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Regulation (EU) 2024/2865 of the European Parliament and of the Council of 23 October 2024 amending Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (Text with EEA relevance)
Version 31 of 31 recorded for CLP, the newest.
First seen by emendrix on , when it first read this version; that is not a legal date.
8 changes in this version
Consolidated versions 02008R1272-20260701 → 02008R1272-20270101. v1 is the previous version, v2 this one.
What changed
Art. 1 Purpose and scope, Modified§
Explanation, written by a model and checked against the cited text
Point (e) now ends with a semicolon instead of a full stop, reflecting the addition of a new following point.
A new point (f) is added, stating an obligation for downstream users, importers and distributors referred to in Article 45(1b) and (1c) to submit information relevant to an adequate emergency health response to appointed bodies in accordance with Annex VIII.
Cited: Art. 1, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, before and after
Previous version, in force 1 July 2026 02008R1272-20260701 → this version, in force 1 January 2027 02008R1272-20270101
Article 1
Purpose and scope
1. The purpose of this Regulation is to ensure a high level of protection of human health and the environment as well as the free movement of substances, mixtures and articles as referred to in Article 4(8) by:
(a) harmonising the criteria for classification of substances and mixtures, and the rules on labelling and packaging for hazardous substances and mixtures;
(b) providing an obligation for:
(i) manufacturers, importers and downstream users to classify substances and mixtures placed on the market;
(ii) suppliers to label and package substances and mixtures placed on the market;
(iii) manufacturers, producers of articles and importers to classify those substances not placed on the market that are subject to registration or notification under Regulation (EC) No 1907/2006;
(c) providing an obligation for manufacturers and importers of substances to notify the Agency of such classifications and label elements if these have not been submitted to the Agency as part of a registration under Regulation (EC) No 1907/2006;
(d) establishing a list of substances with their harmonised classifications and labelling elements at Community level in Part 3 of Annex VI;
(e) establishing a classification and labelling inventory of substances, which is made up of all notifications, submissions and harmonised classifications and labelling elements referred to in points (c) and (d). (d);
(f) providing an obligation for downstream users, importers and distributors referred to in Article 45(1b) and (1c) to submit information relevant to an adequate emergency health response to appointed bodies in accordance with Annex VIII.
2. This Regulation shall not apply to the following:
(a) radioactive substances and mixtures within the scope of Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the danger arising from ionising radiation
OJ L 159, 29.6.1996, p. 1.;
(b) substances and mixtures which are subject to customs supervision, provided that they do not undergo any treatment or processing, and which are in temporary storage, or in a free zone or free warehouse with a view to re-exportation, or in transit;
(c) non-isolated intermediates;
(d) substances and mixtures for scientific research and development, which are not placed on the market, provided they are used under controlled conditions in accordance with Community workplace and environmental legislation.
3. Waste as defined in Directive 2006/12/EC of the European Parliament and of the Council of 5 April 2006 on waste
OJ L 114, 27.4.2006, p. 9. is not a substance, mixture or article within the meaning of Article 2 of this Regulation.
4. Member States may allow for exemptions from this Regulation in specific cases for certain substances or mixtures, where necessary in the interests of defence.
5. This Regulation shall not apply to substances and mixtures in the following forms, which are in the finished state, intended for the final user:
(a) medicinal products as defined in Directive 2001/83/EC;
(b) veterinary medicinal products as defined in Directive 2001/82/EC;
(c) cosmetic products as defined in Directive 76/768/EEC;
(d) medical devices as defined in Directives 90/385/EEC and 93/42/EEC, which are invasive or used in direct physical contact with the human body, and in Directive 98/79/EC;
(e) food or feeding stuffs as defined in Regulation (EC) No 178/2002 including when they are used:
(i) as a food additive in foodstuffs within the scope of Directive 89/107/EEC;
(ii) as a flavouring in foodstuffs within the scope of Directive 88/388/EEC and Decision 1999/217/EC;
(iii) as an additive in feeding stuffs within the scope of Regulation (EC) No 1831/2003;
(iv) in animal nutrition within the scope of Directive 82/471/EEC.
6. Save where Article 33 applies this Regulation shall not apply to the transport of dangerous goods by air, sea, road, rail or inland waterways.
Art. 18 Product identifiers, Modified§
Explanation, written by a model and checked against the cited text
Article 18(3)(1)(b) now lists additional hazard classes that count toward identifying substances in a mixture, adding persistent, bioaccumulative and toxic, very persistent and very bioaccumulative, persistent, mobile and toxic, very persistent and very mobile properties, and endocrine disruption for human health or the environment to the previously listed hazard categories.
The wording "specific target organ toxicity (STOT)" is shortened to "specific target organ toxicity" without the abbreviation, and "aspiration hazard" is followed by a comma rather than the word "or" before the newly added hazard categories.
Cited: Art. 18, v1 (external, EUR-Lex) · Art. 18, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, before and after
Previous version, in force 1 July 2026 02008R1272-20260701 → this version, in force 1 January 2027 02008R1272-20270101
Article 18
Product identifiers
1. The label shall include details permitting the identification of the substance or mixture (hereinafter referred to as product identifiers).
The term used for identification of the substance or mixture shall be the same as that used in the safety data sheet drawn up in accordance with Article 31 of Regulation (EC) No 1907/2006 (hereinafter referred to as safety data sheet), without prejudice to Article 17(2) of this Regulation.
