CELEX: 
Language: en
Date: 2020-08-31 00:00:00
Title: COMMISSION DELEGATED REGULATION (EU) …/... amending Article 25 of Regulation (EC) 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures as regards bespoke paints

EUROPEAN
                            COMMISSION
                                                      Brussels, 31.8.2020
                                                      C(2020) 5759 final
                COMMISSION DELEGATED REGULATION (EU) …/...
                                          of 31.8.2020
   amending Article 25 of Regulation (EC) 1272/2008 of the European Parliament and of
    the Council on classification, labelling and packaging of substances and mixtures as
                                    regards bespoke paints
                                   (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 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 amend
   Annex VIII of Regulation (EC) 1272/2008 as they contain the solutions to solve those
   workability issues.
   In line with the empowerments given under Regulation (EC) 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 addition of paragraph (8) to Article 25 providing for a solution
   for bespoke paints. The act constitutes only part of the solution, namely the consequence for
   the labelling obligations in Article 25 of Regulation (EC) 1272/2008 of the non-necessity to
   create a UFI for bespoke paints. The non-necessity to create a UFI for bespoke paints, being
   the other part of the solution, is stipulated in Commission Delegated Regulation (EU)
   YYYY/XXX [C(2020)5759].
   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
   Agreement on Better Law-Making of 13 April 20163.
   Furthermore, the initiative was published for feedback during the period 12 May 2020 to
   9 June 2020 under the title “Introducing labelling requirements for bespoke paints relevant for
   1
           OJ L 78, 23.3.2017, p. 1–12.
   2
           For example the effects on compliance possibility of mixtures with a highly variable composition due to
           the natural origin of their components; the difficulty of knowing the exact composition of products in
           cases involving complex supply chains; and the impact of multiple suppliers of mixture components
           with the same technical properties and hazards.
   3
           OJ L 123, 12.5.2016, p. 1.
EN                                                        1                                                        EN
 ---pagebreak---    poison             centers”           (https://ec.europa.eu/info/law/better-regulation/have-your-
   say/initiatives/12315-Amending-Regulation-EC-No-1272-2008-as-regards-supplemental-
   labelling-information-for-emergency-health-response). The public feedback received can be
   summarised as follows.
   The Commission received 46 comments from individuals and organisations, mostly
   associated with the chemicals industry and mainly located in Europe.
   More specifically, the vast majority of comments was submitted by industrial stakeholders
   (92% of the comments came from either companies, or business organisations/associations)
   whilst comments submitted by other entities made up 8% in total (4% - EU citizen, 2% -
   NGO, 2% - other).
   Overall, commentators very much welcomed this proposed act stating that much progress was
   made in providing a workable solution for bespoke paints.
   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)5759]. 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.
   Concerning the introduction of Article 25(8), it was commented that no concentration
   threshold for the mentioning of the UFIs on the bespoke paint’s packaging of the hazardous
   mixtures contained in it is set and a 10% threshold was proposed. The expert group consulted
   and quoted above discussed the same matter and reached the conclusion that a much lower
   4
           OJ L 123, 12.5.2016, p. 1.
EN                                                   2                                               EN
 ---pagebreak---    threshold is needed to provide adequate emergency health response. A concentration
   threshold of 0.1% is now introduced, which is consistent with the threshold for the
   identification of hazardous components in a notification.
   Regarding the second subparagraph of Article 25(8) providing for the obligation to include
   the concentration of a mixture with a unique formula identifier on the label of the bespoke
   paint where it exceeds 5%, industrial stakeholders proposed to increase the threshold to 10%
   to properly protect confidential business information. The expert group consulted and quoted
   above discussed the same issue and concluded that the set limit should be kept in order to
   provide adequate emergency health response, taking into account in particular that most paints
   are formulated with a concentration of less than 5% per colouring component. The
   Commission is of the view that since the draft text already allows to indicate a certain
   concentration range instead of a specific concentration, the possibility to reverse engineer the
   chemical composition of the mixture is significantly reduced and that the arguments provided
   were not substantiated sufficiently to justify an additional reduction in the level of safety.
   Further suggestions concerned the broadening of the definition of “bespoke paint” to
   “bespoke colour mixtures” under the third subparagraph of Article 25(8) and subparagraph (5)
   Section 2.4., Part A of Annex VIII in order to allow all bespoke colour mixtures to benefit
   from the derogation. In the Commission’s view, a differentiation needs to be made between
   mixtures having the purpose to add colour and mixtures that are coloured. Coloured mixtures
   cannot fall under the definition of “paint”. No market or incident data of other bespoke colour
   mixtures was provided, thus an extension of the definition without any supporting data would
   be unjustified.
   Further comments suggest deleting the reference to “limited amounts” in the definition of
   “bespoke paint”. The Commission believes that this specification is necessary in order to
   clearly define the bespoke paint concept, as without it an unlimited quantity of bespoke paints
   could be placed on the market which would result in a different risk scenario. At the same
   time, any specific limit set would have been arbitrary and unjustified considering that the
   definition should suit different case scenarios.
