with the subtleties of risk
assessment.
6 EUROFE Table R.12-2 It is noted that the rules for assigning descriptors (i.e. R.12.5) do not cover professional It is important here that the sectors develops its own
R uses and it is assumed that professional uses are not addressed in Tier 1 exposure complementary guidance
assessments. If so, this should be stated in the rules and, if not, this omission needs to be
addressed.
7 EUROFE Appendix R.12-1 In order to avoid confusion and to be consistent with NACE code 24.10 (Manufacture of This has been revised in order to make clear that
R basic iron and steel and of ferroalloys), it is recommended that iron and steel are assigned to handling of articles by consumers, professionals and
SU 10 and that the table in Appendix R.12-1 is annotated accordingly. workers in industrial setting can be relevant.
8 EUROFE Appendix R.12-1 Furthermore, according to the ECHA Guidance on substance identification, ferroalloys may Disagree. In our view consistency with NACE
R be considered either special preparations (i.e. alloys) or multi-constituent substances would be best achieved if basic metals include alloy
[reaction products resulting from a smelting process (produced directly via the chemical production, and SU 10 is reserved for mixing of
reduction of ores and ores concentrates)]. For simplicity and consistency, it is chemical products
recommended that SU 14 is also applied to ferroalloys and that the table in Appendix R.12-
1 is annotated accordingly.

9 EUROFE Appendix R.12-1 Steel semi-finished products are covered by NACE codes 24.10 [Production of semi- Yes indeed, this is what we did. However we have
R finished products of steel (including manufacture of hot-rolled and cold-rolled flat-rolled the feel that the previous and this comment are
products of steel, manufacture of hot-rolled bars and rods of steel, manufacture of hot- contradictive.
rolled open sections of steel, manufacture of sheet piling of steel and welded open sections
of steel and manufacture of railway track materials -unassembled rails- of steel)]; 24.20
(Manufacture of tubes, pipes, hollow profiles and related fittings, of steel); 24.31 (Cold
drawing of bars); 24.32 (Cold rolling of narrow strip); 24.33 (Cold forming or folding) and
24.34 (Cold drawing of wire).

In order to avoid confusion and as the steel industry regards these items as articles (in We see no need to assign article categories, since
accordance with REACH and the ECHA guidance on substances in articles), it is the reference to NACE 24 and 25 is available in the
recommended that they are assigned to SU 14 (rather than SU 15) and that the table is table
annotated accordingly. Particularly, as these articles find applications in many use sectors.

10 EUROFE Appendix R.12-1 NACE code 32.50 (Manufacture of medical and dental instruments and supplies) is not We see no need to assign article categories, since
R specific mentioned in the current or the draft revision of the guidance. As this covers a wide the reference to NACE 24 and 25 is available in the
range of products and materials, it is recommended that it is assigned to SU 20 and that table
reference is made to it in column 3 of the table in the revised guidance.

Furthermore, a reference to veterinary and mortuary equipment within the NACE codes 75 Not implemented, since SU 20 refers to services,
(Veterinary activities) and 96.03 (Funeral and related activities) should also be assigned to not manufacture. We are reluctant to expand the list
SU 20 and it is recommended that the table is annotated accordingly. of sectors of end-use, if there are not particular
reasons to include a new sector into the list. The
registrant is of cause free to specify this end-use in
his registration..

11 EUROFE Appendix R.12- Appendix R.12-2 provides a pick-list of preparation [mixture] categories, where PC 7 (Base Don’t see the specific reasoning.
R 2.1 metals and alloys) and PC 38 (Welding and soldering products, flux products) have
particular relevance for metallic alloys.

As the PC codes apply to preparations (mixtures), the description for PC 7 is inaccurate It has been clarified that PC stands for chemical
because a base metal cannot by definition be a preparation. Furthermore, in chemistry and products and includes substances as such and in
metallurgy the description “based metal” (e.g. copper, lead, etc) would not apply to alloys preparations.
containing noble metals (e.g. gold, platinum, silver, etc). Therefore, it is suggested that the
description for PC 7 is amended to read “metallic alloys”.

