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Textual Amendments
F1 Inserted by Commission Regulation (EU) 2017/542 of 22 March 2017 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures by adding an Annex on harmonised information relating to emergency health response (Text with EEA relevance).
Textual Amendments
F2 Substituted by Commission Delegated Regulation (EU) 2020/11 of 29 October 2019 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures as regards information relating to emergency health response (Text with EEA relevance).
This Annex shall not apply to mixtures classified only for one or more of the following hazards:
gases under pressure;
explosives (unstable explosives and Divisions 1.1 to 1.6)
‘ Mixture for consumer use ’ means a mixture intended to be used by consumers;
‘ Mixture for professional use ’ means a mixture intended to be used by professional users but not at industrial sites;
‘ Mixture for industrial use ’ means a mixture intended to be used at industrial sites only.
Where mixtures have more than one use, the requirements for all relevant categories of use shall be met.
The submission shall contain the information laid down in Part B. It shall be submitted by electronic means in an XML format provided by the Agency and made available free of charge.
A new UFI shall be created when a change in the composition of the mixture or group of mixtures fulfils one or more of the conditions foreseen in points (a), (b) and (c) of the fourth indent of Section 4.1 of Part B.
[F2By way of derogation from the second subparagraph, a new UFI shall not be required for mixtures in a group submission containing perfumes provided that the change in the composition only concerns those perfumes or the addition of new perfumes.]
Where the inner packaging is either in such a shape or so small that it is impossible to affix the UFI on it, the submitter may print or affix the UFI located with the other label elements on an outer packaging.
In the case of mixtures which are not packaged, the UFI shall be indicated in the Safety Data Sheet or be included in the copy of the label elements referred to in Article 29(3), as applicable.
The UFI shall be preceded by the acronym ‘ UFI ’ in capital letters followed by a colon ( ‘ UFI: ’ ) and it shall be clearly visible, legible and indelibly marked.]
The product identifier shall be provided in accordance with Article 18(3)(a).
[F2The complete trade name(s) of the mixture shall be provided, including, where relevant, brand name(s), name of the product and variant names as they appear on the label, without abbreviations and enabling its specific identification.]
In addition, the UFI(s) shall be included in the submission.
The name, full address, telephone number and email address of the submitter shall be provided and, if different, the name, full address, telephone number and email address of the point of contact to be used for obtaining further information relevant for emergency health response purposes.]
In the case of a limited submission as laid down in Section 2.3 of Part A, a name, a telephone number and an email address shall be provided at which rapid access to detailed additional product information relevant for emergency health response purposes is available in the language provided in Section 3.3 of Part A. The telephone number shall be accessible 24 hours per day, 7 days per week.]
This section sets out the information requirements related to the health and physical hazards of the mixture and the appropriate warning information associated with those hazards, as well as the additional information to be included in a submission.
The classification of the mixture for health and physical hazards (hazard class and category) shall be provided in accordance with the classification rules in Annex I.
The following label elements required in accordance with Article 17 shall be provided, if applicable:
hazard pictogram codes (Annex V),
signal word,
hazard statement codes (Annex III, including supplemental hazard information),
precautionary statement codes.
The submission shall include the information on the toxicological effects of the mixture or its components that is required in Section 11 of the Safety Data Sheet of the mixture, in accordance with Annex II to Regulation (EC) No 1907/2006.
The following additional information shall be provided:
the type(s) and size(s) of the packaging used to place the mixture on the market for consumer or professional use,
the colour(s) and the physical state(s) of the mixture, as supplied,
[F2the pH, if available, of the mixture as supplied, or, where the mixture is a solid, the pH of an aqueous liquid or solution at a given concentration. The concentration of the test mixture in water shall be indicated. If the pH is not available, the reasons shall be given,]
product categorisation (see Section 3.4 of Part A),
use (consumer, professional, industrial, or a combination of any of the three).
The chemical identity and the concentrations of the components contained in the mixture shall be indicated in the submission in accordance with Sections 3.2, 3.3 and 3.4.