   Moreover, it was proposed to include “bespoke industrial paints and inks” in the definition of
   bespoke paint under the third subparagraph of Article 25(8) and subparagraph (5) Section
   2.4., Part A of Annex VIII given that mixing tinters or colours at the point of sale also exists
   for the industrial segment. Given the lack of evidence on the need for a derogation for such
   paints and the late timing of the request, the Commission does not find it justified to expand
   the derogation. The matters related to bespoke paints were also discussed with the expert
   group consulted and quoted above and the majority of experts preferred to not extend the
   simplification in any way.
   Comments were raised to provide more flexibility for placing the unique formula identifier(s)
   (UFI(s)) on other parts of the packaging (such as on top, on the lid) instead of in the section
   for supplemental information on the label or the packaging located with the other label
   elements by virtue of Article 29(4a) and Section 5.3. Part A of Annex VIII. The Commission
   is of the view that the current provisions allow for enough flexibility relating to the location of
   the UFI.
   3.        LEGAL ELEMENTS OF THE DELEGATED ACT
   The legal act amends Regulation (EC) 1272/2008. The legal basis of this delegated act is
   Article 53(1) of Regulation (EC) 1272/2008.
EN                                                  3                                                  EN
 ---pagebreak---                     COMMISSION DELEGATED REGULATION (EU) …/...
                                                of 31.8.2020
     amending Article 25 of Regulation (EC) 1272/2008 of the European Parliament and of
      the Council on classification, labelling and packaging of substances and mixtures as
                                          regards bespoke paints
                                        (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 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) No 1907/20065, and in particular Article 53(1) 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’(UFI) in the supplemental information provided on the label of a hazardous
          mixture. 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)    The paints sector has raised a specific concern regarding the workability of the
          emergency health response requirements in the case of paints formulated in limited
          amounts on a tailor made basis for an individual consumer or professional user at the
          point of sale. In order to satisfy customer demand for very specific paint shades,
          formulators can be asked to formulate and supply paints with an almost unlimited
          number of different compositions. Compliance with the emergency health response
          requirements would therefore require formulators either to submit information and
          create UFIs in advance for an extremely large number of paints of all possible colour
          combinations, many of which may never be supplied in reality, or else to postpone
          each supply at the point of sale until the information had been submitted and the UFI
          had been created. Either approach would place a disproportionate burden on the
          bespoke paints industry.
   (3)    In order to avoid disproportionate administrative burden, in particular for small and
          medium sized enterprises, for bespoke paints, the requirements are to be amended by
          Commission Delegated Regulation (EU) YYYY/XXX [OP: please insert reference to
          Commission Delegated Regulation … amending Regulation (EC) No 1272/2008 of the
   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).
EN                                                     4                                                          EN
 ---pagebreak---            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, C(2020)5759] to provide for the
           possibility to exempt bespoke paints from the notification obligations in Annex VIII to
           Regulation (EC) No 1272/2008 and from the obligation in that Annex 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 are to
           remain subject to all the requirements of Annex VIII.
   (4)     In the light of that, it is appropriate to amend Article 25 of Regulation (EC) No
           1272/2008 in order to lay down a rule for bespoke paints for which no information is
           notified and no corresponding UFI created requiring the UFIs of all the mixtures
           contained in the bespoke paint to be indicated on the label of the bespoke paint. In
           addition, if the concentration of a mixture with a UFI contained in the bespoke paint
           exceeds 5%, the concentration should be included in the supplemental information
           indicated on the label of the bespoke paint, since mixtures in bespoke paints of such
           concentration are more likely to be relevant for emergency health responses.
   (5)     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.
   (6)     Regulation (EC) No 1272/2008 should therefore be amended accordingly,
   HAS ADOPTED THIS REGULATION:
                                                  Article 1
   In Article 25 of Regulation (EC) No 1272/2008, the following paragraph is added:
             ‘8. In the case of a bespoke paint for which no submission in accordance with
             Annex VIII has been made and no corresponding unique formula identifier has been
             created, the unique formula identifiers of all the mixtures contained in the bespoke
             paint in a concentration exceeding 0.1% which themselves are subject to notification
             under Article 45 shall be included in the supplemental information on the label of the
             bespoke paint, located together and listed in descending order of the mixtures’
             concentration in the bespoke paint, in accordance with the provisions of section 5 of
             Part A of Annex VIII.
             In a case falling within the first subparagraph, where the concentration of a mixture
             with a unique formula identifier in the bespoke paint exceeds 5%, the concentration
             of that mixture shall also be included in the supplemental information on the label of
             the bespoke paint next to its unique formula identifier, in accordance with section
             3.4. of Part B of Annex VIII.
             For the purposes of this paragraph, ‘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.’
                                                  Article 2
   This Regulation shall enter into force on the day after its publication in the Official Journal of
   the European Union.
EN                                                    5                                               EN
 ---pagebreak---    This Regulation shall be binding in its entirety and directly applicable in the Member States.
   Done at Brussels, 31.8.2020
                                                 For the Commission
                                                 The President
                                                 Ursula VON DER LEYEN
EN                                                 6                                              EN