Guidance

SECTION 2: Hazards identification

Concentrations Chemical name component A not classified 60-80% Chemical name component B not classified 13% Chemical name component C major concern 11-14% Perfume chemical name 1 not classified 1-4% Perfume chemical name 2 not classified 1% Perfume chemical name 3 not classified 0.5% Perfume chemical name 4 acute toxicity, cat 1 0.3-0.6% Perfume chemical name 5 skin corrosion, cat 1C 2-3% Perfume chemical name 6 skin sens. cat. 1 2% Perfume chemical name 7 aspiration toxicity, cat 1 3-6% Perfume chemical name 8 not classified 4% This composition can alternatively also be submitted as presented in option B (below). Perfume components 1 to 3 are indicated with the generic component identifier “Perfumes”. This is allowed since these components are not classified for a health hazard and the total concentration of the components covered by the given generic component identifier does not exceed 5% [B.3.2.3]. ‘Perfume chemical name 4 to 7’ cannot be indicated with a generic component identifier because these components are classified for a health hazard. OPTION B – SOME COMPONENTS INDICATED WITH A GENERIC COMPONENT IDENTIFIER Components Classification Percentage Chemical name component A not classified 60-80% Chemical name component B not classified 13% Chemical name component C major concern 11-14% Perfumes (GCI) not classified 3%, 2-5% Perfume chemical name 4 acute toxicity, cat 1 0.3-0.6% Perfume chemical name 5 skin corrosion, cat 1C 2-3% Perfume chemical name 6 skin sens. cat. 1 2% Perfume chemical name 7 aspiration toxicity, cat 1 3-6% Perfume chemical name 8 not classified 4% Additional notes to the example Perfume chemical name 1’ was indicated in option A with a concentration range of 1- 4%. The actual concentration apparently was 1.5% (only known to the submitter) so the total concentration is 1.5+1+0.5=3% Not all non-classified perfumes can be grouped within the same generic component identifier because if ‘Perfume chemical name 8’ is included, the total concentration is 7%. Other non-classified perfume components must be indicated individually with their chemical name It would also have been possible to, for example, indicate ‘Perfume chemical name 2’ and ‘perfume chemical name 8’ with a generic component identifier “Perfumes” since the total concentration does not exceed 5%. In that case the other non-classified perfume components (1 and 3) must be indicated individually with their chemical name The same generic component identifier “perfumes” could be used more than once in the same submission, without the need to further specify the identity of the components This could be relevant in the case of perfumes with different classifications (e.g. some not classified and others classified for physical hazards) On the indicated concentration The generic component identifier can be indicated with an exact concentration (the sum of the components covered by the same generic identifier, 3% in the example) or a range according to table 2 of Annex VIII, for example 2-5% (3% units bandwidth allowed; with a maximum of 5%) Example 22: Use of generic component identifiers (mixtures varying in colourants only) In this example, a formulator produces a mixture and places it on the market under different trade names (i.e. different products). The composition of the mixture is always the same with the exception of the components used only as colourants. The mixture composition in each product contains a different blend of colourants. These are not classified for any health (or physical) hazard. The total concentration of the colourants in each product varies but does not exceed 25%. In addition, the variation in concentration in each composition falls within the limits set by table 2 of Annex VIII COMMON COMPOSITION Components Classification Concentrations Chemical name component A Minor concern 20-30% Chemical name component B Minor concern 20-30% Chemical name component C Major concern 30-35% COLOURANTS Classificatio Trade name Shining Blue Shining Red Shining Green Colourant 1 Not classified 7% Colourant 2 Not classified 21% Colourant 3 Not classified 10% 9% A single submission can include the three trade names and the mixture composition where the colourant components are indicated with the generic component identifier “Colouring agents” The concentration of the generic colourant component has to be provided within the maximum breadth of range, in accordance with table 2 of Annex VIII, on the basis of the actual concentration The submitter can decide to assign one single UFI or multiple UFIs, according to their business decision 81 SUBMISSION Trade name ABC – Trade name DEF – Trade name GHI UFI: WQYN-341E-V00P-YHNT Components Classification Percentage Chemical name component A Minor concern 20-30 % Chemical name component B Minor concern 20-30 % Chemical name component C Major concern 30-35 % Colouring agents” (GCI) Not classified 14–22 % Additional notes to the example The total concentration of the colourants in the individual mixtures is 18% (Shining Blue), 21% (Shining Red) and 16 % (Shining Green). Therefore, a range of maximum %-units can be used in the submission to cover all the variants. In this case, voluntarily a narrower 8 %-unit range has been chosen If one or more colourants classified only for a physical hazard are added to all mixtures, these should be included separately even if still identified with a generic component identifier. It is indeed possible to use multiple times the same generic component identifier to identify different components included in the submission Limited submission [B.3.1.1] When a company decides to opt for a limited submission (possible for mixtures intended for industrial use only and for mixtures with an end use not subject to submission) the list of components to be provided may be limited to that included in Section 3.2 of the SDS. The information to be provided on the concentrations of such components may be also limited to that contained in the SDS Detailed information on the compilation of the SDS, and in particular of Section 3, is available in the ECHA’s Guidance on the compilation of safety data sheets In practice, the information provided in this case will be less detailed than a standard submission and the poison centre will not have access to the full composition of the mixture For example, Annex II to REACH (on the compilation of SDS) does not require the indication of not classified components, and sets for the hazardous components to be indicated concentration thresholds and ranges which are less strict than Annex VIII to CLP (e.g hazardous components may need to be included in a standard submission even if present in concentration <0.1%) Additionally, in this case information on the packaging is not required and can be provided on voluntary basis Group submission [A.4] Information on multiple mixtures with limited differences in the composition can be provided in the same submission: this is referred to as a ‘group submission’. The general conditions under which such a ‘group submission’ is allowed are specified in Section 4, part A of Annex VIII Mixtures can be grouped in the same submission if they have the same classification for health and physical hazards (this means that a difference in classification for environmental hazard is allowed); have very similar composition; the only differences can concern certain perfumes see section 5.4.2 for details); the same components are reported in the same concentration or concentration range Besides substances indicated with their own chemical name, as explained in section 5.3, the mixtures’ components can include MiM, and components which are allowed to be indicated with generic component identifiers’ (see section 5.3.3) All mixtures in the group must contain the same components, except for perfume components, as referred to in Section A.4.3 of Annex VIII. The latter can differ between mixtures in the group under certain conditions (see section 5.4.2 below) Under the conditions described above, a group submission is basically possible for mixtures with compositions that differ, under certain conditions, in perfumes. These would be ‘product variants’ (possibly marketed under different trade names), for example detergents with a difference in perfumes Note: the grouped mixtures all have to be placed on the market by the same importer or downstream user (and their distributors). A group submission can only include the details of one ‘legal submitter’ (i.e. duty holder). It is not possible to group mixtures that are placed on the market by different duty holders under Article 45 Ultimately, the difference between a standard and a group submission concerns the possibility to group mixtures with variation in perfumes which cannot be indicated with a generic component identifier. As explained earlier in this section, also in a standard submission multiple trade names can be included, as long as the composition of the mixture remains the same Note: The decision whether to provide a standard or group submission (when the conditions are fulfilled) lays with the duty holder and could be based on the specific portfolio. Group submission is an option provided to facilitate the fulfilment of the obligations: the duty holder may always decide to submit a standard submission for each mixture without grouping it with other mixtures 83 Information to be provided in a group submission Information described in part B of Annex VIII should be provided for each of the mixtures in the group The information provided on mixture components in a group submission should apply to all the mixtures in the group, except for perfumes that may only apply to some mixtures in the group under certain conditions (see section 5.4.2 below) Most of the information will be the same but there might be a difference in Product identifiers of the mixture’: a group submission (as well as a standard submission) may cover mixtures placed on the market with different trade names and/or to which different UFIs could be assigned Additional information’ items listed in Part B, Section 2.4, of Annex VIII Colour and physical state of the mixture; o pH; Types and sizes of the packaging; o Use types (consumer, professional, industrial) as described in section 3.4 of this Guidance Trade names, colour, packaging, use types and UFIs should be indicated for every individual mixture in the group. This information may be useful for the emergency responders in order to promptly identify the relevant information for the specific product Nevertheless, for the colour, a limited range of standard types can be used (no need to indicate the exact shade). Exceptionally and for practical reasons, a generic indication of the colour field can be accepted for paints and other similar categories for example inks, where high numbers of products with great colour variability can be included in the same group submission (provided they are not classified68) Regarding the packaging, the specific type is potentially relevant to identify the appropriate emergency response measures to assist with possible product identification. This information should be provided for each mixture of the group placed on the market with a specific trade name The pH value can be indicated for the group as a whole; a range applicable to the whole group can be used. Where the pH value is particularly low or high (i.e. <3 or >10), the range to be indicated should not be bigger than one unit (e.g. 2.5 – 3.5) It is assumed that the toxicological information (as required in Section 2.3, Part B of Annex VIII) should not normally vary across the mixtures of the group. In case of differences, it has to be clear to which mixture the information refers to Mixture components in a group submission Mixtures in a group submission should contain the same components in the same concentration or concentration range, except for perfumes components. Those components may only differ between the mixtures of the group under the conditions described below Section A.4.3 and B.3.1 of Annex VIII). The total concentration of the perfumes which differ in each mixture of the group cannot exceed 5%. In case the concentration of the differing 68 In this case the use of the generic component identifier “colouring agent” can possibly cover different colorants perfumes in a mixture is above this threshold, the mixture cannot be included in the same group submission The intention of this rule is to allow grouping of the mixtures only if their compositions are very similar (and hence the toxicological information does not vary). This means that for a maximum of 5% of the composition, the mixtures’ compositions may differ in perfumes content It is to be underlined that the calculation of the 5% threshold should take into account only the perfumes in each mixture which vary from the others (i.e. which are not present in all the mixtures of the group, but in one or some of them only). In practice this means that if the mixtures contain common perfumes indicated by their chemical name or GCI, the 5% threshold does not refer to those common perfumes The perfumes contained in each mixture of the group must be listed to identify the perfumes they contain, including their classification The information required on the mixture composition in a group submission is illustrated by examples 23 and 24. References to the relevant legal text are made in the notes to the examples (in square brackets) to indicate compliance with the requirements on group submission as well as with requirements on component identification/information where relevant for grouping. For detailed guidance on component identification and information requirements, please see section 5.3 of this guidance document It is important to note that these examples are presented in a simplified form with the sole purpose of illustrating the requirements for group submission. In the examples different formats are used to present the information, but the same principles apply Special case: perfume components not requiring concentration In the case of perfume components in a group submission that are not classified as hazardous or are classified only for skin sensitisation Category 1, 1A or 1B or aspiration toxicity, submitters are not obliged to provide information on their concentration. This applies to both types of perfumes, those which vary across the mixtures of the group and those which are common to all the mixtures For colouring agents with a generic component identifier, the table above (section 5.3.3) applies 85 Example 23: Grouping of mixtures with difference in perfume components Mixtures in the group have a difference in some perfume components that are classified for a health hazard (therefore those components cannot be indicated with a ‘generic component identifier’) GROUPING OF MIXTURES WITH DIFFERENCE IN PERFUME COMPONENTS UFIs Product names N200-U0CW-5009-QWHJ Trade name 1 G500-C029-F00T-D83M P800-U0RP-S009-1KPP Trade name 2 Classification: # Product Category: # Components Percentage Classificationa Chemical name component A 60-80% Not classified Chemical name component B 7-10% Other Chemical name component C 11-14% Major concern Chemical name component D 1-2% Major concern Since some of the perfumes vary between the mixtures contained in the group, a list must be provided of the mixtures and the perfumes they contain, including their classification Name Perfume Classificationa Conc. range Actual conc.b Trade name 1 Perfume chemical name 1 Other 2 % UFI: N200-U0CW- Perfume chemical name 3 Major concern 0.7 % 5009-QWHJ Perfume MiM’ Other – 1.5 % UFI: G500-C029- A67T-VHG2-DMM4-NH2A F00T-D83M UFI and relevant MiM’s information known to the relevant appointed body) Perfume chemical name 5 Other – 4 % Trade name 2 Perfume chemical name 2 Major concern – 0.6 % UFI: P800-U0RP- Perfume chemical name 4 Other – 3 % S009-1KPP Perfumes (GCI) Not classified n.a Perfume chemical name 5 