CELEX: 
Language: en
Date: 2020-02-06 00:00:00
Title: COMMISSION REGULATION (EU) No …/.. amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

EUROPEAN
                            COMMISSION
                                                     Brussels, 6.2.2020
                                                     C(2020) 235 final
                        COMMISSION REGULATION (EU) No …/..
                                         of 6.2.2020
   amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and
   of the Council concerning the Registration, Evaluation, Authorisation and Restriction of
                                    Chemicals (REACH)
                                  (Text with EEA relevance)
EN                                                                                          EN
 ---pagebreak---                                COMMISSION REGULATION (EU) No …/..
                                                     of 6.2.2020
   amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and
   of the Council concerning the Registration, Evaluation, Authorisation and Restriction of
                                              Chemicals (REACH)
                                            (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 1907/2006 of the European Parliament and of the
   Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and
   Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending
   Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission
   Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission
   Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC1, and in particular
   Articles 58 and 131 thereof,
   Whereas:
   (1)    The substances 1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear, and
          dihexyl phthalate and the substance group 1,2-benzenedicarboxylic acid, di-C6-10-
          alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters
          with ≥ 0,3% of dihexyl phthalate meet the criteria for classification as toxic for
          reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 of the
          European Parliament and of the Council2 and therefore meet the criteria for inclusion
          in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(c) of that
          Regulation.
   (2)    The substance trixylyl phosphate meets the criteria for classification as toxic for
          reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and
          therefore meets the criteria for inclusion in Annex XIV to Regulation (EC)
          No 1907/2006 set out in Article 57(c) of that Regulation.
   (3)    The substances sodium perborate; perboric acid, sodium salt and sodium
          peroxometaborate meet the criteria for classification as toxic for reproduction
          (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meet
          the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in
          Article 57(c) of that Regulation.
   (4)    The substances 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane
          [1],        5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane                   [2]
          (covering any of the individual stereoisomers of [1] and [2] or any combination
          thereof) are very persistent and very bioaccumulative in accordance with the criteria
   1
           OJ L 396, 30.12.2006, p. 1.
   2
           Regulation (EC) No 1272/2008 of the European Parliament and the Council of 16 December 2008 on
           classification, labelling and packaging of substances and mixtures (OJ L 353, 31.12.2008, p. 1).
EN                                                         1                                                    EN
 ---pagebreak---            set out in Annex XIII to Regulation (EC) No 1907/2006 and therefore meet the criteria
           for inclusion in Annex XIV to that Regulation set out in Article 57(e) of that
           Regulation.
   (5)     The substances 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328); 2,4-di-tert-
           butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327); 2-(2H-benzotriazol-2-yl)-4-(tert-
           butyl)-6-(sec-butyl)phenol (UV-350) and 2-benzotriazol-2-yl-4,6-di-tert-butylphenol
           (UV-320) are persistent, bioaccumulative and toxic and/or very persistent and very
           bioaccumulative in accordance with the criteria set out in Annex XIII to Regulation
           (EC) No 1907/2006 and therefore meet the criteria for inclusion in Annex XIV to that
           Regulation set out in Article 57(d) and/or (e) of that Regulation.
   (6)     All the above-mentioned substances have been identified and included in the candidate
           list in accordance with Article 59 of Regulation (EC) No 1907/2006. They have
           furthermore been prioritised for inclusion in Annex XIV to Regulation (EC)
           No 1907/2006 by the European Chemicals Agency (‘the Agency’) in its
           recommendations of 10 November 20163 and 5 February 20184, in accordance with
           Article 58(3) and (4) of that Regulation. In addition, the Commission has received
           submissions from interested parties to calls for information on the possible economic,
           social, health and environmental impacts (costs and benefits) of the inclusion in Annex
           XIV to Regulation (EC) No 1907/2006 of the substances proposed by the Agency in
           its draft recommendations.
   (7)     For each of the substances included in Annex XIV to Regulation (EC) No 1907/2006
           by this Regulation a date from which the placing on the market and the use of the
           substance shall be prohibited unless an authorisation is granted should be set as
           required by Article 58(1)(c)(i) of Regulation (EC) No 1907/2006, taking into account
           the Agency’s capacity to handle applications for authorisation. For each of those
           substances there are no reasons why the date referred to in Article 58(1)(c)(ii) of
           Regulation (EC) No 1907/2006 should be set earlier than 18 months before the date
           referred to in Article 58(1)(c)(i) of that Regulation.
