ISOPA interpretation on selection of Use Descriptors - PU Europe
ISOPA interpretation on selection of Use Descriptors - PU Europe
ISOPA interpretation on selection of Use Descriptors - PU Europe
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Revisi<strong>on</strong> Number 0<br />
Revisi<strong>on</strong> Date 18 November 2009<br />
<str<strong>on</strong>g>ISOPA</str<strong>on</strong>g> <str<strong>on</strong>g>interpretati<strong>on</strong></str<strong>on</strong>g> <strong>on</strong> selecti<strong>on</strong> <strong>of</strong> <strong>Use</strong> <strong>Descriptors</strong>:<br />
We refer to the Guidance for Informati<strong>on</strong> requirements and Chemical Safety Assessment<br />
(CSA), Chapter R12 – <strong>Use</strong> Descriptor System. And especially to the new Draft <strong>of</strong> R12 from 07<br />
November 2009, because the view <strong>of</strong> the required main uses has changed.<br />
Link: http://guidance.echa.europa.eu/guidance4_en.htm<br />
Sectors <strong>of</strong> <strong>Use</strong> [SU]<br />
1. There are 3 Main <strong>Use</strong>r Groups, being SU3 [industrial uses], SU21 [c<strong>on</strong>sumer uses] and SU22<br />
[Pr<strong>of</strong>essi<strong>on</strong>al uses]. All other sectors <strong>of</strong> use at industrial level, including SU8 and SU9<br />
[Manufacturing <strong>of</strong> Chemicals/Fine chemicals] and SU10 [Formulati<strong>on</strong>/repackaging], are<br />
subsectors <strong>of</strong> SU3 and are not strictly required to describe. If they are described as a use they<br />
should be described in additi<strong>on</strong> to SU3, e.g. SU3/SU10, and not as sector <strong>of</strong> use <strong>on</strong> its own, e.g.<br />
SU10.<br />
2. SU8 and SU9 [Manufacturing <strong>of</strong> Chemicals/Fine chemicals] is <strong>on</strong>ly related to the synthesis <strong>of</strong><br />
MDI/TDI/polyols, i.e. members <strong>of</strong> <str<strong>on</strong>g>ISOPA</str<strong>on</strong>g>. Eventually, it applies to producers <strong>of</strong> chemically<br />
modified isocyanates, e.g. specialised system houses, who then become substance<br />
manufacturers and may have their own REACH obligati<strong>on</strong>s. In general, SU8 and SU9 will not<br />
be relevant to the “comm<strong>on</strong>” downstream user <strong>of</strong> Isocyanates and polyols who is making<br />
Polyurethane products/articles.<br />
3. The “comm<strong>on</strong>” downstream user <strong>of</strong> MDI, TDI or polyol should select between Sector <strong>of</strong> <strong>Use</strong><br />
SU3/SU22/SU21 depending whether uses are Industrial, Pr<strong>of</strong>essi<strong>on</strong>al or C<strong>on</strong>sumer. We<br />
c<strong>on</strong>sider all other SU’s to be covered by these main group <strong>of</strong> Sectors <strong>of</strong> <strong>Use</strong> applicable for <strong>PU</strong><br />
downstream, i.e. SU3 (Industrial <strong>Use</strong>s) may include: SU11, SU12, SU13, SU16, SU17, SU18,<br />
SU19, SU20, SU23 applicati<strong>on</strong>s. SU22 (Pr<strong>of</strong>essi<strong>on</strong>al <strong>Use</strong>s) may include: SU2, SU12, SU13,….<br />
4. <str<strong>on</strong>g>ISOPA</str<strong>on</strong>g> c<strong>on</strong>siders SU10 as <strong>on</strong>ly applicable for formulators or repackers who do not<br />
manufacture <strong>PU</strong> products for example system houses. E.g. manufacturing <strong>of</strong> coatings or<br />
adhesives is c<strong>on</strong>sidered to be covered under SU3.<br />
5. For SU3 (Industrial <strong>Use</strong>s), the necessary PROC’s and ERC’s are included to cover for in-house<br />
formulati<strong>on</strong> <strong>of</strong> preparati<strong>on</strong>s prior to the manufacture further downstream.<br />
6. Following the guidance <strong>of</strong> the <strong>Use</strong> Descriptor System [R12] for SU3/SU10/SU22 <strong>on</strong>ly PROC's<br />
and ERC's are assigned and for SU21 [C<strong>on</strong>sumer <strong>Use</strong>] <strong>on</strong>ly PC’s and ERC’s.<br />
Process Categories [PROC]<br />
1. PROC 12 related to the use <strong>of</strong> blowing agents forwarded by trade associati<strong>on</strong>s or individual<br />
customers is not c<strong>on</strong>sidered as relevant for the <str<strong>on</strong>g>ISOPA</str<strong>on</strong>g> end uses since the <str<strong>on</strong>g>ISOPA</str<strong>on</strong>g> end uses <strong>on</strong>ly<br />
cover MDI/TDI/polyol substances, excluding other additives, such as blowing agents.<br />
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Revisi<strong>on</strong> Number 0<br />
Revisi<strong>on</strong> Date 18 November 2009<br />
PROC 12 forwarded by trade associati<strong>on</strong>s or individual customers for request to be included as<br />