Components which are not present in a mixture shall not be notified.
[F2By way of derogation from the second subparagraph, in a group submission, perfume components in mixtures shall be present in at least one of the mixtures.
For group submissions where the perfumes vary between the mixtures contained in the group, a list shall be provided of the mixtures and the perfumes they contain, including their classification.]
In the case of a limited submission as laid down in Section 2.3 of Part A, the information to be submitted on the composition of a mixture for industrial use may be limited to the information contained in the Safety Data Sheet in accordance with Annex II to Regulation (EC) No 1907/2006, provided that additional information on the composition is available on request for rapid access in accordance with Section 1.3.]
[F3A mixture component is either a substance or a mixture in mixture.]
Textual Amendments
F3 Inserted by Commission Delegated Regulation (EU) 2020/11 of 29 October 2019 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures as regards information relating to emergency health response (Text with EEA relevance).
The product identifier for the substances identified according to Section 3.3 shall be provided in accordance with Article 18(2). However, an INCI name, a colour index name or another international chemical name may be used, provided the chemical name is well-known and unambiguously defines the substance identity. The chemical name of substances for which an alternative chemical name has been allowed in accordance with Article 24 shall be provided as well.
When a mixture is used in the composition of a second mixture placed on the market, the first mixture is referred to as a mixture in mixture (hereinafter MIM).
[F2Information on the substances contained in a MIM shall be provided in accordance with the criteria of Section 3.2.1, unless the submitter does not have access to information on the full composition of the MIM. In the latter case, the MIM shall be identified by means of its product identifier in accordance with Article 18(3)(a), together with its concentration and UFI, if available and if the appointed body has received the information on the MIM in a prior submission. In absence of a UFI or if the appointed body has not received the information on the MIM in a prior submission, the MIM shall be identified by means of its product identifier in accordance with Article 18(3)(a), together with its concentration and the compositional information contained in the Safety Data Sheet of the MIM and any other known components, as well as the name, email address and telephone number of the MIM supplier.]
By way of derogation from Sections 3.2.1 and 3.2.2, the generic product identifiers ‘ perfumes ’ or ‘ colouring agents ’ may be used for mixture components used exclusively to add perfume or colour, where the following conditions are met:
the mixture components are not classified for any health hazard,
the concentration of mixture components identified with a given generic product identifier does not exceed in total:
5 % for the sum of perfumes; and
25 % for the sum of colouring agents.]
The following mixture components shall be indicated:
mixture components classified as hazardous on the basis of their health or physical effects which:
are present in concentrations equal to or greater than 0,1 %,
are identified, even if in concentrations lower than 0,1 %, unless the submitter can demonstrate that those components are irrelevant for the purposes of emergency health response and preventative measures;
mixture components not classified as hazardous on the basis of their health or physical effects which are identified and present in concentrations equal to or greater than 1 %.]
Submitters shall provide the information laid down in Sections 3.4.1 and 3.4.2 with regard to the concentration of the mixture components, identified in accordance with Section 3.3.]
When mixture components are classified in accordance with this Regulation for at least one of the hazard categories listed below, their concentration in a mixture shall be expressed as exact percentages, in descending order by mass or volume:
acute toxicity, Category 1, 2 or 3,
specific target organ toxicity — Single exposure, Category 1 or 2,
specific target organ toxicity — Repeated exposure, Category 1 or 2,
skin corrosion, Category 1, 1A, 1B or 1C,
serious eye damage, Category 1.
As an alternative to providing concentrations as exact percentages, a range of percentages may be submitted in accordance with Table 1.