   (8)     Article 58(1)(e) in conjunction with Article 58(2) of Regulation (EC) No 1907/2006
           provides for the possibility of exemptions of uses or categories of uses in cases where
           specific Union legislation imposes minimum requirements relating to the protection of
           human health or the environment ensuring proper control of the risks. In accordance
           with the information currently available it is not appropriate to set exemptions based
           on those provisions.
   (9)     As there is no information justifying the need for an exemption for product and
           process orientated research and development, it is not appropriate to consider any such
           exemption.
   (10)    As the available information on the uses of the proposed substances is limited, it is not
           appropriate to set review periods at this stage, pursuant to Article 58(1)(d) of
           Regulation (EC) No 1907/2006 .
   3
           https://echa.europa.eu/documents/10162/13640/7th_axiv_recommendation_november2016_en.pdf/3e11
   377b-edd8-46d3-a29c-1978c41db3ad
   4
           https://echa.europa.eu/documents/10162/13640/8th_axiv_recommendation_february2018_en.pdf/10a99
   e7d-0fac-ff1d-7f17-910d6edb61b9
EN                                                     2                                                  EN
 ---pagebreak---    (11) The substances tetralead trioxide sulphate; pentalead tetraoxide sulphate; orange lead
        (lead tetroxide) and lead monoxide (lead oxide) meet the criteria for classification as
        toxic for reproduction (category 1A) in accordance with Regulation (EC) No
        1272/2008 and therefore meet the criteria for inclusion in Annex XIV to Regulation
        (EC) No 1907/2006 set out in Article 57(c) of that Regulation. They have also been
        identified and included in the candidate list in accordance with Article 59 of
        Regulation (EC) No 1907/2006 and prioritised for inclusion in Annex XIV to that
        Regulation by the Agency's recommendation of 10 November 2016 in accordance
        with Article 58 (3) and (4) of that Regulation. The use of lead and its compounds is
        covered by Council Directive 98/24/EC5 and to some extent by Directive 2010/75/EU
        of the European Parliament and of the Council and its implementing measures
        establishing Best Available Techniques (BAT) conclusions. Furthermore the current
        Union binding occupational limit value and binding biological limit value for lead
        compounds under Directive 98/24/EC will be reviewed. Therefore, and in view of
        possible adoption of more stringent measures at the workplace, it is appropriate to
        postpone a decision on the inclusion of those substances in Annex XIV to Regulation
        (EC) No 1907/2006. In addition, through implementation of Directive 2010/75/EU and
        its predecessors, emissions of lead and its compounds to the environment have
        decreased and continue to decrease as shown by the European Pollutant Release and
        Transfer Register (E-PRTR) reporting and further reductions are expected as new BAT
        conclusions are adopted and as permits are updated to reflect them.
   (12) All uses of 1-methyl-2-pyrrolidone (NMP) are restricted in accordance with Annex
        XVII to Regulation (EC) No 1907/2006. NMP has similar intrinsic properties to those
        of N,N-dimethylacetamide (DMAC) and N,N-Dimethylformamide (DMF), and the
        three substances have similar industrial uses and may be considered as
        interchangeable, at least for some uses, even if in general they cannot be considered
        ‘drop-in’ alternatives. In view of the similarities of the three substances in order to
        ensure a consistent regulatory approach6, the decision on the inclusion of NMP in
        Annex XIV to Regulation (EC) No 1907/2006 should be postponed, as has been done
        for DMAC and DMF when the Commission considered the Agency's
        recommendations of 17 January 20137 and of 6 February 20148, respectively.
