CELEX: 
Language: en
Date: 2020-08-31 00:00:00
Title: COMMISSION DELEGATED REGULATION (EU) …/... amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures in order to improve the workability of information requirements related to emergency health response

EUROPEAN
                             COMMISSION
                                                       Brussels, 31.8.2020
                                                       C(2020) 5758 final
                  COMMISSION DELEGATED REGULATION (EU) …/...
                                           of 31.8.2020
   amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council
      on classification, labelling and packaging of substances and mixtures in order to
     improve the workability of information requirements related to emergency health
                                             response
                                    (Text with EEA relevance)
EN                                                                                      EN
 ---pagebreak---                                    EXPLANATORY MEMORANDUM
   1.       CONTEXT OF THE DELEGATED ACT
   According to Article 45(1) of Regulation (EC) No 1272/2008, Member States' appointed
   bodies shall be responsible for receiving information from importers and downstream users on
   the hazardous chemical mixtures they place on the market. Commission Regulation
   (EU) 2017/542 amended Regulation (EC) 1272/2008 by adding an Annex harmonising the
   information to be provided relating to emergency health response (“Annex VIII”)1.
   Annex VIII was adopted in March 2017. After adoption, Member States and industry
   stakeholders called for amendments of Annex VIII before its compliance date, for reasons of
   serious workability concerns2. The Commission services commissioned a study to assess the
   legitimacy of the claims and the impact on duty holders and concluded that an amendment of
   Annex VIII was indeed necessary. The amendment would constitute a second amendment to
   the Regulation, after the adoption of Regulation (EU) 2020/11, which deferred the compliance
   date for mixtures for consumer use and aimed at a more streamlined interpretation of the
   rules, improving internal coherence and mitigating some unintended consequences that had
   only become apparent since the adoption of Regulation (EU) 2017/542.
   The Commission is now proposing to add paragraph (8) to Article 25 as well as to amend
   Annex VIII of Regulation (EC) 1272/2008 in order to solve the workability issues.
   In line with the empowerments given under Regulation (EC) No 1272/2008, amended through
   Regulation (EU) 2019/1243, and in particular Article 53c thereof, the Commission shall adopt
   a separate delegated act in respect of each power delegated to it. Since powers delegated for
   the amendment of Article 25 and Annex VIII are different, the Commission is proposing two
   separate delegated acts.
   This proposed act contains the amendment of Annex VIII and addresses the concerns raised,
   i.e. the difficulty or impossibility of knowing the exact composition of products in cases
   where raw materials with highly variable or unknown composition are used, where multiple
   suppliers are being used for components that are stored in the same recipient, or where
   complex supply chains are involved, as well as the impossibility to know in advance which
   exact bespoke mixtures will be placed on the market.
   This proposed act introduces a general solution with the concept of an interchangeable
   component group (‘ICG’), as well as more sector specific solutions for gypsum, ready mixed
   concrete, cement and fuels and bespoke paints.
   2.       CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT
   Pursuant to Article 53a(4) of Regulation (EC) No 1272/2008, experts designated by each
   Member State were consulted in the relevant expert group CARACAL (Competent
   Authorities for REACH and CLP (E02385)) according to the rules of the Interinstitutional
   1
           OJ L 78, 23.3.2017, p. 1–12.
   2
           Notably the difficulty or impossibility of knowing the exact composition of products in cases where raw
           materials with highly variable or unknown composition are used, where multiple suppliers are being
           used for components that are stored in the same recipient, or where complex supply chains are involved.
EN                                                        1                                                        EN
 ---pagebreak---    Agreement on Better Law-Making of 13 April 20163. This included also members of the
   European Association of Poison Centres and Clinical Toxicologists (EAPCCT).
   Furthermore, the initiative was published for feedback during the period 12 May 2020 –
   9 June 2020 under the title “Hazardous chemicals - updated requirements for submitting
   information to poison centres” (https://ec.europa.eu/info/law/better-regulation/have-your-
   say/initiatives/12384-Amending-requirements-for-information-for-poison-centers). The public
   feedback received can be summarised as follows.
   The Commission received 21 comments from individuals and organisations, almost all
   associated with the chemicals industry and mainly located in Europe.
   More specifically, the vast majority of comments was submitted by industrial stakeholders
   (95% of the comments came from either companies, or business organisations/associations)
   whilst comments submitted by other entities made up 5% in total.
   Overall, commentators very much welcomed the proposed act and mentioned that the general
   and sector specific solutions provided are workable.