Other – 4 % Note to the tables of example 23 Classifications are indicated in this example with three categories: ‘major concern’ (list of classifications in B3.4.1), ‘other’ (all other hazard classifications) and ‘not classified’ Actual concentrations are reported for internal calculation purposes only; they are not necessarily required to be indicated in the submission Compliance with Annex VIII requirements All mixtures in the group have the same components in the same concentration or concentration ranges [A4.2], except for the components ‘Perfume chemical name 1 - 4’, Perfume MiM’ and the perfumes indicated with the generic component identifier perfumes” that are at least present in one of the mixtures [A4.3]. The component Perfume chemical name 5’ is a common component of all the mixtures in the group Therefore, its concentration is not considered in the allowed limit of perfumes in mixtures part of a group submission The difference between the mixtures concerns only perfumes and ‘the total concentration of the perfumes which differ in each mixture does not exceed 5%’ A.4.3]. This concerns the sum of ‘actual concentrations’ (which are known to the submitter, see below) of these components while a concentration range is indicated in the submission If the composition of a MIM is not fully known, the UFI has to be provided as long as the relevant appointed body has received it as part of a valid submission for the MiM B.3.2.2] The specific concentration of the components included under GCI “Perfumes” does not have to be indicated as the perfume is not classified [B.3.4.2] The concentration of the perfumes components has to be provided as exact value or as ranges of percentages following the same rules as for any other component Trade name 1 Perfume chemical name 1 - indicated 1-2% - actual concentration 1.2% Perfume chemical name 3 - indicated 0.4-0.7% - actual concentration 0.6% Perfume MiM - indicated 0.5-1.5% - actual concentration 1% The actual concentration of differing perfume components in the mixture is 2.8% Trade name 2 Perfume chemical name 2 - indicated 0.3-0.6% - actual concentration 0.4% Perfume chemical name 4 - indicated 1-3% - actual concentration 1.4% Perfumes – not indicated – actual concentration 1.4% The actual concentration of differing perfume components in the mixture is 3.2% Example 24: Grouping of mixtures with difference in perfume components GROUP SUBMISSION UFI: C4P7-GHVS-ED8M-42DH Product category: All-purpose (or multi-purpose) non-abrasive cleaners

2.1 Classification of the substance or mixture

major concern 11-14% Perfumes (GCI) not classified 3%, 2-5% Perfume chemical name 4 acute toxicity, cat 1 0.3-0.6% Perfume chemical name 5 skin corrosion, cat 1C 2-3% Perfume chemical name 6 skin sens. cat. 1 2% Perfume chemical name 7 aspiration toxicity, cat 1 3-6% Perfume chemical name 8 not classified 4% Additional notes to the example: • ‘Perfume chemical name 1’ was indicated in option A with a concentration range of 1- 4%. The actual concentration apparently was 1.5% (only known to the submitter) so the total concentration is 1.5+1+0.5=3%. • Not all non-classified perfumes can be grouped within the same generic component identifier because if ‘Perfume chemical name 8’ is included, the total concentration is 7%. Other non-classified perfume components must be indicated individually with their chemical name. • It would also have been possible to, for example, indicate ‘Perfume chemical name 2’ and ‘perfume chemical name 8’ with a generic component identifier “Perfumes” since the total concentration does not exceed 5%. In that case the other non-classified perfume components (1 and 3) must be indicated individually with their chemical name. • The same generic component identifier “perfumes” could be used more than once in the same submission, without the need to further specify the identity of the components. This could be relevant in the case of perfumes with different classifications (e.g. some not classified and others classified for physical hazards). • On the indicated concentration: The generic component identifier can be indicated with an exact concentration (the sum of the components covered by the same generic identifier, 3% in the example) or a range according to table 2 of Annex VIII, for example 2-5% (3% units bandwidth allowed; with a maximum of 5%). Example 22: Use of generic component identifiers (mixtures varying in colourants only) In this example, a formulator produces a mixture and places it on the market under different trade names (i.e. different products). The composition of the mixture is always the same with the exception of the components used only as colourants. The mixture composition in each product contains a different blend of colourants. These are not classified for any health (or physical) hazard. The total concentration of the colourants in each product varies but does not exceed 25%. In addition, the variation in concentration in each composition falls within the limits set by table 2 of Annex VIII. COMMON COMPOSITION Components Classification Concentrations Chemical name component A Minor concern 20-30% Chemical name component B Minor concern 20-30% Chemical name component C Major concern 30-35% COLOURANTS Classificatio Trade name n Shining Blue Shining Red Shining Green Colourant 1 Not classified 8 % 7% Colourant 2 Not classified 21% Colourant 3 Not classified 10% 9% A single submission can include the three trade names and the mixture composition where the colourant components are indicated with the generic component identifier “Colouring agents”. The concentration of the generic colourant component has to be provided within the maximum breadth of range, in accordance with table 2 of Annex VIII, on the basis of the actual concentration. The submitter can decide to assign one single UFI or multiple UFIs, according to their business decision. 81 SUBMISSION Trade name ABC – Trade name DEF – Trade name GHI UFI: WQYN-341E-V00P-YHNT Components Classification Percentage Chemical name component A Minor concern 20-30 % Chemical name component B Minor concern 20-30 % Chemical name component C Major concern 30-35 % “Colouring agents” (GCI) Not classified 14–22 % Additional notes to the example: • The total concentration of the colourants in the individual mixtures is 18% (Shining Blue), 21% (Shining Red) and 16 % (Shining Green). Therefore, a range of maximum 10 %-units can be used in the submission to cover all the variants. In this case, voluntarily a narrower 8 %-unit range has been chosen. • If one or more colourants classified only for a physical hazard are added to all mixtures, these should be included separately even if still identified with a generic component identifier. It is indeed possible to use multiple times the same generic component identifier to identify different components included in the submission. 5.3.4 Limited submission [B.3.1.1] When a company decides to opt for a limited submission (possible for mixtures intended for industrial use only and for mixtures with an end use not subject to submission) the list of components to be provided may be limited to that included in Section 3.2 of the SDS. The information to be provided on the concentrations of such components may be also limited to that contained in the SDS. Detailed information on the compilation of the SDS, and in particular of Section 3, is available in the ECHA’s Guidance on the compilation of safety data sheets. In practice, the information provided in this case will be less detailed than a standard submission and the poison centre will not have access to the full composition of the mixture. For example, Annex II to REACH (on the compilation of SDS) does not require the indication of not classified components, and sets for the hazardous components to be indicated concentration thresholds and ranges which are less strict than Annex VIII to CLP (e.g. hazardous components may need to be included in a standard submission even if present in concentration <0.1%). Additionally, in this case information on the packaging is not required and can be provided on voluntary basis. 5.4 Group submission [A.4] Information on multiple mixtures with limited differences in the composition can be provided in the same submission: this is referred to as a ‘group submission’. The general conditions under which such a ‘group submission’ is allowed are specified in Section 4, part A of Annex VIII. Mixtures can be grouped in the same submission if they: • have the same classification for health and physical hazards (this means that a difference in classification for environmental hazard is allowed); • have very similar composition; the only differences can concern certain perfumes (see section 5.4.2 for details); • the same components are reported in the same concentration or concentration range. Besides substances indicated with their own chemical name, as explained in section 5.3, the mixtures’ components can include MiM, and components which are allowed to be indicated with ‘generic component identifiers’ (see section 5.3.3). All mixtures in the group must contain the same components, except for perfume components, as referred to in Section A.4.3 of Annex VIII. The latter can differ between mixtures in the group under certain conditions (see section 5.4.2 below). Under the conditions described above, a group submission is basically possible for mixtures with compositions that differ, under certain conditions, in perfumes. These would be ‘product variants’ (possibly marketed under different trade names), for example detergents with a difference in perfumes. Note: the grouped mixtures all have to be placed on the market by the same importer or downstream user (and their distributors). A group submission can only include the details of one ‘legal submitter’ (i.e. duty holder). It is not possible to group mixtures that are placed on the market by different duty holders under Article 45. Ultimately, the difference between a standard and a group submission concerns the possibility to group mixtures with variation in perfumes which cannot be indicated with a generic component identifier. As explained earlier in this section, also in a standard submission multiple trade names can be included, as long as the composition of the mixture remains the same. Note: The decision whether to provide a standard or group submission (when the conditions are fulfilled) lays with the duty holder and could be based on the specific portfolio. Group submission is an option provided to facilitate the fulfilment of the obligations: the duty holder may always decide to submit a standard submission for each mixture without grouping it with other mixtures. 83 5.4.1 Information to be provided in a group submission Information described in part B of Annex VIII should be provided for each of the mixtures in the group. The information provided on mixture components in a group submission should apply to all the mixtures in the group, except for perfumes that may only apply to some mixtures in the group under certain conditions (see section 5.4.2 below). Most of the information will be the same but there might be a difference in: • ‘Product identifiers of the mixture’: a group submission (as well as a standard submission) may cover mixtures placed on the market with different trade names and/or to which different UFIs could be assigned. • ‘Additional information’ items listed in Part B, Section 2.4, of Annex VIII: o Colour and physical state of the mixture; o pH; o Types and sizes of the packaging; o Use types (consumer, professional, industrial) as described in section 3.4 of this Guidance. Trade names, colour, packaging, use types and UFIs should be indicated for every individual mixture in the group. This information may be useful for the emergency responders in order to promptly identify the relevant information for the specific product. Nevertheless, for the colour, a limited range of standard types can be used (no need to indicate the exact shade). Exceptionally and for practical reasons, a generic indication of the colour field can be accepted for paints and other similar categories for example inks, where high numbers of products with great colour variability can be included in the same group submission (provided they are not classified68). Regarding the packaging, the specific type is potentially relevant to identify the appropriate emergency response measures to assist with possible product identification. This information should be provided for each mixture of the group placed on the market with a specific trade name. The pH value can be indicated for the group as a whole; a range applicable to the whole group can be used. Where the pH value is particularly low or high (i.e. <3 or >10), the range to be indicated should not be bigger than one unit (e.g. 2.5 – 3.5). It is assumed that the toxicological information (as required in Section 2.3, Part B of Annex VIII) should not normally vary across the mixtures of the group. In case of differences, it has to be clear to which mixture the information refers to. 5.4.2 Mixture components in a group submission Mixtures in a group submission should contain the same components in the same concentration or concentration range, except for perfumes components. Those components may only differ between the mixtures of the group under the conditions described below (Section A.4.3 and B.3.1 of Annex VIII). The total concentration of the perfumes which differ in each mixture of the group cannot exceed 5%. In case the concentration of the differing 68 In this case the use of the generic component identifier “colouring agent” can possibly cover different colorants. perfumes in a mixture is above this threshold, the mixture cannot be included in the same group submission. The intention of this rule is to allow grouping of the mixtures only if their compositions are very similar (and hence the toxicological information does not vary). This means that for a maximum of 5% of the composition, the mixtures’ compositions may differ in perfumes content. It is to be underlined that the calculation of the 5% threshold should take into account only the perfumes in each mixture which vary from the others (i.e. which are not present in all the mixtures of the group, but in one or some of them only). In practice this means that if the mixtures contain common perfumes indicated by their chemical name or GCI, the 5% threshold does not refer to those common perfumes. The perfumes contained in each mixture of the group must be listed to identify the perfumes they contain, including their classification. The information required on the mixture composition in a group submission is illustrated by examples 23 and 24. References to the relevant legal text are made in the notes to the examples (in square brackets) to indicate compliance with the requirements on group submission as well as with requirements on component identification/information where relevant for grouping. For detailed guidance on component identification and information requirements, please see section 5.3 of this guidance document. It is important to note that these examples are presented in a simplified form with the sole purpose of illustrating the requirements for group submission. In the examples different formats are used to present the information, but the same principles apply. Special case: perfume components not requiring concentration In the case of perfume components in a group submission that are not classified as hazardous or are classified only for skin sensitisation Category 1, 1A or 1B or aspiration toxicity, submitters are not obliged to provide information on their concentration. This applies to both types of perfumes, those which vary across the mixtures of the group and those which are common to all the mixtures. For colouring agents with a generic component identifier, the table above (section 5.3.3) applies. 