CELEX: 
Language: en
Date: 2020-04-08 00:00:00
Title: COMMISSION DELEGATED REGULATION (EU) …/... amending Annex I to Regulation (EU) 2019/1021 of the European Parliament and of the Council as regards the listing of perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds

EUROPEAN
                            COMMISSION
                                                      Brussels, 8.4.2020
                                                      C(2020) 1973 final
                 COMMISSION DELEGATED REGULATION (EU) …/...
                                          of 8.4.2020
   amending Annex I to Regulation (EU) 2019/1021 of the European Parliament and of the
    Council as regards the listing of perfluorooctanoic acid (PFOA), its salts and PFOA-
                                      related compounds
                                  (Text with EEA relevance)
EN                                                                                       EN
 ---pagebreak---                                 EXPLANATORY MEMORANDUM
   1.        CONTEXT OF THE DELEGATED ACT
   Article 1 of Regulation (EU) 2019/1021 establishes as the objective of that Regulation to
   protect human health and the environment from Persistent Organic Pollutants (‘POPs’) by
   prohibiting, phasing out as soon as possible, or restricting the manufacturing, placing on the
   market and use of substances subject to the Stockholm Convention on POPs. At the ninth
   Conference of the Parties to the Stockholm Convention, which took place in Geneva,
   Switzerland from 29 April to 10 May 2019, decisions were taken to include further chemicals
   in Annex A to the Convention. Those regulatory actions and decisions should be reflected in
   Annex I to Regulation (EU) 2019/1021. This delegated act implements decision SC-9/12 on
   perfluoroctanoic acid (PFOA), its salts and PFOA-related compounds. In accordance with the
   second subparagraph of Article 15(1) of Regulation (EU) 2019/1021, separate delegated acts
   will be adopted for the other decisions of the Conference of the Parties concerning inclusion
   of chemicals in Annex A.
   2.        CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT
   The draft amendment was consulted with an expert group (the 'POP CA meeting') on 26
   November 2019 and comments were taken into account as far as possible. The group is
   composed of all the relevant stakeholders - representatives of Member States, of the European
   Chemicals Agency, the chemicals industry and the civil society.
   A public consultation was carried out for the draft act from 7 November 2019 to 5 December
   2019. Several comments were received from stakeholders, mostly concerning the
   discrepancies between the derogations in the existing restriction on PFOA, its salts and related
   compounds in the REACH restriction (entry 68 of Annex XVII to Regulation (EC) No
   1907/2006) and the exemptions in the draft act. The Commission included in the proposal the
   exemptions that are included in both decision SC-9/12 under the Stockholm Convention and
   the REACH restriction. Concerning the duration, the Commission chose 5 years for those
   exemptions that had no time limit in the REACH restriction and the time limit of the REACH
   restriction for those exemptions with a shorter time limit than 5 years. For the derogations that
   were granted under the REACH restriction but not included in decision SC-9/12 under the
   Stockholm Convention, the Commission proposes that such derogations will be applicable
   until the date of entry into force of decision SC-9/12 (3 December 2020). This will allow the
   industries that were benefitting from the derogations of the REACH restriction more time to
   complete the phase-out of PFOA, still respecting the timeline for implementation of decision
   SC-9/12. Other comments concerned Unintentional Trace Contaminant (UTC) limits of
   PFOA in specific substances, mixtures and articles. The Commission has decided to increase
   some UTC limits but to ask ECHA for a detailed scientific assessment with a view to review
   such limits as soon as possible.
   3.        LEGAL ELEMENTS OF THE DELEGATED ACT
   The delegated act amends the list of chemicals in Annex I on the basis of developments under
   the Convention, as required by Article 15(1) of Regulation (EU) 2019/1021.
EN                                                 1                                                 EN
 ---pagebreak---                       COMMISSION DELEGATED REGULATION (EU) …/...
                                                  of 8.4.2020
    amending Annex I to Regulation (EU) 2019/1021 of the European Parliament and of the
      Council as regards the listing of perfluorooctanoic acid (PFOA), its salts and PFOA-
                                           related compounds
                                        (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) 2019/1021 of the European Parliament and of the Council
   of 20 June 2019 on persistent organic pollutants1, and in particular Article 15(1) thereof,
   Whereas:
   (1)    Regulation (EU) 2019/1021 implements the commitments of the Union under the
          Stockholm Convention on Persistent Organic Pollutants2 (‘the Convention’) and under
          the Protocol to the 1979 Convention on Long Range Transboundary Air Pollution on
          Persistent Organic Pollutants3 (‘the Protocol’).