   The vast majority of the comments concerned a request to postpone the first compliance date
   of 1 January 2021 stipulated in Commission Delegated Regulation (EU) YYYY/XXX
   [C(2020)5758]. The reasons provided were the large numbers of mixtures claimed to have to
   be notified, the delay of the adoption of this act compared with the original timeline due to
   COVID-19 and the ensuing impossibility to adopt this act before the non-transmission period
   of the European Parliament and the Council during a certain period in summer4, the concern
   that the necessary IT tools developed by ECHA to which industry needs to adapt their systems
   may not be ready in time and the concern that the IT systems of the Member States may suffer
   from potential security breaches if not ready in time.
   The Commission does not intend to postpone the compliance date of 1 January 2021 for the
   following reasons: The European Chemicals Agency (“Agency”) developed and published the
   submission format as per Part C of Annex VIII already in April 2019. Further, the Agency
   developed and established a searchable database which is operational since November 2019.
   Concerning the readiness of the Member States’ IT systems, the preparation for their access to
   the searchable database is going according to plan for all Member States that have opted to
   use the searchable database of the Agency. Member States only get access to the searchable
   database if they fulfil all security requirements, so the concerns regarding security breaches
   are unfounded.
   Regarding the delay caused by COVID-19 and the ensuing impossibility to adopt this act
   before the non-transmission period of the co-legislators in a certain period in summer, the
   Commission estimates that it amounted to approximately two and a half months. In the view
   of the Commission, this however does not warrant a postponement of the compliance date.
   The feedback pointed out that a significant number of mixtures need to be notified as of
   1 January 2021. It should be taken into account that Annex VIII merely harmonises the
   submission format and that the submission obligations under Article 45 are already applicable
   since Regulation (EC) 1272/2008 entered into force. A transitional period until
   1 January 2025 for already notified mixtures under the existing national systems is foreseen
   under Regulation (EU) 2017/542, so mixtures already placed on the market can benefit from
   it.
   3
           OJ L 123, 12.5.2016, p. 1.
   4
           OJ L 123, 12.5.2016, p. 1.
EN                                                 2                                              EN
 ---pagebreak---    Commentators welcomed in particular the introduction of the ICG concept under Section 3.5.,
   Part B of Annex VIII.
   It was proposed to remove the five components limit under letter (c), second subparagraph of
   Section 3.5. of Part B given that for both the acute hazards (corrosion/irritation, aspiration)
   and the chronic hazard (skin sensitisation), the rationale for a five-component limit is not
   clear. The expert group consulted and quoted above discussed the same matter and reached
   the conclusion that the five component limit was needed as a counterbalance to the alleviated
   set of criteria for components classified for these hazard classes to be grouped in an ICG,
   compared to the set of criteria stipulated in the first subparagraph of Section 3.5 of Part B.
   Indeed, whereas in the first subparagraph all components grouped in an ICG need to have the
   same hazard classification and technical function, this is not required under the second
   subparagraph. The increase in uncertainty for poison centres through alleviation of the
   conditions needed to be balanced by the introduction of a limit to the number of components
   that can be grouped in an ICG.
   A further comment regarded the change of the wording from “toxicological profile” to
   “toxicological properties” under the third indent of letter (a), first subparagraph of Section
   3.5. of Part B, in order to avoid confusion with the meaning of the term ‘toxicological profile’
   that is used in other, international regulatory frameworks. The expert group consulted and
   quoted above discussed the same matter and concluded to change the wording which is now
   introduced in the legal text.
   Further, commentators proposed to clarify that the first and second subparagraph of Section
   3.5. of Part B apply alternatively and suggested to insert the wording “alternatively” at the
   beginning of the second subparagraph of Section 3.5. of Part B. The expert group consulted
   and quoted above discussed the same matter and reached the conclusion that the proposed
   wording emphasises more clearly that it concerns and alternative option, and agreed to add
   this wording which is now introduced.
   Moreover, it was suggested to insert the caveat “where applicable” for the pH requirement
   under letter (b), second subparagraph of Section 3.5. of Part B due to the fact that a pH can
   only be measured in aqeous mixtures. The expert group consulted and quoted above discussed
   the same matter and reached the conclusion to add this wording which is now introduced.
   Stakeholders very much welcomed the solution under Section 3.6. of Part B for mixtures
   complying with a standard formula as specified in Part D (cement, gypsum binder, ready
   mixed concrete) and suggested to the Commission to consider an extension of this solution to
   other sectors. Given the lack of evidence on the need for a simplification for other sectors, the
   Commission currently does not consider to expand this solution.