85 Example 23: Grouping of mixtures with difference in perfume components Mixtures in the group have a difference in some perfume components that are classified for a health hazard (therefore those components cannot be indicated with a ‘generic component identifier’). GROUPING OF MIXTURES WITH DIFFERENCE IN PERFUME COMPONENTS UFIs: Product names: - N200-U0CW-5009-QWHJ - Trade name 1 - G500-C029-F00T-D83M - P800-U0RP-S009-1KPP - Trade name 2 Classification: # Product Category: # Components Percentage Classificationa Chemical name component A 60-80% Not classified Chemical name component B 7-10% Other Chemical name component C 11-14% Major concern Chemical name component D 1-2% Major concern Since some of the perfumes vary between the mixtures contained in the group, a list must be provided of the mixtures and the perfumes they contain, including their classification. Name Perfume Classificationa Conc. range Actual conc.b Trade name 1 Perfume chemical name 1 Other 1 - 2 % 1.2 % UFI: N200-U0CW- Perfume chemical name 3 Major concern 0.4 - 0.7 % 0.6 % 5009-QWHJ ‘Perfume MiM’ Other 0.5 – 1.5 % 1 % UFI: G500-C029- A67T-VHG2-DMM4-NH2A F00T-D83M (UFI and relevant MiM’s information known to the relevant appointed body) Perfume chemical name 5 Other 1 – 4 % Trade name 2 Perfume chemical name 2 Major concern 0.3 – 0.6 % 0.4 % UFI: P800-U0RP- Perfume chemical name 4 Other 1 – 3 % 1.4 % S009-1KPP Perfumes (GCI) Not classified n.a. 1.4 % Perfume chemical name 5 Other 1 – 4 % Note to the tables of example 23: (a) Classifications are indicated in this example with three categories: ‘major concern’ (list of classifications in B3.4.1), ‘other’ (all other hazard classifications) and ‘not classified’. (b) Actual concentrations are reported for internal calculation purposes only; they are not necessarily required to be indicated in the submission. Compliance with Annex VIII requirements: • All mixtures in the group have the same components in the same concentration or concentration ranges [A4.2], except for the components ‘Perfume chemical name 1 - 4’, ‘Perfume MiM’ and the perfumes indicated with the generic component identifier “perfumes” that are at least present in one of the mixtures [A4.3]. The component ‘Perfume chemical name 5’ is a common component of all the mixtures in the group. Therefore, its concentration is not considered in the allowed limit of perfumes in mixtures part of a group submission. • The difference between the mixtures concerns only perfumes and ‘the total concentration of the perfumes which differ in each mixture does not exceed 5%’ [A.4.3]. This concerns the sum of ‘actual concentrations’ (which are known to the submitter, see below) of these components while a concentration range is indicated in the submission. • If the composition of a MIM is not fully known, the UFI has to be provided as long as the relevant appointed body has received it as part of a valid submission for the MiM [B.3.2.2]. • The specific concentration of the components included under GCI “Perfumes” does not have to be indicated as the perfume is not classified [B.3.4.2]. • The concentration of the perfumes components has to be provided as exact value or as ranges of percentages following the same rules as for any other component. Trade name 1: Perfume chemical name 1 - indicated 1-2% - actual concentration 1.2%. Perfume chemical name 3 - indicated 0.4-0.7% - actual concentration 0.6%. Perfume MiM - indicated 0.5-1.5% - actual concentration 1%. The actual concentration of differing perfume components in the mixture is 2.8%. Trade name 2: Perfume chemical name 2 - indicated 0.3-0.6% - actual concentration 0.4%. Perfume chemical name 4 - indicated 1-3% - actual concentration 1.4%. Perfumes – not indicated – actual concentration 1.4% The actual concentration of differing perfume components in the mixture is 3.2%. Example 24: Grouping of mixtures with difference in perfume components GROUP SUBMISSION UFI: C4P7-GHVS-ED8M-42DH Product category: All-purpose (or multi-purpose) non-abrasive cleaners CLP classification: Serious eye damage cat.1 + Skin sensitiser cat.1 Product trade names: ABC, BCD, CDE Product- trade name ABC + Product- trade name BCD + Product-trade name CDE Components Classification Concentration 87 INGREDIENTS Processing aid xxx Surfactant 123 Not classified Serious eye damage cat.1 1-2% 5-6% Surfactant 456 Serious eye damage cat.1 8-9% Soap xyz Not classified 2-5% Sodium carbonate Serious eye irritation cat. 2 7-10% COMMON components Water Not classified 66-76.4% Perfumes As attached or not classified 5-7 % Perfume components: Product- trade name ABC Components Classification UFI or SDS components Concentration MIM: Skin sens. UFI A67T-VHG2-DMM4- Not needed Perfume mixture a Cat. 1 NH2A [B.3.4.2] (UFI not available) MiM: 0.5-1.5% Perfume Skin sens. Cat 1B Substance A SubA: 10-15% mixture b + Asp. tox. Cat. 1 Substance B SubB: 20-30% Substance C SubC: 15-25% Product- trade name BCD Components Classification UFI or SDS components Concentration « Perfume » (Generic Not classified Not applicable 0.6-1.6% component identifier) Product- trade name CDE Components Classification UFI or SDS components Concentration (UFI not available) MiM: 0.5-0.9% Perfume Skin sens. Cat 1B Substance A SubA: 10-15% mixture b + Asp. tox. Cat.1 Substance B SubB: 20-30% Substance C SubC: 15-25% Perfume (GCI) Not classified Not applicable 0.1- 1.1% Notes to the tables of example 24: • Total “perfume a” + “perfume b” in product- trade name ABC should not exceed 5% because both are perfumes components which varies (i.e. are not common to all the mixtures of the group) [A.4.3]. • Total “perfume b” + "perfume" (GCI) in product-trade name CDE should not exceed 5% for the same reason as above [A.4.3]. • Components of “perfume a” are included in the submission of this perfume a by a supplier upstream (link with UFI). • "Perfume" (GCI) does not contain any hazardous component [B.3.2.3]. • The concentration of the MiM “Perfume mixture b” components refers to the MiM itself (MiM composition not fully known). List of perfumes in Group submission Products of the GS where Perfume name Classification the perfume is present Perfume mixture a Skin sens. Cat 1 Product- trade name ABC Skin sens. Cat 1B + Products- trade names Perfume mixture b asp. tox. ABC+CDE Products- trade names Perfume (GCI) NC BCD+CDE 5.5 Interchangeable component group (ICG) [B.3.5] 5.5.1 Grouping of components Providing the standard information on components as required in Annex VIII to CLP (and described in the previous sections), can be challenging in specific situations where very similar components, possibly purchased from different suppliers, are used together in the same production line. It may be difficult to know which exact components are present in the composition at each point in time (e.g. in each batch), and at which concentration. Different components may be grouped in a so-called ‘Interchangeable component group’ (ICG), when they are not chemically identical, but are sufficiently similar to be considered equivalent regarding their hazard and, but not necessarily, regarding their technical function in the final mixture. The final mixture might contain only one of the interchangeable components at a time or a blend of several interchangeable components where the individual concentrations of the components in the blend cannot be precisely identified (e.g. when the interchangeable components are stored in the same storage container or as a result of mixing different batches of the final mixture afterwards). In other words, the components in an ICG do not have to be mutually exclusive (i.e. one does not necessarily exclude the presence of others), but more than one can be present at the same time. When specific conditions for an ICG are met, the submitter is allowed to indicate information on the concentration at ICG level, instead of indicating the concentration of each individual component within the group (as these individual concentrations may simply be unknown). The application of this approach implies that not all the components grouped in an ICG are necessarily always present in each batch of the mixture placed on the market. This is a specific derogation in Annex VIII from the prohibition to notify components which are not present in the mixture. Each component included in an ICG must nevertheless be currently used in the production of the final mixture. The ICG solution is not intended for notifying components which might possibly be used only in the future, and therefore should not be used in order to avoid the need to update the submission. Components in an ICG can be added or removed 89 when needed via an update (see section 7). Section 5.5.2 below provides details on when the ICG approach can be applied. Section 5.5.3 clarifies the information requirements when an ICG is used. It is to be emphasised that even when the criteria for ICG are met, using the ICG approach is optional. The information normally required by Annex VIII is recommended to be provided whenever this is possible. Submitters are encouraged to limit the use of the ICG approach to the specific situations for which this workable solution was envisaged. 5.5.2 Conditions for grouping components in an ICG Components can be grouped in an ICG when they meet one of the two sets of conditions described in Section 3.5, Part B of Annex VIII. These two sets allow certain flexibility in the application of the ICG approach, for example by not limiting it only to components with the same technical function in the final mixture. An ICG can include substances or MiMs69. Where multiple components fulfil the criteria to be grouped in an ICG, it is not mandatory to necessarily group all of them in an ICG. Their concentration, if known, should be reported according to the standard rules. The two sets of criteria are described in sections 5.5.2.1 and 5.5.2.2 below. 5.5.2.1 General rules for grouping components Components in a mixture may have the same technical function even if they are not chemically exactly the same. For example, when they are purchased from different suppliers to ensure continuity of the supply. It is possible to group the components in an ICG when three conditions are met by each individual component in the specific ICG. All components in the same ICG must have: - Identical technical function(s) in the final mixture placed on the market. - Identical classification for health and physical hazard(s). This means that both the hazard class and the hazard category are identical. To be noted that the legal text allows for differences in the subcategory (relevant for certain hazard classes only, e.g. Skin Corr 1A/1B/1C). - Same toxicological properties, at least both target organ(s) and the type of toxicological effects must be the same for all the components in the ICG. Conclusions could be based on the mechanisms of toxicity of the components. Information on the toxicological properties of the components is not part of the submission. The submitter should nevertheless be able to provide this information to the appointed body on their request. In addition to the conditions above, the variation of interchangeable components in the final mixture must not influence the classification and labelling information of the final mixture. The following information has to be always the same, regardless of the interchangeable component(s) present and their individual concentration: 69 A fully known MiM can be grouped in an ICG as a MiM as such even if it will be identified with its product identifier and its full composition (i.e. the concentration of the MiM’s components will refer to the MiM itself). - the classification and the labelling elements of the final mixture, referred to in Sections 2.1 and 2.2, Part B; and - the toxicological information of the final mixture referred to in Section 2.3, Part B; and - the additional information on the final mixture referred to in Section 2.4, Part B: o the types and sizes of the packaging used to place the mixture on the market for consumer or professional use; o the colour(s) and the physical state(s) of the mixture, as supplied; o the pH, if available, of the mixture as supplied; o product category (EuPCS); o use: consumer, professional, industrial, or a combination of any of the three. 5.5.2.2 Alternative rules for grouping components with specific hazard classifications An alternative set of criteria applies to components which are classified only for one or more of the following hazards: o skin corrosion or irritation, o eye damage or irritation, o aspiration toxicity, o respiratory or skin sensitization. Using the ICG solution under this alternative set of criteria is only possible if the ICG does not contain more than five components. The criteria which have to be met by components in order to be grouped in an ICG are the following: - all the components must have the same classification for health and physical hazard(s) (classifications listed above). This means that both the hazard class and the hazard category are identical. Differences in the subcategory (relevant for certain hazard classes only) are allowed. - the pH for all components, where applicable, is the same, i.e., either acidic, neutral or alkaline. This applies to components classified for skin corrosion, skin irritation, eye damage and eye irritation. A certain flexibility is allowed for the grouping of components. Components with a pH between 6 and 8 can be considered ‘neutral’; components with a pH below 7 are considered as acidic, components with a pH above 7 are considered as alkaline for the purposes of the ICG. The variability in the pH cannot nevertheless affect the hazardous properties of the components and the emergency response. The possibility to measure the pH depends on the physic-chemical characteristics of the compound. Similar considerations in order to determine the circumstances when the pH cannot be measured as those made about the final mixture (see section 5.2.3) apply here. However, the pH of the components does not need to be included in the submission and a justification why the pH is not available does not need to be provided. The submitter may nevertheless be asked by the appointed body for information on the pH of the individual components in the ICG. 91 The toxicological properties of components are not an information required to be included in the submission. Nevertheless, in order to facilitate a proper emergency response, it is recommended to only group components with very similar toxicological properties. If it is known that the toxicological properties are different (despite identical classification), the submitter should consider refraining from using an ICG. As for the first set of criteria explained in section 5.5.2.1 above, the components can be grouped in an ICG only if the information on the final mixture remains the same, regardless of the possible combinations (this means identical hazard identification and identical additional information required by Section 2 of Part B on the final mixture). This is important in particular when the submitter decides to group components which have some (possibly limited) differences in the toxicological properties. It is to be underlined that, unlike the criteria explained in section 5.5.2.1, this alternative set of criteria does not require the interchangeable components to have an identical technical function. 