Proposal for a Regulation of the European Parliament and of the Council on persistent organic pollutants and amending Directives 79/117/EEC and 96/59/EC
Date: 2003-06-12
Institutions: European Commission
Subjects: approximation of laws, environmental protection, international convention, organic pollution, public health, waste management

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 12.6.2003
COM(2003) 333 final

2003/0119 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on persistent organic pollutants and amending Directives 79/117/EEC and 96/59/EC

(presented by the Commission)

EXPLANATORY MEMORANDUM

1.

BACKGROUND

Persistent  organic  pollutants  (POPs)  are  chemical  substances  that  persist  in  the
environment,  bioaccumulate  through  the  food  web,  and  pose  a  risk  of  causing
adverse  effects  to  human  health  and  the  environment.  These  pollutants  are
transported  across  international  boundaries  far  from  their  sources,  even  to  regions
where  they  have  never  been  used  or  produced.  The  ecosystems  and  indigenous
people of the Arctic are particularly at risk because of the long-range environmental
transportation  and  biomagnification  of  these  substances.  Consequently,  persistent
organic pollutants pose a threat to the environment and to human health all over the
globe.  The  international  community  has  called  for  actions  to  reduce  and  eliminate
production, use and releases of these substances.

The European Community and its Member States signed the Protocol to the regional
UNECE  Convention  on  Long-Range  Transboundary  Air  Pollution  (CLRTAP)  on
POPs  in  June  1998  and  the  global  Stockholm  Convention  on  POPs  in  May  2001.
Most  of  the  acceding  and  candidate  States  have  also  signed  the  Protocol  and  the
Convention.  Appropriate  implementing  legislation  must  now  be  put  in  place,  at
Community level, in order to conclude these international agreements. The proposals
should be presented as a matter of urgency since:

–  The Stockholm Convention will enter into force on the ninetieth day after the date
of  deposit  of  the  fiftieth  instrument  of  ratification.  As  of  January  2003,
26 countries have already ratified the Convention.

–  The UNECE Protocol on POPs will enter into force on the ninetieth day following
the date on which the sixteenth instrument of ratification has been deposited. As
of January 2003, 14 Parties to the CLRTAP have already ratified the Protocol.

–  The  commitment  to  ratify  the  global  Convention  without  delay  has  been
reinforced 
the  Sixth  Environment  Action  Programme
(Decision No 1600/2002/EC1) and more recently in the political declaration made
at Johannesburg World Summit on Sustainable Development.

inter  alia 

in 

The purpose of the proposed Regulation is to give effect to the main provisions of the
Convention  and  the Protocol which are  not  yet sufficiently  covered  by  Community
legislation.  Separate  proposals  for  Council  Decisions  concerning  the  Community’s
conclusions on these two international agreements are being submitted in parallel to
the present proposal.

1

OJ L 242, 10.9.2002, p. 1.

2

                                                
2.

THE UNECE PROTOCOL

two 

The  Executive  Body  to  the  CLRTAP  adopted  the  Protocol  on  Persistent  Organic
Pollutants  on 24  June  1998  in  Aarhus  (Denmark).  It  focuses  on  a  list  of
16 substances  comprising  eleven pesticides, 
industrial  chemicals  and
to  eliminate  any
three unintentional  by-products.  The  ultimate  objective 
discharges, emissions and losses of POPs. The Protocol bans the production and use
of  some  products  outright  (aldrin,  chlordane,  chlordecone,  dieldrin,  endrin,
hexabromobiphenyl, mirex and toxaphene). Others are scheduled for elimination at a
later  stage  (DDT,  heptachlor,  hexaclorobenzene  and  polychlorinated  biphenyls
(PCBs)).  Finally,  the  Protocol  severely  restricts  the  use  of  DDT,  HCH  (including
lindane) and PCBs. The Protocol includes provisions for dealing with the wastes of
products  that  will  be  banned.  It  also  obliges  Parties  to  reduce  their  emissions  of
dioxins,  furans,  PAHs  and  HCB  below  their  levels  in  1990  (or  an  alternative  year
between 1985 and 1995).  For the incineration of municipal, hazardous and medical
waste, it lays down specific limit values.

is 

The  UNECE  Protocol  on  POPs  was  signed  by  36  of  48  Parties  to  the  CLRTAP,
including  all  present  Member  States  and  all  but  three  candidate  countries
(Estonia, Malta and Turkey). By March 2003, 14 Parties, including 7 Member States
and  2 Candidate  Countries  had  ratified  the  Protocol.  Before  the  Protocol  can  enter
into force, 16 ratifications are required.

3.

THE STOCKHOLM CONVENTION

The  Stockholm  Convention  on  Persistent  Organic  Pollutants  (POPs)  was  formally
the
adopted  by  127  governments  and  signed  by  91  countries  and  by 
European Community  on  22-23 May 2001  in  Stockholm,  upon  completion  of  three
years of negotiations conducted in the framework of the United Nations Environment
in  establishing  a  strong
Programme  (UNEP).  The  negotiations  succeeded 
international regime for promoting global action on an initial cluster of twelve POPs,
which  are  all  included  in  the  UNECE  Protocol,  too.  The  overall  objective  of  the
Convention  is  to  protect  human  health  and  the  environment  from  POPs.  Specific
reference  is  made  to  a  precautionary  approach  as  set  forth  in  Principle  15  of  the
Rio Declaration on Environment and Development. Most importantly, this principle
is made operational in Article 8, which lays down the rules for including additional
chemicals  in  the  Convention.  The  nine  intentionally  produced  chemicals  currently
listed  in  Annex  A  of  the  Convention  (aldrin,  chlordane,  dieldrin,  endrin,
hexachlorobenzene, heptachlor, mirex, toxaphene and PCBs) are subject to a ban on
production  and  use  except  where  there  are  generic  or  specific  exemptions.  In
addition, the production and use of DDT,  a  pesticide  still used  in many  developing
countries for malaria and other disease vector control, is severely restricted, as set out
in Annex B of the Convention.

The generic exemptions allow laboratory-scale research, use as a reference standard
and  unintentional  trace  contaminants  in  products  and  articles.  Articles  in  use
containing  POPs  are  also  subject  to  an  exemption  provided  that  Parties  submit
information on the uses and the national plan for waste management for such articles
to the Secretariat of the Convention.

3

Import and export of the ten intentionally produced POPs is severely restricted by the
Convention. After all substance specific-exemptions have ceased, import and export
is  allowed  only  for  the  purpose  of  environmentally  sound  disposal  under  restricted
conditions.

Special provisions are included  in  the  Convention  for  those  Parties  with  regulatory
assessment schemes to review existing chemicals for POPs characteristics and to take
regulatory  measures  with  the  aim  of  preventing  the  development,  production  and
marketing of new substances with POP characteristics.

Releases of unintentionally produced by-products listed in Annex C (dioxins, furans,
PCBs  and  HCB)  are  subject  to  continuous  minimisation  with,  as  objective,  the
ultimate elimination where feasible.  The  main  tool  for  this  are  the  National  Action
Plans,  which  should  cover  the  source  inventories  and  release  estimates  as  well  as
plans for release reductions. The most stringent control provision with regard to by-
products  is  that  Parties  shall  promote  and,  in  accordance  with  their  action  plans,
require the use of best available techniques for new sources within their major source
categories.

The  Convention  also  foresees  identification  and  safe  management  of  stockpiles
containing  or  consisting  of  POPs.  Waste  containing,  consisting  of  or  contaminated
with POPs should be disposed of in such a way that the POP content is destroyed or
irreversibly transformed so that it does not exhibit POPs characteristics. Where this
does not represent the environmentally preferable option or where the POP content is
low,  waste  shall  be  otherwise  disposed  of  in  an  environmentally  sound  manner.
Disposal  operations  that  may  lead  to  recovery  or  re-use  of  POPs  are  explicitly
forbidden. With regard to shipment of wastes, relevant international rules, standards
and  guidelines,  such  as  the  Basel  Convention  on  the  Control  of  Transfrontier
Movements of Hazardous Waste and their Disposal, are to be taken into account.

In  addition  to  the  control  measures,  the  Convention  includes  several  general
obligations. Each Party is obliged to develop and endeavour to implement a National
Implementation  Plan,  facilitate  or  undertake  the  exchange  of  information  and
promote  and  facilitate  awareness  and  public  access  to  information  on  POPs.  The
Parties  shall  also  encourage  or  undertake  appropriate  research,  development,
monitoring  and  co-operation  pertaining  to  POPs,  and  where  relevant,  to  their
alternatives  and  to  candidate  POPs.  They  shall  also  regularly  report  to  the
Conference of the Parties on the measures taken to implement the provisions of the
Convention.

The  Convention  recognises  the  particular  needs  of  developing  countries  and
countries with economies in transition and therefore specific provisions on technical
assistance  and  on  financial  resources  and  mechanisms  are  included  in  the  general
obligations.

Altogether 150 countries and the Community have signed the Stockholm Convention
in the time limit set for signatories. By March 2003, 30 countries had already ratified
it.  After  the  fiftieth  ratification  the  Convention  will  enter  into  force.  All  EU
Member States and all but two candidate countries to the  EU (Cyprus  and  Estonia)
have  signed  the  Convention,  and  so  far  six  Member  States  and  two  Candidate
Countries have already ratified the Convention.

4

4.

EXISTING COMMUNITY RULES

there 

is  no  Community 

Current Community legislation includes restrictions on marketing and use of most of
the  intentionally  produced  substances  listed  in  the  Convention  and  in  the  Protocol.
However, 
legislation  on  mirex,  chlordecone  or
hexabromobiphenyl. The existing restrictions are given mainly in the framework of
Council  Directive  79/117/EEC2  prohibiting  the  placing  on  the  market  and  use  of
plant protection products containing certain active substances. The use restrictions of
PCBs are laid down in Council Directive 76/769/EEC3 on the approximation of the
laws,  regulations  and  administrative  provisions  of  the  Member  States  relating  to
restrictions  on  the  marketing  and  use  of  certain  dangerous  substances  and
preparations.