   The fuels sector very much welcomed the specific solution for fuels under Section 3.7. of
   Part B. A suggestion was made to delete the wording “until a more suitable solution is found”
   in Recital (5) of this act describing the derogation for fuels to submit the information
   contained in the safety data sheet, as well as any other known information on the products’
   chemical composition. Considering the uncertainty that the simplification provided to the
   sector will provide poison centres with the optimal level of information, the Commission is of
   the view that the wording in Recital (5) should be kept in case a more suitable solution will be
   available in the future.
   The summary of comments on bespoke paints is provided under Commission Delegated
   Regulation (EU) YYYY/XXX [C(2020)5758].
EN                                                 3                                                 EN
 ---pagebreak---    3.       LEGAL ELEMENTS OF THE DELEGATED ACT
   The legal act amends Regulation (EC) No 1272/2008. The legal basis of this delegated act is
   Article 45(4) of Regulation (EC) 1272/2008.
   For the readers’ convenience, this version of Annex VIII entirely repeals and replaces the
   previous version.
EN                                              4                                              EN
 ---pagebreak---                     COMMISSION DELEGATED REGULATION (EU) …/...
                                                of 31.8.2020
   amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council
        on classification, labelling and packaging of substances and mixtures in order to
       improve the workability of information requirements related to emergency health
                                                  response
                                        (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) 1272/2008 of the European Parliament and of the Council
   of 16 December 2008 on classification, labelling and packaging of substances and mixtures,
   amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation
   (EC) 1907/20065, and in particular Article 45(4) thereof,
   Whereas:
   (1)    Regulation (EC) No 1272/2008 was amended by Commission Regulation
          (EU) 2017/5426 to add certain requirements for the submission of information relating
          to emergency health response and for the inclusion of a ‘unique formula identifier’ in
          the supplemental information provided on the label of a hazardous mixture. The
          requirements were amended by Commission Delegated Regulation (EU) 2020/11 7.
          Importers and downstream users are required to start complying with the requirements
          in stages, according to a series of compliance dates depending on the use for which a
          mixture is placed on the market
   (2)    Concerns have been raised by various industry sectors regarding the workability of the
          emergency health response information requirements in certain cases, notably with
          regard to the difficulty of knowing the exact composition of mixtures in cases where
          raw materials with a highly variable or unknown composition are used in the
          manufacture of the mixture, in cases where toxicologically very similar components
          supplied by multiple, different suppliers are used together in the same production line,
          or in cases involving complex supply chains. Concerns have also been raised, in the
          case of bespoke mixtures, about the impossibility of knowing in advance which exact
          bespoke mixtures are to be placed on the market.
   5
          OJ L 353, 31.12.2008, p.1.
   6
          Commission Regulation (EU) 2017/542 of 22 March 2017 amending Regulation (EC) No 1272/2008 of
          the European Parliament and of the Council on classification, labelling and packaging of substances and
          mixtures by adding an Annex on harmonised information relating to emergency health response (OJ L
          78, 23.3.2017, p. 1).
   7
          Commission Delegated Regulation (EU) 2020/11 of 29 October 2019 amending Regulation (EC)
          No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging
          of substances and mixtures as regards information relating to emergency health response (OJ L 6,
          10.1.2020, p. 8).
EN                                                     5                                                          EN
 ---pagebreak---    (3) It is necessary to address the situation where different but toxicologically very similar
       components are used in a mixture, and where it is unknown which component is
       present in a particular mixture placed on the market at a given time. To ensure that the
       emergency health response requirements can be complied with properly in practice,
       importers and downstream users should be allowed to group toxicologically similar
       components of a mixture together in an interchangeable component group and provide
       information on the total concentration of those components present in the mixture,
       without having to specify their separate concentrations. In order to allow poison
       centres to formulate a suitable emergency health response, components should only be
       grouped in an interchangeable component group if their classification for health and
       physical effects is identical and if the hazards identification and the additional hazard
       information are identical for all possible combinations of the resulting final mixture
       incorporating those components. For components classified for certain hazard classes,
       it should also be necessary for them to have the same technical function and the same
       toxicological properties in order to be grouped.
   (4) In order to address particular difficulties encountered by the gypsum, ready-mixed
       concrete and cement sectors and to allow them to comply with the emergency health
       response requirements without reducing the level of safety, it should be possible for
       emergency health response information relating to certain standardised mixtures
       within those three sectors to be submitted by reference to a standard composition.
       However, in order to allow poison centres to formulate a suitable emergency health
       response, this option should only be available in cases where the mixture classification
       does not change according to the mixture’s composition within the concentration
       ranges specified in the standard formula, and where the information on composition is
       at least as detailed as the information contained in the mixture’s safety data sheet,
       drawn up in accordance with Article 31 of Regulation (EC) No 1907/2006 (“safety
       data sheet”). In the event that the information contained in the safety data sheet is
       more detailed than the information on the composition in the standard formula,
       importers and downstream users should be required to notify the information in the
       safety data sheet instead.
