Proposal for a COUNCIL DECISION on the submission, on behalf of the European Union, of a proposal for the listing of additional chemicals in Annex A to the Stockholm Convention on Persistent Organic Pollutants
Date: 2015-03-19
Institutions: European Commission
Subjects: chemical product, environmental protection, international convention, market approval, organic chemical, organic pollution, public health













EUR-Lex - 52015PC0133 - EN











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52015PC0133

Proposal for a COUNCIL DECISION on the submission, on behalf of the European Union, of a proposal for the listing of additional chemicals in Annex A to the Stockholm Convention on Persistent Organic Pollutants /* COM/2015/0133 final - 2015/0066 (NLE) */









EXPLANATORY MEMORANDUM
1.           CONTEXT OF THE PROPOSAL
The Stockholm Convention on Persistent
Organic Pollutants (the Convention), which was approved by Council Decision
2006/507/EC[1],
entered into force on 17 May 2004. The aim of the Convention is to protect
human health and the environment from persistent organic pollutants (POPs). The
Convention provides a framework, based on the precautionary principle, for
elimination of production, use, import and export of currently twenty-three
priority POPs, their safe handling and disposal and elimination or reduction of
releases of certain unintentional POPs.
Regulation (EC) No 850/2004 on persistent
organic pollutants[2]
implements in Union law the commitments set out in the Convention and in the
Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on
Persistent Organic Pollutants (the Protocol), approved by Council Decision
259/2004/EC[3].
Article 8(1) of the Convention stipulates
that any Party may submit a proposal to the Secretariat for listing a chemical
in Annexes A, B or C to the Convention which will then be reviewed by the
Persistent Organic Pollutants Review Committee (POP RC) following Article 8(3)
and (4). The proposal shall contain the information specified in Annex D. The
procedure for the adoption of amendments to Annexes is governed by Article 22
of the Convention.
According to available scientific
information and review reports, as well as taking due account of the screening
criteria laid down in Annex D to the Convention, perfluorooctanoic acid (PFOA),
PFOA salts and PFOA-related substances that can be degraded to PFOA under
environmental conditions exhibit characteristics of POPs. In the following,
reference to “PFOA and its compounds” denotes all forms described pertaining to
this paragraph.
A recent market analysis[4], conducted on behalf of
the European Commission, revealed only one company manufacturing ammonium
pentadecafluorooctanoate (APFO) was active in the Union in 2010. This company
announced cessation of production of APFO as per August 2010 and cessation of
its commercialisation as per November 2010.  The market analysis also showed
that PFOA and APFO are mainly used in the Union in the production of
fluoropolymers and fluoroelastomers[5]
and that entry into the environment occurs at this stage.
On 20 June 2013, following unanimous
agreement of the EU's Member State Committee under Regulation (EC) No 1907/2006
of the European Parliament and the Council, concerning the Registration,
Evaluation, Authorisation and Restriction of Chemicals (REACH)[6], PFOA and APFO were
added to the EU's Candidate List for authorisation[7] having been identified
as Substances of Very High Concern (SVHCs). The identification of PFOA and APFO
as a SVHC was based on an information dossier[8]
prepared by Germany pursuant to Annex XV of Regulation (EC) No 1907/2006.  The
scientific data presented in this dossier showed that PFOA and APFO met the
criteria of Article 57(c) of REACH as toxic for reproduction 1B and in
particular, that they also met the criteria of Article 57(d) of REACH as a
substance which is persistent, bioaccumulative and toxic (PBT).
In October 2013, PFOA and APFO received a
harmonised classification in Annex VI of Regulation (EC) No 1272/2008 on
classification, labelling and packaging of substances and mixtures (CLP)[9], as amended by
Commission Regulation (EU) No 944/2013[10],
as carcinogen category 2, toxic for reproduction category 1B and specific
target organ toxicants on liver following repeated exposure category 1 (STOT RE
1 liver). Following this classification, the placing on the market and use of
PFOA and APFO as substances or in mixtures for supply to the general public are
banned in the Union since 1 January 2015, in accordance with Regulation (EC)
1907/2006 as amended by Regulation (EU) No 317/2014[11].
Since this point, the German and Norwegian
Competent Authorities have jointly compiled a dossier under Annex XV of REACH
with the intention of proposing PFOA compounds for inclusion in the restriction process under REACH. This
Restriction dossier[12]
was submitted to ECHA on 17 October 2014 and proposes a restriction on the
manufacture, use or placing on the market of PFOA compounds
as substances on their own, or as constituents of other
substances, in mixtures or articles. 