2. The product identifier for a substance shall consist of at least the following:
(a) if the substance is included in Part 3 of Annex VI, a name and an identification number as given therein;
(b) if the substance is not included in Part 3 of Annex VI, but appears in the classification and labelling inventory, a name and an identification number as given therein;
(c) if the substance is not included in Part 3 of Annex VI nor in the classification and labelling inventory, the number provided by the CAS (hereinafter referred to as the CAS number), together with the name set out in the nomenclature provided by the IUPAC (hereinafter referred to as the IUPAC Nomenclature), or the CAS number together with another international chemical name(s); or
(d) if the CAS number is not available, the name set out in the IUPAC Nomenclature or another international chemical name(s).
Where the name in the IUPAC nomenclature exceeds 100 characters, one of the other names (usual name, trade name, abbreviation) referred to in section 2.1.2 of Annex VI to Regulation (EC) No 1907/2006 may be used provided that the notification in accordance with Article 40 includes both the name set out in the IUPAC Nomenclature and the other name used.
3. The product identifier for a mixture shall consist of both of the following:
(a) the trade name or the designation of the mixture;
(b) the identity of all substances in the mixture that contribute to the classification of the mixture as regards acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, respiratory or skin sensitisation, specific target organ toxicity (STOT) toxicity, aspiration hazard, persistent, bioaccumulative and toxic, very persistent and very bioaccumulative, persistent, mobile and toxic, very persistent and very mobile properties, or aspiration hazard. endocrine disruption for human health or the environment.
Where, in the case referred to in (b), that requirement leads to the provision of multiple chemical names, a maximum of four chemical names shall suffice, unless more than four names are needed to reflect the nature and the severity of the hazards.
The chemical names selected shall identify the substances primarily responsible for the major health hazards which have given rise to the classification and the choice of the corresponding hazard statements.
Art. 30 Updating information on labels, Modified§
Not in every listWhat this means
Found in the text, but not every source lists it — the text comparison and the amending act's instructions found this change; the EU's own amendment metadata does not list it. The source that does not name it is the EU's own amendment metadata. All are shown; none is overruled.
Explanation, written by a model and checked against the cited text
The updating trigger in paragraph 1 changes from a defined event tied to a new evaluation under Article 15(4), with a fixed 6-month deadline, to a duty to update without undue delay following any classification or labelling change, judged by the nature of the change for human health and environmental protection, and it adds a requirement that suppliers cooperate under Article 4(9) to complete labelling changes without undue delay.
Paragraph 2 removes the reference to results of a new evaluation under Article 15(4) as the trigger for the 18-month deadline, keeping only the 18-month period for other required labelling changes.
The former paragraph 3 exemption for changes triggered by harmonised classification delegated acts is removed, and the former paragraph 4 reference to Regulation (EC) No 1107/2009 and Regulation (EU) No 528/2012 is replaced by a new paragraph 3 referring instead to Directives 91/414/EEC and 98/8/EC.
Cited: Art. 30, v1 (external, EUR-Lex) · Art. 30, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, before and after
texts differ too much for an inline diff; shown separately
Previous version, in force 1 July 2026 02008R1272-20260701
Article 30 Updating information on labels 1. In the event of a change regarding the classification or labelling of a substance or a mixture, which results in the addition of a new hazard class or in a more severe classification, or which requires new supplemental information on the label in accordance with Article 25, the supplier of that substance or that mixture shall ensure that the label is updated without undue delay and in any event no later than 6 months after the results of the new evaluation referred to in Article 15(4) are obtained by, or communicated to, that supplier. 2. Where a change regarding the classification or labelling of a substance or a mixture, other than those referred to in paragraph 1 of this Article, is required, the supplier of that substance or that mixture shall ensure that the label is updated without undue delay and in any event no later than 18 months after the results of the new evaluation referred to in Article 15(4) are obtained by, or communicated to, that supplier. 3. Paragraphs 1 and 2 shall not apply where a change regarding the classification and labelling of a substance or a mixture was triggered by a harmonised classification and labelling of a substance set out in a delegated act adopted pursuant to Article 37(5) or by a provision set out in a delegated act adopted pursuant to Article 53(1). In such cases, the supplier shall ensure that the label is updated by the date set out in the respective delegated act. 4. The supplier of a substance or mixture that falls within the scope of Regulation (EC) No 1107/2009 or Regulation (EU) No 528/2012 shall update the label in accordance with those Regulations
this version, in force 1 January 2027 02008R1272-20270101
Article 30 Updating information on labels 1. The supplier shall ensure that the label is updated, without undue delay, following any change to the classification and labelling of that substance or mixture, where the new hazard is more severe or where new supplemental labelling elements are required under Article 25, taking into account the nature of the change as regards the protection of human health and the environment. Suppliers shall cooperate in accordance with Article 4(9) to complete the changes to the labelling without undue delay. 2. Where labelling changes are required other than those referred to in paragraph 1, the supplier shall ensure that the label is updated within 18 months. 3. The supplier of a substance or a mixture within the scope of Directives 91/414/EEC or 98/8/EC shall update the label in accordance with those Directives.
Art. 45 Appointment of bodies responsible for receiving information relating to emergency health response, Modified§
Explanation, written by a model and checked against the cited text
Three new paragraphs are added: paragraph 1a allows Member States to appoint the Agency as the body receiving the emergency health response information described in paragraph 1, paragraph 1b requires importers and downstream users placing hazardous mixtures on the market to submit the Part B Annex VIII information to the appointed body or bodies, and paragraph 1c imposes a similar submission duty on distributors placing such mixtures on the market when they subsequently distribute, rebrand or relabel them in other Member States, with an exemption if the same information was already received from importers and downstream users.