The  main  deficiency  in  the  present  Community  legislation  is  that  there  is  no
legislation on prohibition of the production of  any of  the currently listed chemicals
nor  is  there  any  framework  to  prohibit  the  production  of  new  POPs  added  in  the
agreements  in  future.  Another  significant  deficiency  is  that  most  of  the  existing
Community prohibitions on the marketing and use of specific POP chemicals are not
complete, as Directive 79/117/EEC only covers use of substances as plant protection
products, not e.g. biocidal or industrial uses. Furthermore, placing on the market and
use  of  chemicals  occurring  as  constituents  of  articles  are  not  in  all  cases  banned,
either,  and exemptions given in the  two limitations Directives  are  wider  than  those
set in the Convention.

Most of the listed POP substances have already been included in Council Regulation
(EEC) No 2455/92 concerning the export and import of certain dangerous chemicals4
and thus export and import of these substances  is already subject to  prior  informed
consent  procedure.  This  Regulation  has  recently  been  replaced  by  Regulation  (EC)
No 304/2003 of the European Parliament and of the Council5, which implements the
obligations  of  the  Rotterdam  Convention  for  the  application  of  the  Prior  Informed
Consent  (PIC)  procedure  for  certain  hazardous  chemicals  and  pesticides  in
international trade. Moreover, Regulation (EC) No 304/2003 prohibits export of the
10 POP  substances  currently  listed  in  the  Stockholm  Convention  according  to  the
provisions therein.

The obligation to prevent marketing and use of new POP-like chemicals can already
be implemented in the assessment schemes set for new substances (in the framework
of  Council  Directive  67/548/EEC6),  plant  protection  products  (Council  Direc-
tive 91/414/EEC7  and  for  biocides  (Directive  98/8/EC  of  the  European  Parliament

2

3

4

5

6

7

OJ L 33, 8.2.1979, p. 36. Directive as last  amended  by  the  Act  of  Accession  of  Austria,  Finland  and
Sweden.
OJ L 262, 27.9.1976, p. 201. Directive as last amended by Commission Directive 2003/11/EC (OJ L 42,
15.2.2003, p. 45).
OJ L 251, 29.8.1992, p. 13. Regulation as last amended by Commission Regulation (EC) No 2247/98
(OJ L 282, 20.10.1998, p. 12).
OJ L 63, 6.3.2003, p. 1.
OJ P 196, 16.8.1967, p. 1. Directive as last amended by Commission Directive 2001/59/EC (OJ L 225,
21.8.2001, p. 1).
OJ  L  242,  19.8.1991,  p.  1.  Directive  as  last  amended  by  Commission  Directive  2003/5/EC  (OJ  L  8,
14.1.2003, p. 7).

5

                                                
and  of  the  Council)8.  However,  production  of  new  substances  with  POP
characteristics  cannot  be  prevented  by  any  of  these  Directives.  This  should  be
covered by the future REACH system proposed in the White Paper on Strategy for a
future Chemicals Policy (Communication of the Commission COM(2001) 88 final).

With  regard  to  unintentionally  produced  POPs,  there  are  several  instruments  in
Community legislation that will have an impact on the reduction of releases of these
substances.  The  main  release  control  measures  are  set  out  in  Directive  96/61/EC
(the IPPC Directive)9, which covers the major stationary sources (industrial sources,
energy 
POPs.
The European pollutant  emission  register  (EPER),  a  Community-wide  inventory  of
the  principal 
established  by
responsible 
Commission Decision  2000/479/EC10  and  it  covers  already  all  unintentionally
produced POPs, except PCBs. The list of pollutants to be registered will be expanded
due to other international obligations and also PCBs will be included.

and  waste  management) 

sources,  was 

by-product 

emissions 

industry 

and 

of 

The  Waste  Incineration  Directive  (Directive 2000/76/EC11),  which  covers  all  waste
incineration  facilities,  deals  with  a  very  important  source  of  by-product  POPs.  In
addition,  the  Directive  on  Large  Combustion  Plants  (Directive  2001/80/EC12)  is
relevant from the POPs emissions point of view. Directive 2000/53/EC13 on  end-of
life  vehicles  imposes  the  segregation  of  hazardous  components  from  the  vehicle
before  any  shredding  of  the  carcass  and  an  adequate  disposal  of  the  shredder
residues. This would help decrease the releases of POPs from shredder plants, which
are  considered  to  be  a  source  of  POPs.  The  recently  adopted  Directives  of  the
Council  and  the  European  Parliament  on  waste  electrical  and  electronic  equipment
(WEEE)  (Directive  2002/96/EC14)  and  on  the  restriction  of  the  use  of  certain
equipment
electrical 
hazardous 
(Directive 2002/95/EC15)  establish  the  mandatory  segregation  of  PCB-containing
components  to  ensure  their  adequate  disposal  and  the  restriction  of  use  of  some
dangerous  substances  in  electric  and  electronic  equipment.  All  these  directives  will
contribute to reduce the releases of POPs in the environment.

substances 

electronic 

and 

in 

With  regard  to  the  prevention  of  accidental  releases  of  dangerous  substances,
Council Directive 96/82/EC16 on the control of major-accident hazards, the so-called
Seveso II Directive, is an important piece of Community legislation.

Regarding  the  releases  of  POPs  to  waters,  Council  Directive  76/464/EEC17  on
pollution caused by discharges of certain dangerous substances has some relevance.

8

9

10

11

12

13

14

15

16

OJ L 123, 24.4.1998, p. 1.
OJ L 257, 10.10.1996, p. 26.
OJ L 192, 28.7.2000, p. 36.
OJ L 332, 28.12.2000, p. 91.
OJ L 309, 27.11.2001, p. 1.
OJ L 269, 21.10.2000, p. 34. Directive as amended by Commission Decision 2002/525/EC (OJ L 170,
29.6.2002, p. 81).
OJ L 37, 13.2.2003, p. 24.
OJ L 37, 13.2.2003, p. 19.
OJ L 10, 14.1.1997, p. 13. Directive as last amended by Commission Decision 98/433/EC (OJ L 192,
8.7.1998, p. 19).

6

                                                
However, concrete Emission Limit Values (ELVs) have not been set for other POPs
than  HCB  (Council  Directive  88/347/EEC18).  Directive  76/464/EEC  is  now
integrated in the Water Framework Directive (Directive 2000/60/EC19) and some of
the listed POPs are included in the list of priority substances.

The  overall  conclusion  with  regard  to  release  control  measures  is  that  the
Community  legislation  is  well  in  accordance  with  the  requirements  set  in  the
two international agreements. However, no  emission reduction  targets  as  such  have
been  set  at  Community  level  and  the  current  release  inventories  do  not  cover  all
sources  of  POPs.  The  present  Community  legislation  on  PAHs  is  very  limited,  but
the  Commission  is  in  the  process  of  preparing  a  proposal  on  a  daughter  directive
under  the  Ambient  Air  Quality  Framework  Directive  96/62/EC  which  would  lay
down an air quality target value for benzo[a]pyrene as a marker for PAHs.

In  2001  the  Commission  adopted  a  Communication  on  a  Community  Strategy  for
Dioxins,  Furans  and  Polychlorinated  Biphenyls  (COM(2001)  593  final).  This
strategy  aims  to  assess  the  current  state  of  the  environment  and  the  ecosystem,  to
reduce  human  exposure  to  dioxins  and  PCBs  in  the  short-term,  to  maintain  human
exposure  at  safe  levels  in  the  medium  to  long  term  and  to  reduce  environmental
effects from dioxins and PCBs. No legislative changes are proposed in the strategy,
but several other measures, including proper enforcement of the current Community
legislation  (in  particular  the  PCB  disposal  Directive  and  the  IPPC  Directive),  are
proposed. As such the strategy could form a Community-wide action plan to reduce
and eliminate releases of these POPs.

The  management  of  stockpiles,  before  they  become  waste,  is  subject  to  existing
chemicals  legislation  and,  in  terms  of  plant  safety  and  when  it  comes  to  larger
storage, Seveso II Directive requirements. Several of the provisions related to waste
management in the UNECE Protocol and the Convention have already been included
in Community legislation,  in  particular  in  Directive  75/442/EEC20  on  waste,  which
constitutes  the  legal  framework  for  Community  policy  on  waste  management.
Directive 91/689/EEC21 contains additional management and monitoring obligations
for  hazardous  waste  and  Council  Directive  96/59/EC  lays  down  special  provisions
for  the  disposal  of  PCBs.  However,  except  for  PCBs,  there  are  currently  no
restrictions in the Community legislation on the recovery of POPs-containing waste
as required in the Convention.

Transboundary 
by  Council  Regu-
lation (EEC) No 259/93 on the supervision and control of shipments of waste within,
into and out of the Community22. This Regulation is the main instrument to transpose

of  waste 

shipments 

covered 

are 

17

18

19

20

21

22

OJ  L  129,  18.5.1976,  p.  23.  Directive  as  last  amended  by  Directive  2000/60/EC  of  the
European Parliament and of the Council (OJ L 327, 22.12.2000, p. 1).
OJ L 158, 25.6.1988, p. 35.
OJ L 327, 22.12.2000, p. 1.
OJ L 194, 25.7.1975, p. 39. Directive as last amended by Commission Decision 96/350/EC (OJ L 135,
6.6.1996, p. 32).
OJ  L  377,  31.12.1991,  p.  20.  Directive  as  last  amended  by  Council  Directive  94/31/EC  (OJ  L  168,
2.7.1994, p. 28).
OJ  L  30,  6.2.1993, p.  1.  Regulation  as  last  amended  by  Commission  Regulation  (EC)  No  2557/2001
(OJ L 349, 31.12.2001, p. 1).

7

                                                                                                                                                        
the Basel Convention into Community legislation. Waste consisting of, containing or
contaminated  with  POP  substances  is  also  covered  by  that  Regulation.  Currently
shipments of such waste within the Community are subject to a procedure based on
prior  written  notification  and  written  consent.  As  regards  exports  out  of  the
Community,  the  Regulation  establishes  that  exports  for  disposal  are  totally  banned
whereas  exports  for  recovery  are  only  allowed  if  destined  for  recovery  in  OECD
countries23.  Imports  into  the  Community  are  allowed  if  they  come  from  EFTA
countries or countries that are Parties to the Basel Convention or, when the waste is
destined for recovery, also from other OECD countries. This Regulation is currently
under  revision.  The  Commission  proposal  establishes  that  shipments  of  waste
consisting,  containing  or  contaminated  with  the  substances  listed  in  the  Stockholm
Convention  are  subject  to  the  same  provisions  as  shipments  of  waste  destined  for
disposal. This means in effect that all shipments within the Community will continue
to be subject to the requirement of written notification and written consent and that
all  exports  out  of  the  Community  will  be  banned.  As  regards  imports  into  the
Community,  these  will  only  be  allowed  if  they  come  from  EFTA  countries  or
countries that are Parties to the Basel Convention.