5.5.3 Information requirements 5.5.3.1 Identification When components are notified as part of an ICG, a meaningful name has to be provided for the group itself. The legal text requires the name to reflect the technical function(s) of the grouped components. This name should normally allow the emergency operator to promptly identify at least the nature and kind of components covered by the group, without the need to look at the full list. When an ICG groups components with different technical functions, all these have to be reflected in the name. Preferably the name should also be toxicologically relevant, such as a chemical group name. ‘Anionic surfactant’ is an example of a combination of ‘function’ and ‘chemical group’ which is toxicologically relevant. Another example is ‘Air-entraining agent with main components surfactants’. Additional information on the identification of the ICG may have to be provided to the appointed body upon their request, if this is considered necessary. Each component (substances or MiMs) in an ICG must be identified following the standard rules for any other component, as described in section 5.3.3 of this Guidance (i.e. in accordance with Section 3.2.1. or 3.2.2 of Annex VIII, Part B, as applicable). 5.5.3.2 Concentration For components which are reported as part of the same ICG, there is no need to provide the concentration of the individual components. Instead, the concentration is to be provided for the ICG as a whole. This reflects a reality where the submitter does not know which interchangeable components are present at each point in time and in which concentration. The concentration for the ICG can be provided as an exact value or as a range of percentages, following the rules described in section 5.3.3 of this Guidance. In principle, there is no limit in the concentration of an ICG in the final mixture. Nevertheless, it is important to underline that the ICG has to be used to group components actually used in the formulation of the same final mixture. 5.5.3.3 Classification The classification for health and physical hazards can in practice be reported either for each component of the group or for the ICG as a whole. This includes hazard classes, categories and statements as for any other component of the mixture. If the classification of the components in an ICG is exactly the same, it is recommended to provide it for the ICG only. 5.5.4 Examples Example 25: Grouping interchangeable components having the same technical function C1 ICG C2 C3 • A + B + C1 • A + B + C2 Complexing A + B Batches • A + B + C3 agent • A + B + (any combination of C1-2-3) C1, C2 and C3 can be part of an ICG In this example, a formulator mixes components A and B plus the complexing agent C in a continuous production process to formulate a final product. Component C is purchased from three different suppliers to ensure the continuity of supply. The formulator does not know whether the components are chemically identical, irrespective of the supplier. Nevertheless, the components have the same technical function in the final mixture and can be used interchangeably. Without the ICG approach, the formulator would need to submit several notifications, one for each combination of components. Yet in a continuous production process, it is not possible to know exactly which component, C1, C2 or C3, is present in the final mixture that is placed on the market. In such cases, the ICG approach can provide a workable solution, provided that the components C1, C2 and C3 fulfil the required conditions set in Section 3.5 of Part B. Components C1, C2 and C3 have the following characteristics: Components supplied by multiple suppliers Component Technical function Hazard classification Toxicological properties C1 Complexing agent Acute toxic oral, cat. 3 Set of properties S1 C2 Complexing agent Acute toxic oral, cat. 3 Set of properties S1 C3 Complexing agent Acute toxic oral, cat. 3 Set of properties S1 Components C1, C2 and C3 all have the same technical function, same classification for health and physical hazards and same toxicological properties (as a minimum the same target organs 93 and toxicological effects). The total concentration of the complexing agent C is known to be 4- 5% following the formulation process, and regardless of the combinations or blends of components C1, C2 and C3, at this concentration the hazard identification of the final mixture is always the same. The additional information required by Annex VIII (Section 2 of Part B) on the product does not change either. Therefore, these components can be grouped in one ICG. The ICG is named ‘Complexing agent’. Components A and B are reported with their identifiers and concentrations as required by Annex VIII. Each of the components C grouped in the ICG are identified in accordance with the standard rules for substances or MiMs (explained in section 5.3 of this Guidance). The concentration is provided for the ICG as a whole as exact value (5%) or with a range, in accordance with Table 1 of Annex VIII (due to the classification of the mixture; maximum 1% unit in this case). Example 26: Grouping components in different ICGs according to the technical function In this example, the formulator relies on different sources for two of the components used in the formulation of the final mixture: a complexing agent C and a dehydrating agent D. Three alternative components (C1, C2 and C3) are used as complexing agents and three alternative components (D1, D2 and D3) used as dehydrating agent. These have the following characteristics: Components supplied by multiple suppliers Component Function Hazard classification Toxicological properties C1 Complexing agent Acute toxic oral, cat. 3 Set of properties S1 C2 Complexing agent Acute toxic oral, cat. 3 Set of properties S1 C3 Complexing agent Acute toxic oral, cat. 1 Set of properties S2

Hazard categories

pH Concentration (%) A Solvent Not classified not relevant 82.3 – 82.6 B Detergent base Acute toxic oral, cat. 4; Acute Toxic not relevant 11 dermal cat. 4; Acute toxic inhalation, cat. 4; Skin corrosion, cat 1B; Eye damage, cat. 1; Specific target organ toxicity, single exposure, Cat. 3 (respiratory irritation) D Solubiliser Not classified not relevant 0.3 E Surfactant Acute toxic oral, cat. 4; Eye damage, not relevant 1.9 cat. 1 Specific components recipe 1 C1 Wetting agent Skin corrosion, cat 1B; Eye damage, Acidic (<7) 2.6 cat. 1 97 F1 Emulsifier/corrosion Skin corrosion, cat 1B; Eye damage, Acidic (<7) 1.6 inhibitor cat. 1 Specific components recipe 2 C2 Wetting agent Skin corrosion, cat 1B; Eye damage, Acidic (<7) 2.6 cat. 1 F1 Emulsifier/corrosion Skin corrosion, cat 1B; Eye damage, Acidic (<7) 1.6 inhibitor cat. 1 Specific components recipe 3 C1 Wetting agent Skin corrosion, cat 1B; Eye damage, Acidic (<7) 2.6 cat. 1 F2 Corrosion inhibitor Skin corrosion, cat 1B; Eye damage, Acidic (<7) 1.2 cat. 1 F3 Emulsifier Skin corrosion, cat 1B; Eye damage, Acidic (<7) 0.7 cat. 1 Specific components recipe 4 C2 Wetting agent Skin corrosion, cat 1B; Eye damage, Acidic (<7) 2.6 cat. 1 F2 Corrosion inhibitor Skin corrosion, cat 1B; Eye damage, Acidic (<7) 1.2 cat. 1 F3 Emulsifier Skin corrosion, cat 1B; Eye damage, Acidic (<7) 0.7 cat. 1 After manufacture and quality control approval, each batch is pumped to a bulk storage tank to release the blending vessel for another product. As orders are received, product from the bulk storage tank will be packaged into containers. The bulk storage tank will normally contain some product before transfer of a batch takes place, and hence different batches of product get mixed in the storage tank. Therefore, it would be practically very difficult for the formulator to make a submission according to the requirements of Annex VIII, as the precise composition of the product at the point of packaging is unknown. Components A, B, D and E are reported individually with their identifiers and concentration as required by Annex VIII (either exact concentrations or ranges in accordance with Tables 1 or 2, as applicable). Components C and F could be all grouped in one ICG, following the alternative set of criteria (section 5.5.2.2 of this Guidance): all components used as wetting agent, emulsifier and/or corrosion inhibitor have the same classification and are classified for the skin corrosion hazard only. The pH, even if not exactly the same, is acidic (<7) within a limited range which does not affect hazardous properties and emergency response. Furthermore, this ICG groups fewer components than the permitted maximum of five. This is possible even when the technical function is not the same for each component in the final mixture. Toxicological sameness is not considered in the grouping of components B, C and E. Nevertheless, their toxicological properties can be expected to be similar based the fact that they have the same classification and the pH is below 6 for all possible components (see 5.5.2.2). 5.6 Special provisions for ready-mixed concrete, gypsum and cement products: Standard Formulas [B.3.6] Providing the required information can be very difficult where raw materials with a highly variable or unknown composition are used in the formulation of the mixture. In these situations, it may not be possible to know the exact composition of the mixtures, which could vary from batch to batch, and to provide the concentration of each component within the limits set in Annex VIII. In order to address potential difficulties encountered by the gypsum, ready-mixed concrete and cement sectors in complying with the standard requirements of Annex VIII, the legal text includes in Part D a list of Standard Formulas which can be used for the submission of the information relevant for emergency health response. Suppliers of mixtures within the three sectors mentioned above, subject to the obligations under Article 45 and conforming with one of those Standard Formulas, are allowed to deviate from the information requirements regarding the composition of the mixture. The intention of the provisons related to Standard Formulas is to allow duty holders to comply with the emergency health response requirements without reducing the level of safety. The information provided on these specific mixtures by using the Standard Formulas is considered as detailed enough for the poison centres to be able to provide effective emergency response in the case of accidents with these specific products. 5.6.1 Standard Formulas Part D of Annex VIII includes a list of 23 Standard Formulas: - 20 Standard Formulas related to cement, - one Standard Formula related to gypsum binder, - two Standard Formulas related to ready-mixed concrete . The list is exhaustive. Only mixtures belonging to these three product types and conforming (as a whole or in part) with one of the Standard Formulas included in Part D can benefit from the special provisions described in this section. For each of these Standard Formulas, the information in Part D includes the list of components with their identifiers and concentration ranges. The latter can be broader than what is allowed by applying Tables 1 and 2 of Part B of Annex VIII. This is based on the assumption that the hazard of the mixture and the emergency measures to be adopted in case of exposure, do not change within the concentration ranges specified for the mixture’s composition in the Standard Formula and included in the notification. Standard Formulas can be used in a submission to describe the final mixture (i.e. the final mixtures’s composition conforms to the Standard Formula) or part of the final mixture (substances or MiMs). (this is explained in section 5.5.2 below). In the latter case, the final mixture compositon may contain additional components besides those included in the Standard Formula. The assumption behind the use of a Standard Formula is that the classification of the final mixture does not change within the components’ concentration ranges specified in the same Standard Formula (regardless the fact that the Standard Formula describes the whole or part of the mixture). “Conforming” with a Standard Formula means that the mixture or part of a mixture contains 99 only and all the components specified in the relevant Standard Formula and within the ranges indicated in it. There is the possibility though that some of the components may not always be present, for example, in each batch of the product (when the concentration range as provided in the Standard Formula includes ‘zero’ as lower limit). This is due to the nature of the components (e.g. natural origin) or of the production process. For mixtures or part of the mixture conforming with one of the Standard Formulas, the information on identification of components and their concentration ranges can be reported as in the Standard Formula itself70. It is important to underline that the derogation from information requirements concerns the composition only. This means that the duty holder is allowed to deviate from the standard requirements concerning which components have to be indicated (Part B, section 3.3 of Annex VIII), how the components should be identified (Part B, Section 3.2 of Annex VIII) and how the concentration should be reported (Part B, Section 3.4 of Annex VIII). All the remaining information about the mixture and the product as required by Part B of Annex VIII has to be provided as per a normal submission. This means that the product has to be identified as required in Section 1 of Part B (explained in section 5.1 of this Guidance) and the hazard identification and product information has to be provided as required in Section 2 of Part B (section 5.2 of this Guidance). The classification of the components has to be provided as set out in Section 3.8, Part B of Annex VIII, and explained in section 5.3.3 of this Guidance. The name and product description of the Standard Formula as indicated in Part D of Annex VIII should be included in the submission. 5.6.2 Using Standard Formulas: whole mixture composition vs part of the mixture composition (substances or MiMs) Annex VIII foresees the possibility to use a Standard Formula either to report the whole composition of the mixture which is intended to be notified or only a part of it. In the first case, all the components of the final mixture are those (and all) listed in the Standard Formula, i.e. the final mixture’s composition conforms to the Standard Formula. The information on identity and concentration ranges of all the components can be provided as in the Standard Formula (as an alternative to the standard requirements of Sections 3.2, 3.3 and 3.4 of Part B of Annex VIII). In the second case, the final mixture itself does not conform to a Standard Formula, but part of it (i.e. one or more of its components) does. In this case, there are two possibilities: - A MiM component can be identified by using a Standard Formula, providing its product identifier (e.g. name of Standard Formula and, if available, the UFI) and composition accordingly (i.e. the compositon of the MiM corresponds to the Standard Formula). - Individual components which together correspond to the Standard Formula in its entirety can be identified as in the Standard Formula itself at the level of the final mixture; this means that identification and concentration of the substance components can be provided as in the Standard Formula included in Part D of Annex VIII. In both cases all other components (not conforming to a Standard Formula) of the final 70 Note that the information available in the SDS may have to be provided instead, see section 5.6.3 below. mixture have to be notified in accordance with Sections 3.2 or 3.4 of Annex VIII, Part B, as explained in section 5.3 of this Guidance. See examples below. When components are reported by using a Standard Formula, their identification and concentration ranges have to be reported exactly as in that Standard Formula (unless more detailed information is available, see next section 5.6.3). When a mixture composition conforms with a Standard Formula, not all components need to be notified as specified in it. Some of the components can still be notified in accordance with the normal rules in Sections 3.2 to 3.4 of Annex VII, Part B. A note to the tables in Part D of Annex VIII indicates that heavy metals and other elements may be present at very low concentrations. When the concentrations are lower than the concentrations indicated71, the elemental substances do not need to be reported even if their presence is known. 