Paragraph 3 is reworded so that the appointed bodies must have at their disposal information required from importers, downstream users and the distributors referred to in new paragraph 1c, rather than only from importers and downstream users responsible for marketing, and the reference now ties the tasks to paragraph 1.
Cited: Art. 45, v2 (external, EUR-Lex) · Art. 45, v1 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, before and after
Previous version, in force 1 July 2026 02008R1272-20260701 → this version, in force 1 January 2027 02008R1272-20270101
Article 45
Appointment of bodies responsible for receiving information relating to emergency health response
1. Member States shall appoint a body or bodies responsible for receiving the relevant harmonised information relating to emergency health response and preventative measures, in accordance with Annex VIII.
1a. Member States may appoint the Agency as the body responsible for receiving information relating to emergency health response and preventative measures referred to in paragraph 1.
1b. Importers and downstream users placing on the market mixtures that are classified as hazardous on the basis of their health or physical effects, shall submit to the body or bodies appointed in accordance with paragraph 1 the information referred to in Part B of Annex VIII.
1c. Distributors placing on the market mixtures that are classified as hazardous on the basis of their health or physical effects shall submit to the body or bodies appointed in accordance with paragraph 1 the information referred to in Part B of Annex VIII where they subsequently distribute those mixtures in other Member States, or where they rebrand or relabel the mixtures. That obligation shall not apply if the distributors can demonstrate that the appointed body or bodies already received the same information from importers and downstream users.
2. The appointed bodies shall provide all requisite guarantees for maintaining the confidentiality of the information received. Such information may only be used:
(a) to 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, the Commission or the Agency, to undertake a statistical analysis to identify where improved risk management measures may be needed.
The information shall not be used for other purposes.
3. The appointed bodies shall have at their disposal all the information required from the importers and importers, downstream users responsible for marketing and distributors referred to in paragraph 1c, to carry out the tasks for which they are responsible. responsible in accordance with paragraph 1.
4. The Commission is empowered to adopt delegated acts in accordance with Article 53a amending Annex VIII to further harmonise the information relating to emergency health response and preventative measures, following consultation with relevant stakeholders such as the European Association of Poison Centres and Clinical Toxicologists (EAPCCT).
Art. 48 Advertisement, Modified§
dates added to the text: 1997-05-20
Not in every listWhat this means
Found in the text, but not every source lists it — the text comparison and the amending act's instructions found this change; the EU's own amendment metadata does not list it. The source that does not name it is the EU's own amendment metadata. All are shown; none is overruled.
Explanation, written by a model and checked against the cited text
The advertisement requirement for hazardous substances changed from listing hazard pictograms, signal words, hazard statements and supplemental EUH statements, plus a general-public label-following notice, to a simpler duty to mention the hazard classes or hazard categories concerned.
For mixtures, the earlier text required indicating the same pictograms, signal words and statements and, for public sales, the label-following notice, whereas the later text instead requires mentioning the type or types of hazard shown on the label, but only where the advertisement lets a member of the general public conclude a purchase contract without first seeing the label, and it adds a new cross-reference to Directive 97/7/EC on distance contracts.
The prior paragraphs on prohibited label-inconsistent statements and on omitting pictograms and signal words for non-visual advertisements no longer appear in the later text shown.
Cited: Art. 48, v1 (external, EUR-Lex) · Art. 48, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, before and after
texts differ too much for an inline diff; shown separately
Previous version, in force 1 July 2026 02008R1272-20260701
Article 48 Advertisement 1. Any advertisement for a substance classified as hazardous shall indicate, as applicable, the hazard pictograms, signal words, hazard statements and supplemental EUH statements set out in Annex II. Any advertisement for such a substance for sale to the general public shall in addition state: Always follow the information on the product label.. 2. Any advertisement for a mixture classified as hazardous or covered by Article 25(6) shall indicate the hazard pictograms, signal words, hazard statements and supplemental EUH statements set out in Annex II. Any advertisement for such a mixture for sale to the general public shall, in addition, state: Always follow the information on the product label.. 3. Any advertisement for a substance or a mixture classified as hazardous shall not contain statements that are not to appear on the label or packaging of that substance or mixture in accordance with Article 25(4). 4. By way of derogation from paragraphs 1 and 2, the hazard pictograms and signal words may be omitted where the advertisement is non-visual.
this version, in force 1 January 2027 02008R1272-20270101
Article 48 Advertisement 1. Any advertisement for a substance classified as hazardous shall mention the hazard classes or hazard categories concerned. 2. Any advertisement for a mixture classified as hazardous or covered by Article 25(6) which allows a member of the general public to conclude a contract for purchase without first having sight of the label shall mention the type or types of hazard indicated on the label. The first subparagraph shall be without prejudice to Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts OJ L 144, 4.6.1997, p. 19..
Art. 48a Distance sales offers, Deleted§
Not in every listWhat this means
Found in the text, but not every source lists it — the text comparison and the amending act's instructions found this change; the EU's own amendment metadata does not list it. The source that does not name it is the EU's own amendment metadata. All are shown; none is overruled.
Explanation, written by a model and checked against the cited text
Article 48a, which required that distance-sales offers of substances or mixtures clearly and visibly show the label elements referred to in Article 17, no longer appears in the text.
