PART A / GENERAL REQUIREMENTS
1. APPLICATION
APPLICATION1.1. Importers and downstream users placing on the market mixtures for consumer use, within the meaning of Section 2.4 of Part A of this Annex, shall comply with this Annex from 1 January 2021.
1.1. Importers and downstream users placing on the market mixtures for consumer use, within the meaning of Section 2.4 of Part A of this Annex, shall comply with this Annex from 1 January 2021.
1.2. Importers and downstream users placing on the market mixtures for professional use, within the meaning of Section 2.4 of Part A of this Annex, shall comply with this Annex from 1 January 2021.
1.2. Importers and downstream users placing on the market mixtures for professional use, within the meaning of Section 2.4 of Part A of this Annex, shall comply with this Annex from 1 January 2021.
1.3. Importers and downstream users placing on the market mixtures for industrial use or mixtures with an end use not subject to notification within the meaning of Section 2.4 of Part A of this Annex, shall comply with this Annex from 1 January 2024.
1.3. Importers and downstream users placing on the market mixtures for industrial use or mixtures with an end use not subject to notification within the meaning of Section 2.4 of Part A of this Annex, shall comply with this Annex from 1 January 2024.
1.4. Importers and downstream users having submitted information relating to hazardous mixtures to a body appointed in accordance with Article 45(1) before the dates of applicability mentioned in Sections 1.1, 1.2 and 1.3 and which are not in accordance with this Annex, shall for those mixtures not be required to comply with this Annex until 1 January 2025.
1.4. Importers and downstream users having submitted information relating to hazardous mixtures to a body appointed in accordance with Article 45(1) before the dates of applicability mentioned in Sections 1.1, 1.2 and 1.3 and which are not in accordance with this Annex, shall for those mixtures not be required to comply with this Annex until 1 January 2025.
1.5. By way of derogation from Section 1.4, if one of the changes described in Section 4.1 of Part B of this Annex occurs before 1 January 2025, importers and downstream users shall comply with this Annex before placing that mixture, as changed, on the market.
1.5. By way of derogation from Section 1.4, if one of the changes described in Section 4.1 of Part B of this Annex occurs before 1 January 2025, importers and downstream users shall comply with this Annex before placing that mixture, as changed, on the market.
2. PURPOSE, SCOPE AND DEFINITIONS
PURPOSE, SCOPE AND DEFINITIONS2.1. This Annex sets out the requirements that importers and downstream users placing mixtures on the market, hereinafter ‘submitters’ shall fulfil in respect of the submission of information so that appointed bodies shall have at their disposal the information to carry out the tasks for which they are responsible under Article 45.
2.1. This Annex sets out the requirements that importers and downstream users placing mixtures on the market, hereinafter ‘submitters’ shall fulfil in respect of the submission of information so that appointed bodies shall have at their disposal the information to carry out the tasks for which they are responsible under Article 45.
2.2. This Annex shall not apply to mixtures for scientific research and development and to mixtures for product and process oriented research and development as defined in Article 3(22) of Regulation (EC) No 1907/2006.
2.2. This Annex shall not apply to mixtures for scientific research and development and to mixtures for product and process oriented research and development as defined in Article 3(22) of Regulation (EC) No 1907/2006.
This Annex shall not apply to mixtures classified only for one or more of the following hazards:
Gases under pressure;
Gases under pressure;
Gases under pressure;
Explosives (Unstable explosives and Divisions 1.1 to 1.6).
Explosives (Unstable explosives and Divisions 1.1 to 1.6).
Explosives (Unstable explosives and Divisions 1.1 to 1.6).
2.2a. In the case of bespoke paints, submitters may, without prejudice to Article 25(8), opt not to submit information and not to create a Unique Formula Identifier in accordance with this Annex.
2.2a. In the case of bespoke paints, submitters may, without prejudice to Article 25(8), opt not to submit information and not to create a Unique Formula Identifier in accordance with this Annex.
2.3. In the case of mixtures with an end use not subject to notification or mixtures placed on the market for industrial use only, submitters may opt for a limited submission, as an alternative to general submission requirements, in accordance with the second subparagraph of Section 3.1 of Part B, provided that a rapid access to additional detailed product information is available in accordance with Section 1.3 of that Part.
