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, B and/or C to the Stockholm Convention on Persistent Organic Pollutants
Date: 2016-03-17
Institutions: Directorate-General for Environment, European Commission
Subjects: chemical product, environmental protection, international convention, market approval, organic chemical, organic pollution, pollution control measures, public health, toxic substance

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   EUROPEAN COMMISSION  Brussels, 17.3.2016  COM(2016) 154 final 2016/0083 (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, B and/or C to the Stockholm Convention on Persistent Organic Pollutants  
 
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, 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 implements in Union 
law  the  commitments  set  out  in  the  Convention  and  in  the  Protocol  on  Persistent 
Organic  Pollutants  to  the  1979  Convention  on  Long-Range  Transboundary  Air 
Pollution (the Protocol), approved by Council Decision 259/2004/EC. 

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 Articles 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. 

This  proposal  for  a  Council  decision  is  addressing  the  intention  of  the  European 
Union  to  submit  a  proposal  for  the  listing  of  octamethylcyclotetrasiloxane  (D4), 
which  entails  the  submission  of  an  Annex  D  dossier  containing  screening  criteria 
information on that chemical and initiates the review to be done by the POP RC. 

If D4 meets the screening criteria, further information necessary to establish the risk 
profile  of  that  chemical  will  be  submitted.  This  includes  inter  alia  information  on 
production, uses, hazard assessments and risk evaluations in the Union. In the event 
that a risk management evaluation will be prepared, additional information on socio-
economic  considerations  reflecting  the  situation  in  the  Union  pursuant  to  Annex  F 
will be submitted. 

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,  D4 
exhibits characteristics of POPs.  

D4  is  manufactured  in  the  EU,  and  also  imported  as  a  substance  (on  its  own  or  in 
mixtures)  and  in  articles.  D4  is  released  from  the  formulation  and  processing  stage 
("production"),  the  service  life  of  products  and  articles  and  from  the  waste  stage 
(recycling, landfilling and incineration). The major use of D4 is as a feedstock for the 
production of silicone polymers. 

According to the ECHA dissemination website, the registered tonnage band for D4 is 
100,000 – 1,000,000 tonnes/year.  

The  United  Kingdom  Competent  Authorities  have  prepared  a  dossier  under  Annex 
XV  to  REACH  with  the  intention  of  proposing  two  siloxane  compounds  for 
inclusion in the restriction process under REACH. This Restriction dossier proposes 
a 
and 
decamethylcyclopentasiloxane  (D5) in  concentrations equal to or  greater than 0,1% 
by weight in personal care products that are washed off in normal use conditions. 

the  market  or  use  of  D4 

the  placing  on 

restriction  on 

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The  major  use  of  these  substances  is  as  a  feedstock  for  the  production  of  silicone 
polymers. Those silicone fluids, elastomers, gels and resins in turn have a very wide 
range  of uses, including as  rubber; elastomers for coatings  and sealants; antifoams; 
flow and/or gloss improvers in alkyd paints and varnishes; softening, waterproofing 
and  wetting  agents  in  textile  manufacturing;  components  of  polishes  and  other 
surface treatment formulations; lubricants, greases, anti-adhesion coatings and mould 
release  agents;  paper  coatings;  hydraulic,  dielectric  and  heat  transfer  fluids;  and 
consumer products such as personal, household, and automotive care products. The 
polymers may also be modified with additional functional groups, with a myriad of 
other  applications.  D4  and  D5  are  used  in  various  consumer  products  as  well  as  in 
industrial  applications,  and  these  uses  lead  to  the  wide-dispersive  release  into  the 
environment. 

The Member State Committee at the European Chemicals Agency (ECHA) at its 41st 
Meeting in 2015 adopted an opinion1 on the persistence (P/vP) and bioaccumulation 
(B/vB) of D4 and D5 at the request of the Executive Director of ECHA under Article 
77(3)c of REACH. This Committee was of the opinion that both D4 and D5 fulfil the 
REACH  Annex  XIII  criteria  for  vP  and  vB.  Therefore,  they  fulfil  the  Annex  D 
criteria of the Convention for persistency and bioaccumulation. 

D4 has a harmonised classification in Annex VI of Regulation (EC) No 1272/2008 
on classification, labelling and packaging of substances and mixtures (CLP) as toxic 
for reproduction category 2 and as toxic to aquatic life category 4. However, the new 
criteria  on  chronic  aquatic  toxicity  introduced  by  Commission  Regulation  (EU)  No 
286/2011  in  the  CLP  Regulation  is  expected  to  result  in  a  more  stringent 
environmental  classification  since  the  lowest  reliable  aquatic  chronic  no  observed 
effect concentration (NOEC) is around 4.4 µg/L. This chronic NOEC is expected to 
result in a harmonised classification of chronic aquatic toxicity category 1. Therefore 
D4 would meet the POP criteria for toxicity based on both aquatic and mammalian 
end points. 

