CELEX: 
Language: en
Date: 2019-11-07
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

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 [insert date] and comments were taken into account. 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 [insert date] to [insert date] [summarise comments received and replies] 
            
            
               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. 
            
            
               COMMISSION DELEGATED REGULATION (EU) …/...
            
            
               of XXX
            
            
               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 pollutants
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               , 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 Pollutants
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                (‘the Convention’) and under the Protocol to the 1979 Convention on Long Range Transboundary Air Pollution on Persistent Organic Pollutants
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                (‘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 Council
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               , 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 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) 2019/639
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               , 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 Agency
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               , 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 3 years with a view to lowering the limits.
            
            
               (8)Regulation (EU) 2019/1021 should therefore be amended accordingly.
            
            
               (9)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.
            
            
               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,
            
            
               
                     For the Commission
               
               
                     The President
                     […]
                     
                  
            
         
         
      
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               EN
            
            
               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), its salts and PFOA-related compounds
                     
                     
                        “Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds”means the following:
                     
                     
                        (I)perfluorooctanoic acid, including any of its branched isomers;
                     
                     
                        (II)its salts; 
                     
                     
                        (III)PFOA-related compounds which, for the purposes of the Convention, are any substances that degrade to PFOA, including any substances (including salts and polymers) having a linear or branched perfluoroheptyl group with the moiety (C7F15)C as one of the structural elements.
                     
                     
                        The following compounds are not included as PFOA-related compounds:
                     
                     
                        (I)C8F17-X, where X= F, Cl, Br;
                     
                     
                        (II)fluoropolymers that are covered by CF3[CF2]n-R’, where R’=any group, n>16;
                     
                     
                        (III)perfluoroalkyl carboxylic acids (including their salts, esters, halides and anhydrides) with ≥8 perfluorinated carbons; 
                     
                     
                        (IV)perfluoroalkane sulfonic acids and perfluoro phosphonic acids (including their salts, esters, halides and anhydrides) with ≥9 perfluorinated carbons;  
                     
                     
                        (V)perfluorooctane sulfonic acid and its derivatives (PFOS), as listed in Annex I .
                     
                  
                  
                     
                        335-67-1 and others 
                     
                  
                  
                     
                        206-397-9 and others 
                     
                  
                  
                     
                        1. For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of PFOA or any of its salts equal to or below 0,025 mg/kg (0,0000025 % by weight) where they are present in substances, mixtures or articles.
                     
                     
                        2. For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of any individual PFOA-related compound or a combination of PFOA-related compounds equal to or below 1 mg/kg (0,0001 % by weight) where they are present in substances, mixtures or articles.
                     
                     
                        3. For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of  PFOA-related compounds equal to or below 20 mg/kg (0,002 % by weight) where they are  present in a substance to be used  as a transported isolated intermediate within the meaning of Article 3 point 15 (c) of Regulation (EC) No 1907/2006 and fulfilling the strictly controlled conditions set out in Article 18(4)(a) to (f) of that Regulation  for the production of fluorochemicals with a carbon chain equal to or shorter than 6 atoms. This exemption shall be reviewed and assessed by the Commission by [… Publications Office: please insert date that is 3 years after entry 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 gamma irradiation of up to 400 kilograys. 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 by [… Publications Office: please insert date that is 3 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 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 polyinylidene 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) in installed 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 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) by the end of 2022, uses of fire-fighting foam that contains or may contain PFOA, its salts and/or PFOA-related compounds shall be restricted to sites where all releases can be contained;
                     
                     
                        (d) fire-fighting foam stockpiles and wastes that contain or may contain PFOA, its salts and/or PFOA-related compounds shall be managed in accordance with Article 5 and 7, respectively.
                     
                     
                        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 at the latest 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 fourth subparagraphs shall apply in relation to such articles.”