   (2)    Annex A to the Convention (‘Elimination’) contains a list of chemicals for which each
          Party to the Convention is required to prohibit and/or take the legal and administrative
          measures necessary to eliminate their production, use, import and export.
   (3)    The Conference of the Parties to the Convention has, pursuant to Article 8(9) of the
          Convention, decided in its ninth meeting to amend Annex A to the Convention in
          order to include perfluorooctanoic acid (‘PFOA’), its salts and PFOA-related
          compounds in that Annex. That amendment contains various specific exemptions.
   (4)    Part A of Annex I to Regulation (EU) 2019/1021, which contains a list of the
          substances listed in the Convention and in the Protocol as well as substances listed
          only in the Convention, should therefore also be amended to include PFOA, its salts
          and PFOA-related compounds.
   (5)    PFOA, its salts and PFOA-related compounds are listed in Annex XVII to Regulation
          (EC) No 1907/2006 of the European Parliament and of the Council4, subject to certain
          derogations. Those derogations were assessed by the Persistent Organic Pollutants
          Review Committee (‘POPRC’) with the result that not all of them were recommended
   1
           OJ L 169, 25.6.2019, p. 45.
   2
           OJ L 209, 31.7.2006, p. 3.
   3
           OJ L 81, 19.3.2004, p. 37.
   4
           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/EC (OJ L 396, 30.12.2006, p. 1).
EN                                                     2                                                  EN
 ---pagebreak---          to the Conference of the Parties. Consequently, the decision adopted by the
         Conference of the Parties (SC-9/12) contains some but not all derogations previously
         granted under Regulation (EC) No 1907/2006. Considering that the POPRC
         assessment was based on more recent information and considering Council Decision
         (EU) 2019/6395, it is appropriate to allow in Annex I to Regulation (EU) 2019/1021
         only those specific exemptions that are granted under the Convention and needed in
         the Union.
   (6)   The Conference of the Parties to the Convention decided in its ninth meeting on a
         specific exemption that is not included in Annex XVII to Regulation (EC) No
         1907/2006. It concerns the use of perfluoroctyl bromide containing perfluorooctyl
         iodide for the purpose of producing pharmaceutical products. Considering that
         information on this use was not available at the time of the listing of PFOA, its salts
         and PFOA-related compounds in Annex XVII to Regulation (EC) No 1907/2006 and
         considering the subsequent assessment by the European Chemicals Agency6, it is
         considered appropriate to include that specific exemption in Annex I to Regulation
         (EU) 2019/1021.
   (7)   In order to reinforce the application and enforcement in the Union of Article 3 of
         Regulation (EU) 2019/1021, a limit value should be set for PFOA, its salts and PFOA-
         related compounds occurring as an unintentional trace contaminant in substances,
         mixtures and articles. That limit value should be set at 0,025 mg/kg for PFOA
         including its salts, and at 1 mg/kg for the individual PFOA-related compounds or a
         combination of those compounds. For applications where those concentration limits
         cannot currently be met, higher concentration limits should be established, subject to
         review by the Commission within 2 years with a view to lowering the limits.
   (8)   Regulation (EU) 2019/1021 should therefore be amended accordingly.
   (9)   Considering that some derogations previously granted in the restriction on PFOA, its
         salts and PFOA-related compounds in Annex XVII to Regulation (EC) No 1907/2006
         are still needed by industry for a transitional period but are not among the specific
         exemptions in Annex I to Regulation (EU) 2019/1021, such derogations should apply
         until 3 December 2020, which is the date of entry into force of the amendment of
         Annex A to the Stockholm Convention concerning PFOA, its salts and PFOA-related
         compounds.
   (10)  The restriction on PFOA, its salts and PFOA-related compounds in Annex XVII to
         Regulation (EC) No 1907/2006, which the Commission now plans to delete, would
         normally start to apply on 4 July 2020. For reasons of coherence and to facilitate the
         implementation of Regulation (EU) 2019/1021, this Regulation should apply from the
         same date,
   HAS ADOPTED THIS REGULATION:
                                                   Article 1
   Annex I to Regulation (EU) 2019/1021 is amended in accordance with the Annex to this
   Regulation.