[F2Concentration ranges applicable to hazardous components of major concern for emergency health response]
| Concentration range of the hazardous component contained in the mixture (%) | Maximum width of the concentration range to be used in the submission |
|---|---|
| ≥ 25 - < 100 | 5 % units |
| ≥ 10 - < 25 | 3 % units |
| ≥ 1 - < 10 | 1 % units |
| ≥ 0,1 - < 1 | 0,3 % units |
| > 0 - < 0,1 | 0,1 % units |
The concentration of the hazardous components in a mixture that are not classified for any of the hazard categories listed in Section 3.4.1 and of the identified components not classified as hazardous shall be expressed, in accordance with Table 2, as ranges of percentages in descending order by mass or volume. As an alternative, exact percentages may be provided.
By way of derogation from the first subparagraph, for perfume components that are not classified or only classified for skin sensitisation Category 1, 1A or 1B or aspiration toxicity, submitters shall not be required to provide information on their concentration, provided that their total concentration does not exceed 5 %.
Concentration ranges applicable to other hazardous components and components not classified as hazardous
| Concentration range of the component contained in the mixture (%) | Maximum width of the concentration range to be used in the submission |
|---|---|
| ≥ 25 - < 100 | 20 % units |
| ≥ 10 - < 25 | 10 % units |
| ≥ 1 - < 10 | 3 % units |
| > 0 - < 1 | 1 % units] |
The classification of mixture components for health and physical hazards (hazard classes, hazard categories and hazard statements) shall be provided. This includes the classification for at least all substances referred to in Point 3.2.1 of Annex II to Regulation (EC) No 1907/2006 on requirements for the compilation of Safety Data Sheets. In the case of a MIM identified by means of its product identifier and its UFI in accordance with Section 3.2.2 of Part B, only the classification for health and physical hazards of the MIM shall be provided.]
when the mixture product identifier (including the UFI) has changed,
when the mixture classification for health or physical hazards has changed,
when 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,
if a change in the composition of the mixture fulfils one of the following conditions:
addition, substitution, or deletion of one or more components in the mixture that shall be indicated in accordance with Section 3.3;
change in the concentration of a component in the mixture beyond the concentration range provided in the original submission;
the exact concentration of a component was provided in accordance with Sections 3.4.1 or 3.4.2, and a change occurs to that concentration beyond the limits identified in Table 3.
[F2Variations of the concentration of components requiring a submission update]
| Exact concentration of the component contained in the mixture (%) | Variations (±) of the initial component concentration requiring a submission update |
|---|---|
| > 25 - ≤ 100 | 5 % |
| > 10 - ≤ 25 | 10 % |
| > 2,5 - ≤ 10 | 20 % |
| ≤ 2,5 | 30 % |
[F2When the perfumes in a group submission change, the list of mixtures and the perfumes they contain as required in Section 3.1 shall be updated.]
The submission update shall comprise a revised version of the previous submission containing the new information available as described in Section 4.1.
The submission of information to appointed bodies in accordance with Article 45 shall be in a format to be provided by the Agency. The submission format shall address the following elements:
Complete trade name(s) of the product (in case of group submission, all product identifiers shall be listed)
Other names, synonyms
Unique Formula Identifier(s) (UFI)
Other identifiers (authorisation number, company product codes)
Name
Full address
Telephone number
Email address
Name
Telephone number (accessible 24 hours per day, 7 days per week)
Email address]
Hazard class and category
Hazard pictogram codes (Annex V)
Signal word
Hazard statement codes, including supplemental hazard information codes (Annex III)
Precautionary statement codes (Annex IV)
Description of the toxicity of the mixture or its components (as required in Section 11 of the Safety Data Sheet in accordance with Annex II to Regulation (EC) No 1907/2006)
Colour(s)
The pH, if available, of the mixture as supplied, or, where the mixture is a solid, the pH of an aqueous liquid or solution at a given concentration. The concentration of the test mixture in water shall be indicated. If the pH is not available, the reasons shall be given
Physical state(s)
Packaging (type(s) and size(s))
Intended use (product category)
Uses (consumer, professional, industrial)]
Chemical/trade name of the components
CAS number (where applicable)
EC number (where applicable)
UFI (where applicable)
Exact concentration or concentration range
Hazard classification (where applicable)
Additional identifiers (where applicable and relevant for health response)