   (5) In order to address particular difficulties anticipated for certain fuels, and taking into
       account the facts that fuels placed on the market normally conform to a technical
       standard and that poison centres have communicated a low number of poisoning
       incidents with fuels, it should be possible, until a more suitable solution is found, to
       submit emergency health response information by reference to the information
       contained in the safety data sheet, as well as any other known information on the
       products’ chemical composition.
   (6) In order to satisfy customer demand for very specific paint shades, formulators are
       sometimes asked to formulate and supply paints on a bespoke basis at the point of sale.
       These bespoke paints could have an almost unlimited number of different
       compositions. Therefore, without any mitigating measures, compliance with the
       emergency health response requirements in Annex VIII to Regulation (EC) No
       1272/2008 would require formulators of bespoke paints either to submit information
       and create unique formula identifiers (UFIs) in advance for an extremely large number
       of paints of all possible colour combinations, many of which might never be supplied
       in reality, or to postpone each supply until the information had been submitted and the
       UFI had been created. Either approach would place a disproportionate burden on the
       bespoke paints industry, in particular small and medium sized enterprises, without
       improving the level of safety significantly.
EN                                              6                                                 EN
 ---pagebreak---    (7)    Poison centres have not communicated a significant number of accidents related to
          paints. In light of the apparently lower risks compared to other mixtures, it is justified
          to allow a more flexible approach, as this would not be reducing the current level of
          safety.
   (8)    It is therefore appropriate to provide for the possibility to exempt bespoke paints from
          the notification obligations in Annex VIII and from the requirement to create a UFI.
          However, in that case, in order to allow poison centres to formulate a suitable
          emergency health response, the individual mixtures contained in bespoke paints
          should remain subject to all the requirements of that Annex. Alongside this
          Regulation, Commission Delegated Regulation (EU) YYYY/XXX [OP: Please insert
          reference to the act amending Article 25 of Regulation (EC) No 1272/2008 of the
          European Parliament and of the Council on the classification, labelling and
          packaging of substances and mixtures as regards bespoke paints, C(2020)5758]
          amends Article 25 of Regulation (EC) No 1272/2008 to add a new rule, in the case of
          bespoke paints for which no submission in accordance with Annex VIII has been
          made and no corresponding UFI has been created, requiring the UFIs of all the
          individual mixtures contained in the bespoke paint to be indicated on the label of the
          bespoke paint, together with the specific concentration of each such mixture with a
          UFI that is present in a concentration exceeding 5%.
   (9)    Given the number of changes to Annex VIII to Regulation (EC) No 1272/2008, it is
          appropriate to replace the whole Annex for the sake of legal clarity.
   (10)   Considering that the compliance date for mixtures for consumer and professional use
          of 1 January 2021 laid down in Annex VIII to Regulation (EC) No 1272/2008 is
          approaching, and that this Regulation enables all sectors to comply with that Annex,
          this Regulation should enter into force as early as possible.
   (11)   Regulation (EC) No 1272/2008 should therefore be amended accordingly,
   HAS ADOPTED THIS REGULATION:
                                               Article 1
   Annex VIII to Regulation (EC) No 1272/2008 is replaced by the text in the Annex to this
   Regulation.
                                               Article 2
   This Regulation shall enter into force on the day after its publication in the Official Journal of
   the European Union.
   This Regulation shall be binding in its entirety and directly applicable in all Member States.
   Done at Brussels, 31.8.2020
                                                 For the Commission
                                                 The President
                                                 Ursula VON DER LEYEN
EN                                                 7                                                  EN
 ---documentbreak---                              EUROPEAN
                             COMMISSION
                                                     Brussels, 31.8.2020
                                                     C(2020) 5758 final
                                                     ANNEX
                                           ANNEX
                                            to the
                       COMMISSION DELEGATED REGULATION
   amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council
      on classification, labelling and packaging of substances and mixtures in order to
     improve the workability of information requirements related to emergency health
                                           response
EN                                                                                      EN
 ---pagebreak---                                              ‘ANNEX
        HARMONISED INFORMATION RELATING TO EMERGENCY HEALTH
                      RESPONSE AND PREVENTATIVE MEASURES
                                             PART A
                                GENERAL REQUIREMENTS
   1.      APPLICATION
   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.
   1.3.  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.
   1.5.  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
   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.
         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)
EN                                               1                                              EN
 ---pagebreak---    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 usedby
                 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.