5.6.3 Standard Formulas vs SDS information Even when a mixture or part of it qualifies for the derogation described in this section, the duty holder is required to provide the most detailed information available to them. Therefore, when the SDS of the mixture contains more detailed information than what would be provided by using a Standard Formula, the information on the identity and concentration of all the mixture’s components as specified in the Safety Data Sheet has to be provided instead of using the Standard Formula. The above is applicable not only when the full mixture composition of the final mixture conforms with a Standard Formula, but it may also be applicable where a Standard Formula is used to identify some of the components (e.g. a MiM), while other components are reported in accordance with the Annex VIII requirements. If this information as a whole is less detailed than that given in the SDS for the final mixture, the information on the identity and concentration of all the mixture’s components conforming with the Standard Formula has to be provided as given in the SDS. This can be the case when, e.g., the concentration ranges shown in the SDS are narrower than those in the Standard Formulas for the same components. The comparison between Standard Formula and SDS shoud take into account the completeness of the composition and the width of the concentration ranges. The duty holder is therefore still allowed to deviate from the Annex VIII standard information requirements with regard to the composition (points 3.2, 3.3 and 3.4 of Part B) for the components conforming to the Standard Formula, but the more detailed available information from the SDS has to be provided. 5.6.4 Examples In this section, the use of the Standard Formulas included in Part D of Annex VIII is explained by means of examples intended to address different possible submission scenarios. In all the examples, the duty holder is expected to submit a notification for a generic ‘mixture A’ which they intend to place on the EU market. Except where clearly indicated otherwise, the reference is to a generic Standard Formula “SF1”. 71 As, Ba, Cd, Cr, Co, Cu, Hg, Mo, Ni, Pb, Sb, Sn, Te, Tl, V below 0,1 w/w % and Mn, Sr, Zn below 1 w/w %. 101 Note. The following is applicable to all the example scenarios: - Classification and labelling information and other additional information as requested in Annex VIII, Part B, has to be provided for the final mixture A. This includes: o Product identifier of the mixture and submitter details (see section 5.1) o Toxicological information (section 5.2.2) o Additional information on the product (section 5.2.3) - Classification information on single components has to be provided as for any standard notification. Generally speaking, there are two main ways how Standard Formulas can be of use: 1. Final mixture A conforms to Standard Formula. 2. Final mixture A does not conform with any Standard Formula but part of it does (i.e. contains at least one mixture component that conforms with a Standard Formula). Example 29: Final mixture conforms with a Standard Formula The final mixture A (i.e. the mixture to be notified) conforms with SF1 included in Part D of Annex VIII. All its components are reported as in SF1 (all the components which are part of the Standard Formula are also part of the mixture composition): Composition Identification Concentration Classification of final mixture A Component A As in SF1 To be provided Component B The whole As in SF1 To be final provided composition Component C As in SF1 To be conforms with provided SF1 Component D As in SF1 To be provided Example 30: Only part of the final mixture conforms with a Standard Formula (not the final mixture as a whole) The following scenario aims to exemplify a case where a Standard Formula is used to describe a part of the final composition. The full composition of the final Mixture A does not conform with any specific Standard Formula. One or more components of the final mixture are reported as in a Standard Formula. Scenario 1 The final mixture A itself (i.e. mixture to be notified) does not conform with any Standard Formula included in Part D, but includes one MiM which does conform with SF1 listed in Part D. In this example, the Standard Formula is included as a MiM in the final mixture: Composition Identification Concentration Classification of final mixture A Component A As in B.3.2 As in B.3.4 To be provided Component B As in B.3.2 As in B.3.4 To be provided Component C As in B.3.2 As in B.3.4 To be provided MiM D (SF1) The MiM Name of Concentration of To be conforms with Standard MiM in final provided SF1 Formula “SF1” mixture to be given according Composition to B.3.4. information as in SF1 Concentration of components of MiM to be given according to SF1 Scenario 2 The final mixture A (i.e. mixture to be notified) does not conform with any of the Standard Formulas included in Part D but part of its composition does conform with Standard Formula listed in Part D. The Standard Formula “Gypsum binder” is taken as an example for simplicity as it contains two components only. In this example, the components from the Standard Formula “Gypsum binder” are notified individually as components of the final mixture (as an alternative to the scenario above). Composition Identification Concentration Classification of final mixture A Component A As in B.3.2 As in B.3.4 To be provided Component B As in B.3.2 As in B.3.4 To be provided Component C As in B.3.2 As in B.3.4 To be provided Component D: This part As in Gypsum To be Gypsum conforms with Binder Standard provided sulphate Standard Formula: Formula 231-900-3 ≥50% and ≤ “Gypsum 100% binder NB: this value, Standard taken from the Formula” Standard Formula in Part D, refers to the composition of the final mixture Component E: As in Gypsum As in Standard To be Calcium Binder Standard Formula provided dihydroxide Formula: 215- Gypsum Binder: 137-3 (e.g. <5%) NB: as above 103 5.7 Special provisions for fuels conforming with standards or technical specifications [B.3.7] Annex VIII includes special provisions for specific fuels, listed in Section 3.7, Part B of the same Annex. These products are normally formulated from naturally occurring substances, which vary in composition. Fuel products are produced to meet EN standards and/or technical specifications. These standards define the required technical performance of the products rather than the detailed composition. This means that while the major mixture components are well understood, the specific composition (as per the Annex VIII requirements) may vary due to the natural variations in the natural base material (crude oil). Furthermore, petroleum products (i.e. mixtures) are produced as a continuous blending process, meaning that there can be frequent small incremental compositional changes. These changes could lead to a need for frequent notification updates. Ultimately, fuels placed on the market normally conform to a technical standard and/or technical specifications rather than a specific chemical composition. Different batches of what industry considers to be the ‘same’ commercial product (under relevant standards such as e.g. EN590, which describes the characteristics that all automotive diesel fuels must meet if it is to be sold in the EU and Switzerland) can have sufficiently different chemical compositions to necessitate, in principle, separate Annex VIII notifications. This would also result in multiple UFI numbers being generated for the ‘same’ commercial product, containing the same ingredients (albeit in different concentrations). EN standards and technical specifications provide requirements in terms of chemical compositions of petroleum products with wide ranges of concentrations and generic description of components, which can be hazardous or non-hazardous chemicals. In order to address such issues, and considering the low number of poisoning incidents with fuels reported by Poison Centres, a derogation from the standard requirements for Annex VIII notifications is foreseen for the fuels listed in table 3 under Section 3.7, part B. Instead of providing exact concentrations or ranges according to tables 1 and 2 in Annex VIII, it is allowed to submit compositional information as contained in the safety data sheet, complemented with the identity and concentration of any other known component (including for instance non-hazardous components), so as to reduce to the minimum the uncertainty regarding the composition. The submitter should normally aim at providing the full composition, in cases when the information is available to him. 5.7.1 Definition of fuels A fuel is a material that is burned to produce heat or power for a plant, vehicle or machine. The derogation from the normal notification regime applies to the fuels listed in Table 3, Section 3.7, Part B of Annex VIII. Table 4: List of fuels - Table 3, Part B of Annex VIII Fuel Product description Gasoline EN228 Automotive fuels - Unleaded petrol Gasoline E85 Automotive fuels –Ethanol (E85) automotive fuel Gasoline alkylate Motor fuels – special petrol for powered implements LPG Liquefied Petroleum Gas used as fuel LNG Liquefied Natural Gas used as fuel Diesel fuel Automotive fuels - diesel engine fuels with/without biofuel Paraffinic diesel fuels Automotive fuels - Paraffinic diesel fuel from synthesis or (e.g., GTL, BTL or hydrotreatment HVO) Heating oil Liquid mineral fuels with the characteristics of domestic fuel oil MK 1 diesel Automotive fuels – Diesel fuel oil of environmental class 1 and 2 for high-speed diesel engines Aviation fuels Aviation turbine engine and piston engine fuels Kerosene - Illuminating Illuminating paraffin lampoil Type B and C paraffin Heavy fuel oil All grades of heavy fuel oil Marine fuel Marine fuels, containing or not biodiesel Fatty acid methyl Fatty acid methyl esters (FAME) for use in diesel engines and esters (FAME) – Diesel heating applications B100 All commercially available fuels conform to either an international or a national standard or another technical specification. Some examples include: - ISO 8127 Petroleum products — Fuels (class F) — Specifications of marine fuels - ASTM D1655 - Standard Specification for Aviation Turbine Fuels - EN589 - Automotive fuels. LPG - ÖNORM C 1109 – Liquid fuels - Domestic fuel oil - Gasoil for heating purposes (Austria) Enforcement authorities may inquire about the documentation of the standard and/or technical specification met by a product placed on the market. A typical composition of a fuel is a mix of: - one or more petroleum fuel substances and its stabilizers; - one or more non-petroleum components and its stabilisers with concentration varying from zero to a certain level; - specific well identified additives which can be e.g. colourants for tax purposes; - performance additives, usually proprietary. The compositions of such blends vary due to the complex supply chains and continuous blending process except for the performance additives. The concentration of the latter does not normally vary as they are often added at the step before delivery to customer. 5.7.2 Information requirements on composition The submission for fuels can deviate from the standard information requirements with regard to: - Section 3.2, Part B: Identification of mixture components; - Section 3.3, Part B: Mixture components subject to submission requirements; - Section 3.4, Part B: Concentration and concentration ranges of mixture components. Section 3.7, Part B specifies that the identification and concentration of the components can be reported as in the SDS and do not need to follow the standard Annex VIII requirements. The identity and concentration of any other known component not listed in the SDS has to be reported as well. Non-hazardous known components present in concentrations equal or greater than 1% and known hazardous components present in concentrations equal or greater than 105 0.1% should at least be included. Known components not included in the SDS should be reported according to the standard rules (i.e. with regard to identity and concentration). Industry is researching and introducing more sustainable and often less hazardous substitutes of fuels’ components. An example is the use of non-hazardous component Fatty Acid Methyl Esters (FAME) instead of certain hazardous components in diesel fuels EN 590, listed in Table 3 of Annex VIII, Part B as “Diesel fuel - Automotive fuels - diesel engine fuels with/without biofuel”. Being non-hazardous, FAME does not need to be included in section 3 of the SDS even if it partially substitutes some of the hazardous components listed there. Therefore, when it is not listed in the SDS, it is not required to be included in the submission, unless its presence in the fuel is known. The classification of the components has to be provided as required in Section 3.8, Part B of Annex VIII, as explained in section 5.3 of this Guidance. All other information required by Annex VIII has to be provided according to standard rules: - information on the identification of the mixture, submitter and, if relevant, contact point (section 5.1 of this Guidance); - hazard identification of the mixture (section 5.2 of this Guidance); - additional information on the product (section 5.2 of this Guidance). Example 31: Submission of information for a fuel product listed in Table 3 of Annex VIII The submission to the relevant appointed bodies for a fuel product listed in Table 3 of Annex VIII needs to include information on the composition as shown in the generic table below: Fuel type and name as mentioned in Table 3, Section 3.7, Part B of Annex VIII Composition of fuel Identification Concentration Classification product Component A As in SDS Hazardous, (i.e., deviating from classification to B.3.4) be provided Component B As in SDS Hazardous, (i.e., deviating from classification to B.3.4) be provided Component C As in SDS Hazardous, (i.e., deviating from classification to B.3.4) be provided Component D As in SDS Hazardous, (i.e., deviating from classification to B.3.4) be provided Component E Not listed in SDS Hazardous because because concentration concentration is is below threshold for below threshold for inclusion (REACH Annex II). If known, provide concentration provide according to standard identification Annex VIII rules according to standard Annex VIII rules Component F Listed in the SDS Provide as in the SDS even if not required Not hazardous according to Annex 106 II to REACH). Identification to be provided as in the SDS. Component G Not listed in the If the presence is Not hazardous SDS. If known, known, provide as per identification to be Annex VIII, Part B, provided according section 3.4 rules. to standard Annex VIII rules Based on the generic table above, the compositional information to be included in a submission for (as an example) a diesel fuel meeting the standard EN590 and which is included in the list in Section 3.7, Part B as “Diesel fuel: Automotive fuels – Diesel engine fuels with/without biofuel”, would have to be notified as illustrated below. The composition of the product varies seasonally and geographically according to the availability of components and operational requirements. A typical composition of a diesel fuel is shown in the table below: Chemical Name EC No. Concent Classification ration w/w% Fuels, diesel 269-822- 0-100% Flam. Liq. 3 (H226), Acute Tox. 4 7 (H332), Carc. 2 (H351), Asp. Tox. 1 (H304), Skin Irrit. 2 (H315), STOT RE 2 (H373), Aquatic Chronic 2 (H411) C8-C26 – branched and 481-740- 0-100% Flam. Liq. 3 (H226), Asp. Tox. 1 linear hydrocarbons – 5 (H304) Distillates Renewable 618-882- 0-100% Asp. Tox 1 (H304) hydrocarbons (diesel 6 type fraction) 700-571- 2 Fatty acids, C16-18 and 267-015- 0-7% Not classified C18-unsatd. methyl 4 esters Fatty acids, vegetable 273-606- 0-7% Not classified oil, methyl esters 8 Fatty acids, C14-18 and 267-007- 0-7% Not classified C16-18-unsatd., Me 0 esters Performance additive A UFI A 300 ppm Asp. Tox 1 (H304), Skin Irrit 2. (H315), Eye Irrit. (H319), Skin Sens. 1 (H317), Carc. 2 (H351), STOT SE 3 (H336), Aquatic Chronic 2 (H411) 2-EHN cetane 248-363- 1-8.5 Acute Tox 4 (H302), Aquatic Chronic 2 6 ppm (H411) The information in Section 3 of the SDS for the same product is given in table below. 