part <strong>of</strong> <str<strong>on</strong>g>ISOPA</str<strong>on</strong>g> intended use is c<strong>on</strong>sidered not relevant and pose no obligati<strong>on</strong> to <str<strong>on</strong>g>ISOPA</str<strong>on</strong>g><br />
members to adopt PROC12 in the <str<strong>on</strong>g>ISOPA</str<strong>on</strong>g> use descriptors.<br />
2. PROC 15 related to laboratory activities is c<strong>on</strong>sidered to be relevant for all <strong>PU</strong> applicati<strong>on</strong>s at<br />
industrial level [SU3].<br />
3. PROC 19 related to intended and intimate c<strong>on</strong>tact and forwarded by trade associati<strong>on</strong>s or<br />
individual customers is not c<strong>on</strong>sidered as an intended use at industrial level [SU3] or<br />
pr<strong>of</strong>essi<strong>on</strong>al level [SU22], sine this PROC is intended for uses where manual c<strong>on</strong>tact with<br />
substances is c<strong>on</strong>sidered as intenti<strong>on</strong>al or general practice, e.g. hair dresser, artists working with<br />
clay. For manual activities PROC 5 [“mixing or blending in batch processes for formulati<strong>on</strong> <strong>of</strong><br />
preparati<strong>on</strong>s and articles (multistage and/or significant c<strong>on</strong>tact)”] has been regarded as<br />
representative for these exposure scenarios.<br />
PROC 19 forwarded by trade associati<strong>on</strong>s or individual customers for request to be included as<br />
part <strong>of</strong> intended use will not be c<strong>on</strong>sidered as intended use in the <str<strong>on</strong>g>ISOPA</str<strong>on</strong>g> use descriptors and<br />
pose no obligati<strong>on</strong> to <str<strong>on</strong>g>ISOPA</str<strong>on</strong>g> members to adopt PROC 19 in the <str<strong>on</strong>g>ISOPA</str<strong>on</strong>g> use descriptors.<br />
4. PROC21 at industrial level or pr<strong>of</strong>essi<strong>on</strong>al level [SU3/SU22] related to low energy<br />
manipulati<strong>on</strong> <strong>of</strong> substances in form <strong>of</strong> massive metal or bound in other materials and/or articles.<br />
<str<strong>on</strong>g>ISOPA</str<strong>on</strong>g> regards PROC21 applicable for post foaming/curing handling activities such as<br />
demoulding, trimming etc. <str<strong>on</strong>g>ISOPA</str<strong>on</strong>g> regards PROC21 as NOT applicable for cured <strong>PU</strong> products.<br />
<str<strong>on</strong>g>ISOPA</str<strong>on</strong>g> regards cured <strong>PU</strong> products as products which are 24 hours old post producti<strong>on</strong> and/or<br />
<strong>PU</strong> products which are no l<strong>on</strong>ger hot or sticky or otherwise proved that residual m<strong>on</strong>omeric<br />
diisocyanates do not pose a risk. Cured products do not require exposure scenarios.<br />
PROC21 forwarded by trade associati<strong>on</strong>s or individual customers for request to be included as<br />
part <strong>of</strong> intended use for scenarios including cured <strong>PU</strong> products will not be c<strong>on</strong>sidered as<br />
intended use in the <str<strong>on</strong>g>ISOPA</str<strong>on</strong>g> use descriptors and pose no obligati<strong>on</strong> to <str<strong>on</strong>g>ISOPA</str<strong>on</strong>g> members to adopt<br />
PROC 21 for these uses in the <str<strong>on</strong>g>ISOPA</str<strong>on</strong>g> use descriptors.<br />
5. <str<strong>on</strong>g>ISOPA</str<strong>on</strong>g> regards PROC24, high energy work-up like sawing or milling activities <strong>of</strong> massive<br />
metals or substances bound in materials and/or articles and likely resulting in exposure to dusts<br />
or aerosols as not applicable since this scenario can <strong>on</strong>ly take place <strong>on</strong> cured products and<br />
MDI/TDI/polyols are not c<strong>on</strong>sidered any l<strong>on</strong>ger as a substance bound in the article since the<br />
substance has reacted away to such a degree that m<strong>on</strong>omeric levels are below the threshold for<br />
describing exposure scenarios, e.g. 0.1%. Reacted away (see point 4 above). PROC24<br />
forwarded by trade associati<strong>on</strong>s or individual customers for request to be included as part <strong>of</strong><br />
intended use for scenarios including cured <strong>PU</strong> products will not be c<strong>on</strong>sidered as intended use<br />
in the <str<strong>on</strong>g>ISOPA</str<strong>on</strong>g> use descriptors and pose no obligati<strong>on</strong> to <str<strong>on</strong>g>ISOPA</str<strong>on</strong>g> members to adopt PROC 24 for<br />
these uses in the <str<strong>on</strong>g>ISOPA</str<strong>on</strong>g> use descriptors. If this scenario is occurring <strong>on</strong> uncured products, the<br />
supplier needs to be informed to verify if this use can be supported.<br />
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Revisi<strong>on</strong> Number 0<br />
Revisi<strong>on</strong> Date 18 November 2009<br />