Cited: Art. 48a, v1 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex
Deleted in this version, from 02008R1272-20260701
Article 48a Distance sales offers When substances or mixtures are placed on the market through distance sales, the offer shall clearly and visibly indicate the label elements referred to in Article 17.
Annex II SPECIAL RULES FOR LABELLING AND PACKAGING OF CERTAIN SUBSTANCES AND MIXTURES, Modified§
Not in every listWhat this means
Found in the text, but not every source lists it — the text comparison found this change; the EU's own amendment metadata does not list it and the amending act's instructions do not mention it. Only the text comparison found it. All are shown; none is overruled.
Explanation, written by a model and checked against the cited text
In section 2, the introductory sentence now refers only to sections 2.1 to 2.10 and no longer includes a reference to section 2.12.
In section 5, the heading changes from a description of a list to the phrase naming a list, and the body text is shortened to a single reference to ready mixed cement and concrete in the wet state, removing the earlier description of label-copy obligations and the separate paragraph on filling-station pumps and receptacles.
Cited: Annex II, v1 (external, EUR-Lex) · Annex II, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, before and after
Previous version, in force 1 July 2026 02008R1272-20260701 → this version, in force 1 January 2027 02008R1272-20270101
ANNEX II
SPECIAL RULES FOR LABELLING AND PACKAGING OF CERTAIN SUBSTANCES AND MIXTURES
This Annex consists of 5 parts:
Part 1 contains special rules for the labelling of certain classified substances and mixtures.
Part 2 sets out rules for additional hazard statements to be … 620 unchanged words … mixtures in addition to classification for skin corrosivity, if no acute inhalation test data are available and which may be inhaled.
2. PART 2: SPECIAL RULES FOR SUPPLEMENTAL LABEL ELEMENTS FOR CERTAIN MIXTURES
The statements set out in sections 2.1 to 2.10 and 2.12 shall be assigned to mixtures in accordance with Article 25(6).
2.1. Mixtures containing lead
The label on the packaging of paints and varnishes containing lead in quantities exceeding 0,15 % (expressed as weight of metal) of the total weight of the mixture, … 2,181 unchanged words … and Annex V of that Directive, the labelling for plant protection products subject to Directive 91/414/EEC shall also include the following wording:
EUH401 — To avoid risks to human health and the environment, comply with the instructions for use
5. PART 5: LIST OF HAZARDOUS SUBSTANCES AND MIXTURES TO WHICH ARTICLE 29(3) APPLIES
Ready mixed cement and concrete in the wet state shall be accompanied by a copy of the label elements in accordance with Article 17.
For a substance or a mixture supplied at a filling station and directly pumped into a receptacle that forms an integral part of a vehicle and from where the substance or mixture is normally not intended to be removed, the label elements referred to in Article 17 shall be provided on a visible place on the respective pump. When vehicle fuels are supplied at a filling station through pumping into portable receptacles designed to be used for fuels, a physical copy of the label elements referred to in Article 17 shall, in addition to the visible place on the pump, also be provided to be attached to the receptacle. state.
Annex VIII HARMONISED INFORMATION RELATING TO EMERGENCY HEALTH RESPONSE AND PREVENTATIVE MEASURES, Modified§
Not in every listWhat this means
Found in the text, but not every source lists it — the text comparison and the EU's own amendment metadata found this change; the amending act's instructions do not mention it. The source that does not name it is the amending act's instructions. All are shown; none is overruled.
Explanation, written by a model and checked against the cited text
The revised Annex now names distributors referred to in Article 45(1b) and (1c), alongside importers and downstream users, as subject to the application and definitions provisions in Part A sections 1 and 2, and also adds a new definition of a composition conforming with a standard formula in section 2.4.
Part B section 1.1a is newly added requiring the name and product description of the standard formula or fuel name to be included in a submission, section 3.1 adds text on notifying standard formula components with concentration ranges including 0%, and section 3.6's heading and text are adjusted to refer to compositions conforming with a standard formula, while section 3.7's fuel table column heading changes from Fuel to Fuel name and section 4.1 adds a new residual category covering other changes relevant for emergency health response.
Part C section 1.4 and the standard formula tables in Part D now include a standard formula name and product description field that was not present before, and the text is truncated before showing the remainder of the Part D changes.
Cited: Annex VIII, v2 (external, EUR-Lex) · Annex VIII, v1 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, before and after
Previous version, in force 1 July 2026 02008R1272-20260701 → this version, in force 1 January 2027 02008R1272-20270101
ANNEX VIII
HARMONISED INFORMATION RELATING TO EMERGENCY HEALTH RESPONSE AND PREVENTATIVE MEASURES
PART A
GENERAL REQUIREMENTS
1. APPLICATION
1.1. Importers and Importers, downstream users and distributors referred to in Article 45(1b) and (1c) placing on the market mixtures for consumer use, within the meaning of Section section 2.4 of Part A of this Annex, shall comply with this Annex from 1 January 2021.
1.2. Importers and Importers, downstream users and distributors referred to in Article 45(1b) and (1c) placing on the market mixtures for professional use, within the meaning of Section section 2.4 of Part A of this Annex, shall comply with this Annex from 1 January 2021.
1.3. Importers and Importers, downstream users and distributors referred to in Article 45(1b) and (1c) placing on the market mixtures for industrial use or mixtures with an end use not subject to notification within the meaning of Section section 2.4 of Part A of this Annex, shall comply with this Annex from 1 January 2024.