   (13) In order to avoid the premature obsolescence of articles or complex products that are
        no longer produced after the sunset dates referred to in Annex XIV to Regulation (EC)
        No 1907/2006, some substances (by themselves or in mixtures) included in that Annex
        need to be available for the production of spare parts as articles or as complex products
        for the repair of those articles or complex products, where those articles or complex
        products cannot function as intended without those spare parts, as well as where some
        Annex XIV substances (by themselves or in mixtures) are necessary for the repair of
        such articles or complex products. In order to facilitate application for authorisation
        for those uses, the existing transitional arrangements should be extended, allowing the
   5
        Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from
        the risks related to chemical agents at work (fourteenth individual Directive within the meaning of
        Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
   6
        https://echa.europa.eu/rmoa/-/dislist/details/0b0236e181ffe81a
   7
                  https://echa.europa.eu/documents/10162/13640/4th_a_xiv_recommendation_17jan2013_en.pd
        f/cfa4a66b- 9d82-4e45-8cb7-920593db92c1
   8
                  https://echa.europa.eu/documents/10162/13640/5th_a_xiv_recommendation_06feb2014_en.pd
        f/17ab7722-0164-4fe8-80b6-8b4ac76e8f0f
EN                                                      3                                                     EN
 ---pagebreak---            adoption of implementing measures for simplified application for authorisations in
           such cases. In addition, the wording of the notes to the table of Annex XIV to
           Regulation (EC) No 1907/2006 should be revised in order to ensure consistency of the
           terminology as regards articles and complex products in the light of the judgement of
           the Court of Justice in Case C-106/149.
   (14)    Regulation (EC) No 1907/2006 should therefore be amended accordingly.
   (15)    The measures provided for in this Regulation are in accordance with the opinion of
           the Committee established under Article 133 of Regulation (EC) No 1907/2006,
   HAS ADOPTED THIS REGULATION:
                                                    Article 1
   Annex XIV to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to
   this Regulation.
                                                    Article 2
   This Regulation shall enter into force on the twentieth day following that of 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, 6.2.2020
                                                      For the Commission
                                                      The President
                                                      Ursula VON DER LEYEN
   9
           Judgment of the Court of Justice of 10 September 2015, Fédération des entreprises du commerce et de
           la distribution (FCD) and Fédération des magasins de bricolage et de l’aménagement de la maison
           (FMB), C-106/14, ECLI:EU:C:2015:576.
EN                                                      4                                                      EN
 ---documentbreak---                             EUROPEAN
                            COMMISSION
                                                    Brussels, 6.2.2020
                                                    C(2020) 235 final
                                                    ANNEX
                                           ANNEX
                                            to the
                        COMMISSION REGULATION (EU) No…/..
   amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and
   of the Council concerning the Registration, Evaluation, Authorisation and Restriction of
                                    Chemicals (REACH)
EN                                                                                          EN
 ---pagebreak---                                                                                ANNEX
  The table in Annex XIV to Regulation (EC) No 1907/2006 is amended as follows:
  (1)    The following entries are added:
                                                                        Transitional arrangements
  Entry                 Substance                      Intrinsic         Latest application    Sunset date(2)      Exempted      Review periods
                                                     property(ies)              date(1)                          (categories of)
    Nr
                                                     referred to in                                                   uses
                                                       Article 57
   ‘44.    1,2-Benzenedicarboxylic acid, dihexyl Toxic for reproduction [Date of entry into [Date of entry into         -              -
           ester, branched and linear            (category 1B)          force + 18 months]* force + 36 months]**
           EC No:        271-093-5
           CAS No:       68515-50-4
    45.    Dihexyl phthalate                     Toxic for reproduction [Date of entry into [Date of entry into         -              -
                                                 (category 1B)          force + 18 months]* force + 36 months]**
           EC No:        201-559-5
           CAS No:       84-75-3
    46.    1,2-benzenedicarboxylic acid, di-C6-  Toxic for reproduction [Date of entry into [Date of entry into         -              -
           10-alkyl esters; 1,2-                 (category 1B)          force + 18 months]* force + 36 months]**