5.

IMPLEMENTATION STRATEGY

The Community and the Member States are strongly committed to a rapid ratification
and effective implementation of both international agreements on POPs. The present
status of ratifications lays down a stringent timetable for the Community if it wishes
to  be  sure  of  becoming  a  Party  before  the  first  Conference  of  the  Parties,  which  is
likely to be held in 2004.

Most  of  the  acceding  and  candidate  States  have  also  signed  the  international
agreements  on  POPs.  In  a  recent  survey,  all  10  acceding  States  confirmed  their
intentions  to  implement  the  international  obligations  on  POPs.  The  situation  with
regard  to  practical  implementation  of  the  proposed  provisions  in  the  acceding  and
candidate States is expected to be largely similar to the present Member States, but in
the  absence  of  exact  detailed  information,  it  has  not  been  possible  for  the
Commission to analyse this in a full and comprehensive manner before the adoption
of  this  proposal.  Therefore,  the  Commission  will,  during  the  early  stages  of  the
decision-making procedure,  gather  further scientific  information  about  the  situation
in these  countries, including through consultations with the acceding  and  candidate
States,  to  find  out  whether  there  will  be  impacts  on  these  countries  going  beyond
those on the current Member States. Following this survey, the Commission will, if
appropriate,  take  relevant  action  in  the  framework  of  the  Treaties  of  Accession,
including a possibility to make modifications to the enclosed proposal.

The POP agreements are  very wide  in scope in the sense that the control measures
cover 
to  disposal.
Secondary Community legislation does not yet fully cover all these measures.

life  cycle  of  POPs, 

from  production 

the  whole 

23

The terminology used is: Countries to which the OECD Decision applies. The OECD Decision refers to
the  Decision  of  the  OECD  Council  of  30  March  1992  on  the  control  of  transfrontier  movements  of
wastes destined for recovery operations, as amended.

8

                                                
Although most of the listed POPs are no longer produced or used in the Community,
the  present  chemicals  legislation  does  not  include  actual  provisions  to  prevent  and
eliminate intentionally produced POPs from being placed on the market. In addition,
Community  legislation  on  waste  does  not  include  all  the  measures  set  forth  in  the
Stockholm Convention.

At  the  same  time  as  the  current  proposal,  the  Commission  is  preparing  a
comprehensive reform of the chemicals legislation as a follow-up to the White Paper
on  Strategy  for  a  future  Chemicals  Policy  affecting  all  the  main  current  chemicals
legislation.  This  new  legislation  would  be  the  best  instrument  to  implement  the
necessary  control  measures  on  production,  marketing  and  use  of  intentionally
produced POPs. However, given the scale and complexity of the proposal on the new
chemicals  legislation,  the  final  adoption  of  the  new  rules  may  take  some  time.
Therefore,  and  in  order  to  facilitate  early  ratification  of  the  two  international  POP
agreements,  the  implementation  measures  related  to  production,  marketing  and  use
of  the  currently  listed  POPs  are  included  in  the  present  proposal  as  a  temporary
measure. In the medium term, it is intended that these measures will be subsequently
incorporated  in  the  new  chemicals  legislation.  The  proposal  for  the  new  chemicals
legislation will therefore include measures to transfer these provisions from the POP
Regulation.

Some  control  provisions  in  the  two  POP  agreements  are  aspirational  rather  than
legally  binding  obligations.  In  addition,  while  some  of  the  provisions  clearly  fall
under  Community  competence,  others  belong  to  competence  shared  with  or  left  to
the  Member  States.  Therefore,  not  all  provisions  of  the  agreements  require  new
provisions  at  Community  level.  In  general,  the  Community  has  exercised  its
competence  in  the  field  of  all  control  measures  and,  in  addition,  in  the  fields  of
inter alia research and monitoring. However, while control measures on intentionally
produced  chemicals  would  continue  to  have  to  be  fully  harmonised  in  order  to
prevent  any  distortion  of  the  internal  market,  the  implementation  of  additional
release control measures on by-products, provisions on soil contamination as well as
certain general obligations of the Convention could be addressed in accordance with
the subsidiarity principle.

Against this background, it appears that the most appropriate way to implement the
main  control  provisions  of  the  Convention  and  the  UNECE  Protocol  within  a
reasonable  timeframe  is  via  a  single,  horizontal  legal  instrument.  Later  on,  the
provisions on production, marketing and use of the listed POPs and on the prevention
of  production  and  use  of  substances  exhibiting  POP  characteristics  are  to  be
introduced  as  a  part  of  the  new  chemicals  legislation.  In  future,  as  Community
legislation and the international agreements on POPs develop, other provisions may
also need to be introduced in Community legislation.

The proposal takes the form of  a Regulation, as it would allow  for  more  rapid  and
straightforward  implementation  throughout  the  Community,  including  the  new
Member  States.  It  will  also  avoid  legislative  gaps  and  inconsistencies  between
different  Community  and  national  texts  and  allow  for  more  consistent  practical
application.

The  principal  aim  of  the  Regulation  is  the  protection  of  human  health  and  the
environment and therefore the legal basis is Article 175(1) of the Treaty. However,
prohibitions  and  restrictions  of  production,  placing  on  the  market  and  use  of  POPs

9

are relevant to the functioning of the internal market and their legal basis is therefore
Article 95(1) of the Treaty.

6.

PROPOSED NEW RULES

The  proposed  Regulation  of  the  European  Parliament  and  the  Council  would
implement  the  main  provisions  of  the  Stockholm  Convention  and  the  UNECE
Protocol  on  intentionally  produced  POPs  by  prohibiting  the  production,  use  and
placing on the market of the listed substances. To ensure a high level of protection of
health and the environment, the proposed new Regulation would not make use of the
possibility  offered  by  the  international  agreements  to  continue  the  production,
placing on the market and use of some of the listed substances for limited uses.

The  proposed  Regulation  would  also  contain  certain  provisions  on  stockpiles  and
waste, which  to  some  extent  would  go  beyond  those  set  in  the  Convention.  As  the
necessary  legislation  on  the  listed  by-products  is  to  a  great  extent  in  place,  it  is
proposed to include only provisions  on  release inventories and on  the  development
and implementation of the national action plans in the Regulation.

In addition to provisions on control measures, the Regulation would contain certain
general obligations based on the provisions of the Convention and the Protocol.

Adding  new  POP  substances  is  a  crucial  element  of  the  proposed  Regulation,  and
new chemicals will most likely be added relatively soon both in the Convention and
in  the  UNECE  Protocol.  After  a  decision  on  listing  of  a  substance  is  made  under
either of  the two  international  legally binding instruments  on POPs, the Regulation
would be amended, as appropriate, by using a regulatory committee procedure. This
is  sufficient  because  all  Member  States  and  the  Council  would  have  already  dealt
with  the  listing  of  a  new  POP  during  international  negotiations.  This  procedure
provides a possibility also for the European Parliament to react on the Commission
proposals and decisions taken. The regulatory committee procedure would enable the
Community  to  decide  on  the  inclusion  of  a  substance  in  the  given  one  year
timeframe.

For the sake of legal clarity, it is proposed to repeal the obsolete marketing and use
restrictions  on  eight  POP  pesticides  set  out  in  Council  Directive  79/117/EEC.  In
addition, 
the
PCB Disposal Directive (96/59/EC).  However,  the  present  restrictions  on  PCBs
would remain intact.

amendment 

to  make 

proposed 

slight 

in 

is 

it 

a 

7.

CONTENT OF THE REGULATION

Article 1

This article outlines the subject matter and scope of the Regulation by  emphasising
the type of control measures to be taken. It also emphasises the subordination of the
Regulation  to  the  international  legally  binding  instruments.  In  addition,  the  second
paragraph  clarifies  that  the  control  measures  concerning  the  production,  marketing
and use specified in Article 3 and 4 do not apply to waste.

10

Article 2

Only few definitions are deemed to be necessary for the purposes of the Regulation.
These definitions are based either on the Convention or on the existing Community
legislation, except the definition of ‘articles’. For definitions of ‘substance’, ‘waste’
and  ‘recovery’  the  text  refers  to  definitions  of  relevant  existing  Community
legislation.

Article 3

Article  3  lays  down  the  prohibitions  and  restrictions  on  production,  placing  on  the
market and use of the intentionally produced POPs. In the first paragraph reference is
made to Annex I, which contains both the ten intentionally produced POPs currently
listed  in  the  Convention  and  two  of  the  additional  three  substances  listed  in  the
UNECE Protocol. There is no known production  or  uses of these substances  in  the
current Member States (with the exception of use of existing PCB equipment) and no
specific exemptions have been asked for by the Community or by the Member States
under  the  Convention.  According  to  available  information,  most  of  the  Candidate
Countries  have  banned  the  import  and  use  of  the  listed  substances,  and  these
substances are not produced, either. Two of the Candidate Countries have, however,
provisionally  requested  a  country-specific  exemption  on  use  of  HCB  as  an
intermediate.  In  line  with  the  aim  of  elimination,  it  is  proposed  nonetheless  to
prohibit  the  production  and  use  of  these  substances  completely,  even  though  the
international agreements would allow production and use of some of them.

