emendrix

Annex VIII

Classification, Labelling and Packaging Regulation · 32008R1272 · every event for this act · on EUR-Lex

HARMONISED INFORMATION RELATING TO EMERGENCY HEALTH RESPONSE AND PREVENTATIVE MEASURES

4 changes recorded across 4 events, newest first.

in force 2025-02-01 MODIFIED+431 −3,135

Amended by Regulation (EU) 2023/1435 32023R1435

applies from: unchanged

Sources disagree — 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. All are shown; none is overruled.

References to distributors acting under Article 45(1b) and (1c) are removed throughout Part A, so the obligations in sections 1.1 to 1.5 and 2.1 now name only importers and downstream users as the actors placing mixtures on the market.

Section 2.4's closing sentence drops the former point (6) defining a composition conforming with a standard formula, and section 3.1's third subparagraph removes the added text about standard-formula components remaining notifiable even at a 0% range, simplifying the notification-of-absent-components rule to depend only on interchangeable component group or range submission status.

Section 3.6's heading changes from referring to a mixture's composition conforming with a standard formula to referring to mixtures complying with standard formulas, section 4.1 drops the closing indent about other changes relevant for emergency health response, and Part C section 1.4 removes the standard formula name and product description line while section 1.2 restructures the product identifier and standard formula/fuel name entries; the standard formula tables in Part D are relabelled from "Standard formula name" plus a separate number line to a single "Cement Standard Formula – [number]" heading.

Cited: Annex VIII, v1 · Annex VIII, v2

text before / after

02008R1272-2024121002008R1272-20250201

ANNEX VIII HARMONISED INFORMATION RELATING TO EMERGENCY HEALTH RESPONSE AND PREVENTATIVE MEASURES PART A GENERAL REQUIREMENTS 1. APPLICATION 1.1. Importers, Importers and 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, Importers and 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, Importers and 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, Importers and 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, importers and downstream users and distributors referred to in Article 45(1b) and (1c) shall comply with this Annex before placing the mixture concerned that mixture, as changed, on the market. 2. PURPOSE, SCOPE AND DEFINITIONS 2.1. This Annex sets out the requirements that importers, importers and downstream users and distributors referred to in Article 45(1c) (submitters) placing mixtures on the market market, hereinafter submitters 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; (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. met. 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 those components they 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 formula formulas 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 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 (in case of group submission, all product identifiers shall be listed Name and listed) Other names, synonyms Unique Formula Identifier(s) (UFI) Other identifiers (authorisation number, company product 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) codes) Contact details of the submitter, as defined in Section 2.1 of Part A of this Annex, submitter 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) A list as provided for in List according to 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 Product description Ready mixed concrete with concrete 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 Product description Ready mixed concrete with concrete 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

in force 2024-12-10 MODIFIED

Amended by Regulation (EU) 2024/2865 32024R2865

applies from: unchanged

Sources disagree — 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. All are shown; none is overruled.

The revised Annex extends the application, purpose and derogation provisions of Part A sections 1 and 2 to distributors referred to in Article 45(1b) and (1c), in addition to importers and downstream users, and adds a new definition of a composition conforming with a standard formula in section 2.4.

Part B adds a new section 1.1a requiring the name and product description of the relevant standard formula or fuel name to be included in a submission, adds wording in section 3.1 requiring notification of standard-formula components even where the formula's range includes 0%, renames section 3.6 and Table 3's fuel column heading, and adds a further ground for a submission update in section 4.1 covering other changes relevant to the emergency health response under Article 45.

Part C's section 1.4 (and related identification text) is updated to add references to the standard formula name and product description and to a defined submitter contact point, alongside minor wording adjustments to the trade name and list descriptions, while the standard formula tables in Part D are relabelled with a separate "Standard formula name" field instead of embedding the formula number in the product description line.

Cited: Annex VIII, v2 · Annex VIII, v1

text before / after, on the event page →

in force 2020-11-14 MODIFIED

Amended by Regulation (EU) 2020/1676 32020R1676 · Regulation (EU) 2020/1677 32020R1677

applies from: unchanged

The revised Annex broadens Section 1.3's applicability wording to also cover mixtures with an end use not subject to notification, adds a new Section 2.2a exempting bespoke paints from submission and UFI creation, and expands the definitions in Section 2.4 to add the concepts of 'mixture with an end use not subject to notification' and 'bespoke paint', while also reworking the consumer and professional use definitions to cover mixtures incorporated into other mixtures.

Part A's rules on UFI creation, UFI placement and limited submissions are rewritten with new derogations, including a new interchangeable-component-group exception to UFI creation and reordered/renumbered UFI location provisions, and Part B introduces new Sections 3.5 through 3.8 covering grouping of components into interchangeable component groups, standard formulas and fuels, alongside changes to how mixtures in mixtures are identified in Section 3.2.2 and how submission updates are triggered in Section 4.1.

Part C's Section 1.4 heading and content are changed to address mixture components and interchangeable component groups rather than only mixture components, and a wholly new Part D setting out standard formulas (including cement formulas) is added, though that Part D text is truncated in the material shown.

Cited: Annex VIII, v1 · Annex VIII, v2

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in force 2020-01-01 INSERTED

Amended by Regulation (EU) 2020/11 32020R0011 · Regulation (EU) 2017/542 32017R0542

applies from: unknown (an inserted provision states its own application date only in prose)

This is a newly inserted Annex setting out harmonised information requirements for emergency health response and preventative measures, covering who must submit information, what must be submitted, unique formula identifiers, group submissions, and the submission format itself.

The Annex's own text states differing compliance dates for different categories of mixtures and for prior submissions, rather than a single applicability date for the whole provision.

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.

Cited: Annex VIII, v2

text before / after, on the event page →