1.4. Importers and Importers, downstream users and distributors referred to in Article 45(1b) and (1c) 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 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 section 1.4, if one of the changes described in Section section 4.1 of Part B of this Annex occurs before 1 January 2025, importers and importers, downstream users and distributors referred to in Article 45(1b) and (1c) shall comply with this Annex before placing that mixture, as changed, the mixture concerned on the market.
2. PURPOSE, SCOPE AND DEFINITIONS
2.1. This Annex sets out the requirements that importers and importers, downstream users and distributors referred to in Article 45(1c) (submitters) placing mixtures on the market, hereinafter submitters market shall fulfil in respect of the submission of information so that appointed bodies shall have at their disposal the information required 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.
This Annex shall not apply to mixtures classified only for one or more of the following hazards:
(1) Gases under pressure;
(2) 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.
2.3. 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:
(1) 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;
(2) 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;
(3) mixture for industrial use means a mixture intended to be used at industrial sites only;
(4) 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;
(5) 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. met;
(6) composition conforming with a standard formula specified in Part D means a composition which includes all the components listed in one of the standard formulas referred to in Part D of this Annex, where those components are present in the mixture in concentrations within the ranges specified in that standard formula.
3. SUBMISSION REQUIREMENTS
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 … 824 unchanged words … 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.
1.1a. Name and product description of standard formula or name of fuel
For mixtures with a composition conforming with a standard formula specified in Part D, the name and product description of the relevant standard formula as indicated in that Part shall be included in the submission.
For fuels listed in Table 3, the name of the fuel shall be provided as indicated in that table.
1.2. Details of the submitter and contact point
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 … 437 unchanged words … with Annex II to Regulation (EC) No 1907/2006, provided that additional information on the composition is rapidly available on request in emergencies in accordance with Section 1.3.
Components which are not present in a mixture shall not be notified. However, if they those components are notified as part of an interchangeable component group in accordance with Section 3.5 section 3.5. or their concentration has been submitted as a range of percentages in accordance with Sections sections 3.6 or 3.7, they may be notified if it is certain that they will certainly be present in the mixture at some point in time.
In addition, for mixtures with a composition conforming with a standard formula specified in Part D for which the composition is notified in accordance with section 3.6, first indent, components listed in the relevant standard formula shall be notified even if the component is potentially not, or not permanently, present in cases where the indicated concentration range in Part D includes 0 %.
By way of derogation from the third 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 … 1,400 unchanged words … in an interchangeable component group not classified as hazardous, shall be expressed, in accordance with Table 2 of Section 3.4.2, as ranges of percentages in descending order by mass or volume. As an alternative, exact percentages may be provided.
3.6. Mixtures complying with a composition conforming with a standard formulas formula
By way of derogation from Sections 3.2, 3.3 and 3.4, for a mixture with a composition conforming with a standard formula specified in Part D, where the mixture classification does not change depending on the components’ concentration within the ranges of percentages specified in the corresponding standard formula:
if the information on composition in the standard formula, together with information as specified in Sections 3.2 to 3.4 on the identity and concentration of the components not specified in the standard formula, is not less detailed than that contained in the Safety Data Sheet in accordance with Annex II to Regulation (EC) No 1907/2006, the identity and concentration of one or more of the mixture’s components may be submitted as specified in the standard formula for the components mentioned in that formula and as specified in Sections 3.2 to 3.4 for the other components,
if the information referred to in the previous indent is less detailed than that contained in the Safety Data Sheet in accordance with Annex II to Regulation (EC) No 1907/2006, the information on the identity and concentration of all the mixture’s components contained in the Safety Data Sheet in accordance with Annex II to Regulation (EC) No 1907/2006 shall be given.
3.7. Fuels
By way of derogation from Sections 3.2, 3.3 and 3.4, for those fuels listed in Table 3, the identity and concentration of the mixture’s components listed in the Safety Data Sheet in accordance with Annex II to Regulation (EC) No 1907/2006 may be submitted. The identity and concentration of any other known component shall also be submitted.
Table 3
List of fuels
Fuel name 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 … 343 unchanged words … the mixture beyond the concentration range provided in the original submission;
(c) 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 4.
when there are other changes to a mixture placed on the market which are relevant for the emergency health response referred to in Article 45
By way of derogation from the fourth indent of the first subparagraph, the following shall apply:
(a) a submission update for mixtures with a composition conforming with any of the standard formulas specified in Part D is required only when the composition of the mixture changes in such a manner that the mixture’s composition no longer conforms with the standard formula;
(b) for mixtures where the information on composition is provided based on the Safety Data sheet in accordance with Section 3.6 or 3.7 a submission update is required when Section 3 of the Safety Data Sheet is updated.
Table 4
Variations 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 %
When perfumes in a group submission change, the list of mixtures and the perfumes they contain as required in Section 3.1 shall be updated.
4.2. Content of the submission update
The submission update shall comprise a revised version of the previous submission containing the new information available as described in Section 4.1.