There is a potential for confusion with regard to welding and soldering products based on done
metals and alloys. Welding filler rods and wires may be supplied with or without flux
coatings or flux cores. It is suggested, therefore, that a distinction is made between these
products. Uncoated and core-free welding filler rods could be assigned to category PC 7,
while coated or cored welding filler rods could be assigned to PC 38 (Welding and
soldering products, flux products).
12 EUROFE Appendix R.12.3 There appears to be a potential for overlap between PROC 14 and PROC 21, where So what do you suggest?
R extrusion of metals and alloys could be placed in either category.
13 EUROFE Appendix R.12.3 Welding is also associated with gases (as a source of heat or for shielding the weld pool to done
R prevent oxidation). Therefore, it is suggested that the column marked « example and
explanations » is amended as follows:-
“Exposure is predominantly expected to fumes and gases”
14 EUROFE Appendix R.12- In Appendix 12-4.1, the categories ERC1 and ERC 3 need to be reconciled with the It has been clarified that SU is only related to use
R 4.1 comments made above with regard to alloy production and whether or not it is included in (not to manufacture). There is actually no link
SU 14. It may be beneficial to add a note to the appropriate entry in Appendix 12-4.1 (e.g. between SU (sector of endues) and the ERCs. We
for substances in metallic alloys link SU 14 with ERC3). have not understood what you suggest.

Page 7
15 EUROFE Appendix R.12- Restructure AC code based on the presented thought starter The AC list has been restructured by systematically
R 5.1 including a reference to articles used by workers.
But only a few examples for particular articles have
been included in order to keep the list manageable.
The list is now essentially material based with 2
categories for complex articles (vehicles and
machinery/equipment). A reference to the TARIC
system has been included for each article category
in order to support further specification of articles if
needed. The category "construction articles" has
been removed and included as example into the
material based categories.

16 EUROFE Appendix R.12- Metal products (e.g. AC-7.1 Metal products: cutlery, cooking utensils, pots, pans) are not The AC list has been restructured by systematically
R 5.2 listed in Appendix R.12-5.2: Consumer articles as being addressed in the TRA tier 1 including a reference to articles used by workers.
exposure estimation tool. This would appear to be an oversight or, if not, it is a serious But only a few examples for particular articles have
omission from the TRA tier exposure estimation tool. been included in order to keep the list manageable.
The list is now essentially material based with 2
categories for complex articles (vehicles and
machinery/equipment). A reference to the TARIC
system has been included for each article category
in order to support further specification of articles if
needed. The category "construction articles" has
been removed and included as a subcategory into
the material based categories.

1 EUROM Appendix R.12-3 The powder industry has checked the coverage of its different processes and wonders if Not implemented. The PROC system aims to
ETAUX things could not be further simplified by having a PROC 26 named ‘metal powder describe unit operations and not to identify titles for
handling’ rather than, with explanations Handling of metal powders. Involving activities integrated description of processing chains.
such as packaging/unpacking, transportation, weighing, pressing, milling, sieving and
mixing of metal powders, as well as sintering processes. Such a PROC would cover most of
their processes, rather than having them spread over PROC 9,14, 22, 26, 27.

2 EUROM R.12.3.4 We acknowledge the introduction of Environmental Release Categories (ERCs) OK


ETAUX as an additional descriptor. Please note that we will try to further work on the development
of SPERCs for metals, in line with what is started by other sectors, as the current ERCs are
too conservative to be used. We will keep you informed on where we arrive.

1 UNILEV R.12.1 "For downstream users it would be more efficient to receive standardised exposure ok
ER scenarios" Comment: It is not only more efficient, but “essential”.
2 UNILEV R.12.1 "This guidance therefore provides a system of use descriptors to allow the building of short ok
ER titles for exposure scenarios. Such short titles are meant to flag the scope and applicability
of an ES." Comment: It has other purposes: mapping the supply chain for environmental
assessment, allowing the DU to report uses in a language that the M/I can directly translate
into ES, etc.
3 UNILEV R.12.1 "If a DU wishes to report uses in line with Article 37(2), he should use this chapter and ok
ER describe the uses based on the same system." Comment: A reference to Article 37(2) and
the right of DU to report uses is missing
4 UNILEV R.12.2 "The chemical product category (PC) describes in which types of preparations (mixtures) Yes, but it is important here to make clear that we
ER the substance is contained on end-use." Comment: Delete chemical – to be consistent PC do not talk about articles.
stands for product category
5 UNILEV Table R.12.1. Table R.12.1: consistent use of PC should be “product category”, not “preparation done
ER category”
6 UNILEV R.12.2 "The same applies to consumer preparation /article categories and environmental release done
ER categories." Comment: Should be “product/article categories, as this refers to PC”