   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 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.
EN                                                  2                                                 EN
 ---pagebreak---    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.
   3.5. 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
   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).
   4.3. 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.
   5.     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.
        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
EN                                               3                                                EN
 ---pagebreak---          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.
   5.3.  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
   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.
EN                                                 4                                              EN
 ---pagebreak---                                                 PART B
                       INFORMATION CONTAINED IN A SUBMISSION
   1.       IDENTIFICATION OF THE MIXTURE AND OF THE SUBMITTER
   1.1.     Product identifier of the mixture
   The product identifier shall be provided in accordance with Article 18(3)(a).
   The complete trade name(s) of the mixture shall be provided, including, where relevant, brand
   name(s), name of the product and variant names as they appear on the label, without
   abbreviations and enabling its specific identification.
   In addition, the UFI(s) shall be included in the submission.
   1.2.     Details of the submitter and contact point
   The name, full address, telephone number and e-mail address of the submitter shall be
   provided, and, if different, the name, full address, telephone number and e-mail address of the
   point of contact to be used for obtaining further information relevant for emergency health
   response purposes.
   1.3.     Name, telephone number and e-mail address for rapid access to additional
            product information
   In the case of a limited submission as laid down in Section 2.3 of Part A, a name, a telephone
   number and an e-mail address shall be provided at which rapid access to detailed additional
   product information relevant for emergency health response purposes is available in the
   language provided in Section 3.3 of part A. The telephone number shall be accessible 24
   hours per day, 7 days per week.
   2.       HAZARDS IDENTIFICATION AND ADDITIONAL INFORMATION
   This Section sets out the information requirements related to the health and physical hazards
   of the mixture and the appropriate warning information associated with those hazards, as well
   as the additional information to be included in a submission.
   2.1.     Classification of the mixture
   The classification of the mixture for health and physical hazards (hazard class, category and
   statement) shall be provided in accordance with the classification rules in Annex I.
   2.2.     Label elements
   The following label elements required in accordance with Article 17 shall be provided, if
   applicable:
            –      hazard pictogram codes (Annex V);
            –      signal word;
            –      hazard statement      codes   (Annex     III, including   supplemental   hazard
                   information);
            –      precautionary statement codes (Annex IV).
EN                                                  5                                              EN
 ---pagebreak---    2.3.      Toxicological information
   The submission shall include the information on the toxicological effects of the mixture or its
   components that is required in Section 11 of the Safety Data Sheet of the mixture, in
   accordance with Annex II to Regulation (EC) No 1907/2006.
   2.4.      Additional information
   The following additional information shall be provided:
             –     the type(s) and size(s) of the packaging used to place the mixture on the market
                   for consumer or professional use;
             –     the colour(s) and the physical state(s) of the mixture, as supplied;
             –     the pH, if available, of the mixture as supplied, or where the product is a solid,
                   the pH of an aqueous liquid or solution at a given concentration. The
                   concentration of the test mixture in water shall be indicated. If the pH is not
                   available, the reasons shall be given;
             –     product category (see Section 3.4 of Part A);
             –     use (consumer, professional, industrial, or a combination of any of the three).
   3.        INFORMATION ON MIXTURE COMPONENTS
   3.1.      General requirements
   The chemical identity and the concentrations of the components contained in the mixture shall
   be indicated in the submission in accordance with Sections 3.2, 3.3 and 3.4.
   By way of derogation from the first subparagraph, in the case of a limited submission as laid
   down in Section 2.3 of Part A, the information to be submitted on the composition of a
   mixture for industrial use or a mixture with an end use not subject to notification may be
   limited to the information contained in the Safety Data Sheet in accordance with Annex II to
   Regulation (EC) No 1907/2006, provided that additional information on the composition is
   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 are
   notified as part of an interchangeable component group in accordance with Section 3.5. or
   their concentration has been submitted as a range of percentages in accordance with Sections
   3.6. or 3.7., they may be notified if they will certainly be present in the mixture at some point
   in time .
   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 list shall be provided of the mixtures and the perfumes they contain, including their
   classification.
   3.2.      Identification of mixture components
   A mixture component is either a substance or a mixture in mixture.
   3.2.1.    Substances
   The product identifier for the substances identified according to Section 3.3 shall be provided
   in accordance with Article 18(2). However, an INCI name, a colour index name or another
   international chemical name may be used, provided the chemical name is well known and
EN                                                  6                                                 EN
 ---pagebreak---    unambiguously defines the substance identity. The chemical name of substances for which an
   alternative chemical name has been allowed in accordance with Article 24 shall be provided
   as well.