In  the  second  paragraph  reference  is  made  to  Annex  II,  which  contains  a  list  of
substances that would be subject to restrictions of production, placing on the market
and  use.  At  the  moment  only  HCH  (lindane)  is  included  in  this  Annex.  The
production and use of HCH is restricted under the Protocol but several main uses are
still  allowed.  In  the  Community,  the  marketing  and  use  of  lindane  for  plant
in  Commission
protection  purposes  ceased 
Decision 2000/801/EC.  However,  according  to  available  information,  some  minor
biocidal  and  pharmaceutical  uses  seem  still  to  exist  in  some  Member  States  and
possibly  also  in  some  Candidate  Countries.  Therefore  a  total  ban  of  production,
marketing  and  use  is  not  yet  regarded  possible  and  consequently  lindane  has  been
listed under  Annex  II with specification of the  allowed  uses.  These  remaining  uses
are all in accordance with the current international obligations.

in  July  2002,  as  set  out 

In  the  Convention,  the  term  ‘use  of  substance’  includes  not  only  the  use  of  a
substance  as  such  and  in  chemical  preparations  but  also  as  constituents  of
manufactured  articles  (e.g.  wood  preserved  with  chemicals).  This  is  emphasised  in
Article 3 of the Regulation.

Article 4

This  Article  defines  certain  general  exemptions  from  the  provisions  concerning
production, placing on the market and use. These exemptions follow closely the very
limited  general  exemptions  given  in  Article  3(5)  and  Annexes  A  and  B  of  the
Convention.  For  the  sake  of  clarity  and  consistency,  the  same  limited  exemptions
would  apply  to  the  three  additional  substances  listed  in  the  Protocol,  although  the
Protocol  would  in  principle  allow  much  wider  exemptions  (e.g.  for  public  health
emergencies and so called minor applications).

11

General  exemptions  would  apply  to  quantities  of  substances  to  be  used  for
laboratory-scale research or as reference standards or occurring as unintentional trace
contaminants  in  products  and  articles.  Substances  used  as  constituents  of  articles
manufactured  or  already  in  use  before  the  entry  into  force  of  the  prohibition  in
question  would  be  allowed  in  cases  where  the  Community  has  notified  the
Secretariat  of  the  remaining  use  of  such  articles.  However,  this  notification
obligation  applies  only  to  substances  listed  in  the  Convention,  and  therefore
reference is made to Part A of Annexes I and II. As this exemption might involve not
only use but also placing on the market of articles (e.g. in case where articles have
been  manufactured  or  imported  but  not  sold  before  the  entry  into  force  of  the
prohibition),  it  should  be  applied  throughout  the  Community  and  thus  the
Commission  should  notify  the  Secretariat.  An  initiative  for  the  notification  should
usually come  from the  Member State wishing to apply the exemption.  It  should  be
noted  that  this  procedure  would  not  apply  to  the  existing  PCB  equipment  as  the
Convention  and  Annex  I  of  the  Regulation  contain  a  special  exemption  on  them.
Concerning  the  other  substances  currently  listed  in  the  Convention,  no  treated
articles are known to be on the market or in use in the Community. The situation in
the  acceding  and  candidate  States  may  be  different,  but  by  notifying  such  possibly
remaining articles, their use could still continue.

The  Convention  allows  the  use  of  DDT  and  HCB  as  closed-system  site-limited
intermediates  with  certain  conditions.  In  line  with  the  aim  of  elimination,  these
substance-specific  exemptions  are  not  transposed  in  the  Regulation.  However,  the
concept as such is introduced in the third paragraph to be applied for possible future
substances. With regard to the substances listed in the Convention and consequently
in Part A of Annex I or II of this Regulation, the intermediate use has to be notified
to  the  Secretariat.  As  by  definition  no  placing  on  the  market  can  take  place,  this
notification  obligation  would  be  left  for  the  Member  States.  However,  the
Commission and other Member States should be informed about such notifications.

Article 5

Article  5  follows  the  provisions  laid  down  in  Article  6  of  the  Convention  and
contains  provisions  to  identify  stockpiles  of  intentionally  produced  POPs  and
manage  them  in an  environmentally  sound  manner.  However,  the  provisions  in  the
Regulation are more specific than those in the Convention. This is deemed necessary
as  obsolete  or  carelessly  stored  POP  stockpiles  have  caused  severe  risks  to  human
health and the environment.

The first paragraph stipulates that the possibly remaining stockpiles consisting of or
containing POPs which are totally prohibited should be treated as waste. This waste
will be subject to Community waste legislation and Article 7 of this Regulation. It is
assumed that no such stockpiles of the chemicals currently listed in Annex I are left
in  the  Member  States.  The  situation  is  different  in  some  of  the  acceding  and
candidate  States,  which  have  large  amounts  of  obsolete  pesticides.  To  provide  a
status of stockpiles in the 10 acceding States, the Commission has recently had made

12

a study24 on the issue. The results indicate that there are large stockpiles of obsolete
pesticides in Poland and in the Baltic states and that these stockpiles could contain up
to 27 000 tons of POP pesticides. To dispose of these stockpiles safely, EU financial
and technical assistance through existing financial instruments may be necessary for
e.g. to support capacity building for waste management planning or for the building
of safe disposal facilities.

The  second  paragraph  defines  provisions  applied  to  stockpiles  of  POP  substances,
which are only subject to restrictions. The holders of stockpiles over 100 kg should
notify the competent authority of the Member State about the nature and quantity of
these  stockpiles  within  12  months  of  entry  into  force  of  the  restriction  in  question
and  yearly  thereafter  until  the  end  of  the  time  warranted  for  restriction.  The
Member States  would  be  obliged  to  monitor  that  the  stockpiles  are  stored,  handled
and managed appropriately.

In addition, Article 12 of the Regulation requests Member States every three years to
submit  a  summary  report  to  the  Commission  on  any  stockpiles  they  have  been
informed about. This would allow the Commission to monitor and evaluate the need
for  additional  Community  measures  to  ensure  that  the  objectives  of  the  Regulation
are met.

Article 6

In  order  to  capture  all  the  main  control  provisions  and  the  listed  substances  of  the
Convention and the Protocol, certain general provisions related to release reduction
are  included  in  the  Regulation.  Article  8  obliges  Member  States  to  develop  and
maintain release inventories for dioxins, furans and other by-product POPs listed in
the  two  international  agreements  and  specified  in  Annex  III  to  the  Regulation.
Moreover,  Member  States  are  obliged  to  develop  and  implement  National  Action
Plans designed to identify, characterise and reduce the releases of these substances,
as laid down in the Convention. Both the release inventories and the National Action
Plans  are  regarded  as  essential  tools  for  cost-effective  and  continuing  release
reduction of by-product POPs.

Article 7

Community legislation on waste applies already now to all waste containing  POPs.
However, as article 6(1)(d) of the Convention lays down certain detailed provisions
not  yet  covered  by  Community  legislation,  an  Article  on  these  specific  waste
management provisions is included in the Regulation.

Article 7 lays down the general rules on waste containing substances listed either in
the  Convention  or  in  the  Protocol.  However,  polycyclic  aromatic  hydrocarbons
(PAHs) are not listed in the Convention. As it would be very difficult to apply these
specific  rules  to  waste  containing  PAHs,  this  group  of  substances  is  left  out  of  the
scope of this Article. For the sake of legal clarity, a separate Annex IV is established
for the purposes of the waste provisions.

24

Obsolete  Pesticides  Status 
European Commission, Directorate General for Environment.

in  Candidate  Countries.  Final  Report,  September 

2002.

13

                                                
As  a  general  rule,  waste  containing  any  of  the  listed  POPs  should  be  disposed  of
without undue delay in such a way that the POP content is destroyed or irreversibly
transformed. However, the Convention recognises that it is not always  advisable or
feasible  to  eliminate  the  POP  content  totally.  Therefore,  the  second  paragraph
stipulates  that  waste  may  be  otherwise  disposed  of  in  accordance  with  Article  4  of
Directive 75/442/EEC when the content of the listed substances in waste is below the
concentration limits given in Annex  IV of the Regulation.  In the current Annex  IV
there  are  no  limit  values  but  these  are  currently  under  development  and  will  be
introduced later by the regulatory committee procedure.

The  Convention  would  also  allow  exemption  from  the  basic  obligation  in  cases
where destruction does not represent the environmentally preferable option. It is not
proposed to transpose this exemption in the Community legislation as the destruction
of POPs is regarded as the only environmentally sustainable way to deal with waste
with  high  POP  concentration.  Based  on 
in
Directive 96/59/EC  on PCB/PCT disposal  allowing permanent  underground  storage
in  salt  mines  as  a  disposal  method  regardless  of  the  POP  concentration  would
become obsolete. To prevent this disposal possibility and for the sake of legal clarity,
it is proposed to amend Directive 96/59/EC accordingly in Article 18.

the  provision 

this  view, 

In  accordance  with  the  Convention,  paragraphs  3  and  4  stipulate  that  re-use  or
recovery  of  waste  containing  POPs  is  not  allowed  unless  the  POP  content  can  be
destroyed in the recovery process or isolated from the waste carrier and subsequently
disposed  of  in  an  environmentally  safe  manner.  PCB  waste,  however,  is  already
covered by  a complete  recovery ban laid  down  in  Directive  96/59/EC. This stricter
provision  is  meant  to  take  precedence  and  therefore  a  specific  reference  to  that
Directive is made in paragraph 4.

Article 8

This Article sets out the obligation to develop an implementation plan, as requested
in  Article  7  of  the  Convention.  As  a  Party  to  the  Convention,  also  the  Community
has to develop a plan of implementation. However, as the competence with regard to
matters  under  the  Convention  is  shared  between  the  Community  and  the
Member States,  this  share  of  duties  should  also  be  reflected  in  the  implementation
plans.

The  plans  should  subsequently  be  implemented  and,  as  appropriate,  updated  and
renewed.  In  order  to  facilitate  co-operation  and  information  exchange  within  the
Community,  the  Implementation  Plans  are  to  be  submitted  to  the  Commission  and
other Member States.

Article 9

Article  9  lays  down  an  obligation  for  the  Commission  and  the  Member  States  to
establish,  in  close  co-operation,  appropriate  programmes  and  mechanisms  for  the
environmental  monitoring  of  three  of  the  listed  substances,  namely  dioxins,  furans
and  PCBs.  This  obligation  goes  beyond  the  provisions  of  the  international
agreements  but  it  is  based  on  the  Communication  from  the  Commission  on  the
Strategy for Dioxins, Furans and PCBs. Taking into account the current lack of data
on the environmental levels and trends of dioxins, furans and PCBs and the need to
evaluate the effectiveness of the control measures, a specific provision on monitoring

14

is considered necessary. However, it is necessary that measurement  and monitoring
tools  are  available  that  allow  appropriate  conditions  for  such  activities.  It  can  be
expected that such tools will be fully available within a time scale of 10 to 15 years.