7 UNILEV R.12.3.1 "They represent the minimum level of detail a registrant is expected to provide in included
ER describing the sector of use." Comment: They are important to the assessor as they help
direct the exposure assessment (selecting the appropriate tools).
8 UNILEV R.12.3.1 "The discussion of SU selection might be completed by adding the following: “In some done
ER cases, the PC better describes the market sector than the SU. In such a case, the user may
consider that the main user group SU and the PC is the best way to describe the market
sector. “
9 UNILEV Table R.12.1. PC should consistency be “product category”, not “chemical product category” nor done
ER “preparation category”.
10 UNILEV R.12.3.2 "In the right hand column those categories are indicated that directly correspond to a The relation between product categories (PC) and
ER consumer product category that can be assessed with the TRA consumer exposure the subcategories used as entries to the TRA tool is
estimation tool." Comment: It will, for example, make a difference in terms of exposure no presented in a stand alone appendix R.12.2.2.
whether a substance (e.g. solvent) is used in air care products (PC3) or in cleaning products The descriptor list (Appendix R.12.1) is
(PC35). For consumer uses that are assessed using the TRA, it is important to select the PC independent of the TRA.
in the second column, as far as possible (for example, sodium hypochlorite acting as a
disinfectant in a cleaning product: PC35 is probably the best descriptor in comparison to
PC8 because the function of the substance as a disinfectant has no impact on the exposure
calculation; the formulation has to assessed and authorised under the Biocidal Products
Directive anyway. In addition, PC8 is not included in the TRA consumers so it would not
help the assessor to report PC8).

11 UNILEV R.12.3.2 "Uses the manufacturer is not aware of, for example supplied through distributors or a done
ER longer chain of formulators, may be communicated to him from downstream during the
REACH implementation process." Comment: Several DU associations have mapped the
main sector uses and published tables of uses on their websites: this is also a useful
reference for the M/I. CEPE and A.I.S.E. did. COLIPA is imminent; FEICA as well.

12 UNILEV R.12.3.2 Note: In order to achieve harmonisation across the market, new categories should only be done
ER defined if existing ones really do not fit for a type of process to be briefly described. If
further relevant details of an activity need to be described, they can be always be addressed
within the exposure scenario itself.
This note is generally applicable; not only to PROC. It should be moved upfront, e.g. end done
of R12.2

Page 8
13 UNILEV R.12.3.4 "The substance is meant to act as a processing aid and as such is released from the process done
ER (e.g. surfactants in cleaning processes) or the chemical product (e.g. solvents from paints
and coatings) to the environment." Comment: It would be worth mentioning that
“processing” in this wording does not only refer to chemicals used in processes in
production facilities, but is a general term that may also apply to consumer uses (the
surfactant example).

b UNILEV R.12.5 R.12.5 should contain a description of the role of SUs. If the main user group SU is done
ER considered “mandatory”, then it should be 3 descriptors, and the SU should be mentioned in
the list.
15 UNILEV R.12.5 A paragraph on the TRA sub-product categories and sub-article categories would be done
ER worthwhile as an addendum, or in Appendix 12-2.2
It should advise M/I to closely consider which sub-PC applies (exposure levels vary done
considerably e.g. in a spray that can be inhaled or in a liquid). It should also advise the DU
who reports uses to mention the sub-PC.
16 UNILEV Appendix R.12-1 SU 22 and SU 21 have been exchanged compared to the previous version. Could you corrected
ER change back: SU 21 Consumer uses, SU 22 Professional uses to remain consistent.

17 UNILEV Appendix R.12-1 Some SUs appear in part 1 and part 2 of the table: SU8, 9 should they be deleted in part 2? Approach has been fundamentally revised. SU only
ER refers to uses anymore. See above.
18 UNILEV Appendix R.12- The table on page 21 (Appendix 12-2.2) is incomplete. In order to be aligned with the has been corrected
ER 2.2 Consumer TRA, the product subcategories listed in the last row (PC35) should also include:

