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REACH Annex XVII Status 1904
REACH Annex XVII Status 1904
REACH Annex XVII Status 1904
Functional Description
1. DESCRIPTION
The rule set “REACH Annex XVII Status” determines the components from the standard com-
position which are subject of restriction according to Title VIII of the Regulation 1907/2006
(REACH Annex XVII). In addition the rule set reads the EU GHS Hazard Classes and Cat-
egories on product level and checks for GHS Hazard Classes and Categories defined by
REACH Annex XVII entry 3 and 40, in order to determine if a product is concerned.
The rule set mainly writes the number on list, a status and additional information to this property
as well as the according regulatory base and regulatory list.
The rule set assumes that the product and its components have been classified by using the
GHS EU rule set.
2. INPUT DATA
The rule set uses input values as described in the following section. For a detailed technical
description of the input data, please refer to the Appendix.
Beside the premise, a specification is considered to be relevant according to entry 3 if its GHS
class/category (GHS list = GHS_EU) is maintained in accordance with Regulation (EC) No
1272/2008 or are fulfilling the criteria for any of the following hazard classes or categories set
out in Annex I to Regulation (EC) No 1272/2008: (a) hazard classes 2.1 to 2.4, 2.6 and 2.7,
2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15
types A to F; (b) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility
or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10; (c) hazard class 4.1;
(d) hazard class 5.1.
A specification is classified as CMR if its GHS class/category (GHS list = GHS_EU) is carcino-
gen, mutagen or reprotox with category 1A or 1B.
A specification is considered as listed in REACH Appendix 1-6 if the restriction list “ZEU_RMU”
and the restriction type “Restricted to professional users” are maintained in the property “Pro-
hibitions and Restrictions”.
Mixtures:
A mixture needs to be considered if it contains any component that is listed in REACH Appendix
1-6 and that is contained with a concentration above the relevant specific concentration limit
or above the general limit.
A component is considered as listed in REACH Appendix 1-6 if the restriction list “ZEU_RMU”
and the restriction type “Restricted to professional users” are maintained in the property “Pro-
hibitions and Restrictions”.
A component is classified as CMR if its GHS class/category (GHS list = GHS_EU) is carcino-
gen, mutagen or reprotox with category 1A or 1B. Furthermore, the restriction category in the
property "Prohibitions and Restrictions" is checked. Only if the component's concentration is
greater than or equal to the specific concentration limit or greater than or equal to the general
limit, then the component is considered to be relevant for REACH Annex XVII. If a specific
concentration limit is given, then the general limits are ignored.
A positive outcome is only written if the relevant component is contained with a concentration
above the limit given in the regulatory list. If there is no limit given in the list, then the rule set
applies the value maintained in the external values database.
3. OUTPUT DATA
The following property is written in EHS:
The following characteristics of this property are written dependent from the respective restric-
tion:
• Regulatory List
• Regulatory Basis
• Number on List
• Status
• Additional Information
• Composition
A negative statement "not applicable" is written in case that the product is not relevant to any
of the restrictions described above.
In order to find out more easily in the EHS-dialogue which calculation has been written by EHS-
EXPERT, reference is made for each value assignment type to EHS-EXPERT as having been
used as source and to the respective rule set "REACH_Annex_XVII_Status_<ERC release>"
as legal basis.
E = Error (rule set will abort calculation and no data will be written back)
W = Warning
I = Information
The message text is given formatted as bold text. Text in <> will be filled in from the rule set
when giving the message. For example <specification key> stands for the specification key
used from EHS.
Than follows a description of the message and after the signs >>>>> the action that can be
done.
The rule set aborts the calculation due to a manually maintained exception phrase
>>>>> Remove the "no calculation" phrase to process the specification by the
appropriate rule set.
Remark on table:
The category of these messages can be tailored to customer requirements, i.e. the customer
can choose, whether these messages will be shown as error messages (red), warnings (yellow)
or information (green) in the message log of the rule set run. This will be done for each rule
set separately. To select a different category for a message, an additional parameter for each
category to be changed has to be set in the user exit of the specific rule set.
Where:
<Category> = “E” meaning Error Message, “W” meaning Warning, “I” meaning Information
Example:
For this purpose, two new parameters are to be set in the user exit:
EXPERT_ADD_PARAM_01 026:I
EXPERT_ADD_PARAM_02 027:I
5. EXTERNAL VALUES
In addition to the files for the rule set (ruc files and the mapping data base) a separate MS-
Access data base (REACH_Annex_XVII_externvalues.mdb) is delivered. The purpose of it is
to allow the user to modify the preconfigured data according to his needs.
Regulatory_list
Concentration_limit
6. APPENDIX
6.1. Installation settings
The settings to implement this rule set are documented in the Administration Manual in the
Appendix: Technical Settings Expert Rules. For further details please see section "Settings to
implement the rule set package EU".
Remarks:
Remarks:
The default phrase mapping is based on the CED Phrase Catalogue. The first part of the
phrase key (column: External_id) always signifies the active phrase catalogue in EHS. The
default value for the active phrase catalogue is CUST. If the active phrase catalogue in the EHS
system is named differently, then the mapping has to be changed (using the replace function
in MS Access).
Entries which are not analysed in the rule set, have same internal and external key and are
not described further. These entries suppress the Warning “External Id < xxx> is not contained
in the mapping table for phrases” (CM_EXPERT 355).
The following tables are copied from the table ExpPhraseMap and are organised according to
the phrase sets or customizing tables.
exposure in contact
with skin.
[#H372c#] CUST- Causes damage to or-
N15.00930260 gans through pro-
longed or repeated
exposure if inhaled.
[#H373#] CUST- May cause damage to
N15.00930280 organs through pro-
longed or repeated
exposure.
[#H373a#] CUST- May cause damage to
N15.00930300 organs through pro-
longed or repeat-
ed exposure if swal-
lowed.
[#H373b#] CUST- May cause damage to
N15.00930310 organs through pro-
longed or repeated
exposure in contact
with skin.
[#H373c#] CUST- May cause damage to
N15.00930290 organs through pro-
longed or repeated
exposure if inhaled.