PART C
SUBMISSION FORMAT
1. SUBMISSION FORMAT
1.1. Submission Format
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:
1.2. Identification of the mixture, submitter and contact point
Product identifier
Complete trade name(s) of the product (in including, where relevant, brand name(s), name of the product and variant name(s) as they appear on the label, without abbreviations or non-alphanumerical symbols and enabling specific identification of the product
Unique formula identifier(s) (UFI)
Other identifiers (authorisation number, company product codes)
In the case of group submission, all product identifiers shall be listed)
Other names, synonyms
Unique Formula Identifier(s) (UFI)
Other identifiers (authorisation number, company listed
Name and product codes) description of standard formula or name of fuel
Standard formula name and product description as specified in Part D (where applicable)
Fuel name as specified in Table 3 of Part B (where applicable)
Contact details of the submitter submitter, as defined in Section 2.1 of Part A of this Annex, and contact point
Name
Full address
Telephone number
Email address
Contact details for rapid access to additional product information (24 hours/7 days). Only for limited submission.
Name
Telephone number (accessible 24 hours per day, 7 days per week)
Email address
1.3. Classification of the mixture, label elements and toxicology
Classification of the mixture and label elements
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)
Toxicological information
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 No 1907/2006)
Additional information on the mixture
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)
1.4. Information on the mixture components and interchangeable component groups
Identification of the mixture components
Chemical/trade name of the components
CAS number (where applicable)
EC number (where applicable)
UFI (where applicable)
Standard formula name and product description (where applicable)
Name of interchangeable component groups (where applicable)
Concentration and concentration ranges of the mixture components
Exact concentration or concentration range
Classification of mixture components
Hazard classification (where applicable)
Additional identifiers (where applicable and relevant for health response)
List according to A list as provided for in Part B, Section section 3.1, fifth subparagraph (where applicable)
PART D
STANDARD FORMULAS
For standard formulas 1-17 the following conditions apply:
Heavy metal, trace elements: As, Ba, Cd, Cr, Co, Cu, Hg, Mo, Ni, Pb, Sb, Sn, Te, Tl, V are below 0,1 w/w % and Mn, Sr, Zn are below 1 w/w %
PAHs are not present
Note applying to standard formulas 1-17:
(1) UVCB substance consists of variable amounts of calcite, tricalcium silicate, dicalcium silicate, calcium oxide, quartz, potassium chloride, potassium sulfate, calcium sulfate, sodium aluminium silicate, magnesium aluminium silicate, muscovite, …
1. CEMENT
Standard formula name Cement Standard Formula – 1
Product description Portland cement
with one main constituent: clinker
Component name EC No Concentration (w/w%)
Portland cement clinker 266-043-4 86,5 – 100
Calcium sulfate 231-900-3 0 – 8
Flue dust (1) 270-659-9 0 – 5
Inorganic natural mineral materials 310-127-6
Iron(II) sulfate 231-753-5 0 – 1
Tin(II) sulfate 231-302-2 0 – 0,1
Standard formula name Cement Standard Formula – 2
Product description Portland-slag cement and Blast furnace cement
with two main constituents: clinker and slag
Component name EC No Concentration (w/w %)
Portland cement clinker 266-043-4 4,6 – 94
Granulated blast furnace slag 266-002-0 5,5 – 95
Calcium sulfate 231-900-3 0 – 8
Flue dust (1) 270-659-9 0 – 5
Inorganic natural mineral materials 310-127-6
Iron(II) sulfate 231-753-5 0 – 1
Tin(II) sulfate 231-302-2 0 – 0,1
Standard formula name Cement Standard Formula – 3
Product description Portland-silica fume cement
Portland cements with two main constituents: clinker and silica fume
Component name EC No Concentration (w/w%)
Portland cement clinker 266-043-4 82 – 94
Silica fume 273-761-1 5,5 – 10
Calcium sulfate 231-900-3 0 – 8
Flue dust (1) 270-659-9 0 – 5
Inorganic natural mineral materials 310-127-6
Iron(II) sulfate 231-753-5 0 – 1
Tin(II) sulfate 231-302-2 0 – 0,1
Standard formula name Cement Standard Formula – 4
Product description Portland-pozzolana cement, Pozzolanic cement
Portland cements with two main constituents: clinker and pozzolan (natural or natural calcined pozzolan)
Component name EC No Concentration (w/w %)
Portland cement clinker 266-043-4 41 – 94
Natural (calcined) pozzolana 310-127-6 5,5 – 55
Calcium sulfate 231-900-3 0 – 8
Flue dust (1) 270-659-9 0 – 5
Inorganic natural mineral materials 310-127-6
Iron(II) sulfate 231-753-5 0 – 1
Tin(II) sulfate 231-303-2 0 – 0,1
Standard formula name Cement Standard Formula – 5