Similar  obligations  with  regard  to  other  POPs  is  not  deemed  necessary  but  the
general  encouragement  on  monitoring  laid  down  in  the  Convention  is  regarded
sufficient at the moment.

Article 10

The provisions on information exchange laid down in Article 9 of the Convention are
transposed by Article 10 of the Regulation. Transposition is considered necessary as
the exchange of  information between  the  countries, public  awareness and  access to
information play a vital role in the elimination of pollution caused by POPs. In line
with  the  Convention,  Article  10  also  lays  down  the  provisions  on  confidential
information.

Article 11

This  Article  is  based  on  Article  12  of  the  Convention  and  sets  out  the  general
obligations  of  the  Commission  and  the  Member  States  in  providing  technical
assistance  to  developing  countries  and  countries  with  economies  in  transition.
Technical  assistance  should  be  designed  to  strengthen  the  capacities  of  these
countries and to find solutions for such issues as the remaining use of DDT in some
developing countries. The Convention still allows the production and use of DDT for
disease  vector  control  in  countries  where  safe,  effective  and  affordable  alternatives
are not available. In order to gradually eliminate the use of DDT and in line with the
final)25, 
research,
Communication 
development and introduction of alternatives to DDT should be promoted.

the  Commission 

(COM(2003)  93 

from 

Within  the context of technical assistance,  the  Commission  and  the  Member  States
should  also  consider  giving  support  to  non-governmental  organisations,  the  role  of
which can be very important.

Article 12

The first paragraph of Article 12 deals with reporting within the Community. On the
basis  of  the  information  provided  by  Member  States  and  its  own  monitoring,  the
Commission can assess the overall functioning of the Regulation.

The second paragraph sets out a specific reporting obligation on the production and
placing on the market of substances listed in Annex I or II, as laid down in Article 15
of  the  Convention.  Given  that  issues  concerning  internal  market  belong  to
Community competence, the Commission would compile a joint report on the basis
of the information provided by the Member States and provide it to the Secretariat.
This is laid down in the fourth paragraph.

25

Communication from the Commission to the Council and the European Parliament. “Update on the EC
Programme  of  Action  -  Accelerated  action  on  HIV/AIDS,  malaria  and  tuberculosis  in  the  context  of
poverty reduction”. 26.2.2003.

15

                                                
The  third  paragraph  lays  down  two  specific  reporting  obligations  for  the
Member States.  Every  three  years  they  would  have  to  submit  summary  reports  on
stockpiles  and  release  inventories.  This  would  allow  the  Commission  to  assess  the
functioning  of  the  control  measures  at  the  Community  level  and,  if  necessary,
propose appropriate amendments.

Apart from these particular reporting obligations, provisions on general reporting as
foreseen in  the  Convention and the Protocol are not included in the Regulation but
the issue is left for the Member States.

Article 13

This Article is a standard provision for penalties in the event of infringements.

Article 14

This  Article,  together  with  Article  16  lays  down  the  procedures  to  be  followed  for
amending  and  updating  the  Annexes  of  the  Regulation.  When  a  decision  has  been
taken at the international level on the inclusion of a substance in the Convention or in
the  UNECE  Protocol, the Commission  would prepare  a  proposal  on  amendment  of
relevant  Annexes.  The  decision  would  be  taken  using  the  regulatory  committee
procedure. According to Article 22 of the Convention, amendments to Annex A, B or
C will enter into force on the expiry of one year from the date of communication on
the  amendment  decision,  unless  the  Party  notifies  that  it  is  unable  to  accept  the
amendment  or  unless  the  Party  has  made  a  specific  declaration  together  with  its
ratification instrument, in accordance with Article 25(4) of the Convention.

The detailed conditions and possible exemptions for prohibitions and restrictions of
substances listed in the Annexes should  be reviewed by the Commission at  regular
intervals.  In  particular,  the  Commission  should,  before  31  December  2007,  review
the entry in Part B of Annex II concerning hexachlorocyclohexane HCH, including
lindane,  in  the  light  of  the  results  of  risk  assessments  and  of  the  development  of
knowledge  and  techniques  in  respect  of  substitutes  for  HCH.  Appropriate
modifications  should  be  made  on  the  basis  of  the  developments  in  the  Community
and under the Convention and the Protocol.

Article 15

The  Convention  or  the  Protocol  does  not  require  Parties  to  designate  competent
authorities.  However,  as  the  Regulation  lays  down  several  duties  for  the
Member States, it is deemed appropriate that specific authorities are designated to act
for the performance of the administrative functions required by the Regulation.

Article 16

This Article outlines the committee procedures to be followed. It is not proposed to
establish a new committee but the Committee established by Directive 67/548/EEC
should assist the Commission.

16

Articles 17 and 18

These  Articles  would  repeal  certain  existing  provisions.  Restrictions  adopted  under
Directive 79/117/EEC on eight POP pesticides become obsolete and good legislative
practice would require these to be repealed. In addition, it is proposed to amend the
provision  of  Council  Directive  96/59/EC  on  the  disposal  of  PCBs/PCTs  allowing
permanent storage of PCB waste in accordance with the rules of the Convention and
the  proposed  Regulation.  It  should  be  noted  that  the  other  specific  restrictions  of
PCBs under that Directive would remain valid.

Article 19

This standard  Article  is  relating to  entry into force and application  of the proposed
new  Regulation.  As  the  Regulation  implements  provisions  of  two  self-standing
international agreements, it is not appropriate to link the application date to the entry
into force of these agreements. Instead a fixed date is proposed.

Annexes

The Annexes contain the lists of persistent organic pollutants subject to the various
provisions  under  the  two  international  agreements  and,  consequently,  under  this
Regulation. Once agreed in the framework of either of the international agreements,
new substances will be added to one or more of the Annexes. In addition, Annexes
may be modified, in accordance with Article 14. Due to the differences in the lists of
POPs and in the provisions of the two agreements, several Annexes are needed in the
Regulation in order to clearly specify the scope of each control measure.

Annex  I  sets  out  the  list  of  10  intentionally  produced  substances  listed  both  in  the
Convention  and  the  Protocol  (Part  A)  and  the  list  of  2  additional  substances  listed
only  in  the  Protocol.  These  substances  are  subject  to  total  prohibitions  pursuant  to
Article  4(1).  There  is  only  one  substance  specific  exemption  in  that  Annex,
concerning  existing  equipment  containing  PCBs.  However,  for  substances  added
later,  certain uses  (e.g.  as  an  intermediate)  could  be  allowed,  if  in  accordance  with
the international agreements.

Annex  II  lists  the  substances  subject  to  restrictions  on  production,  placing  on  the
market and use pursuant to Article  3(2). As Annex I,  also  this Annex is divided in
two parts, in accordance with the status of the substances under the two international
agreements.  Currently  it  contains  only  one  substance  in  Part  B,  namely  HCH
(lindane), which for the time being is  still  allowed  for certain limited uses. Two of
these  uses  are  time  limited,  while  others  remain  open-ended.  However,  the
Commission  should  review  the  remaining  uses  by  the  end  of  2007  and  a  specific
provision to that effect is laid down in Article 14(2).

Annex  III  lists  the  unintentionally  produced  substances,  which  are  all  subject  to
release inventories and release reduction measures pursuant to Article 6.

Annex  IV  lists  the  substances,  which  are  subject  to  specific  waste  management
provisions laid down in Article 7. In addition, this Annex contains the concentration
limits  referred  to  in  paragraph  2  of  that  Article.  As  these  limits  are  still  under
development in the framework of the Basel and Stockholm Conventions and as the

17

Commission  is  launching  its  own  studies  on  this  issue,  no  limit  values  are  yet
included in Annex IV.

8.

COSTS

Economic impact of the present proposal is deemed negligible in the present Member
States.  In  some  acceding  and  candidate  States  there  are  considerable  amounts  of
obsolete  stockpiles  of  POPs  and  their  safe  disposal  is  likely  to  cause  significant
financial  impacts.  However,  EU  technical  and  financial  assistance  through  existing
financial  instruments  is  available  for  inter  alia  to  support  capacity  building  for  the
waste management planning and for the building of safe disposal facilities.

In general, the Regulation should not bring additional costs to those already imposed
by existing Community legislation. In the Commission, no additional resources other
than those already allocated to POPs related tasks are needed. In the Member States,
there  will  be  an  impact  in  terms  of  slightly  increased  administrative  burden  due  to
certain notification and reporting obligations.

The  costs  have  to  be  weighed  against  the  benefits:  The  provisions  contribute  to
elimination  of  the  most  harmful  substances  of  global  concern.  Furthermore,  the
Regulation  would  transpose  international  obligations  to  which  the  Community,  the
Member  States  and  most  of  the  acceding  and  candidate  States  have  already
committed themselves.

18

2003/0119 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on persistent organic pollutants and amending Directives 79/117/EEC and 96/59/EC

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular
Article 95(1) and Article 175(1) thereof,

Having regard to the proposal from the Commission26,

Having regard to the opinion of the European Economic and Social Committee27,

Having regard to the opinion of the Committee of the Regions28,

Acting in accordance with the procedure laid down in Article 251 of the Treaty29,

Whereas:

(1)

(2)

(3)

This  Regulation  primarily  concerns  environmental  protection  and  the  legal  basis  is
therefore  Article  175(1)  of  the  Treaty.  However,  in  so  far  as  the  prohibitions  and
restrictions  as  regards  the  production,  placing  on  the  market  and  use  of  persistent
organic  pollutants  are  relevant  to  the  functioning  of  the  internal  market,  this
Regulation is based also on Article 95(1) of the Treaty.

The Community is seriously concerned by the continuous release of persistent organic
pollutants  into  the  environment.  These  chemical  substances  are  transported  across
international  boundaries  far  from  their  sources  and  they  persist  in  the  environment,
bioaccumulate  through  the  food  web,  and  pose  a  risk  to  human  health  and  the
environment.  Further  measures  need  therefore  to  be  taken  in  order  to  protect  human
health and the environment against these pollutants.