* Cleaners, liquids (all purpose cleaners, sanitary products, floor cleaners, glass cleaners,
carpet cleaners, metal cleaners)
* Cleaners, trigger sprays (all purpose cleaners, sanitary products, glass cleaners)
19 UNILEV Appendix R.12- AC13-1 cannot be run in the Consumer TRA and should therefore be deleted from this has been removed
ER 5.2 table
1 KEML General We find that the current version is developed mainly towards linking use descriptions to
existing tools for first level exposure assessments. This link is urgently needed but we find
it necessary to remind of the multiple aims of the use descriptor system. It should facilitate
registrants’ and down stream users’ communication on identified uses and exposure
scenarios. It should be possible to use for specific CSAs as well, with higher level of
details, e.g. for authorisation. Furthermore, it should allow quick scanning of registered
uses by ECHA and MSCAs, systematic priority setting, targeted compliance checks and
national enforcement activities. But to fulfil all these aims, it should be constructed in a
way that suits database handling and each use descriptor should cover only one piece of
information. The current version introduces information duplications between the original
descriptors and an additional descriptor, the ERCs, without clarifying how consequences
will be dealt with.

Therefore, we cannot see that the guidance is sufficiently worked through on how to The use descriptor system was primarily developed
achieve useful and workable use descriptions. i) to achieve a basis level of standardisation in the
communication up and down the supply and ii) to
support tier 1 exposure estimates based on i) use
description and ii) limited additional information on
conditions of use. There is however no basis in
REACH to make the use of this system obligatory.
Data base search based on IUCLID and those CSRs
submitted in data base format is of cause desirable.
The reporting format that will be included into the
IUCLID update and the CSR chapter 2 is now
explained in a new section R.12.5.3 As far as we
can see, the system of 5 descriptors will allow
queries in various ways. The impact of the ERC
descriptor will be as follows: i) Each worker use
will at least be described with a PROC, an ERC and
with the indication whether the setting is industrial
or professional (non-industrial). The ERC
assignment will imply an additional information
whether service life in article is relevant. ii) Each
consumer use will at least be described with a PC
and an ERC. The ERC assignment will imply the
information whether the use is indoor or outdoor
and whether service life has to be considered.

2 KEML Document "All “other” has been moved from the last position in the pick-list to the first position" has been put to the end of the list again. Systematic
history Comment: To us it seems more logical that this choice should be presented last in the pick- reference to NACE, TARIC and UCN is now
list (with a high number code), to be considered only when the already available codes are included in the text and the tables. No further action
not appropriate. If it is pre-scented first, the possibilities to complement with anything else taken therefore.
than codes from existing hierarchical systems (NACE, UCN, TARIC) should be prevented.
In the current version such possibilities are differently described in guidance text and
footnotes to the appendices, respectively. We would be happy to explain this in more detail,
based on experiences from our product registry.

3 KEML Document  Splitting of the Sector of Use descriptor into two blocks: Main User Groups (SU 3, 9, 10, There is no obligation in REACH to register the
history 14, 21, 22) and Sector of End-Use. See Appendix R.12-1. With two levels of Sector of Use sector of end use. The sector of end-use will be used
it will not be possible to get dimensions of the use in sectors of end-use as they mostly will by industry case by case as needed. There is no
be re-ported as e.g. SU 3 Industrial uses. The obligation to reg-ister Sector of End-Use change in the guidance in this respect.. Nevertheless
should be expressed much more distinct in the guidance. we have removed the split in two tables since it
seems to lead to confusion. Also we clarify that the
table only refers to (end)uses, not to manufacture

4 KEML Document " More clearly distinguishing of the two functions of the Chemical Product Category (PC) Text has been refined in this sense
history in section R.12.3.2: (i) describing the preparation types and (ii) consumer prepa-ration
types. See Appendix R.12-2.1" Comment: Deleted: sectors formulating preparations by

5 KEML Document  Remove the reference to industrial or professional set-ting from most of the process No, since PROC 7, 11 and 16 do not allow for a
history categories (this should also be done in PROCs 7, 11 and 16). The choice can be made in the choice between industrial and professional.
exposure estimation itself. At use descrip-tion level, SU 3 or SU 21 indicate, whether a use
is ex-pected to happen under industrial or non industrial set-ting.

Page 9
6 KEML Document " Introduction of the Environmental Release Category (ERC) as an additional descriptor See response further down.
history (see section R.12.3.4)" Comment: It is fully recognised that points of entry into existing
tools for first level exposure assessment are urgently needed. However, it is important to
ensure transparency on how exposure factors are established, but we are not aware that the
development of ERCs have been much tried or validated. Furthermore, a use description
system should build on combinations of separate and discriminatory descriptors that do not
overlap. Unlike the original four descriptors, the ERCs are not discriminatory, but rather
aggregates of different descriptor elements. Therefore, the guidance has not been
sufficiently worked through on how to achieve useful use descriptions.