107 Chemical Name EC No. Concentr Classification ation Fuels, diesel 269- 0-100% Flam. Liq. 3 (H226), Acute Tox. 4 822-7 (H332), Carc. 2 (H351), Asp. Tox. 1 (H304), Skin Irrit. 2 (H315), STOT RE 2 (H373), Aquatic Chronic 2 (H411) C8-C26 – branched 481- 0-100% Flam. Liq. 3 (H226), Asp. Tox. 1 (H304) and linear 740-5 hydrocarbons – Distillates Renewable 618- 0-100% Asp. Tox 1 (H304) hydrocarbons (diesel 882-6 type fraction) 700- 571-2 The following components are not listed in section 3 of the SDS in accordance with the requirements in section 3.2 of Annex II of REACH on SDS72: • Fatty acids, C16-18 and C18-unsatd. Me esters: not hazardous • Fatty acids, vegetable oil, methyl esters: not hazardous • Fatty acids, C14-18 and C16-18-unsatd., Me esters: not hazardous • Performance additive A: hazardous but concentration below 0.1% • 2-EHN cetane: hazardous but concentration below 1% In addition to the components listed in section 3 of the SDS, the submitter must provide the information on the components which are not listed in the SDS but are known to him. According to the general rules of Annex VIII (Section 3.3, Part B), non-hazardous components which are identified have to be notified when are present in concentrations equal or above 1%, while classified components should be notified even when are in concentrations under 0.1%, if known and relevant. Applying these rules to the example, the components not included in section 3 of the SDS will be handled as follows for the notification: - The 3 non-hazardous fatty acid methyl esters and their know ranges will be included in the notification. Standard rules apply (unless these components are included in section 3 of the SDS), therefore the concentration should be given either as exact percentage or with a range in accordance with Table 2 of Annex VIII. - The cetane improver, given the low concentration, low level of toxicity (Acute toxicity 4) and the fact that the component “Fuel, diesel” classified as acute tox 4 and present in higher concentration is notified, will not be mentioned in the notification. The submitter considers it irrelevant for emergency response and is able to demonstrate it in case of inquiry from the relevant authorities. - The performance additive A will be included because, despite its concentration being below 0.1%, it is considered relevant for the emergency response due to the skin sens. 1. The submitter cannot report the components which are not known to him and it is not required to investigate further. Examples are colourants or specific performance additives. In the notification format, it should be mentioned which type of fuel product from table 3, section 3.7, part B of annex VIII the product conforms to. Applying this to the example of diesel B7, the notification will contain the information as given 72 These components can be voluntarily included in the Section 3 of the SDS. In this case the concentration can be provided as in the SDS. in table below. In this example the three FAME components are not listed in Section 3 of the SDS, therefore the concentration has to be provided in accordance with Table 1 of Annex VIII. Diesel fuel: Automotive fuels – Diesel engine fuels with/without biofuel Component Identificati Concentrati Classification on Fuels, diesel 269-822-7 0-100% Flam. Liq. 3 (H226), Acute Tox. 4 (H332), Carc. 2 (H351), Asp. Tox. 1 (H304), Skin Irrit. 2 (H315), STOT RE 2 (H373), Aquatic Chronic 2 (H411) C8-C26 – branched 481-740-5 0-100% Flam. Liq. 3 (H226), Asp. Tox. and linear 1 (H304) hydrocarbons – Distillates Renewable 618-882-6 0-100% Asp. Tox 1 (H304) hydrocarbons (diesel 700-571-2 type fraction) Fatty acids, C16-18 267-015-4 0-1% Not classified and C18-unsatd. methyl esters Fatty acids, vegetable 273-606-8 0-1% Not classified oil, methyl esters Fatty acids, C14-18 267-007-0 0-1% Not classified and C16-18-unsatd., methyl esters Performance additive UFI A 300 ppm Asp. Tox 1 (H304), Skin Irrit 2. A (H315), Eye Irrit. (H319), Skin Sens. 1 (H317), Carc. 2 (H351), STOT SE 3 (H336), Aquatic Chronic 2 (H411) 6. Preparation and submission of information: available tools The submission of the required information has to be done electronically and using the XML format provided by ECHA [A.3.1]. The tools developed and maintained by ECHA assist both the submitters and the Member States appointed bodies in fulfilling their obligations and performing their tasks. The tools support the preparation of the submission in the correct format, allow the submission of the information and facilitate the distribution and accessibility of the submitted information to the relevant Member State(s). 6.1 UFI generator The generation of the UFI(s) can be done at any time before the actual submission. It should be preferably done during the mapping and analysis of the portfolio while preparing the submission strategy. Generation and use of UFI is explained in section 4 (in particular subsection 4.2) which addresses the general submission requirements. 6.2 XML format Annex VIII to CLP mandates ECHA to specify, maintain and update the electronic XML-based format that must be used for the submission of the harmonised information [A.6]. 109 The use of this format is mandatory and alternatives (e.g. paper submissions or other electronic formats) are not allowed. The format is harmonised and it applies in all Member States. ECHA, being strongly engaged in the OECD international initiatives aiming to promote the definition and use of commonly agreed formats for the electronic exchange of information on chemicals, developed the XML format in the IUCLID application (International Uniform Chemical Information Database). The format is available for download from ECHA’s Poison Centres website (https://poisoncentres.echa.europa.eu/poison-centres-notification-format) and its use is free of charge. The usage of the format and creation of submission files containing required information can be executed offline using the IT systems available to duty holders. 6.3 Tools for preparing IUCLID XML files There are three ways to prepare dossiers (IUCLID XML files). The submitter can decide which one to use based on their specific business needs and IT systems. • Online in the ECHA Submission portal: The portal features IUCLID Cloud, an online tool to guide the user through the preparation of a dossier, allowing to enter data manually and store the information in the ECHA Cloud. • Offline in IUCLID 6: In IUCLID 6, data can be entered manually using a specific poison centres notification interface. This option is available for companies using local installations of IUCLID. The desktop and server versions of the software can be downloaded from the IUCLID 6 website. • Using the PCN format in the company’s own system: companies can prepare and create a dossier directly in their own systems, using the IUCLID-compatible PCN format. 6.4 Submission of information The dossier, once prepared and containing the required information, must be submitted to the appointed bodies, as stipulated by Article 45(1) CLP. Submissions must be made to the appointed bodies by electronic means endorsed by them for that purpose. It is at the discretion of each Member State to define the technical means of submission, including the possibility to ‘outsource’ this task and allow the submission of information centrally via the ECHA Submission portal. Submitters are invited to carefully verify the conditions and instructions for the submission of the information with the countries where the mixture is placed on the market. Dossiers can be submitted through the ECHA Submission portal in one of two different ways, either: • Directly online through the portal: Regardless of whether or not a dossier has been created online or offline, the ECHA Submission portal will make available the dossier to all Member States indicated in the IUCLID XML file. This means that a single submission can reach several Member States. • Through a system-to-system (S2S) transfer service: An automatic S2S transfer service allows companies that have created IUCLID XML files in their own systems to make their submission through the ECHA Submission portal. Dossiers are then made available to all the relevant Member States. The ECHA Submission portal can be accessed from the ECHA Poison Centre website at https://poisoncentres.echa.europa.eu/echa-submission-portal. More information on the S2S service is available at https://poisoncentres.echa.europa.eu/system-to-system-service. Secure access to the information by designated authority users is available on the ECHA Poison Centre website at https://poisoncentres.echa.europa.eu/tools-for-authorities. Whether the submissions are received by Member States centrally through the ECHA Submission portal, or locally through Member States submission systems, it is still the Member States that are responsible for any enforcement related to the submission of information, including compliance with the date for submission, content, quality and update of the submissions etc. 6.4.1 Validation of information Dossiers submitted through the ECHA Submission portal are also subject to validation rules, developed in cooperation with appointed bodies, poison centres and industry. Incompliance with some of these rules may lead to non-acceptance of the notifications (i.e. submissions are not successfully dispatched to the relevant appointed bodies). Other rules may trigger a warning, which do not prevent the submission but forward a validation report (containing the warnings) along with the dossier to the receiving Member State. A validation assistant is made available by ECHA to industry in order to validate the information before submission. The list of validation rules is also published on ECHA’s Poison Centres website at https://poisoncentres.echa.europa.eu/poison-centres-notification-format. The validation rules concern the specific aspects of the dossier content, which can be expected to be checked by an automated tool without expert judgement: • presence of information (preventing submission of dossiers not in compliance with the information required by Annex VIII); • quality of certain pieces of information (ensuring that information provided is meaningful to operations of poison centres); • internal dossier consistency (ensuring that information in various sections of the dossier is not contradictory); • dossier accuracy with previously submitted information (updates). For Member States the following main features are provided: • submissions can be downloaded manually together with a submission report; • submissions are received automatically via system-to-system integration (i.e. eDelivery solution). • access to submissions in a central data base (view and search) hosted by ECHA. 6.5 Fees The usage of XML formats, UFI generator, EuPCS and the ECHA Submission Portal provided by the Agency is free of charge. However, it needs to be noted that while most Member States have indicated that they will not solicit a fee, this may be levied in some Member State for each submission. It is at the discretion of the competent authority of the Member State where the submission is to be made to decide whether fees are applicable for submission to the national appointed body/bodies. The document “Overview of Member State decision on implementing Annex VIII to the CLP” available on the Poison Centres website provides an overview of the available information. 111 7. Post-submission 7.1 General introduction Successful submission of the information to the appointed body is the basic requirement before placing the product containing the mixture on the market of the relevant Member State. This requires the submission to be compliant with the requirements of Annex VIII. It is to be noted that some of the Member States currently require additional information that goes beyond the scope of Article 45 and Annex VIII to be submitted before placing the product on their market. This information is normally requested within different legal frameworks and for purposes potentially different from those described in this guidance (see section 7.3). No additional information can be requested under national legislation to that specified in Annex VIII for the purposes provided for under Article 45. The XML format defined for the purpose of Annex VIII implementation does not foresee such additional requirements. Submitters have to make sure that the submitted information is constantly up to date in order to ensure that poison centres have the relevant information on the products available on the market at their disposal. Changes which trigger a mandatory update of the submission are detailed in section 7.4. 7.2 Additional requests by appointed bodies Appointed bodies may perform a quality check of the submitted information, either on a regular basis or following specific criteria (for example on the basis of the warnings resulting from execution of validation rules by the ECHA Submission portal - see section 6.4 - or other “alerts”, e.g. under indication of the poison centre). Should the appointed bodies identify areas that are deficient, unclear or maybe considered conflicting, they could contact the company who made the submission and request clarification or justification for any open or conflicting areas (e.g. regarding the quality of toxicological information provided or its consistency with other information). These checks are related to the overall compliance of the submitted information with the requirements of the Annex VIII. Additionally, according to Section A.3.2 of Annex VIII, an appointed body can make a “reasoned” request for additional information or clarification if this is necessary to carry out its tasks under Article 45. In the case of an emergency, unforeseeable situations or in general on an ad hoc basis, appointed bodies may request under Section A.3.2 other information (potentially exceeding the boundaries of Annex VIII) which is necessary to perform the activities under Article 45 (see section 7.3 below). These requests should be justified, limited to particular cases, cannot be made on a systematic basis and can occur at any point in time. These requests should be addressed to the contact point indicated in addition to the submitter and mentioned in section 5.1 of this Guidance. Examples of a reason for requesting additional information could be the following: - A need for more detailed information as a result of the analysis of warnings delivered by the ECHA Submission portal. - A need for access to more detailed data, based on which the toxicological information was prepared by the submitter. - To evaluate the correctness of an assigned product category according to EuPCS. - To enquire about possible presence of non-classified components which are not required to be included in the submission (low concentration thresholds) but could be relevant to assess the hazard (e.g. synergistic effects) or the potential exposure (e.g. bittering agents). - To enquire about relevant toxicological information related to components grouped in an ICG (e.g. to verify the sameness of the toxicological information). - To enquire about packaging information not included in the submission following incidents involving children (e.g. child-resistant fastening). - To discuss and obtain information relevant for toxicovigilance activities. 