In  view  of  its  responsibilities  for  the  protection  of  the  environment,  the  Community
signed  on  24  June  1998  the  Protocol  to  the  1979  Convention  on  Long-Range
Transboundary  Air  Pollution  on  Persistent  Organic  Pollutants,  hereinafter  “the
Protocol”,  and  on  22  May  2001  the  Stockholm  Convention  on  Persistent  Organic
Pollutants, hereinafter “the Convention”.

26

27

28

29

OJ C
OJ C
OJ C
OJ C

19

                                                
(4)

(5)

(6)

(7)

(8)

(9)

30

31

32

In  order  to  ensure  coherent  and  effective  implementation  of  the  Community’s
obligations  under  the  Protocol  and  the  Convention,  it  is  necessary  to  establish  a
common  legal  framework,  within  which  to  take  measures  designed  in  particular  to
eliminate  the  production,  placing  on  the  market  and  use  of  intentionally  produced
persistent organic pollutants.

Moreover,  having  regard  to  the  precautionary  principle  and  in  view  of  the  ultimate
objective  of  eliminating  the  release  of  persistent  organic  pollutants  into  the
environment, it is appropriate in certain cases to provide for control measures stricter
than those under the Protocol and the Convention.

The best instrument by means of which to implement the necessary control measures
on  production,  placing  on  the  market  and  use  of  the  listed  substances  would  be  the
legislation  planned  to  implement  the  Commission’s  White  Paper  on  Strategy  for  a
future  Chemicals  Policy30.  However,  on  account  of  its  scale  and  complexity,  that
legislation  is  expected  to  take  some  time  to  be  adopted  and,  since  it  is  important  to
ratify  the  Convention  and  the  Protocol  as  soon  as  possible,  this  Regulation  should
temporarily implement those measures.

laid  down 

the  prohibitions 

In the Community, the placing on the market and use of most of the persistent organic
pollutants  listed  in  the  Protocol  or  the  Convention  has  already  been  phased  out  as  a
result  of 
in  Council  Directive  79/117/EEC
of 21 December 1978 prohibiting the placing on the market and use of plant protection
products  containing  certain  active  substances31  and  Council  Directive  76/769/EEC
of 27 July 1976  on  the  approximation  of  the  laws,  regulations  and  administrative
provisions  of  the  Member  States  relating  to  restrictions  on  the  marketing  and  use  of
certain  dangerous  substances  and  preparations32.  However,  in  order  to  fulfil  the
Community’s obligations under the Protocol and the Convention and to minimise the
release of persistent organic pollutants, it is necessary and appropriate also to prohibit
the production of those substances and to restrict exemptions to a minimum.

The  production  and  use  of  hexachlorocyclohexane  (HCH),  including  lindane,  is
subject to restrictions under the Protocol but not totally prohibited. That substance is
still used in some Member States and therefore it is not yet appropriate to prohibit all
uses. However, in view of the harmful properties of HCH and the possible risks related
to  its  release  into  the  environment,  its  production  and  uses  should  be  confined  to  a
minimum and ultimately phased out.

Obsolete  or  carelessly  managed  stockpiles  of  persistent  organic  pollutants  may
seriously  endanger  the  environment  and  human  health  through,  for  instance,
contamination  of  soil  and  ground  water.  It  is  appropriate,  therefore,  to  adopt
provisions that  go beyond the  provisions  laid down in the Convention. Stockpiles of
prohibited  substances  should  be  treated  as  waste,  while  stockpiles  of  substances  the

COM(2001) 88 final.
OJ L 33, 8.2.1979, p. 36. Directive as last  amended  by  the  Act  of  Accession  of  Austria,  Finland  and
Sweden.
OJ L 262, 27.9.1976, p. 201. Directive as last amended by Commission Directive 2003/11/EC (OJ L 42,
15.2.2003, p. 45).

20

                                                
production  or  use  of  which  is  still  allowed  should  be  notified  to  the  authorities  and
properly supervised.

(10)

In line with the Communication from the Commission on the Community Strategy for
Dioxins,  Furans  and  Polychlorinated  Biphenyls  (PCBs)33,  and  with  the  Protocol  and
the  Convention,  releases  of  persistent  organic  pollutants  which  are  unintentional  by-
products of industrial processes should be identified and reduced with the aim of their
ultimate  elimination.  Appropriate  national  action  plans,  covering  all  sources  and
measures, including those provided for under existing Community legislation, should
be drawn up and implemented to reduce the releases continuously and cost-effectively.

(11)

In line with that Communication, appropriate programmes and mechanisms should be
established to provide adequate monitoring data on the presence of dioxins, furans and
PCBs in the environment. However, it is necessary to ensure that appropriate tools are
available and can be used under economically and technically viable conditions.

(12) Under  the  Convention,  the  persistent  organic  pollutant  content  in  waste  is  to  be
destroyed  or  irreversibly  transformed  into  substances  that  do  not  exhibit  similar
characteristics.  Since  current  Community  legislation  on  waste  does  not  lay  down
specific rules as regards those substances, they should be laid down in this Regulation.
To  ensure  both  the  high  level  of  protection  and  the  feasibility  of  the  requirements,
limit values defining a low content of the substances in waste will be established later.

(13)

(14)

(15)

(16)

The Convention provides that each Party is to draw up a plan for the implementation
of its obligations under the Convention. Since the Community and the Member States
share  competence  in  that  regard,  implementation  plans  should  be  drawn  up  both  at
national and Community level. Co-operation and an exchange of information between
the Commission and the authorities of the Member States should be promoted.

In accordance with the Convention and the Protocol, information on persistent organic
pollutants should be provided to other Parties. The exchange of information with third
countries not party to those Agreements should also be promoted.

In order to achieve the aims of the Convention, it is necessary, where appropriate, to
give  technical  assistance  to  developing  countries  and  countries  with  economies  in
transition.  The  Commission  and  the  Member  States  should  therefore  provide
appropriate  and  timely  technical  assistance  designed  especially  to  strengthen  the
capacity of those countries to implement the Convention, including such issues as the
remaining use of DDT in disease vector control and development and implementation
of suitable alternative products, methods and strategies.

There  should  be  regular  evaluation  of  the  effectiveness  of  the  measures  taken  to
reduce  releases  of  persistent  organic  pollutants.  To  that  end,  Member  States  should
report  regularly  to  the  Commission,  in  particular  as  regards  release  inventories,
notified  stockpiles  and  the  production  and  placing  on  the  market  of  restricted
substances.

33

OJ C 322, 17.11.2001, p. 2.

21

                                                
(17)

(18)

The  Convention  and  the  Protocol  provide  that  Parties  thereto  may  propose  other
substances  for  international  action  and  consequently  additional  substances  may  be
listed  under  those  Agreements,  in  which  case  this  Regulation  should  be  amended
accordingly.  Furthermore,  it  should  be  possible  to  modify  the  existing  entries  in
Annexes to this Regulation, inter alia for the purposes of adapting them to scientific
and technical progress.

Since the measures necessary for the implementation of this Regulation are measures
of  general  scope  within  the  meaning  of  Article  2  of  Council  Decision  1999/468/EC
of 28 June 1999 laying down the procedures for the exercise of implementing powers
conferred  on  the  Commission34,  they  should  be  adopted  by  use  of  the  regulatory
procedure provided for in Article 5 of that Decision.

(19) Member States should lay down rules on penalties applicable to infringements of the
provisions  of  this  Regulation  and  ensure  that  they  are  implemented.  Those  penalties
should be effective, proportionate and dissuasive.

(20)

Since the objectives of this Regulation, namely to protect the environment and human
health  from  persistent  organic  pollutants,  cannot  be  sufficiently  achieved  by  the
Member  States  acting  alone,  owing  to  the  transboundary  effects  of  those  pollutants,
and can therefore be better achieved at Community level, the Community may adopt
measures, in accordance with the principle of subsidiarity as set out in Article 5 of the
Treaty. In accordance with the principle of  proportionality, as set out in that Article,
this  Regulation  does  not  go  beyond  what  is  necessary  in  order  to  achieve  those
objectives.

(21)

In  the  light  of  the  above,  Directive  79/117/EEC  and  Council  Directive  96/59/EC
the  disposal  of  polychlorinated  biphenyls  and
of 16 September  1996  on 
polychlorinated terphenyls (PCBs/PCTs)35 should be amended,

HAVE ADOPTED THIS REGULATION:

1.

2.

34

35

Article 1
Subject-matter and scope

This  Regulation  concerns  the  production,  placing  on  the  market,  use,  release  and
disposal  of  substances  subject  to  prohibitions  or  restrictions  under  the  Stockholm
Convention  on  Persistent  Organic  Pollutants,  hereinafter  “the  Convention”,  or
the 1998  Protocol 
the  1979  Convention  on  Long-Range  Transboundary
Air Pollution on Persistent Organic Pollutants, hereinafter “the Protocol”.

to 

Those substances are listed in Annexes I to IV to this Regulation.

Articles 3 and 4 shall not apply to waste consisting of, containing or contaminated by
any substance listed in Annexes I or II.

OJ L 184, 17.7.1999, p. 23.
OJ L 243, 24.9.1996, p. 31.

22

                                                
For the purposes of this Regulation:

Article 2
Definitions

(a)

(b)

(c)

(d)

(e)

‘placing on the market’ means supplying or making available, whether in return for
payment or free of charge;

‘article’  means  an  object  composed  of  one  or  more  substances  and/or  preparations
which during production is given a specific shape, surface or design determining its
end use function to a greater extent than its chemical composition does;

‘substance’ is as defined in Article 2 of Council Directive 67/548/EEC36;

‘waste’ is as defined in Article 1(a) of Council Directive 75/442/EEC37;

‘recovery’ is as defined in Article 1(f) of Directive 75/442/EEC.

For the purposes of this Regulation, imports into the customs territory of the Community shall
also be deemed to be placed on the market.

Article 3
Control of production, placing on the market and use

1.

2.

The  production,  placing  on  the  market  and  use  of  substances  listed  in  Annex  I,
whether  on  their  own,  in  preparations  or  as  constituents  of  articles,  shall  be
prohibited.