7 KEML Document Clarification that PC22 covers fertilisers used by consumers The use of two fertiliser codes The emission factors have mostly been derived from
history will confuse data handling and cause mistakes when used. It is better to have all fertilizer as the previous A-tables by worst case choice. For
PC12 and remove the fertilizer in PC22. The consumer use of PC12 will be clear anyhow articles, they have been derived from the ESD on
from sector of use SU22. plastic additives. For high erosion or intend release
100% is assumed. In this respect they are pretty
transparent. Of cause, the background of the factors
in the A table is not documented in the old TGD,
but this was already a weakness in the old system.
The ERC approach was generally agreed in
Guidance R.16. Different industry sectors have
started to develop less conservative emission factors
with the corresponding documentation of the
condition of use (SPERCs). Regarding the
discriminatory nature, we do not fully understand
your concern. The ERC categories are
discriminatory in itself. The PROCs and the ERCs
have of cause some overlaps in their information
content, but which practical problem arises here?

8 KEML R.12.1 Note also the multiple aims of the use descriptor system: facilitate communication between ok
registrants and down stream users (identified uses, exposure scenarios); for specific CSAs
with higher level of details e.g. authorisation; quick scanning by ECHA and MSCAs of
registered uses; systematic priority setting by ECHA and MSCAs; targeting compliance
checks and national enforcement activities.
9 KEML R.12.2 "• The chemical product category (PC) describes in which types of preparations (mixtures) done
the substance is contained on end-use." Comment: Please use the same terminology
throughout the guidance (see for instance Table R.12.1 and heading of Appendix R.12-2.1)

10 KEML Table R.12.1


11 KEML R.12.2 A reference to TRA is needed here. Footnote 8 indicates a publication date in July 2009? Done

12 KEML R.12.2 What will be the consequence for the coding system if entries are duplicated, like the SUs, We see that there is (naturally) some overlap in the
PROCs and ERCs seem to be? How useful will the use description be? information content encoded in the categories.
However this does not lead to conflicting
information or other negative consequences.

13 KEML R.12.3.1 Five six? main user groups Text has bee revised
14 KEML R.12.3.1 f he considers that it is sufficient to be less specific regarding the use in industry, he may done
instead assign only a main user group, Comment: Deleted: not. Deleted: a sector of end use
but
15 KEML R.12.3.1 Quite a few Sectors of Use are missing in the list that, according to the Swedish products Apart from the services in the public domain, we
registry, may be considerable users of chemicals. For instance some 736 chemicals were included your proposals.
sold in 2006 to “Manufacture of wood products” (NACE 16); about 30 % of the quantity
was hazardous to health. Speciality chemicals are sold to NACE 35 (Electricity, gas, steam
and air conditioning supply), NACE 36 (Water collection, treatment and supply), NACE 37
(Sewerage), NACE 72 (Scientific research and development) and many chemicals are also
used in NACE I (Accommodation and food service activities) and NACE 81 (Service to
buildings and landscape activities, particularly 81. Cleaning activities).

16 KEML R.12.3.2 The Chemical Product Category characterizes the use of a substance by the type of [PCs Yes, that's why the guidance text is now streamlined
will also need to cover substances used in industry] preparation (e.g. lubricant, cleaner, to (Chemical) Products = substances as such or in
adhesive) Comment: Deleted: end-use preparation. Nevertheless we think that the
(industrial, professional or consumer) end-use is
relevant (see definition in footnote 2) and not the
sequential mixing over various stages.

17 KEML R.12.3.2 If M/I is unable to identify a suitable category for his product in this system, M/I or DU can We have skipped this sentence to discourage free
describe the technical function of the preparation type in his own words. Will this be text when using the descriptor system.
reviewed and lead to adaptation of the descriptor?
18 KEML R.12.3.2 Appendix R.12.7 could with advantage be merged with PC-list 12-2.1 as pure substances We disagree. Focussing the PC list on product types
when they are sold also are products and quite often have the same name/function as a for end-use (may the product consistent of one or of
preparation e.g. Absor-bent, Laboratory chemical or Fragrance. Just add product types that more substances) rather than substance functions
are specific for the industrial use stage of the life cycle, semi products like Binder, Solvent, was one of the fundamental choices for the
Anticorrosive, Pigment etc. descriptor system. This choice was agreed by
stakeholders before publication in 2008. We will not
change this. We are aware that the list in Appendix
6 and Appendix 2 has some overlaps.