Product description Portland-fly ash cement, Pozzolanic cement
Portland cements with two main constituents: clinker and fly ash (siliceous and calcareous fly ash)
Component name EC No Concentration (w/w %)
Portland cement clinker 266-043-4 41 – 94
Fly ash 931-322-8 5,5 – 55
Calcium sulfate 231-900-3 0 – 8
Flue dust (1) 270-659-9 0 – 5
Inorganic natural mineral materials 310-127-6
Iron(II) sulfate 231-753-5 0 – 1
Tin(II) sulfate 231-302-2 0 – 0,1
Standard formula name Cement Standard Formula – 6
Product description Portland-burnt shale cement
Portland cements with two main constituents: clinker and burnt shale
Component name EC No Concentration (w/w %)
Portland cement clinker 266-043-4 59 – 94
Burnt shale 297-648-1 5,5 – 35
Calcium sulfate 231-900-3 0 – 8
Flue dust (1) 270-659-9 0 – 5
Inorganic natural mineral materials 310-127-6
Iron(II) sulfate 231-753-5 0 – 1
Tin(II) sulfate 231-302-2 0 – 0,1
Standard formula name Cement Standard Formula – 7
Product description Portland-limestone cement
Portland cements with two main constituents: clinker and limestone
Component name EC No Concentration (w/w %)
Portland cement clinker 266-043-4 59 – 94
Limestone 215-279-6 5,5 – 35
Calcium sulfate 231-900-3 0 – 8
Flue dust (1) 270-659-9 0 – 5
Inorganic natural mineral materials 310-127-6
Iron(II) sulfate 231-753-5 0 – 1
Tin(II) sulfate 231-302-2 0 – 0,1
Standard formula name Cement Standard Formula – 8
Product description Portland-composite cement, Composite cement (slag – limestone)
Portland cements with three main constituents: clinker, slag and limestone
Component name EC No Concentration (w/w %)
Portland cement clinker 266-043-4 31,9 – 88
Granulated blast furnace slag 266-002-0 5,5 – 59
Limestone 215-279-6 5,5 – 29
Calcium sulfate 231-900-3 0 – 8
Flue dust (1) 270-659-9 0 – 5
Inorganic natural mineral materials 310-127-6
Iron(II) sulfate 231-753-5 0 – 1
Tin(II) sulfate 231-302-2 0 – 0,1
Standard formula name Cement Standard Formula – 9
Product description Portland-composite cement, Composite Cement (slag – fly ash)
Portland cements with three main constituents: clinker, blast-furnace slag, siliceous and calcareous fly ash
Component name EC No Concentration (w/w %)
Portland cement clinker 266-043-4 18,2 – 88
Granulated blast furnace slag 266-002-0 5,5 – 59
Fly ash 931-322-8 5,5 – 49
Calcium sulfate 231-900-3 0 – 8
Flue dust (1) 270-659-9 0 – 5
Inorganic natural mineral materials 310-127-6
Iron(II) sulfate 231-753-5 0 – 1
Tin(II) sulfate 231-302-2 0 – 0,1
Standard formula name Cement Standard Formula – 10
Product description Portland-composite cement, Composite cement (slag – pozzolana)
Portland cements with three main constituents: clinker, blast-furnace slag, natural or natural calcined pozzolan
Component name EC No Concentration (w/w %)
Portland cement clinker 266-043-4 18,2 – 88
Granulated blast furnace slag 266-002-0 5,5 – 49
Natural (calcined) pozzolana 310-127-6 5,5 – 49
Calcium sulfate 231-900-3 0 – 8
Flue dust (1) 270-659-9 0 – 5
Inorganic natural mineral materials 310-127-6
Iron(II) sulfate 231-753-5 0 – 1
Tin(II) sulfate 231-302-2 0 – 0,1
Standard formula name Cement Standard Formula – 11
Product description Portland-composite cement (slag – burnt shale)
Portland cements with three main constituents: clinker, blast-furnace slag, burnt shale
Component name EC No Concentration (w/w %)
Portland cement clinker 266-043-4 59 – 94
Granulated blast furnace slag 266-002-0 5,5 – 29
Burnt shale 297-648-1 5,5 – 29
Calcium sulfate 231-900-3 0 – 8
Flue dust (1) 270-659-9 0 – 5
Inorganic natural mineral materials 310-127-6
Iron(II) sulfate 231-753-5 0 – 1
Tin(II) sulfate 231-302-2 0 – 0,1
Standard formula name Cement Standard Formula – 12
Product description Portland-composite cement (limestone – fly ash)
Portland cements with three main constituents: clinker, limestone, siliceous and calcareous fly ash
Component name EC No Concentration (w/w %)
Portland cement clinker 266-043-4 46 – 94
Limestone 215-279-6 5,5 – 29
Fly ash 931-322-8 5,5 – 44
Calcium sulfate 231-900-3 0 – 8
Flue dust (1) 270-659-9 0 – 5
Inorganic natural mineral materials 310-127-6
Iron(II) sulfate 231-753-5 0 – 1
Tin(II) sulfate 231-302-2 0 – 0,1
Standard formula name Cement Standard Formula – 13
Product description Portland-composite cement (limestone – pozzolana)
Portland cements with three main constituents: clinker, limestone, natural or natural calcined pozzolan
Component name EC No Concentration (w/w %)
Portland cement clinker 266-043-4 46 – 94
Limestone 215-279-6 5,5 – 29
Natural (calcined) pozzolana 310-127-6 5,5 – 44
Calcium sulfate 231-900-3 0 – 8
Flue dust (1) 270-659-9 0 – 5
Inorganic natural mineral materials 310-127-6
Iron(II) sulfate 231-753-5 0 – 1
Tin(II) sulfate 231-302-2 0 – 0,1
Standard formula name Cement Standard Formula – 14
Product description Portland-composite cement (limestone – burnt shale)