7.3 Use of submitted information As indicated in Article 45 of CLP, appointed bodies have to ensure that the submitted information is used only to: (a) meet medical demand by formulating preventative and curative measures, in particular in the event of an emergency; and (b) where requested by the Member State, undertake statistical analysis to identify where improved risk management measures may be needed. Appointed bodies or poison centres may undertake statistical analysis of the submitted information to identify where improved risk management measures may be needed. These data can help to identify particular trends in incidents or to adjust the focus of preventative actions. 7.3.1 Security and confidentiality of the submitted information Information submitted to appointed bodies may contain sensitive and confidential elements. Systems which handle this information should be designed to follow strict security standards. The information can only be used by personnel authorised by the appointed bodies. ECHA guarantees the security of the information submitted and stored in its protected IT- infrastructure. Submission portal and data base are secured according to the same security practices as other ECHA databases which contain sensitive registration data. Access to the searchable database is strictly controlled, its security settings are hardened, and security is continuously monitored as well as content of the database is regularly backed up. Appointed bodies and poison centres, which have access to the searchable database through ECHA’s standard secure remote access system, have to provide all requisite guarantees for maintaining the confidentiality of the information received. In the event of emergency, they are required to provide health response without disclosing directly confidential business information, unless it is necessary to inform health care professionals about a specific substance to ensure the patient receives the correct treatment. 7.4 Keeping information up to date 7.4.1 Introduction This section provides guidance on when the information submitted has to be updated and covers in particular Section 4, Part B of Annex VIII. It covers also voluntary updates following changes not listed under B.4.1. After a submission, changes may be made to the mixture as placed on the market or new information about it may become available. It is necessary to ensure that the information submitted to the appointed body is relevant and up to date for 113 every product being and having been placed on the market. Duty holders are required to provide the relevant information in compliance with Annex VIII before placing a product on the market. This will make sure that adequate advice can be given in poisoning accidents by poison centres and medical services. The legal text indicates which changes trigger specific actions from the submitter. It should be noted that existing submissions made in accordance with national rules are valid until 1 January 2025 (see section 3.5). However, if a change described in Section 4, Part B takes place before that date (and after the relevant compliance date according to the use type described in section 3.4), a submission update has to be made in accordance with Annex VIII. 7.4.2 Update rules according to Annex VIII The updating rules apply to both new submissions in the harmonised format and to mixtures already notified in accordance with the existing national rules before the entering into force of Annex VIII and the relevant compliance date (see section 3.5.1 above). According to Section B.4.1 of Annex VIII, a submission update is required when: 1. the name of the mixture (the product identifier, e.g. trade name/brand/identification of the mixture) or the UFI is changed, or 2. the mixture classification for health or physical hazards changes, or 3. relevant new toxicological information that is required in Section 11 of the safety data sheet becomes available on the hazardous properties of the mixture or its components, or 4. the composition of the mixture is changed following: a) Addition, substitution or deletion of one or more of the components that needs to be indicated73, or b) Change in the concentration range provided in the original submission; i.e. the concentration of a component of the mixture, is changed beyond the concentration range provided in Table 1 and 2 Annex VIII, or c) Change in the exact concentration provided in the original mixture; i.e. the concentration of a component in the mixture is changed beyond the limits indicated in Table 3 of Annex VIII and reported in table 5 below (i.e. Table 4 of Annex VIII). With regard to submissions made by referring to Standard Formulas included in Part D (for ready-mixed concrete, cements and gypsum products as explained in section 5.6 of this Guidance) and for fuels listed in Part B, section 3.7 of Annex VIII, part B, specific provisions apply with regard to the update obligations under point 4 above. These are addressed in detail in the sections 7.4.2.3 and 7.4.2.4 below. Note that whenever changes listed above occur, an update of the submitted information is required before the mixture, as changed, is placed on the market. When a submission includes one or more interchangeable component group, the submission has to be updated if a component is added, deleted or replaced within an existing ICG. However, there is no need to change the UFI. Note that a change in the mixture composition and/or the information available (i.e. revision of 73 To be noted that the substitution of one component (substance or MiM) by another with identical composition and hazard profile (possibly following a change of supplier) does not trigger the need for an update or a new submission. classification criteria in Annex I to CLP or new toxicological information) could be such that the mixture is no longer classified for any health or physical hazards. Also in this case an update of the notification is required. This is to avoid misleading and confusing information which may lead to over-treatment (both original mixture and mixture as changed may be simultaneously on the market or available to users). In the case of changes in the composition, the UFI has to be changed as well (or ultimately no UFI is needed if the new mixture falls outside the scope of Article 45 or Annex VIII). 7.4.2.1 When declaring concentration ranges Changes in the mixture component concentration ranges, for instance for a hazardous component of major concern (see Table 1 in Part B of Annex VIII), can be illustrated in example 31. The component ‘B’ present at a concentration of 20.5%, can be reported using a range of 3% (for instance 19.9-22.9%). If the new concentration falls out of this range (e.g. the new concentration is 23.5%), an update of the submission is required and a new UFI has to be created. However, if the change in the concentration stays within the mentioned range (e.g. the new concentration is 22.1%), there is no obligation to update the submission (and no need to update the UFI). The same applies when components are grouped in an ICG and its concentration is reported with a range. Example 32: Mixture components with classification of major concern MIXTURE COMPONENTS WITH CLASSIFICATION OF MAJOR CONCERN Component Exact Concentration New concentration concentration ranges provided in requiring a submission in the mixture the original update (%) (%) submission (%) Comp A 3.5 3.2-4.2 <3.2 or >4.2 Comp B 20.5 19.9-22.9 <19.9 or >22.9 Comp C 76 71-76 <71 or >76 7.4.2.2 When declaring exact concentrations When declaring the exact concentration of mixture components, only limited changes to the exact value are allowed within a certain variation without the need to update. Allowed variations are listed in Table 4 of Annex VIII (see Table 5 below). If the new concentration exceeds the allowed variation, an update is required and a new UFI has to be created. Example 32 illustrates that if a component is present in a mixture in a concentration of 72% when the original submission is made, an allowed variation of ±5% (or more) of the initial concentration triggers the need to update the submission. Therefore an update is needed if the new concentration is <68.4% or >75.6%. The same applies when components are grouped in an ICG and its concentration is reported with an exact value. 115 Table 5: Variations of the concentration of components requiring a submission update (Table 4 of Annex VIII) Variations (±) of the initial Exact concentration of the component component concentration requiring a contained in the mixture (%) submission update > 25 - ≤ 100 5% > 10 - ≤ 25 10% > 2,5 - ≤ 10 20% ≤ 2,5 30% Example 33: Mixture submitted with exact concentrations of components MIXTURE SUBMITTED WITH EXACT CONCENTRATIONS OF CLASSIFIED COMPONENTS Component Exact Variations (±) of New concentration component concentration concentration provided in the requiring a submission requiring a new submission (%) update (%) UFI (%) Comp D 1 30 <0.7 or >1.3 Comp E 5 20 <4 or >6 Comp F 22 10 <19.8 or >24.2 Comp G 72 5 <68.4 or >75.6 Note the use of Table 3 of Annex VIII deserves some clarification the reference concentration to define whether a UFI change is required should be always the original one. This allows avoiding the situation where many small changes (followed by voluntary updates) and not requiring a UFI update lead to the situation where eventually the concentration has changed significantly from the original one, yet the UFI remains the same. 7.4.2.3 When referring to a Standard Formula included in Part D When the whole or a part of a mixture composition is provided by using a Standard Formula included in Part D of Annex VIII, a submission update is required when the composition of the full mixture or that part changes in a way that it does no longer conform with the Standard Formula. This can be the case when: - A new component is added, which is not included in the Standard Formula; - The concentration of an existing component changes and it exceeds the concentration ranges listed in the relevant Standard Formula; - A component listed in the Standard Formula is removed from the mixture (a component where the lower limit of the allowed concentration range is above zero). When such changes occur, the mixture (or part of it) no longer conforms with the Standard Formula listed in Part D. Therefore, the special provisions can no longer be applied, and an update is required, with new UFI and the full information required by Annex VIII. For mixtures conforming with one of the Standard Formulas listed in part D, for which the information from the SDS is provided because it is more detailed than the Standard Formula, an update of the submission is required when Section 3.2 of the SDS is updated (a new UFI is needed when the Section 3 of the SDS is updated with regard to the composition in a way that the mixture does not conform anymore with the original Standard Formula; this is addressed in section 4.2.7). The requirements for compiling an SDS are laid down in Annex II to REACH. For mixtures, the substances to be included in Section 3.2 are specified in section 3.2.1 of Annex II to REACH. Further details are given in the Guidance on the compilation of safety data sheets available at https://echa.europa.eu/guidance-documents/guidance-on-reach. To be noted that, among other triggers, the need to update the SDS is triggered when new information affecting the risk management measures or new information on hazard becomes available74. An update of section 3.2 of the SDS due to the addition of a component classified for the environment only would also trigger a need to update the submission. If the initial submission contains other substances in addition to those in the Standard Formula (i.e. only part of the mixture conforms to the Standard Formula), changes in these other components may trigger the need to update the submission (including the UFI). These are the cases described earlier in this section 7.4.2 of this Guidance. In this case the part of the final composition conforming with the Standard Formula continues to benefit from the derogation from the standard Annex VIII requirements. 7.4.2.4 When referring to a fuel included in Part B, Section 3.7 of Annex VIII When a submission for a fuel listed in Section 3.7, Part B, is made by providing the information on component identity and concentrations from the SDS, an update is required when Section 3 of the SDS is updated. This means that an update of the submission is required even if there are no changes in the actual composition but the Section 3 of the SDS is nevertheless, for any reason, updated. The requirements for compiling an SDS are laid down in Annex II to REACH. This defines specific concentration thresholds which trigger the need to indicate the component. As an example, when the following occur the submission needs to be updated: - a substance which is required to be included in Section 3 of the SDS is added, and therefore the SDS is updated; or - a substance which was required to be included in Section 3 of the SDS is removed, and therefore the SDS is updated; or - the concentration of an existing substance included in Section 3 of the SDS exceeds the original range, and therefore the SDS is updated. Changes in the composition requiring update of Section 3 of the SDS, trigger the need to update both submission and UFI. Normal update rules apply to components not listed in the SDS but included in the submission because they are known. A change in their concentration will trigger the need for an update including a new UFI if the variation exceeds the limit in Table 4 of Annex VIII (in the case of exact values) or the new concentration falls outside the original range. 7.4.3 Other updates relevant for an emergency health response It is an obligation for the duty holder to make sure that a submission containing all the relevant information on a product placed on the market and required by Annex VIII, is made to 74 See Article 31(9) of REACH. 117 the relevant appointed body(s). Changes other than those listed in Section 4.1 Part B of Annex VIII may take place and these may be relevant for the purposes of the CLP Regulation, in particular for an emergency health response (e.g. a change in the contact details of the submitter or in the physical parameters of the mixture). Furthermore, the submitter may want to correct information for different reasons (e.g. spelling mistakes, which are particularly relevant when affecting mixture identifiers) or update a submission with new information (e.g. change in packaging type). The submitter is required to update the submission as soon as one or more pieces of the information not listed in Section 4.1 Part B of Annex VIII changes. It is important that a submission always reflects the most recent information about a product. Change of UFI is not required in these cases. 7.4.4 How updates are technically handled While all the changes described above require or should trigger an update of the information submitted (depending on the legal or voluntary reason), they may be handled differently at the technical level by the system provided by ECHA in order to respond to the need of the ultimate users, i.e. the poison centres. From the submitter’s perspective it may always appear as being an update of the submitted information, but from a technical point of view, different changes (either listed under Section B.4.1 of Annex VIII or not) may trigger different “scenarios” which have different consequences for the end user (i.e. the appointed bodies and poison centres). These are: (i) addition of information (e.g. new additional trade name, new additional packaging, new additional UFI for MiM component); the information originally submitted remains relevant for the poison centre (e.g. mixture keep being placed on the market with the original name in addition to the new one). In the system this is referred to as an “update” where the mixture composition remains the same. Both versions remain potentially relevant for the poison centres and appointed bodies. (ii) replacement of old, no longer relevant information with new relevant information (e.g. new classification due to changes in the criteria - the original classification is not relevant anymore; new contact information for rapid access to additional product information – the original contact details are not valid anymore); the information originally submitted is not relevant anymore for the emergency responders even for products already on the market; only the new information should be considered. In the system this is also referred to as an “update” where the mixture composition remains the same, as in the previous case. (iii) creation of a technically new ‘submission’ as a change in composition leads de facto to two different mixtures on the market; the two sets of information (referring to the original and new composition) remain relevant (both products may remain on the market for potentially a long time). It is still an update from a regulatory point of view but technically it becomes a “new notification after significant change of composition”. Examples and clarifications Table 5 below presents some examples of changes and the associated scenarios. In most cases they apply to both single and group submissions. Information specific for updates of group submissions, when different from single submissions, can be found in the next section (7.4.5). 