   5
          Council Decision (EU) 2019/639 of 15 April 2019 on the position to be taken on behalf of the European
          Union at the ninth meeting of the Conference of the Parties as regards amendments to Annexes A and B
          to the Stockholm Convention on Persistent Organic Pollutants (OJ L 109, 24.4.2019, p. 22).
   6
          https://echa.europa.eu/documents/10162/c9666f21-532b-49a0-ace3-c843b7b8e5b0
EN                                                      3                                                       EN
 ---pagebreak---                                                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.
   It shall apply from 4 July 2020.
   This Regulation shall be binding in its entirety and directly applicable in all Member States.
   Done at Brussels, 8.4.2020
                                                 For the Commission
                                                 The President
                                                 Ursula VON DER LEYEN
EN                                                 4                                                EN
 ---documentbreak---                             EUROPEAN
                            COMMISSION
                                                    Brussels, 8.4.2020
                                                    C(2020) 1973 final
                                                    ANNEX
                                            ANNEX
                                             to the
                COMMISSION DELEGATED REGULATION (EU) …/...
   amending Annex I to Regulation (EU) 2019/1021 of the European Parliament and of the
    Council as regards the listing of perfluorooctanoic acid (PFOA), its salts and PFOA-
                                      related compounds
EN                                                                                       EN
 ---pagebreak---                                                  ANNEX
         In Part A of Annex I to Regulation (EU) 2019/1021, the following entry is added:
   Substance                              CAS No     EC No            Specific exemption on
                                                                    intermediate use or other
                                                                            specification
   “Perfluorooctanoic acid (PFOA), 335-67-1          206-397- 1. For the purposes of this entry,
   its salts and PFOA-related and                    9     and point (b) of Article 4(1) shall
   compounds                              others     others    apply to concentrations of PFOA
   Perfluorooctanoic acid (PFOA),                              or any of its salts equal to or
   its salts and PFOA-related                                  below 0,025 mg/kg (0,0000025 %
   compounds”means the following:                              by weight) where they are present
    (i) perfluorooctanoic           acid,                      in substances, mixtures or
          including     any     of    its                      articles.
          branched isomers;
    (ii) its salts;                                            2. For the purposes of this entry,
                                                               point (b) of Article 4(1) shall
    (iii) PFOA-related compounds
                                                               apply to concentrations of any
          which, for the purposes of
          the Convention, are any                              individual             PFOA-related
          substances that degrade to                           compound or a combination of
          PFOA,       including      any                       PFOA-related compounds equal
          substances (including salts                          to or below 1 mg/kg (0,0001 %
          and polymers) having a                               by weight) where they are present
          linear       or      branched                        in substances, mixtures or
          perfluoroheptyl group with
                                                               articles.
          the moiety (C7F15)C as one
          of the structural elements.                          3. For the purposes of this entry,
   The following compounds are not                             point (b) of Article 4(1) shall
   included as PFOA-related                                    apply to concentrations of
   compounds:                                                  PFOA-related compounds equal
    (i) C8F17-X, where X= F, Cl,                               to or below 20 mg/kg (0,002 %
          Br;                                                  by weight) where they are
    (ii) fluoropolymers that are                               present in a substance to be used
          covered by CF3[CF2]n-R’,                             as     a     transported   isolated
          where R’=any group, n>16;                            intermediate within the meaning
    (iii) perfluoroalkyl      carboxylic                       of Article 3 point 15 (c) of
          acids (including their salts,                        Regulation (EC) No 1907/2006
          esters,      halides       and                       and      fulfilling    the  strictly
          anhydrides)       with      ≥8
                                                               controlled conditions set out in
          perfluorinated carbons;
                                                               Article 18(4)(a) to (f) of that
    (iv) perfluoroalkane        sulfonic                       Regulation for the production of
          acids      and       perfluoro
                                                               fluorochemicals with a carbon
EN        phosphonic acids (including
          their salts, esters, halides
                                                   1           chain equal to or shorter than 6     EN
          and anhydrides) with ≥9                              atoms. This exemption shall be
 ---pagebreak---        perfluorinated carbons;         reviewed and assessed by the
   (v) perfluorooctane      sulfonic   Commission no later than […
       acid and its derivatives        Publications Office: please insert
       (PFOS), as listed in this       date that is 2 years after entry
       Annex.                          into force of this amending
                                       Regulation]
                                       4. For the purposes of this entry,
                                       point (b) of Article 4(1) shall
                                       apply to concentrations of PFOA
                                       and its salts equal to or below 1
                                       mg/kg (0,0001 % by weight)
                                       where they are present in
                                       polytetrafluoroethylene (PTFE)
                                       micropowders       produced     by
                                       ionising irradiation of up to 400
                                       kilograys     or    by     thermal
                                       degradation as well as in mixtures
                                       and articles for industrial and
                                       professional uses containing
                                       PTFE        micropowders.      All
                                       emissions of PFOA during the
                                       manufacture and use of PTFE
                                       micropowders shall be avoided
                                       and, if not possible, reduced as
                                       far as possible. This exemption
                                       shall be reviewed and assessed by
                                       the Commission no later than […
                                       Publications Office: please insert
                                       date that is 2 years after entry
                                       into force of this amending
                                       Regulation].