Due to their outstanding technical
properties (to provide water, oil, and grease repellency) PFOA compounds are used in various consumer
products as well as in industrial applications. These uses lead to the
wide-dispersive release of PFOA, its salts and related substances into the
environment. Globally, the sources of PFOA have been significantly reduced in
the USA, Japan and the Union. However, it is important to note, that the
manufacture of fluoropolymers is shifting to countries such as Russia and
China, where it is assumed that a large share of fluoropolymers is still
produced using PFOA. This can be seen from consumer articles containing PFOA
which are often imported from outside the Union. The global fluoropolymer
market is continuously growing (5-6% per year globally). 
The dossier estimates, based on available
information, that 40 tonnes per annum (t/a) of PFOA and
its salts are currently imported into the Union. In addition, it estimates that
100 - 1000 t/a of PFOA-related substances are manufactured in the Union and
that a further 100 – 1000 t/a are imported into the Union. In addition, the
PFOA-related substances enter the Union via imported articles, such as
textiles, which are expected to account for significant volumes of PFOA-related
substances.
In addition to their proven PBT qualities,
as evidenced in the REACH and CLP classifications noted above, the Annex XV
Restriction dossier also investigates the long-range environmental transport
(LRT) potential of PFOA and its compounds. The dossier makes reference to a report conducted by the OECD in
2006 that concluded that PFOA and its compounds are subject to long range environmental transport and have been
found in remote areas such as the Arctic[13].
The dossier concludes that this confirms emissions of PFOA and its compounds as a transboundary pollution
problem.
Given the information currently available
regarding the PBT and LRT qualities of PFOA and its
compounds and, on the basis of the studies and reports
outlined above, it is proposed that PFOA and its compounds
meet the criteria of Annex D to the Convention and
therefore could be considered as a POP.
PFOA and its compounds are still produced, used or unintentionally
emitted in significant amounts in third countries. Due to the potential for
long-range environmental transport of these chemicals, the measures taken
nationally or at the Union level are not sufficient to safeguard the high level
of protection of the environment and human health and wider international
action is necessary.
With a view to the next POPRC meeting in
October 2015, it is appropriate that the Commission submit on behalf of the
Union a proposal for the listing of PFOA and its compounds for inclusion in Annex A to the Secretariat
of the Stockholm Convention. This constitutes a position to be adopted on the
Union's behalf for the purpose of Article 218(9) TFEU.
2.           RESULTS OF CONSULTATIONS
WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENTS
A paper[14]
concerning the common understanding between the Convention, the Protocol and
REACH was endorsed by the Competent Authorities of the EU Member States in July
2014.
The decision to submit a proposal for the
listing of PFOA and its compounds in Annex A to the Convention is based on the
conclusions of this common understanding paper in which it states that the process
for including a substance in Annex XVII (Restriction) of REACH can run
concurrently with the process of including a substance in one of the Annexes to
the Convention and, furthermore, that the completion of the REACH Restriction
process for a substance could facilitate the development of the EU position for
the Conference of Parties when the listing of that substance will have to be
decided.
In the event that PFOA and its compounds are nominated for listing in Annex A to the
Convention, a further period of consultation and assessment will commence with
interested stakeholders and any other interested Parties to the Convention.
3.           LEGAL ELEMENTS OF THE
PROPOSAL
This proposal will result in the
compilation of an information dossier pursuant to the provisions of Article
8(1) and criteria of Annex D to the Convention upon which a proposal will be
submitted to the Convention's Secretariat to add PFOA and its compounds to
Annex A of the Convention. 
2015/0066 (NLE)
Proposal for a
COUNCIL DECISION
on the submission, on behalf of the
European Union, of a proposal for the listing of additional chemicals in Annex
A to the Stockholm Convention on Persistent Organic Pollutants
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the
Functioning of the European Union, and in particular Article 191(1), in
conjunction with Article 218(9) thereof,
Having regard to the proposal from the
European Commission,
Whereas:
(1)       The Union ratified the
Stockholm Convention on Persistent Organic Pollutants (the Convention) on 16
November 2004 by Council Decision 2006/507/EC of 14 October 2004 concerning the
conclusion, on behalf of the European Community, of the Stockholm Convention on
Persistent Organic Pollutants[15].
(2)       As a Party to the
Convention, the Union may make proposals for amendment of the Annexes to the
Convention. Annex A to the Convention lists persistent organic pollutants
(POPs) to be eliminated.
(3)       With regard to available
scientific information and review reports as well as taking due account of the
screening criteria laid down in Annex D to the Convention, perfluorooctanoic
acid (PFOA), its salts and PFOA-related
substances that can be degraded to PFOA under environmental conditions
(hereinafter PFOA and its compounds) exhibit characteristics of POPs. 