In  addition  to  the  proven  PBT/vPvB  properties,  as  evidenced  in  the  REACH 
assessment  noted  above,  the  Annex  XV  Restriction  dossier  also  investigates  the 
long-range environmental transport (LRT) potential of D4 and D5 and concluded that 
due to  their propensity to reside in  the air compartment and  their long  atmospheric 
half-lives,  D4  and  D5  also  have  the  potential  to  undergo  long-range  transport  to 
remote regions via the atmosphere. 
Health  Canada  concluded  in  their  2008  screening  assessment2  that,  based  on 
modelling data that estimated the characteristic travel distance of D4, the long-range 
atmospheric  transport  potential  of  D4  is  high,  supporting  that  D4  is  subject  to 
atmospheric transport to remote regions such as the Arctic. 

According to the Member State Committee opinion D4 can be found in a wide range 
of organisms (particularly fish and aquatic invertebrates but also birds and mammals) 
and  is  present  in  biota  in  remote  regions,  including  fish  and  birds  in  the  European 
Arctic.  

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http://echa.europa.eu/documents/10162/13641/art77-
3c_msc_opinion_on_d4_and_d5_20150422_en.pdf. 
Environment  Canada 
Octamethylcyclotetrasiloxane (D4) Chemical Abstracts Service Registry Number 556-67-2. 
November 2008. See: http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=2481B508-1#a1. 

and  Health  Canada.  Screening  Assessment 

for 

the  Challenge 

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Given the information currently available regarding the PBT and LRT properties of 
D4  and  considering  the  studies  and  reports  outlined  above,  it  is  proposed  that  D4 
meets the criteria of Annex D to the Convention and therefore could be considered as 
a POP. 

D4 is a high production volume chemical that is widely used in household goods and 
personal care  products. Due to  the potential  for long-range environmental transport 
of this chemical, 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 POP RC meeting in September 2016, it is appropriate that 
the  Commission  submits  on  behalf  of  the  Union  a  proposal  for  the  listing  of 
octamethylcyclotetrasiloxane for inclusion in Annex A, B and/or C 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. 

STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS 

In  the  event  that  D4  meets  the  screening  criteria  pursuant  to  Annex  D  to  the 
Convention, all Parties and observers will be invited to provide information allowing 
to establish the risk profile of that chemical. This includes inter alia information on 
production, uses, hazard assessments and risk evaluations. If, on the basis of the risk 
profile, it is decided to proceed with the next step and to prepare a risk management 
evaluation, all Parties and observers will be invited to submit information on socio-
economic  considerations  pursuant  to  Annex  F  to  the  Convention.  The  broad 
invitation  for  submission  of  information  addressed  to  all  Parties  and  observers  has 
the objective to  prepare a comprehensive evaluation of the impact  of that chemical 
on  human  health  and  the  environment  and  to  reflect  due  regard  for  the  differing 
capabilities  and  conditions  among  the  Parties  with  respect  to  risk  management  and 
elimination. 

If  the  POP  RC  comes  to  the  conclusion  that  D4  meets  the  screening  criteria 
according to Annex D of the Stockholm Convention, the Commission will launch a 
study  in  order  to  gather  information  on  the  socio-economic  impacts  of  a  possible 
listing of D4. 

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 D4 to Annex A, B 
and/or C of the Convention. 

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2016/0083 (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, B and/or C 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) 

(2) 

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 Pollutants3. 

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, whereas Annex B lists POPs to be restricted, and 
Annex C lists POPs of which the unintentional production needs to be addressed. 

(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, 
octamethylcyclotetrasiloxane (CAS No 556-67-2) exhibits characteristics of POPs.  

(4) 

(5) 

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Based on the available information, octamethylcyclotetrasiloxane meets the criteria of 
Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the 
Council4  for  both  a  ‘persistent,  bioaccumulative  and  toxic’  (PBT)  and  a  ‘very 
persistent and very bioaccumulative’ (vPvB) substance in the environment.  

Under Article 69(4) of Regulation (EC) No 1907/2006, the United Kingdom prepared 
an Annex XV restriction dossier5 on octamethylcyclotetrasiloxane to address the risk 
to environment from the placing on the market or use of octamethylcyclotetrasiloxane 
in concentration equal to or greater than 0,1% by weight in personal care products that 
are washed off in normal use conditions. 

OJ L 209, 31.7.2006, p. 1. 
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). 
Available at: http://www.echa.europa.eu/web/guest/restrictions-under-consideration 
Decamethylcyclopentasiloxane is also included in the scope of the restriction proposal. 

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(6) 

Octamethylcyclotetrasiloxane  is  a  substance  with  worldwide  dispersive  uses  and  is 
detected  in  the  environment.  Due  to  the  potential  for  long-range  environmental 
transport  of  octamethylcyclotetrasiloxane,  the  measures  taken  nationally  or  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 octamethylcyclotetrasiloxane in Annex A, B and/or C to the Convention, 

HAS ADOPTED THIS DECISION:  

1. The Union shall submit a proposal for the listing of octamethylcyclotetrasiloxane in Annex 
A,  B  and/or  C  to  the  Stockholm  Convention  on  Persistent  Organic  Pollutants  (the 
Convention). 

Article 1 

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. 

This Decision shall enter into force on the date of its adoption. 

Done at Brussels, 

Article 2 

For the Council 
The President 

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