2.3. In the case of mixtures with an end use not subject to notification or mixtures placed on the market for industrial use only, submitters may opt for a limited submission, as an alternative to general submission requirements, in accordance with the second subparagraph of Section 3.1 of Part B, provided that a rapid access to additional detailed product information is available in accordance with Section 1.3 of that Part.
2.4. For the purposes of this Annex, the following definitions shall apply:
2.4. For the purposes of this Annex, the following definitions shall apply:
‘mixture for consumer use’ means a mixture intended to be used by consumers, either on its own or incorporated in another mixture that is intended to be used by consumers and is subject to the information requirements in Article 45;
‘mixture for consumer use’ means a mixture intended to be used by consumers, either on its own or incorporated in another mixture that is intended to be used by consumers and is subject to the information requirements in Article 45;
‘mixture for consumer use’ means a mixture intended to be used by consumers, either on its own or incorporated in another mixture that is intended to be used by consumers and is subject to the information requirements in Article 45;
‘mixture for professional use’ means a mixture intended to be used by professional users but not at industrial sites, either on its own or incorporated in another mixture that is intended to be used by professional users but not at industrial sites and is subject to the information requirements in Article 45;
‘mixture for professional use’ means a mixture intended to be used by professional users but not at industrial sites, either on its own or incorporated in another mixture that is intended to be used by professional users but not at industrial sites and is subject to the information requirements in Article 45;
‘mixture for professional use’ means a mixture intended to be used by professional users but not at industrial sites, either on its own or incorporated in another mixture that is intended to be used by professional users but not at industrial sites and is subject to the information requirements in Article 45;
‘mixture for industrial use’ means a mixture intended to be used at industrial sites only;
‘mixture for industrial use’ means a mixture intended to be used at industrial sites only;
‘mixture for industrial use’ means a mixture intended to be used at industrial sites only;
‘mixture with an end use not subject to notification’ means a mixture, incorporated in another mixture where the latter is intended to be used by consumers or professional users, but which is not subject to the information requirements in Article 45;
‘mixture with an end use not subject to notification’ means a mixture, incorporated in another mixture where the latter is intended to be used by consumers or professional users, but which is not subject to the information requirements in Article 45;
‘mixture with an end use not subject to notification’ means a mixture, incorporated in another mixture where the latter is intended to be used by consumers or professional users, but which is not subject to the information requirements in Article 45;
‘bespoke paint’ means a paint that is formulated in limited amounts on a tailor-made basis for an individual consumer or professional user at the point of sale by tinting or colour mixing.
Where mixtures have more than one use, the requirements for all relevant categories of use shall be met.
‘bespoke paint’ means a paint that is formulated in limited amounts on a tailor-made basis for an individual consumer or professional user at the point of sale by tinting or colour mixing.
Where mixtures have more than one use, the requirements for all relevant categories of use shall be met.
‘bespoke paint’ means a paint that is formulated in limited amounts on a tailor-made basis for an individual consumer or professional user at the point of sale by tinting or colour mixing.
Where mixtures have more than one use, the requirements for all relevant categories of use shall be met.
3. SUBMISSION REQUIREMENTS
SUBMISSION REQUIREMENTS3.1. Before placing mixtures on the market, submitters shall provide information relating to mixtures classified as hazardous on the basis of their health or physical effects to the bodies appointed under Article 45(1) (‘appointed bodies’), in the Member State or Member States where the mixture is placed on the market.
3.1. Before placing mixtures on the market, submitters shall provide information relating to mixtures classified as hazardous on the basis of their health or physical effects to the bodies appointed under Article 45(1) (‘appointed bodies’), in the Member State or Member States where the mixture is placed on the market.
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.
3.2. Where following receipt of a submission under Section 3.1 an appointed body makes a reasoned request to the submitter that additional information or clarification is necessary for that appointed body to carry out the tasks for which it is responsible under Article 45, the submitter shall provide the necessary information or clarification requested without undue delay.
3.2. Where following receipt of a submission under Section 3.1 an appointed body makes a reasoned request to the submitter that additional information or clarification is necessary for that appointed body to carry out the tasks for which it is responsible under Article 45, the submitter shall provide the necessary information or clarification requested without undue delay.
3.3. The submission shall be in the official language(s) of the Member State(s) where the mixture is placed on the market, unless the Member State(s) concerned provide(s) otherwise.
3.3. The submission shall be in the official language(s) of the Member State(s) where the mixture is placed on the market, unless the Member State(s) concerned provide(s) otherwise.