19 KEML R.12.3.3 This use description will develop during the implementation of REACH, and hence the Yes, since working with process categories is
free-text field (PROCxyz) what about PROC 0 at the top? plays an important role for relative new.
communication of process types which cannot be assigned to one of the categories proposed
so far. Will this be reviewed and lead to adaptation of the descriptor?

20 KEML R.12.3.4 Environmental release categories [ERC] label the characteristics of a use based on six Text has been restructured to make it more reader
aspects eight bullet points below? relevant from the environmental perspective: friendly and to explain better the relevance of the
ERC information content.

Page 10
21 KEML R.12.3.4 The general conditions of use, including a) It has been clarified in the guidance that the SU is
o the life cycle stage at which a use takes place (manufacture, formulation or end-use) This only applied for uses not for manufacture.
seems to be covered already by SUs Nevertheless there is a link between SU 10 and ERC
o the dispersiveness of use and emission (use at industrial sites [point sources] and/or wide 2/3. b) Yes there is a link between i) the sets of
dispersive use in professional and consumer applications) This seems to be covered al- ERCs addressing point source uses with SU3 and
ready by SUs the sets of ERC describing disperse uses and
o whether the substance is contained by definition during use (e.g. hydraulic fluids) This SU21/22. c) No it is not, since the PROC only
seems to be covered already by PROCs describes the occupational perspective; d) drives the
o whether the use takes place indoors or outdoors Why is this of importance? availability of the means to capture air, water and
o and whether substances in articles are used under release-promoting conditions (such as waste emissions; drives releases by weathering
abrasion)

22 KEML R.12.3.5 To each of these categories a set of default (worst case) release factors has been assigned
Important to clarify how they are assigned! providing a Tier 1 release estimation (see
Appendix 12-4.2). Such release estimates can be used to derive a Tier 1 exposure estimate
based on the degree of dispersion in the environment described in the EUSES fate model
(see Guidance Chapter R.16). For all uses, an ERC should be assigned.

It looks like ERCs are aggregates of selected use descriptors (SUs or PROCs). If a Yes, it is necessary. During the RIP 3.2.2 project it
substance is used in a product in a certain sector and with a certain process, it can already was tried out to reflect the environmental aspects by
be described with the original descriptors. The ERCs express only once more how the the combination of the other 4 descriptors. This
substance is used, but not how much is released to the environment, so no new information turned out to be impossible and hence triggered the
is added. If there can be just one ERC for each combination of SU, PC and PROC or AC, ERC concept. The IUCLID update will anyway
then is it necessary? And if there can be more than one, then how many, and how contain the ERCs.
meaningful will ERCs be as use descriptors for instance in ESs?
However, the ERCs may provide an important interface between use description and
exposure estimation. But it is highly questionable if the ERCs should be built into the use
descriptor system and if registrants should select them. The guidance is insufficient for this.
Could the selection be built in IUCLID instead? Or could a set of questions be built into a
decision tree?

23 KEML R.12.3.5 The purpose of the present set of descriptors in Appendix R.12-5.1 is not clear: are they AC List has been restructured and has been
chosen just to fit the six TRA consumer tool cases presented in the right column? In the systematically linked to the TARIC system.
long run it would seem wiser to adopt the links to the tool to the universal TARIC system
for classification of articles rather than adopting the descriptor to the tool. The code-set now
presented as descriptor will exclude many important kinds of articles. We suggest that the
globally harmonized TARIC classification system should be used as Article Category
descriptor, with two or four digit code levels. It is continuously updated, easily available on
the web and well known to most manufacturing companies.

24 KEML R.12.4.1 Table R.12-2 illustrates for a number of processes/activities which descriptor to assign and It would not add relevant information in this
which generic characteristics of the use conditions the descriptor encodes. The example is example. However, it may well be that the SU may
related to workers’ indoor uses (industrial or professional) of a substance intended to become relevant when a particular end-use sector
become part of an article. The examples show that various types of activities can be needs a particular exposure scenario (e.g. coatings
expressed by one category for workers’ exposure and one category for environmental used in toy industry).
exposure. Why are the SUs not included?