(4)       In accordance with Article
59(1) and an Annex XV dossier[16]
of Regulation (EC) No 1907/2006 of the European Parliament and the Council,
concerning the Registration, Evaluation, Authorisation and Restriction of
Chemicals (REACH)[17],
PFOA and its ammonium salt (APFO) have been included in the Candidate List of
substances of very high concern having been identified as meeting the criteria
of Article 57(c) of that regulation as toxic for reproduction 1B and in
particular, that it also met the criteria of Article 57(d) of that regulation
as a substance which is persistent, bioaccumulative and toxic.
(5)       Further to the provisions
of Article 69(4) of REACH, PFOA and its compounds are currently the subject of
an Annex XV dossier[18],
submitted to the European Chemical Agency, aiming to restrict the manufacture,
use or placing on the market of PFOA and its compounds on their own, or as
constituents of other substances, in a mixture or articles.
(6)       PFOA and its compounds are
substances with worldwide dispersive uses and are ubiquitously detected in the
environment. Due to the potential for long-range environmental transport of
PFOA, the measures taken at Union level are not sufficient to safeguard the
high level of protection of the environment and human health and wider international
action is necessary.
(7)       The Union should therefore
submit a proposal to the Secretariat of the Convention for the listing of PFOA
and its compounds in Annex A to the Convention. This proposal and the Union's
position regarding the conditions for listing PFOA and its compounds in Annex A
to the Convention should take account of any relevant information obtained in
the course of the on-going restriction procedure under Articles 68 to 73 of
REACH.
HAS ADOPTED THIS DECISION: 
Article 1
1. The Union shall submit a proposal for
the listing of PFOA and its compounds in Annex A to the Stockholm Convention on
Persistent Organic Pollutants (the Convention).
2. The Commission shall communicate the
proposal on behalf of the Union to the Secretariat of the Convention with all
the information required under Annex D to the Convention.
Article 2
This Decision shall enter into force on the
day of its adoption.
Done at Brussels,
                                                                       For
the Council
                                                                       The
President
[1]               OJ L 209, 31.7.2006, p. 1.
[2]               OJ L 158, 30.4.2004, p. 7.
[3]               OJ L 81, 19.3.2004, p. 35.
[4]               van der Putte I, Murin M, van Velthoven M, Affourtit
F. 2010. Analysis of the risks arising from
the
industrial use of Perfluorooctanoic Acid (PFOA) and Ammonium Perfluorooctanoate
(APFO)
and from
their use in consumer articles. Evaluation of the risk reduction measures for
potential
restrictions
on the manufacture, placing on the market and use of PFOA and APFO. European
Commission,
DG Enterprise and Industry.
[5]               Fluoropolymers are high performance plastic materials
and fluoroelastomers are high performance synthetic rubbers.
[6]               OJ L 396, 30.12.2006, p. 1.
[7]               ED/69/2013 - Available at:
http://echa.europa.eu/documents/10162/b54352de-0f2f-454c-bc83-04f191c560b7
[8]               Available at:         http://echa.europa.eu/documents/10162/1b26b219-6783-4981-9acf-154d620937b4
[9]               OJ L 353, 31.12.2008, p. 1.
[10]             Commission Regulation (EU) No 944/2013 (5th Adaption to
Technical Progress (ATP) to Regulation (EC) 1272/2008) (OJ L 261, 03.10.2013,
p. 5).
[11]             Commission Regulation (EU) No 317/2014 amending
Regulation (EC) No 1907/2006 as regards Annex XVII (CMR substances) (OJ L 93,
28.03.2014, p. 24).
[12]             Restriction Report for PFOA, compiled by DE and NO,
published on ECHA website on 17/12/14. Available at: http://www.echa.europa.eu/web/guest/restrictions-under-consideration
[13]             OECD, 2006. SIDS Initial Assessment Report after SIAM
22 - Ammonium Perfluorooctanoate & Perfluorooctanic Acid, pp. 1-210.
[14]             CA/29/2014 – endorsed at the 15th Meeting of
the Competent Authorities for REACH and CLP (CARACAL) in July 2014.
[15]             OJ L 209, 31.7.2006, p. 1.
[16]             Available at:         http://echa.europa.eu/documents/10162/1b26b219-6783-4981-9acf-154d620937b4
[17]             Regulation (EC) No 1907/2006 of the European Parliament
and the Council of 18 December 2006 concerning the Registration, Evaluation,
Authorisation and Restriction of Chemicals (REACH) (OJ L 369, 30.12.2006, p.
1).
[18]             Restriction Report for PFOA, compiled by DE and NO,
published on ECHA website on 17/12/14. Available at: http://www.echa.europa.eu/web/guest/restrictions-under-consideration