   3.2.2.    Mixture in mixture
   When a mixture is used in the composition of a second mixture placed on the market, the first
   mixture is referred to as a mixture in mixture (‘MIM’).
   Information on the substances contained in a MIM shall be provided in accordance with the
   criteria of Section 3.2.1, unless the submitter does not have access to information on the full
   composition of the MIM. In the latter case,
                   (a)    if a UFI has been created for the MIM and the appointed body has
                          received the information on the MIM in a prior submission, the MIM
                          shall be identified by means of its product identifier in accordance with
                          Article 18(3)(a), together with its concentration and UFI;
                   (b)    if a UFI has been created for the MIM, but the appointed body has not
                          received the information on the MIM in a prior submission, the MIM
                          shall be identified by means of its product identifier in accordance with
                          Article 18(3)(a), together with its concentration and UFI and the
                          compositional information contained in the Safety Data Sheet in
                          accordance with Annex II to Regulation (EC) No 1907/2006 of the MIM
                          and any other known components, as well as the name, e-mail address
                          and telephone number of the MIM supplier;
                   (c)    in absence of a UFI, the MIM shall be identified by means of its product
                          identifier in accordance with Article 18(3)(a), together with its
                          concentration and the compositional information contained in the Safety
                          Data Sheet in accordance with Annex II to Regulation (EC)
                          No 1907/2006 of the MIM and any other known components, as well as
                          the name, e-mail address and telephone number of the MIM supplier.
   3.2.3.    Identification by generic component identifiers
   By way of derogation from Sections 3.2.1. and 3.2.2., the generic component identifiers
   ‘perfumes’, or ‘colouring agents’ may be used for mixture components used exclusively to
   add perfume or colour, where the following conditions are met:
             –     the mixture components are not classified for any health hazard;
             –     the concentration of mixture components identified with a given generic
                   component identifier does not exceed in total:
                   (a)    5% for the sum of perfumes, and
                   (b)    25% for the sum of colouring agents.
   3.3.      Mixture components subject to submission requirements
   The following mixture components shall be indicated:
             (1)   mixture components classified as hazardous on the basis of their health or
                   physical effects which:
                   –      are present in concentrations equal to or greater than 0.1%;
EN                                                   7                                              EN
 ---pagebreak---                   –     are identified, even if in concentrations lower than 0.1%, unless the
                        submitter can demonstrate that those components are irrelevant for the
                        purposes of emergency health response and preventative measures;
            (2)   mixture components not classified as hazardous on the basis of their health or
                  physical effects which are identified and present in concentrations equal to or
                  greater than 1%.
   3.4.     Concentration and concentration ranges of the mixture components
   Submitters shall provide the information laid down in Sections 3.4.1 and 3.4.2 with regard to
   the concentration of the mixture components, identified in accordance with Section 3.3.
   3.4.1.   Hazardous components of major concern for emergency health response and
            preventative measures
   When mixture components are classified in accordance with this Regulation for at least one of
   the hazard categories listed below, their concentration in the mixture shall be expressed as
   exact percentages, in descending order by mass or volume.
            –     Acute toxicity, Category 1, 2 or 3;
            –     Specific target organ toxicity - Single exposure, Category 1 or 2;
            –     Specific target organ toxicity - Repeated exposure, Category 1 or 2;
            –     Skin corrosion, category 1, 1A, 1B or 1C;
            –     Serious eye damage, Category 1.
   As an alternative to providing concentrations as exact percentages, a range of percentages
   may be submitted in accordance with Table 1.
                                                    Table 1
        Concentration ranges applicable to hazardous components of major concern for
                                     emergency health response
                 Concentration range of the                  Maximum width of the
             hazardous component contained in            concentration range to be used
                      the mixture (%)                           in the submission
                        ≥ 25 - < 100                              5 % units
                         ≥ 10 - < 25                              3 % units
                          ≥ 1 - < 10                              1 % units
                         ≥ 0.1 - < 1                             0.3 % units
                         > 0 - < 0.1                             0.1 % units
   3.4.2.   Other hazardous components and components not classified as hazardous
   The concentration of the hazardous components in the mixture that are not classified for any
   of the hazard categories listed in Section 3.4.1 and of the identified components not classified
   as hazardous shall be expressed, in accordance with Table 2, as ranges of percentages in
   descending order by mass or volume. As an alternative, exact percentages may be provided.