118 Table 6: Examples of possible changes requiring an update and their related scenarios. Changes Scenario triggered Technical option Addition of a new trade name only(a). Scenario (i) – addition of Update information. Addition of a new UFI only(a). Scenario (i) – addition of Update information. Modification of the classification for Scenario (ii) – replacement Update health or physical hazard(b) following of old (i.e. no longer change in classification criteria. relevant) with new information. Addition of new toxicological information Scenario (i) – addition of Update (e.g. results from new tests on the information. mixture become available). The existing information remains valid. New packaging Scenario (i) – addition of Update information. Note, the mixture in original packaging may remain on the market for long time. Addition of a component in an existing Scenario (i) – addition of Update ICG (e.g. from a new supplier). information. Change in telephone number for rapid Scenario (ii) – replacement Update access to additional product information. of old with new information. - Addition, substitution(c), deletion of Scenario (iii) – creation of a New notification component(s). technically new ‘notification’. after significant change in - Supplier changes MiM’s UFI due to Note that a new UFI must composition compositional changes of MiM, which be provided. impact composition of final mixture. (For group submissions with perfumes or generic product identifiers, see below 7.4.5). The composition changes and cannot be considered the same as the original one. 119 Changes Scenario triggered Technical option Modification of reported concentration Scenario (iii) – creation of a New notification ranges, beyond the indicated range. new ‘notification record’. after significant change in The composition changes and cannot be Note that a new UFI must composition considered the same as the original one. be provided. Modification of reported exact Scenario (iii) – creation of a New notification concentration beyond the indicated new ‘notification record’. after significant range. change in Note that a new UFI must composition The composition changes and cannot be be provided. considered the same as the original one. Modification in reported concentration Scenario (iii) – creation of a New notification range of one or more components, new ‘notification record’. after significant beyond the range indicated in the change in Note that a new UFI must Standard Formula. composition be provided. The composition changes and cannot be considered the same as the original one. Addition of an ICG which was not Scenario (iii) – creation of a New notification present in the original submission new ‘notification record’. after significant (regardless of whether it includes an change in Note that a new UFI must existing component). composition be provided. Notes to the table: (a) Rationale: products with the old identifier may still be on the market for an unspecified period of time. (b) The classification of a mixture may change when a new harmonised classification of a component in the mixture is agreed or when new information becomes available. Furthermore, the classification criteria in Annex I to CLP may be revised via ATPs. In that case, an update is required no later than when the new classification becomes applicable. (c) Substitution is in this case intended with a component which is chemically different. If a component is replaced by another one which is chemically the same (i.e. same composition and hazard profile) but (e.g.) from a different supplier, it is not considered to be substitution. 7.4.5 Updates – special cases with generic component identifiers When ingredients covered by the generic component identifiers “perfumes” or “colouring agents” are included (see section 5.3), an update is not required if a perfume or colouring agent for which a generic component identifier can be used is added, substituted or removed from the mixture. This applies as long as the total concentration of ingredients covered by the generic component identifier remains below the allowed maximum level (5% for perfumes and 25% for colouring agents) and none of those ingredients is classified for any health hazard. If the concentration or concentration range of the component identified with the GCI exceeds the allowable limits as described in section 7.4.2 of this Guidance, an update with a new UFI is required. An exception to this is when existing components originally notified together under one single GCI are split into several GCI (e.g. to reflect a different classification for physical hazards) or are identified individually with their proper identifiers. In addition, for perfume components in a group submission which are not classified or only classified for skin sensitisation Category 1, 1A or 1B or aspiration toxicity, there is no need to provide the concentration (exact or range) of the single components. This means that variations in the components' concentration within the limits mentioned above do not require to update the submission. This specific provision applies to perfume components not necessarily identified with a generic component identifier. When changes are made to components declared as generic product identifiers in a group submission, refer to section 7.4.6 below. 7.4.6 Updates – special cases with group submissions Notification for a mixture initially made as a standard submission, is updated to a group submission When a mixture is initially notified with a standard submission (i.e. not a group submission), it is possible to update it to a group submission to include one or more mixtures differing for perfumes only (the total concentration of the differing perfumes is not more than 5%). A new UFI is not required (i.e. the same UFI can be used for all the mixtures in the group, or alternatively, each mixture could also be assigned a different UFI). Addition, substitution, deletion of perfumes (covered and not covered by generic component identifiers) in a group submission When the perfumes in a group submission change (if added, substituted or removed) in one or more of the mixtures in the group, the list of mixtures and the perfumes they contain as required in Annex VIII Section 3.1 must be updated. If the change of perfumes is the only change, a new UFI is not required. Nevertheless, if a perfume covered by the generic component identifier is added to a mixture already containing such a generic component identifier, but the total concentration of the generic component identifiers remains <5 %, no update is required. It is to be reminded that if the change leads to an increase in the content of differing perfumes in a certain mixture above 5%, this cannot be part of the same group submission and a new submission for that mixture is required. The original group submission does not need an update as it is assumed that the original mixture may remain on the market. Note: The rules for updates are one of the factors to be taken into consideration when it is possible to decide between standard and group submission. The decision needs to take into account not only the convenience of preparing the initial submission, but also the 121 consequences for the updates in the future. Examples and clarifications Example 34: Changes in a group submission for two mixtures with a difference in perfume components, submitted to an appointed body. GROUP SUBMISSION OF TWO MIXTURES WITH DIFFERENCE IN PERFUME COMPONENTS UFI: C4P7-GHVS Product names: ED8M-42DH - Trade name 1 Classification: # - Trade name 2 Product Category: # Common components Percentage Actual conc.a Classificationb Chemical name comp. A 60-80% Not classified Chemical name comp. B 7-10% Other Chemical name comp. C 11-14% Major concern Chemical name comp. D 1-2% Major concern Perfume components in Percentage Actual conc.a Classificationb Trade name 1 Chemical name perfume 1 1-4% 1.5 Other Chemical name perfume 3 1-2% 1.1 Major concern ‘Perfume MiM’ 1-4% 1.8 Other UFI: A67T-VHG2-DMM4- NH2A Perfumes components in Percentage Actual conc.a Classificationb Trade name 2 Chemical name perfume 2 0.3-0.6% 0.4 Major concern Chemical name perfume 4 not applicable 0.5 Other (skin sens. cat. 1) (but <5%) Perfumes (Generic 3-5% 2 Not classified component identifier) The total concentration of perfumes identified with a given generic component identifier in each mixture cannot exceed 5% [B.3.2.3]. Perfumes not classified or only classified for skin sensitisation Category 1, 1A or 1B or aspiration toxicity do not need information on concentration if the total concentration of such perfumes) in each mixture does not exceed 5% [B.3.4.2]. Notes to the tables: (a) Actual concentrations are reported for internal calculation purposes only; they are not necessarily required to be indicated in the submission. (b) Classifications are indicated in this example with three categories: ‘major concern’ (list of classifications in B3.4.1], ‘other’ (all other hazard classifications) and ‘not classified’. The following changes may occur affecting the information included in the submission exemplified above: • Change of concentration of generic component identifiers If the total concentration of components indicated with GCI perfumes is changed beyond the original interval, but still does not exceed 5 %, an update is required but the UFI can remain the same. • Change of concentration of classified perfume component If the concentration of Chemical name perfume 2 is changed to <0,3 % or >0,6 % an update with a new concentration interval for Chemical name perfume 2 is required, but an updated list is not. No need for a new UFI. • Addition of classified perfume to a mixture in a group submission - If Chemical name perfume 1 is added to Trade name 2 an updated list is required. No need for new UFI. - If a classified perfume, not declared among the components, is added to either of the mixtures, Trade name 1 or Trade name 2, an update of the components is required, as well as an updated list. No need for new UFI. • Addition of not classified perfume to a mixture in a group submission - If a perfume not classified for any health hazards is added (i.e. which can be identified via the GCI), but the total concentration of the components identified via the same generic component identifier remains within the original range, no update is required. - If a perfume not classified for any health hazards is added and it is indicated with the chemical name, an update of the composition is needed. If the total concentration of this perfume together with the components identified via the generic component identifiers remains <5 %, the concentration does not need to be indicated [B.3.4.2]. • Deletion of a classified perfume in a mixture in a group submission - If Chemical name perfume 3 is removed from Trade name 1 an update of the components is required as well as an updated list. No need for new UFI. Note: the total concentration of all perfumes contained in each mixture of the group could exceed 5% when considering both perfumes which vary and common perfumes. If the perfumes which vary in a specific mixture exceed 5%, this mixture cannot be grouped and a separate submission is required for that mixture (with a new UFI). 123 7.5 Validity of the submission In practice, many products may remain on the market (on shelves, in storehouses or in households) for years after a company has ceased marketing those products. Information may still be needed by poison centres in case of accidental exposure to those products. Therefore, submissions related to those products cannot just be retracted or deleted upon the cease of marketing or after the last placing on the market. It is not possible to establish for every product – based on the type, use and market – a specific deadline after which the possibility of exposure to a mixture by consumers, professionals and even industrial users can reasonably be excluded. For this reason, in principle, the information remains available to appointed bodies and poison centres (and in general for the personnel dealing with emergency response) indefinitely. It is the responsibility of the importer/downstream user to make sure that the submission is correct at any time and keep it up to date until the last date of placing on the market. Nevertheless, companies have the possibility to indicate to authorities the ceasing of their activity with regard to a specific mixture (i.e. the mixture is no longer placed on one or more markets). In case new relevant information becomes available to the company after the last placing on the market, it is recommended that the information submitted for the purposes of Annex VIII is voluntarily updated in order to facilitate the emergency response work. It should be noted that after the last placing on the market, appointed bodies and/or poison centres can still request additional information from submitters, if needed for emergency reasons or statistical analysis for improved risk management measures in the context of 3.2. of Part A of Annex VIII. It is at the discretion of each Member State to decide whether to apply a cut-off date to 'clean' information from their databases for practical reasons, for example 20-25 years after the submitter indicated cease of the activity (diminishing the likelihood of an incident), or after, for example, 10 years if there has been no incident involving the mixture during that period. 8. Additional support Below is a list of additional sources of information and support tools, which may be relevant and is currently available: ECHA Poison Centres Website (https://poisoncentres.echa.europa.eu/) - ECHA Submission portal and o PCN: a practical Guide o ECHA accounts manual - Overview of Member States decisions in relation to implementation of Annex VIII to the CLP; - ‘News’ updates on the ECHA poison centre project; - Frequently asked Q&As which are regularly updated on a range of Annex VIII related topics; - UFI generator and the user guide in all EU languages; - PCN format and support documentation (including data model); - European product categorisation system and manual; - Targeted support pages e.g. for industry (“Step for industry” which supports in fulfilling the obligations step by step); - Publications e.g. ‘In brief’ material; - Animations. ECHA Website, support section (https://echa.europa.eu/support), which contains a range of support material besides the Guidance, including: - Webinars - Helpdesk support National Helpdesks National Helpdesks have been established as the first point of contact for questions on regulatory advice in your own language. You can find more details on your National Helpdesk here: https://echa.europa.eu/support/helpdesks EUROPEAN CHEMICALS AGENCY ANNANKATU 18, P.O. BOX 400, FI-00121 HELSINKI, FINLAND