                                       5. By way of derogation, the
                                       manufacturing, placing on the
                                       market and use of PFOA, its salts
                                       and PFOA-related compounds
                                       shall be allowed for the following
                                       purposes:
                                       (a) photolithography or etch
                                       processes     in    semiconductor
                                       manufacturing, until 4 July 2025;
                                       (b) photographic coatings applied
EN                                   2                                    EN
 ---pagebreak---      to films, until 4 July 2025;
     (c) textiles for oil- and water-
     repellency for the protection of
     workers from dangerous liquids
     that comprise risks to their health
     and safety, until 4 July 2023;
     (d) invasive and implantable
     medical devices, until 4 July
     2025;
     (e)            manufacture          of
     polytetrafluoroethylene (PTFE)
     and       polyvinylidene      fluoride
     (PVDF) for the production of:
          (i) high-performance,
               corrosion-resistant      gas
               filter membranes, water
               filter membranes and
               membranes for medical
               textiles,
          (ii) industrial waste heat
               exchanger equipment,
          (iii) industrial         sealants
               capable of preventing
               leakage of volatile organic
               compounds and PM2.5
               particulates,
     until 4 July 2023.
     6. By way of derogation, the use
     of PFOA, its salts and PFOA-
     related compounds shall be
     allowed in fire-fighting foam for
     liquid fuel vapour suppression
     and liquid fuel fire (Class B fires)
     already installed         in systems,
     including both mobile and fixed
     systems, until 4 July 2025,
     subject        to    the    following
     conditions:
               (a) fire-fighting foam that
               contains or may contain
EN 3                                        EN
 ---pagebreak---              PFOA, its salts and/or
             PFOA-related compounds
             shall not be used for
             training;
             (b) fire-fighting foam that
             contains or may contain
             PFOA, its salts and/or
             PFOA-related compounds
             shall not be used for
             testing unless all releases
             are contained;
             (c) as from 1 January
             2023, uses of fire-fighting
             foam that contains or may
             contain PFOA, its salts
             and/or        PFOA-related
             compounds shall only be
             allowed in sites where all
             releases can be contained;
             (d) fire-fighting foam
             stockpiles that contain or
             may contain PFOA, its
             salts and/or PFOA-related
             compounds        shall   be
             managed in accordance
             with Article 5.
     7. By way of derogation, the use
     of     perfluooroctyl       bromide
     containing perfluoroctyl iodide
     for the purpose of producing
     pharmaceutical products shall be
     allowed, subject to review and
     assessment by the Commission
     by 31 December 2026, every four
     years thereafter and by 31
     December 2036.
     8. Use of articles already in use in
     the Union before 4 July 2020
     containing PFOA, its salts and/or
     PFOA-related compounds shall
     be allowed. Article 4(2), third and
EN 4                                      EN
 ---pagebreak---      fourth subparagraphs shall apply
     in relation to such articles.
     9. By way of derogation, the use
     of PFOA, its salts and/or PFOA-
     related compounds shall be
     allowed until 3 December 2020 in
     the following articles:
     (a) medical devices other than
     implantable ones, within the
     scope of Regulation (EU)
     2017/745*;
     (b) latex printing inks;
     (c) plasma nano-coatings.
     --------
     *Regulation (EU) 2017/745 of
     the European Parliament and of
     the Council of 5 April 2017 on
     medical      devices,      amending
     Directive 2001/83/EC,
     Regulation (EC) No 178/2002
     and         Regulation         (EC)
     No 1223/2009 and repealing
     Council Directives 90/385/EEC
     and 93/42/EEC. ”.
EN 5                                     EN