EN                                                  8                                               EN
 ---pagebreak---                                                       Table 2
                  Concentration ranges applicable to other hazardous components and
                                    components not classified as hazardous
                         Concentration range of the                    Maximum width of the
                   component contained in the mixture              concentration range to be used
                                      (%)                                in the submission
                                 ≥ 25 - < 100                              20 % units
                                  ≥ 10 - < 25                              10 % units
                                  ≥ 1 - < 10                                3 % units
                                   >0-<1                                    1 % units
   By way of derogation from the first subparagraph, for perfume components in a group
   submission that are not classified or only classified for skin sensitisation Category 1, 1A or
   1B or aspiration toxicity, submitters shall not be required to provide information on their
   concentration.
   3.5.     Grouping of components in an interchangeable component group
   Components may be grouped in a submission in an interchangeable component group
   provided that:
            (a)   for all components in the interchangeable component group,
                  –       the technical function(s) for which the components are used in the
                          mixture for which the submission is made is (are) identical, and
                  –       the classification for health and physical hazards is identical (hazard class
                          and category), and
                  –       the toxicological properties, including at least the type of toxicological
                          effect(s) and the target organ(s), are the same, and
            (b)   for all possible combinations of the resulting final mixture based on the
                  components in the interchangeable component group, the hazards identification
                  and additional information referred to in Section 2 of Part B are identical.
   Alternatively, components that are classified only for skin corrosion, skin irritation, eye
   damage, eye irritation, aspiration toxicity, or respiratory or skin sensitisation, or a
   combination thereof, may be grouped in an interchangeable component group provided that:
            (a)   the classification for health and physical hazards (hazard class and category) is
                  identical for all components, and
            (b)   the pH, where applicable, of all components classified for skin corrosion, skin
                  irritation, eye damage, or eye irritation is either acidic, neutral or alkaline, and
            (c)   the interchangeable component group does not contain more than five
                  components, and
            (d)   for all possible combinations of the resulting final mixture based on the
                  components grouped in the interchangeable component group, the hazards
                  identification and additional information referred to in Section 2 of Part B are
                  identical.
EN                                                    9                                                 EN
 ---pagebreak---    3.5.1.    Name of interchangeable component group and identification of grouped
             components
   An interchangeable component group shall be given a name which corresponds to the
   technical function(s) of the grouped components for which they were incorporated in the
   mixture.
   Each component in an interchangeable component group shall be identified in accordance
   with Section 3.2.1. or 3.2.2., as applicable.
   3.5.2.    Concentration and concentration ranges of grouped components
   By way of derogation from the first subparagraph of Section 3.4., for components grouped in
   an interchangeable component group, submitters shall provide the information laid down in
   Sections 3.4.1 and 3.4.2 with regard to the total concentration of all components present in the
   mixture and grouped in the interchangeable component group.
   When mixture components grouped in an interchangeable component group are classified in
   accordance with this Regulation for at least one of the hazard categories listed in Section
   3.4.1., the total concentration of the components present in the mixture and grouped in the
   interchangeable component group shall be expressed as exact percentages, in descending
   order by mass or volume. As an alternative, a range of percentages may be submitted in
   accordance with Table 1 of that Section.
   The total concentration of the hazardous components present in the mixture and grouped in an
   interchangeable component group that are not classified for any of the hazard categories listed
   in Section 3.4.1, and the total concentration of the identified components present in the
   mixture and grouped 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 standard 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
EN                                                  10                                               EN
 ---pagebreak---    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.
EN                                            11                                           EN
 ---pagebreak---                                                        Table 3
                                                     List of fuels
           Fuel              Product description
           Gasoline EN228    Automotive fuels - Unleaded petrol
           Gasoline E85      Automotive fuels –Ethanol (E85) automotive fuel
           Gasoline          Motor fuels – special petrol for powered implements
           alkylate
           LPG               Liquefied Petroleum Gas used as fuel
           LNG               Liquefied Natural Gas used as fuel
           Diesel fuel       Automotive fuels - diesel engine fuels with/without biofuel
           Paraffinic diesel Automotive fuels - Paraffinic diesel fuel from synthesis           or
           fuels (e.g GTL,   hydrotreatment
           BTL or HVO)
           Heating oil       Liquid mineral fuels with the characteristics of domestic fuel oil
           MK 1 diesel       Automotive fuels – Diesel fuel oil of environmental class 1 and 2 for
                             high-speed diesel engines
           Aviation fuels    Aviation turbine engine and piston engine fuels
           Kerosene        - Illuminating paraffin lampoil Type B and C
           Illuminating
           paraffin
           Heavy fuel oil    All grades of heavy fuel oil
           Marine fuel       Marine fuels, containing or not biodiesel
           Fatty acid methyl Fatty acid methyl esters (FAME) for use in diesel engines and heating
           esters (FAME) –   applications
           Diesel B100
   3.8.      Classification of mixture components
   The classification for health and physical effects (hazard classes, hazard categories and hazard
   statements) of substances identified in accordance with Section 3.3 and contained in the
   mixture shall be provided. This includes the classification for at least all substances, indicated
   pursuant to Point 3.2.1. of Annex II to Regulation (EC) 1907/2006 in the Safety Data Sheet of
   the mixture and in the Safety Data Sheet of any MIM contained in the mixture. For MIMs
   identified in accordance with Section 3.3 where the submitter does not have access to the full
   composition of the MIM, the classification for health and physical effects of the MIM shall be
   provided in addition.