25 KEML Table R.12-2 Air dispersive techniques, like e.g. Spraying (PROC 7 or PROC 11) PROC 7 could be linked with ERC 4-6, PROC 11
Industrial use or wide dispersive professional. This can be covered by SUs! use of with ERC 8 A-C, depending on the technical fate of
substance intended to become part of an article (ERC 5) (ERC 8C) the substance

26 KEML Table R.12-2 Immersion operations such as dipping and pouring (PROC 13) PROC 13 could be linked to ERC 4, ERC 5 or ERC
Industrial This can be covered by SUs! use of substances intended to be-come part of an 6 (depending on the technical fate of the substance).
article (ERC 5) PROC 13 would allow the choice between
professional and industrial, thus also ERC 8A to 8C
may apply.
27 KEML R.12.4.2 Table R.12-3 Comment: Deleted: 2 done
28 KEML Figure R.12-2 It is not clear how the use description(s) will be selected ? See rules under 12.5
29 KEML R.12.5 For each use at least 2 [3] out of five? why? descriptors are needed to address the Text rephrased.
characteristics of a use how about the short title for Exposure Scenarios, how about
communication between M/I and DU? and to be able to link to a Tier 1 exposure
estimation: Comment: Deleted: broad
30 KEML R.12.5 Why not use SUs?Assignment of market sectors term? SUs? is not needed to derive SU addresses the sector of end-use while the PC is
exposure estimation. meant to describe the relevant formulating sector,
e.g. paint makers, adhesive producers, producers of
cleaners, producers of lubricants. Text has been re-
phrased.
31 KEML Appendix R.12-1 SU23 Recycling Is this the sector of use? It is at least a NACE category, however we agree
that is should be removed. If at all it can be
manufacture.
32 KEML Appendix R.12- Preparation category [for describing market sectors regarding all uses (workers and con- Has been streamlined.
2.1 sumers) inconsistent terminology]
33 KEML Appendix R.12- PC20 Products such as ph-regulators, flocculants, precipitants, neutralization agents, other done
2.1 un-specific please delete!
34 KEML Appendix R.12- PC22 Lawn and Garden Preparations, including fertilizers please delete Done. Based on other comments PC 22 has been
2.1 referenced to PC 12 and deleted (still to be finally
confirmed by ECETOC)
35 KEML Appendix R.12-3 PROC 0 Other Process or activity done
PROC xyz replaced?

36 KEML Appendix R.12-3 PROC 2 Use in closed, continuous process with occasional controlled exposure done
Comment: Deleted: (e.g. sampling)
37 KEML Appendix R.12-3 PROC 7 Industrial This is covered by SUs! Spraying see response for PROC 22, PROC 7 always relates
to industrial setting, PROC 11 always to non
industrial setting.
38 KEML Appendix R.12-3 PROC 11 Non industrial This is covered by SUs! Spraying see response for PROC 22

39 KEML Appendix R.12-3 PROC 16 Using material as fuel sources, limited exposure to unburned product to be removed.
expected
Industrial or non-industrial setting; This is covered by SUs!

40 KEML Appendix R.12-3 PROC 17 (Examples and explanations) Lubrication at high energy conditions (temperature, done
friction) between moving parts and substance; significant part of proc-ess is open to
workers Comment: Deleted: or to the environment
Page 11
41 KEML Appendix R.12-3 PROC 22 Potentially ? closed or not? closed process-ing operations with minerals/metals Phrasing taken over from EUROMETAUX and
at elevated temperature TRA category. Also, the category has to be seen in
Industrial setting This is covered by SUs! relation to the other (old) TRA categories which
mostly deal with products of the hydrocarbon
industry, for which partly open processing at
elevated temperature does not play a role. While
most other PROC entries to the TRA include a
choice between industrial and professional setting,
this is fixed by default for PROC 22.