3.4. The intended use of the mixture shall be described in accordance with a harmonised product categorisation system provided by the Agency.
3.4. The intended use of the mixture shall be described in accordance with a harmonised product categorisation system provided by the Agency.
3.5. A submission update shall be made without undue delay when the conditions laid down in Section 4.1 of Part B are met.
3.5. A submission update shall be made without undue delay when the conditions laid down in Section 4.1 of Part B are met.
4. GROUP SUBMISSION
GROUP SUBMISSION4.1. A single submission may be provided for more than one mixture where all the mixtures in a group have the same classification for health and physical hazards. Such a submission shall be referred to as a ‘group submission’.
4.1. A single submission may be provided for more than one mixture where all the mixtures in a group have the same classification for health and physical hazards. Such a submission shall be referred to as a ‘group submission’.
4.2. A group submission shall only be permitted when all mixtures in the group contain the same components (as identified in Section 3.2 of Part B), and for each of the components, the reported concentration range is the same for all mixtures (as provided in Section 3.4 of Part B).
4.2. A group submission shall only be permitted when all mixtures in the group contain the same components (as identified in Section 3.2 of Part B), and for each of the components, the reported concentration range is the same for all mixtures (as provided in Section 3.4 of Part B).
4.3. By way of derogation from Section 4.2, a group submission shall also be allowed where the difference in the composition between different mixtures in the group only concerns perfumes, provided that the total concentration of the differing perfumes contained in each mixture does not exceed 5 %.
4.3. By way of derogation from Section 4.2, a group submission shall also be allowed where the difference in the composition between different mixtures in the group only concerns perfumes, provided that the total concentration of the differing perfumes contained in each mixture does not exceed 5 %.
4.4. In the case of a group submission, the information required in Part B shall be provided for each of the mixtures contained in the group where applicable.
4.4. In the case of a group submission, the information required in Part B shall be provided for each of the mixtures contained in the group where applicable.
5. UNIQUE FORMULA IDENTIFIER (UFI)
UNIQUE FORMULA IDENTIFIER (UFI)5.1. The submitter shall create a Unique Formula Identifier (‘UFI’) by electronic means made available by the Agency. The UFI is a unique alphanumeric code that unambiguously links the submitted information on the composition of a mixture or a group of mixtures to a specific mixture or group of mixtures. The assignment of a UFI is free of charge.
5.1. The submitter shall create a Unique Formula Identifier (‘UFI’) by electronic means made available by the Agency. The UFI is a unique alphanumeric code that unambiguously links the submitted information on the composition of a mixture or a group of mixtures to a specific mixture or group of mixtures. The assignment of a UFI is 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 laid down in points (a), (b) and (c) of the fourth indent of the first subparagraph of Section 4.1 of Part B or, as the case may be, one or other of the conditions laid down in the second subparagraph of that Section.
By way of derogation from the second subparagraph of this Section, 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.
By way of derogation from the second subparagraph of this Section, a new UFI shall not be required where a change fulfilling the condition foreseen in point (a) of the fourth indent of the first subparagraph of Section 4.1 of Part B solely concerns one or more components grouped in an interchangeable component group already included in the submission in accordance with Section 3.5 of Part B.
5.2. 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.
5.2. 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.
5.3. Instead of including the UFI in the supplemental information on the label, the submitter may opt to print or affix it on the inner packaging located with the other label elements.
5.3. Instead of including the UFI in the supplemental information on the label, the submitter may opt to print or affix it on the inner packaging located with the other label elements.
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.
In the case of packaged mixtures supplied for use at an industrial site, instead of including the UFI on the label or packaging, the submitter may opt to indicate it in the Safety Data Sheet.
6. FORMATS AND TECHNICAL SUPPORT FOR SUBMISSION OF INFORMATION
FORMATS AND TECHNICAL SUPPORT FOR SUBMISSION OF INFORMATION6.1. The Agency shall specify, maintain and update the UFI generator, the XML formats for submissions and a harmonised product categorisation system and make them available free of charge on its website.
6.1. The Agency shall specify, maintain and update the UFI generator, the XML formats for submissions and a harmonised product categorisation system and make them available free of charge on its website.
6.2. The Agency shall provide technical and scientific guidance, technical support and tools facilitating the submission of information.
6.2. The Agency shall provide technical and scientific guidance, technical support and tools facilitating the submission of information.