The  production,  placing  on  the  market  and  use  of  substances  listed  in  Annex  II,
whether on their own, in preparations or as constituents of articles, shall be restricted
in accordance with the conditions set out in that Annex.

Article 4
Exemptions from control measures

1.

Article 3 shall not apply in the case of:

(a)

a substance used for laboratory-scale research or as a reference standard;

(b)

a  substance  occurring  as  an  unintentional  trace  contaminant  in  substances,
preparations or articles.

36

37

OJ P 196, 16.8.1967, p. 1. Directive as last amended by Commission Directive 2001/59/EC (OJ L 225,
21.8.2001, p. 1).
OJ L 194, 25.7.1975, p. 39. Directive as last amended by Commission Decision 96/350/EC (OJ L 135,
6.6.1996, p. 32).

23

                                                
2.

3.

1.

2.

Article  3  shall  not  apply  in  the  case  of  a  substance  occurring  as  a  constituent  of
articles  produced  or  already  in  use  before  or  on  the  date  of  entry  into  force  of  the
relevant provision of this Regulation.

However,  immediately  upon  becoming  aware  of  articles  referred  to  in  the
first subparagraph, a Member State shall inform the Commission accordingly.

Whenever  the  Commission  is  so  informed  or  otherwise  learns  of  such  articles,  it
shall,  where  appropriate,  notify  the  Secretariat  of  the  Convention  accordingly
without further delay.

Where  a  substance  is  listed  in  Part  A  of  Annex  I  or  in  Part  A  of  Annex  II,  a
Member State wishing to permit, until the deadline specified in the relevant Annex,
the production and use of that substance as a closed-system site-limited intermediate
shall notify accordingly the Secretariat of the Convention.

However,  such  notification  may  be  made  only  if  the  following  conditions  are
satisfied:

(a)

(b)

an  annotation  has  been  entered  in  the  relevant  Annex  expressly  to  the  effect
that such production and use of that substance may be permitted;

the manufacturing process will transform the substance into one or more other
substances  that  do  not  exhibit  the  characteristics  of  a  persistent  organic
pollutant;

(c)

it is not expected that either humans or the environment will be exposed to any
significant quantities of the substance during its production and use.

The notification shall be communicated also to  the other  Member  States and  to  the
Commission and shall give details of actual or estimated total production and use of
the  substance  concerned  and  the  nature  of  the  closed-system  site-limited  process,
specifying the amount of any non-transformed and unintentional trace contamination
by any persistent organic pollutant starting material in the final product.

The deadlines referred to in the first subparagraph may be amended in cases where,
following a repeat notification from the Member State concerned to the Secretariat of
the  Convention,  express  or  tacit  consent  is  issued  under  the  Convention  for  the
continued production and use of the substance for another period.

Article 5
Stockpiles

The  holder  of  a  stockpile  which  consists  of  or  contains  any  substance  listed  in
Annex I shall dispose of that stockpile as waste and in accordance with Article 7.

The  holder  of  a  stockpile  greater  than  100  kg  and  consisting  of  or  containing  any
substance  listed  in  Annex  II  shall  provide  the  competent  authority  of  the
Member State in which the stockpile is established with information concerning the
nature  and  size  of  that  stockpile.  Such  information  shall  be  provided  within
12 months  of  the  entry  into  force  of  the  relevant  provision  of  this  Regulation  and
annually thereafter until the deadline specified in Annex II for restricted use.

24

The holder shall manage the stockpile in a safe, efficient and environmentally sound
manner.

3.

Member States shall monitor the use and management of notified stockpiles.

Article 6
Release reduction

Within two years of the date of entry into force of this Regulation, Member States shall draw
up and maintain release inventories for the substances listed in Annex III.

Within the same period, Member States shall also draw up a national action plan designed to
identify, characterise and reduce the total releases derived from anthropogenic sources of each
of the substances listed in Annex III.

Each  Member  State  shall  implement  its  national  action  plan  as  part  of  its  national
implementation plan drawn up pursuant to Article 8.

Article 7
Waste management

1.

2.

3.

4.

Waste consisting of, containing or contaminated by any substance listed in Annex IV
shall  be  disposed  of  without  undue  delay  and  in  such  a  way  as  to  ensure  that  the
persistent  organic  pollutant  content  is  destroyed  or  irreversibly  transformed  so  that
the  remaining  waste  and  releases  do  not  exhibit  the  characteristics  of  persistent
organic pollutants.

By  way  of  derogation  from  paragraph  1,  waste  consisting  of,  containing  or
contaminated by any substance listed in Annex IV may be otherwise disposed of in
accordance with Article 4 of Directive 75/442/EEC, provided that the content of the
listed substances in the waste is below the concentration limits specified in Annex IV
to this Regulation.

The  re-use  or  recovery  of  waste  consisting  of,  containing  or  contaminated  by  any
substance listed in Annex IV shall be prohibited.

By  way  of  derogation  from  paragraph  3,  the  recovery  of  waste  consisting  of,
containing  or  contaminated  by  any  substance  listed  in  Annex  IV  shall  be  allowed,
provided that the operator demonstrates that the persistent organic pollutant content
is  destroyed  during  the  recovery  operation,  irreversibly  transformed  during  the
recovery operation or isolated from the waste carrier and subsequently disposed of in
accordance with paragraph 1.

The first subparagraph shall apply without prejudice to Directive 96/59/EC.

Article 8
Implementation plans

1.

Each Member State shall, within two years of the entry into force of this Regulation,
draw up a plan for the implementation of its obligations under the Convention.

25

As  soon  as  a  Member  State  has  adopted  its  national  implementation  plan,  it  shall
communicate it both to the Commission and to the other Member States.

Each  Member  State  shall  implement  its  plan  and  shall  review  and  update  it,  as
appropriate.

2.

The  Commission  shall,  within  two  years  of  the  entry  into  force  of  this  Regulation,
draw  up  a  plan  for  the  implementation  of  Community  obligations  under  the
Convention.

As  soon  as  the  Commission  has  adopted  the  Community  implementation  plan,  it
shall communicate it to the Member States.

The  Commission  shall  review  and  update  the  Community  implementation  plan,  as
appropriate.

Article 9
Monitoring

The  Commission  and  the  Member  States  shall  establish,  in  close  co-operation,  appropriate
programmes and mechanisms, consistent with the state of the art, for the continuous provision
of  comparable  monitoring  data  on  the  presence  of  dioxins,  furans  and  PCBs  in  the
environment.  When  establishing  such  programmes  and  mechanisms,  due  account  shall  be
taken of developments under the Protocol and the Convention.

Article 10
Information exchange

1.

2.

3.

The Commission and the Member States shall facilitate and undertake the exchange
within  the  Community  and  with  third  countries  of  information  relevant  to  the
reduction  or  elimination  of  the  production,  use  and  release  of  persistent  organic
pollutants  and  to  alternatives  to  those  substances,  specifying  the  risks  and  the
economic and social costs related to such alternatives.

The Commission and the Member States shall promote and facilitate awareness and
public  availability  of  information  on  persistent  organic  pollutants  and  on  the
reduction or elimination of their production, use and release.

The Commission  and  the  Member  States  shall  protect  any  confidential  information
received  from  a  third  country,  in  accordance  with  any  agreement  with  that  third
country.  Without  prejudice  to  Council  Directive  90/313/EEC38,  information  on
human  health  and  safety  and  on  the  environment  shall  not  be  regarded  as
confidential.

38

OJ L 158, 23.6.1990, p. 56.

26

                                                
Article 11
Technical assistance

The Commission and the Member States shall co-operate in providing appropriate and timely
technical  assistance,  including  training,  or  support  to  non-governmental  organisations,  to
developing  countries  and  countries  with  economies  in  transition  to  assist  them,  taking  into
account  their  particular  needs,  to  develop  and  strengthen  their  capacity  to  implement  their
obligations under the Convention.

Article 12
Reporting

1.

2.

3.

4.

5.

Member States shall every three years forward to the Commission information on the
application of this Regulation.

Member States shall provide the Commission every year with statistical data on the
actual or estimated total production and placing on the market of any substance listed
in Annex I or II.

Within three years of the date of entry into force of this Regulation and every three
years thereafter, Member States shall provide the Commission with:

(a)

(b)

(c)

summary  information  compiled  from  the  notifications,  concerning  stockpiles,
received pursuant to Article 5(2);

summary information compiled from the release inventories drawn up pursuant
to Article 6(1);

summary  information  on  the  presence  of  dioxins,  furans  and  PCBs  in  the
environment, as compiled pursuant to Article 9.

Regarding the substances listed in the Convention, the Commission shall, at intervals
to  be  determined  by  the  Conference  of  the  Parties  of  the  Convention,  compile  a
report on the basis of the information provided by the Member States in accordance
with paragraph 2 and communicate it to the Secretariat of the Convention.

The  Commission  shall  regularly  compile  a  report  on  the  application  of  this
Regulation and shall integrate it with the information provided by the Member States
under paragraphs 1, 2 and 3 to form a synthesis report. It shall forward a summary of
the synthesis report to the European Parliament and to the Council.

Article 13
Penalties

Member  States  shall  lay  down  the  rules  on  penalties  applicable  to  infringements  of  the
provisions  of  this  Regulation  and  shall  take  all  measures  necessary  to  ensure  that  they  are
implemented. The penalties provided for must be effective, proportionate and dissuasive. The
Member States shall notify those provisions to the Commission one year after entry into force
of this Regulation at the latest and shall notify it without delay of any subsequent amendment
affecting them.

27

Article 14
Amendment of Annexes

1.

2.

Whenever  a  substance  is  listed  in  the  Convention  or  the  Protocol,  the  Commission
shall,  where  appropriate,  amend  the  Annexes  to  this  Regulation  accordingly,  in
accordance with the procedure referred to in Article 16(2).

Modifications  to  the  existing  entries  in  the  Annexes,  including  their  adaptation  to
scientific and technical progress, shall be adopted by the Commission in accordance
with the procedure referred to in Article 16(2).