42 KEML Appendix R.12- Description for Environmental Release Categories relation to SUs? see above
4.1
43 KEML Appendix R.12- Life cycle stage – relation to SU? See sentence included in section 12.3.4.for
4.2 Level of containment – relation to PROC? clarification. Regarding the questions: 1) The life
Indoor / outdoor – importance? cycle reference has been removed from the SU.
Release promotion – relation to PROCs? Thus, the SU only refers to uses, not to manufacture
and not to article service life. Industrial/non
How will the use description finally look? industrial is reflected in SU and ERC. 2) PROCs
only address the level of containment with regard to
workplaces, not with regard to envi releases. Thus, a
closed system PROC may nevertheless generate
waste water. 3) Regarding the availability of waste
water treatment and releases to soil, indoor/outdoor
conditions play an important role. Also the releases
from articles are generally promoted by outdoor
conditions. 4) As regards workers, the PROC reflect
release promotion, but not with regard to articles
expected to be eroded in the environment (tyres,
brake pads). However its true that an ERC for
processing of articles by industrial workers was
missing so far. This has been included now as R.12.

44 KEML Appendix R.12-6 Articles with intended release of chemical substances Comment: Deleted: Substances in a revised.

comment A brief piece of guidance should be added, on how to further process use descriptions that Has been added as appendix 12-7
of PEG have been generated based on the pick-lists before the recent modifications were
meeting introduced, e.g. reporting on construction products and construction articles (now removed
from both lists)
comment
of PEG
meeting The appendix R.12-1 with the “sector of use” descriptor should be slightly modified:
comment done
of PEG o Connect both tables in order to avoid the impression that an additional descriptor is
meeting introduced here.
comment These descriptors are now now called key
of PEG o Call the three entries in the upper part of the list “Core descriptors for the sector of descriptors.
meeting use” (recommended to be always applied)
comment These descriptors are now now called
of PEG o Call the second list “sectors of economy “, make clear it is optional case by case, and supplementary descriptors. The sector of end-use
meeting that it is not a determinant for exposure estimates. Reconsider whether to call the list has been maintained, but additional explanation has
“sector or end-use” been added in sectionR.12.3.1
comment
of PEG
meeting Clarify the definition of some PROCs
comment no time reference; presence at workplace is the
of PEG reference
meeting o PROC 15: Time reference of the amount
comment More detailed abstract definition not possible if
of PEG PROC 14 and PROC 21 are to be used as entries
meeting into the TRA.. Main difference: PROC 14 applies to
solids and liquids, PROC 21 only to solids.
ETRMA/CEFIC/EUPC proposals partly taken over,
but category 14 also covers formation of dust due to
o PROC 14 and 21: clarify the difference and provide an abstract definition for processing of powdered substances as such or in
PROC14 and examples. ETRMA has proposed a text that should be considered for preparations.
inclusion into the guidance.
comment At use descriptor level this may be useful, however
of PEG for the tier 1 exposure estimate based on PROC 9 as
meeting o Consider to split PROC 9 according to the level of automatisation or dedication into an entry there basis for this split in the underlying
9a and 9b (see analog PROC 8). data set of the TRA.
comment Make more explicit that the list of substance functions (Appendix R.12-6) i) refers to Included.
of PEG dangerous substances only (and not preparations) and ii) is not part of the core use
meeting descriptor system to describe identified uses and to build exposure scenarios under
REACH.
comment It would be useful to include some rules into the guidance how to fill the fields in the use done
of PEG description fields of IUCLID (see table R.12-5). For example clarify that the reference
meeting between the identified use name and the exposure scenario should be based on the short free
title (or number) of the ES.
comment
of PEG In section12.5.1 the “tree” approach needs to be better explained (the ”tree” is not really
meeting visible):
comment some explanation added
of PEG
meeting o the role “formulator” needs better explanation
comment checked
of PEG o the “market sector” – PC relationship need to be consistently phrased across the
meeting document
comment explanatation refined
of PEG o the relationship between the description at stage level (for environment) and at use
meeting level (for worker and consumers) should be better explained
comment checked and corrected
of PEG
meeting o the figure of 16 combinations between stages and user groups should be checked
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comment done
of PEG Harmonize the style of descriptor numbering (with or without blanks before the number;
meeting small or capital letters)
comment Make it still more explicit that the descriptor lists are not complete (in particular PC and done
of PEG AC related to consumer products and articles; remove the table structure in the AC list
meeting regarding the examples. Put all examples in one row.
comment Make more clear that the ES needs to be transparent and relevant for the user. Thus ES included
of PEG covering more than one activity (and corresponding set of OC and RMM) must still be
meeting readable and understandable to the DU.
comment included
of PEG Make clear, that the TRA is not the only tool for carrying out exposure estimates for
meeting consumers.
comment Split PROC 27 into hot dry processes and wet proccesses. done
of PEG
meeting

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