Article Categories [AC]<br />
1. Following the ECHA guidance <strong>of</strong> the <strong>Use</strong> Descriptor System [R12] Article Categories are<br />
<strong>on</strong>ly relevant when the service life <strong>of</strong> article is <strong>of</strong> relevance for exposure. Exposure during<br />
service life is c<strong>on</strong>sidered relevant when the substance is intended to be released from an article<br />
or when the substance is still present at levels > 0.1% in article with no intended release.<br />
Based <strong>on</strong> current available data, <str<strong>on</strong>g>ISOPA</str<strong>on</strong>g> does not c<strong>on</strong>sider both c<strong>on</strong>diti<strong>on</strong>s relevant for cured<br />
<strong>PU</strong> products because the substances covered [MDI, TDI, polyols] are chemically reacted up<strong>on</strong><br />
use and are not becoming part <strong>of</strong> an article and therefore are no l<strong>on</strong>ger available for further life<br />
cycle steps, i.e. c<strong>on</strong>sumer/worker service life cycle stage, or emissi<strong>on</strong> to the envir<strong>on</strong>ment.<br />
For this reas<strong>on</strong>, Article Categories are not used. Article Categories forwarded by associati<strong>on</strong><br />
or customers do not pose an obligati<strong>on</strong> to <str<strong>on</strong>g>ISOPA</str<strong>on</strong>g> members to adopt these in the <str<strong>on</strong>g>ISOPA</str<strong>on</strong>g> use<br />
descriptors. Unless it can be dem<strong>on</strong>strated that <strong>PU</strong> articles are produced with intended release<br />
<strong>of</strong> substances being part <strong>of</strong> that article.<br />
Product categories [PC]:<br />
1. Following the R12 Draft Versi<strong>on</strong> 2.0, October 2009 for SU21 [C<strong>on</strong>sumer <strong>Use</strong>] <strong>on</strong>ly PC and<br />
ERC’s are required.<br />
2. PC10, Building and C<strong>on</strong>structi<strong>on</strong> Preparati<strong>on</strong>s not covered elsewhere, has been deleted as PC<br />
in R12 Draft Versi<strong>on</strong> 2.0, 07 November 2009 and should be covered under “others”.<br />
Envir<strong>on</strong>mental release categories [ERC]:<br />
1. ERC5: ERC5 describes industrial use <strong>of</strong> substances in articles with a specific functi<strong>on</strong> and<br />
substances remaining in the article after having been used as processing aids for some <strong>PU</strong><br />
applicati<strong>on</strong>s like Flexible Foam, Rigid foam, elastomers and T<strong>PU</strong> and part <strong>of</strong> other <strong>PU</strong><br />
composites applicati<strong>on</strong>s, MDI/TDI/polyols do not have a specific functi<strong>on</strong>, such as e.g. a fire<br />
retardant. For the other applicati<strong>on</strong>s MDI/TDI has a particular functi<strong>on</strong> as a binding/curing<br />
agent and can be regarded in some occasi<strong>on</strong>s as processing aid.<br />
If there are any remaining discrepancies, please inform your trade associati<strong>on</strong> before<br />
c<strong>on</strong>tacting your supplier(s) to keep <str<strong>on</strong>g>ISOPA</str<strong>on</strong>g> and your trade associati<strong>on</strong> aligned. The trade<br />
associati<strong>on</strong> will discuss any remaining issues with <str<strong>on</strong>g>ISOPA</str<strong>on</strong>g>.<br />
W. Frank<br />
Secretary General<br />
<str<strong>on</strong>g>ISOPA</str<strong>on</strong>g><br />
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Revisi<strong>on</strong> Number 0<br />
Revisi<strong>on</strong> Date 18 November 2009<br />
Disclaimer<br />
<str<strong>on</strong>g>ISOPA</str<strong>on</strong>g> has compiled the pages <strong>on</strong> these documents very carefully, and the informati<strong>on</strong> placed <strong>on</strong> it is <strong>of</strong>fered in<br />
utmost good faith.<br />
This informati<strong>on</strong> is believed to be correct. Nevertheless, <str<strong>on</strong>g>ISOPA</str<strong>on</strong>g> makes no representati<strong>on</strong>s or warranties as to the<br />
completeness or accuracy <strong>of</strong> any <strong>of</strong> this informati<strong>on</strong>.<br />
This informati<strong>on</strong> is made available <strong>on</strong> the c<strong>on</strong>diti<strong>on</strong> that each <strong>of</strong> them will make his/her own determinati<strong>on</strong> whether<br />
the informati<strong>on</strong> is suitable prior to make any appropriate use <strong>of</strong> it.<br />
<str<strong>on</strong>g>ISOPA</str<strong>on</strong>g> will in no event be resp<strong>on</strong>sible for damages <strong>of</strong> any nature whatsoever resulting from the use or reliance to the<br />
informati<strong>on</strong> c<strong>on</strong>tained in these documents.<br />
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