   4.        SUBMISSION UPDATE
   4.1.      Conditions for submission update
   Where one of the following changes applies to a mixture in an individual or group
   submission, submitters shall provide a submission update before placing that mixture, as
   changed, on the market:
   –         when the mixture product identifier or the UFI has changed;
   –         when the mixture classification for health or physical hazards has changed;
   –         when relevant new toxicological information that is required in Section 11 of the
             Safety Data Sheet becomes available on the hazardous properties of the mixture or its
             components;
EN                                                    12                                              EN
 ---pagebreak---    –        if a change in the composition of the mixture fulfils one of the following conditions:
            (a)    addition, substitution, or deletion of one or more components in the mixture
                   that shall be indicated in accordance with Section 3.3;
            (b)    change in the concentration of a component in 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.
   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               Variations (±) of the initial
                   component contained in the mixture             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.
EN                                                  13                                             EN
 ---pagebreak---                                                 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 case of group submission, all
                  product identifiers shall be listed)
            –     Other names, synonyms
            –     Unique Formula Identifier(s) (UFI)
            –     Other identifiers (authorisation number, company product codes)
   Contact details of the submitter and contact point
            –     Name
            –     Full address
            –     Telephone number
            –     E-mail 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)
            –     E-mail 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)
EN                                                  14                                            EN
 ---pagebreak---    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)
   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 Part B, Section 3.1, fifth subparagraph (where applicable)
EN                                                  15                                                EN
 ---pagebreak---                                                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
                                         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
                                     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
EN                                                 16                                                EN
 ---pagebreak---    Iron(II) sulfate  231-753-5 0-1
   Tin(II) sulfate   231-302-2 0 -0.1
EN                  17                EN
 ---pagebreak---                                        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
                                    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
                                       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 %)
EN                                                 18                                                 EN
 ---pagebreak---      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
                                    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
EN                                                19                                          EN
 ---pagebreak---                                        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
                                    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
EN                                                 20                                               EN
 ---pagebreak---                                     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
                                  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
EN                                                21                                                 EN
 ---pagebreak---                                       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
              (1)
   Flue dust                                       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
                                      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
EN                                                22                                                    EN
 ---pagebreak---                                       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
                                      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
EN                                                 23                                                  EN
 ---pagebreak---                                       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
                                      Cement Standard Formula - 16
   Producct 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           266-002-0                    5.5 - 23
   Natural (calcined) pozzolana            310-127-6
   Fly ashes                               931-322-8
   Burnt shale                             297-648-1215-279-6
   Limestone                               273-761-1
   Silica fume
   Calcium sulfate                         231-900-3                    0-8
   Flue dust (1)                           270-659-9                    0-5
   Inorganic natural mineral materials     310-127-6                    0-5
   Iron(II) sulfate                        231-753-5                    0-1
   Tin(II) sulfate                         231-302-2                    0 - 0.1
EN                                                  24                                                       EN
 ---pagebreak---                                       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
                                      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
EN                                                  25                                                     EN
 ---pagebreak---                                     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 / hydrated lime acc. to EN 459    215-138-9, 215-  1 - 75
                                                   137-3
   Other, non-hazardous inorganic constituent      310-127-6        0 - 74
   Inorganic pigments acc. to EN 12878             -                0-1
                                    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
EN                                               26                                            EN
 ---pagebreak---    2.      GYPSUM BINDER
                         Gypsum binder Standard Formula
   Component name          EC No                 Concentration
                                                 (w/w %)
   Calcium sulphate        231-900-3             ≥ 50 and < 100
   Calcium dihydroxide     215-137-3             > 0 and ≤ 5
EN                                      27                      EN
 ---pagebreak---    3.        READY MIXED CONCRETE
                             Ready mixed concrete Standard Formula 1
        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
      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  -              0 - 0.15
   (admixture)
   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
                             Ready mixed concrete Standard Formula 2
         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  -             0 - 0.15
   (admixture)
   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
EN                                                  28                                   EN