           benzenedicarboxylic acid, mixed
           decyl and hexyl and octyl diesters
           with ≥ 0.3% of dihexyl phthalate (EC
           No. 201-559-5)
           EC No:        271-094-0; 272-013-1
           CAS No:       68515-51-5; 68648-93-1
EN                                                                                 1                                                           EN
 ---pagebreak---    47. Trixylyl phosphate                     Toxic for reproduction [Date of entry into [Date of entry into  - -
                                              (category 1B)          force + 21 months]* force + 39 months]**
       EC No:         246-677-8
       CAS No:       25155-23-1
   48. Sodium perborate;       perboric acid, Toxic for reproduction [Date of entry into [Date of entry into  - -
       sodium salt                            (category 1B)          force + 21 months]* force + 39 months]**
       EC No:         239-172-9; 234-390-0
       CAS No:       -
   49. Sodium peroxometaborate                Toxic for reproduction [Date of entry into [Date of entry into  - -
                                              (category 1B)          force + 21 months]* force + 39 months]**
       EC No:         231-556-4
       CAS No:       7632-04-4
       5-sec-butyl-2-(2,4-dimethylcyclohex-   vPvB                   [Date of entry into [Date of entry into  - -
   50. 3-en-1-yl)-5-methyl-1,3-dioxane [1],                          force + 24 months]* force + 42 months]**
       5-sec-butyl-2-(4,6-dimethylcyclohex-
       3-en-1-yl)-5-methyl-1,3-dioxane [2]
       [covering any of the individual
       stereoisomers of [1] and [2] or any
       combination thereof]
       EC No:         -
       CAS No:       -
   51. 2-(2H-benzotriazol-2-yl)-4,6-          PBT, vPvB              [Date of entry into [Date of entry into  - -
       ditertpentylphenol (UV-328)                                   force + 27 months]  force + 45 months]
       EC No:         247-384-8
       CAS No:       25973-55-1
   52. 2,4-di-tert-butyl-6-(5-                vPvB                   [Date of entry into [Date of entry into  - -
       chlorobenzotriazol-2-yl)phenol (UV-                           force + 27 months]  force + 45 months]
       327)
EN                                                                              2                                 EN
 ---pagebreak---            EC No:        223-383-8
           CAS No:       3864-99-1
    53.    2-(2H-benzotriazol-2-yl)-4-(tert-            vPvB              [Date of entry into   [Date of entry into             -                     -
           butyl)-6-(sec-butyl)phenol (UV-350)                            force + 27 months]    force + 45 months]
           EC No:        253-037-1
           CAS No:       36437-37-3
    54.    2-benzotriazol-2-yl-4,6-di-tert-             PBT, vPvB         [Date of entry into   [Date of entry into             -                     -
           butylphenol (UV-320)                                           force + 27 months]    force + 45 months]
           EC No:        223-346-6
           CAS No:       3846-71-7
      (1)     Date referred to in Article 58(1)(c)(ii).
      (2)     Date referred to in Article 58(1)(c)(i).’
  (2)     The sign ‘*’     is inserted next to the date indicated in the ‘Latest application date’ column for the following substance entries: 32-43.
  (3)     The sign ‘**’ is inserted next to the date indicated in the ‘Sunset date’ column for the following substance entries: 32-43.
  (4)     The notes after the table are replaced by the following:
  ‘(*) 1 September 2021 for the use of the substance in the production of spare parts as articles or as complex products for the repair of articles or
  complex products, the production of which ceased or will have ceased before the sunset date indicated in the entry for that substance, where that
  substance was used in the production of those articles or complex products and these cannot function as intended without that spare part and the spare
  part cannot be produced without that substance, and for the use of the substance (on its own or in a mixture) for the repair of such articles or complex
  products where that substance on its own or in a mixture was used in the production of those articles or complex products and they cannot be repaired
  otherwise than by using that substance.
  (**) 1 March 2023 for the use of the substance in the production of spare parts as articles or as complex products for the repair of articles or complex
  products the production of which ceased or will have ceased before the sunset date indicated in the entry for that substance, where that substance was
EN                                                                                   3                                                                   EN
 ---pagebreak---   used in the production of those articles or complex products and these cannot function as intended without those spare parts and the spare part cannot
  be produced without that substance, and for the use of the substance (on its own or in a mixture) for the repair of such articles or complex products,
  where that substance on its own or in a mixture was used in the production of those articles or complex products and they cannot be repaired otherwise
  than by using that substance.
  (***) Does not meet the criteria for identification as a carcinogen if it contains < 0,005 % (w/w) benzo[a]pyrene (Einecs No 200-028-5).’
EN                                                                               4                                                                     EN