Portland cements with three main constituents: clinker, limestone and burnt shale
Component name EC No Concentration (w/w %)
Portland cement clinker 266-043-4 59 – 94
Limestone 215-279-6 5,5 – 29
Burnt shale 297-648-1 5,5 – 29
Calcium sulfate 231-900-3 0 – 8
Flue dust (1) 270-659-9 0 – 5
Inorganic natural mineral materials 310-127-6
Iron(II) sulfate 231-753-5 0 – 1
Tin(II) sulfate 231-302-2 0 – 0,1
Standard formula name Cement Standard Formula – 15
Product description Portland-composite cement, Pozzolanic cement (fly ash – pozzolana)
Portland cements with three main constituents: clinker, siliceous and calcareous fly ash, natural or natural calcined pozzolan
Component name EC No Concentration (w/w %)
Portland cement clinker 266-043-4 41 – 94
Natural (calcined) pozzolana 310-127-6 5,5 – 55
Fly ash 931-322-8 5,5 – 55
Calcium sulfate 231-900-3 0 – 8
Flue dust (1) 270-659-9 0 – 5
Inorganic natural mineral materials 310-127-6
Iron(II) sulfate 231-753-5 0 – 1
Tin(II) sulfate 231-302-2 0 – 0,1
Standard formula name Cement Standard Formula – 16
Product description Portland-composite
Portland cements with four main constituents: clinker and three of these constituents: blast-furnace slag, silica fume, fly ash, pozzolan, burnt shale, limestone
Component name EC No Concentration (w/w %)
Portland cement clinker 266-043-4 59 – 94
Granulated blast furnace slag
Natural (calcined) pozzolana
Fly ashes
Burnt shale
Limestone
Silica fume 266-002-0
310-127-6
931-322-8
297-648-1
215-279-6
273-761-1 5,5 – 23
Calcium sulfate 231-900-3 0 – 8
Flue dust (1) 270-659-9 0 – 5
Inorganic natural mineral materials 310-127-6
Iron(II) sulfate 231-753-5 0 – 1
Tin(II) sulfate 231-302-2 0 – 0,1
Standard formula name Cement Standard Formula – 17
Product description Composite cement
Portland cements with four main constituents: clinker, slag, siliceous fly ash and natural or natural calcined pozzolan
Constituent EC No Concentration (w/w%)
Portland cement clinker 266-043-4 18,3 – 64
Granulated blast furnace slag 266-002-0 16,5 – 49
Natural (calcined) pozzolana 310-127-6 5,5 – 43
Fly ash 931-322-8 5,5 – 43
Calcium sulfate 231-900-3 0 – 8
Flue dust (1) 270-659-9 0 – 5
Inorganic natural mineral materials 310-127-6
Iron(II) sulfate 231-753-5 0 – 1
Tin(II) sulfate 231-302-2 0 – 0,1
Standard formula name Cement Standard Formula – 18
Product description Calcium aluminate cement
Constituent EC No Concentration (w/w %)
Calcium aluminate cement clinker 266-045-5 86,5 – 100
Grinding aid - 0 – 0,2
Standard formula name Cement Standard Formula – 19
Product description Masonry cements – with clinker and lime – MC 5, MC 12,5, MC 22,5
Component name EC No Concentration (w/w %)
Portland cement clinker 266-043-4 25 – 60
Building lime acc. to EN 459 215-138-9, 1 – 75
Hydrated lime acc. to EN 459 215-137-3
Other, non-hazardous inorganic constituent 310-127-6 0 – 74
Inorganic pigments acc. to EN 12878 - 0 – 1
Standard formula name Cement Standard Formula – 20
Product description Masonry cements – with clinker and without lime – MC 5, MC 12,5, MC 22,5
Component name EC No Concentration (w/w %)
Portland cement clinker 266-043-4 25 – 60
Other, non-hazardous inorganic constituent 310-127-6 40 – 75
Inorganic pigments acc. to EN 12878 0 – 1
2. GYPSUM BINDER
Standard formula name Gypsum binder Standard Formula
Product description Gypsum binder
Component name EC No Concentration
(w/w %)
Calcium sulphate 231-900-3 ≥ 50 and < 100
Calcium dihydroxide 215-137-3 > 0 and ≤ 5
3. READY MIXED CONCRETE
Standard formula name Ready mixed concrete Standard Formula 1
Concrete Product description Ready mixed concrete with concrete strength classes C8/10, C12/15, C16/20, C20/25, C25/30, C28/35, C32/40, C35/45, C40/50, C45/55, C50/60 C50/60, LC8/9, LC12/13, LC16/18, LC20/22, LC25/28, LC30/33, LC35/38, LC40/44, LC45/50, LC50/55, LC55/60
Component name EC No Concentration (w/w %)
Cement 270-659-9 3 – 18
Water 231-791-2 5 – 8
Aggregates 273-727-6 70 – 80
Air entrainers (admixture) - 0 – 0,08
Plasticisers/superplasticisers (admixture) - 0 – 0,15
Retarders (admixture) - 0 – 0,4
Accelerators (admixture) - 0 – 0,2
Water resisting (admixture) - 0 – 0,25
Fly ash 931-322-8 0 – 8
Silica fume 273-761-1 0 – 3
GGBS 266-002-0 0 – 6
Standard formula name Ready mixed concrete Standard Formula 2
Concrete Product description Ready mixed concrete with concrete strength classes C55/67, C60/75, C70/85, C80/95, C90/105, C100/105,
LC 60/66, LC70/77, LC80/88
Component name EC No Concentration (w/w %)
Cement 270-659-9 12 – 25
Water 231-791-2 5 – 8
Aggregates 273-727-6 70 – 80
Air entrainers (admixture) - 0,04 – 0,08
Plasticisers/superplasticisers (admixture) - 0 – 0,15
Retarders (admixture) - 0 – 0,4
Accelerators (admixture) - 0 – 0,2
Water resisting (admixture) - 0 – 0,25
Fly ash 931-322-8 0 – 8
Silica fume 273-761-1 0 – 3
GGBS 266-002-0- 0 – 6
The full entry is committed at eu/32008R1272/CHANGELOG.md.