In particular, the  Commission shall, before 31  December 2007,  review  the  entry  in
Part  B  of  Annex  II  concerning  hexachlorocyclohexane  HCH,  including  lindane,  in
the light of the results of risk assessments and of the development of knowledge and
techniques in respect of substitutes for HCH.

Article 15
Competent authorities

Each Member State shall designate the competent authority or authorities responsible for the
administrative  tasks  required  by  this  Regulation.  It  shall  inform  the  Commission  of  such
designation at the latest three months after the entry into force of this Regulation.

Article 16
Committee procedure

1.

2.

The  Commission  shall  be  assisted  by  the  Committee  established  by  Article  29
of Directive 67/548/EEC.

Where reference is made to this paragraph, Article 5 and 7 of Decision 1999/468/EC
shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be three months.

3.

The Committee shall adopt its rules of procedure.

Article 17
Amendments to Directive 79/117/EEC

In  Part  B  of  the  Annex  to  Directive  79/117/EEC,  'Persistent  Organochlorine  compounds',
items 1 to 8 are deleted.

Article 18
Amendments to Directive 96/59/EC

In Article 2 of Directive 96/59/EC, point (f) is replaced by the following:

‘(f)  “disposal”  means  operations  D  8,  D  9,  D  10  and  D  15  provided  for  in  Annex  II  to
Directive 75/442/EEC.’

28

Article 19
Entry into force

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,

For the European Parliament
The President

For the Council
The President

29

ANNEX I

LIST OF SUBSTANCES SUBJECT TO PROHIBITIONS

PART A – SUBSTANCES LISTED IN THE CONVENTION AND IN THE PROTOCOL

SUBSTANCE

CAS No

EC No

SPECIFIC EXEMPTION ON
INTERMEDIATE USE OR
OTHER SPECIFICATION

Aldrin

309-00-2

206-215-8

Chlordane

57-74-9

200-349-0

Dieldrin

Endrin

60-57-1

200-484-5

72-20-8

200-775-7

Heptachlor

76-44-8

200-962-3

Hexachlorobenzene

118-74-1

200-273-9

Mirex

2385-85-5

219-196-6

Toxaphene

8001-35-2

232-283-3

Polychlorinated
Biphenyls (PCB)

1336-36-3
and others

215-648-1
and others

-

-

-

-

-

-

-

-

prejudice 

to
Without 
Directive 96/59/EC, 
articles
already in use at the time of entry
into  force  of  this  Regulation  are
allowed to be used.

50-29-3

200-024-3

-

DDT
(1,1,1-trichloro-2,2-
bis(4-chlorophenyl)
ethane)

PART B – SUBSTANCES LISTED ONLY IN THE PROTOCOL

SUBSTANCE

CAS No

EC No

Chlordecone

143-50-0

Hexabromobiphenyl

36355-01-8

-

-

SPECIFIC EXEMPTION ON
INTERMEDIATE USE OR
OTHER SPECIFICATION

30

ANNEX II

LIST OF SUBSTANCES SUBJECT TO RESTRICTIONS

PART A – SUBSTANCES LISTED IN THE CONVENTION AND IN THE PROTOCOL

SUBSTANCE

CAS No

EC No

CONDITIONS OF
RESTRICTION

-

PART B – SUBSTANCES LISTED ONLY IN THE PROTOCOL

SUBSTANCE

CAS No

EC No

HCH, including
lindane

608-73-1,
58-89-9

210-168-9,
200-401-2

CONDITIONS OF
RESTRICTION

Technical HCH is restricted to use
as  an  intermediate  in  chemical
manufacturing.

Products in which at least 99% of
the  HCH  isomer  is  in  the  gamma
form (lindane) are restricted to the
use as public health and veterinary
topical insecticide.

By  way  of  derogation, 
following 
uses 
until 1.9.2006:

are 

the
allowed

a)  Professional 
industrial  treatment  of 
timber and logs;

remedial  and
lumber,

Indoor 

b) 
residential applications.

industrial 

and

31

LIST OF SUBSTANCES SUBJECT TO RELEASE REDUCTION PROVISIONS

ANNEX III

SUBSTANCE (CAS No)

Polychlorinated dibenzo-p-dioxins and
dibenzofurans (PCDD/PCDF)

Hexachlorobenzene (HCB)
(CAS No: 118-74-1)

Polychlorinated biphenyls (PCB)

Polycyclic aromatic hydrocarbons (PAHs)

32

ANNEX IV

LIST OF SUBSTANCES SUBJECT TO WASTE MANAGEMENT PROVISIONS SET
OUT IN ARTICLE 7

SUBSTANCE

CAS No

EC No

LIMIT CONCENTRATION
REFERRED TO IN
ARTICLE 7(2), ppm
(parts per million)

Aldrin

Chlordane

Dieldrin

Endrin

Heptachlor

309-00-2

206-215-8

57-74-9

60-57-1

72-20-8

76-44-8

200-349-0

200-484-5

200-775-7

200-962-3

Hexachlorobenzene

118-74-1

200-273-9

Mirex

2385-85-5

219-196-6

Toxaphene

8001-35-2

232-283-3

Polychlorinated
Biphenyls (PCB)

1336-36-3
and others

215-648-1

50-29-3

200-024-3

DDT
(1,1,1-trichloro-2,2-
bis(4-chlorophenyl)
ethane)

Chlordecone

143-50-0

Polychlorinated
dibenzo-p-dioxins and
dibenzofurans
(PCDD/PCDF)

HCH, including
lindane

608-73-1,
58-89-9

210-168-9,
200-401-2

33

IMPACT ASSESSMENT FORM

THE IMPACT OF THE PROPOSAL ON BUSINESS WITH SPECIAL REFERENCE
TO SMALL AND MEDIUM-SIZED ENTERPRISES( SMEs)

TITLE OF PROPOSAL

Proposal for a Regulation of the European Parliament and of the Council on persistent organic
pollutants and amending Directives 79/117/EEC and 96/59/EC.

DOCUMENT REFERENCE NUMBER

-

THE PROPOSAL

1.

Taking  account  of  the  principle  of  subsidiarity,  why  is  Community  legislation
necessary in this area and what are its main aims?

The Regulation lays down at Community level requirements for the implementation
of  the  Stockholm  Convention  on  Persistent  Organic  Pollutants  and  the  UNECE
Protocol on Persistent Organic Pollutants, in accordance with the shared competence
between  the  Member  States  and  the  Community.  The  ultimate  objective  of  these
international  agreements  is  to  protect  human  health  and  the  environment  from
persistent organic pollutants.

The  Regulation  aims  at  facilitating  rapid  and  effective  implementation  of  the
two agreements.  It  also  aims  to  avoid  legislative  gaps  and  inconsistencies  between
different  Community  and  national  texts  and  to  allow  for  more  consistent  practical
application. This approach should also contribute to the effective functioning of the
internal market.

THE IMPACT ON BUSINESS

2.

Who will be affected by the proposal?

In principle, all sizes of business related to the production, marketing, use,  releases
and  disposal  of  the  listed  persistent  organic  pollutants  are  affected.  It  should  be
noted,  however,  that  there  is  hardly  any  production  of  the  listed  substances  in  the
Community  or  in  the  acceding  or  candidate  States  and  thus  the  direct  impact  is
regarded as low.

The  proposal  would  have  a  similar  impact  over  the  entire  Community,  and  in  the
acceding and candidate States. It is not aimed at any particular region.

34

3.

What will business have to do to comply with the proposal?

As  there  is  no  known  production  or  stockpiles  of  the  listed  substances  in  the
Community,  there  are  currently  no  direct  obligations  to  business  in  the  present
Member  States.  In  some  acceding  and  candidate  States  there  are  considerable
amounts of obsolete stockpiles of POPs, but most of these stockpiles are held by the
Government,  not  by  companies.  When  additional  substances  are  listed  in  the
Regulation,  and  if  they  are  still  being  produced,  used  or  exported,  the  companies
involved  have  to  ensure  that  the  rules  and  conditions  are  respected  and  to  report
regularly on the production, import, export and stockpiles.

With  regard  to  release  prevention  and  control  of  the  listed  persistent  organic
pollutants  and  their  monitoring,  no  additional  direct  provisions  are  addressed  to
business.  The  industries  releasing  the  highest  quantities  of  these  substances  are
already  subjected  to  prevention,  control  and  monitoring  obligations  under  existing
Community legislation.

Waste containing the listed POPs has to be disposed of without undue delay and in
accordance  with  the  specific  requirements.  This  may  lead  to  changes  in  waste
management practices in some enterprises.

4.

What economic effects is the proposal likely to have?

Precise assessment of the economic impact of the proposal is difficult to make. The
proposed Regulation goes beyond the requirements of the international agreements in
certain respects. However, in most cases these additional requirements will have no
effect as the currently listed substances are no longer being produced or used in the
Community. Therefore it is assessed that the proposal will have no significant effects
on  employment,  investment  and  the  creation  of  new  businesses  or  on  the
competitiveness of businesses.

5.

Does the proposal contain measures to take account of the specific situation of small
and medium-sized firms (reduced or different requirements etc)?

The scope of the proposal is horizontal and its  provisions  are  generic.  Therefore,  it
does  not  contain  measures  specifically  aimed  at  or  adapted  for  small  and  medium-
sized firms.

CONSULTATION

6.

List  the  organisations,  which  have  been  consulted  about  the  proposal  and  outline
their main views.

No separate external consultation has been launched on the proposal as it is based on
the  outcome  of  wide  international  negotiations  which  were  closely  followed  by
chemical industry associations, environmental and consumer organisations and other
stakeholders.  The  joint  positions  of  the  Community  and  the  Member  States  were
prepared  in  co-ordination  meetings  and  the  information  gathered  in  these  contexts
has been utilised in the preparation of the implementation proposals.

35

During  the  negotiation  conferences,  separate  meetings  were  arranged  to  exchange
views with the acceding and candidate States. After the negotiations were concluded,
the Community implementation and the situation and plans in various acceding and
candidate  States  with  regard  to  these  international  obligations  have  been  discussed
with  these  countries  in  some  bilateral  and  regional  meetings.  Moreover,  a  special
study focussing on obsolete POP pesticides in the 10 acceding States has been made
in  order  to  inter  alia  gather  background  information  for  the  preparation  of  the
Commission proposals.

36