Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC
Date: 2004-04-29
Institutions: Council of the European Union, European Parliament
Subjects: environmental protection, organic pollution, public health

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REGULATION (EC) No 850/2004 OF THE EUROPEAN PARLIAMENT

AND OF THE COUNCIL

of 29 April 2004

on persistent organic pollutants

and amending Directive 79/117/EEC

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

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

thereof,

Having regard to the proposal from the Commission 1,

Having regard to the Opinion of the European Economic and Social Committee 2,

After consulting the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty 3,

1

2

3

OJ C
OJ C
Opinion of the European Parliament of 26 February 2004 (not yet published in the Official
Journal) and Decision of the Council of 26 April 2004.

                                                
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Whereas:

(1) This Regulation primarily concerns environmental protection and the protection of human

health.  The legal basis is therefore Article 175(1) of the Treaty.

(2) 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.

(3)

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".

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(4) While legislation at Community level relating to persistent organic pollutants has been put in

place, its main deficiencies are that there is an absence of, or incomplete legislation on,

prohibition of the production and use of any of the currently listed chemicals, that there is no

framework to subject additional persistent organic pollutant substances to prohibitions,

restrictions or elimination, nor any framework to prevent the production and use of new

substances that exhibit persistent organic pollutant characteristics.  No emission reduction

targets, as such, have been set at Community level and the current release inventories do not

cover all sources of persistent organic pollutants.

(5)

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.

Furthermore, persistent organic pollutants' characteristics should be taken into consideration

in the framework of the relevant Community assessment and authorisation schemes.

(6) Coordination and coherence should be ensured when implementing at Community level the
provisions of the Rotterdam 1, Stockholm and Basel Conventions 2 and when participating in

the development of the Strategic Approach to International Chemicals Management (SAICM)

within the United Nations framework.

1 

2 

Convention on the prior informed consent procedure for certain hazardous chemicals and
pesticides in international trade.
Convention on the control of transboundary movements of hazardous wastes and their
disposal.

                                                
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(7) Moreover, considering that the provisions of this Regulation are underpinned by the

precautionary principle as set forth in the Treaty, and mindful of Principle 15 of the Rio

Declaration on Environment and Development and in view of the aim of elimination, where

feasible, of 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.

(8)

In the future, the proposed REACH Regulation could be an appropriate instrument by which

to implement the necessary control measures on production, placing on the market and use of

the listed substances and the control measures on existing and new chemicals and pesticides

exhibiting persistent organic pollutants' characteristics.  However, without prejudice to the

future REACH Regulation and since it is important to implement these control measures on

the listed substances of the Protocol and the Convention as soon as possible, this Regulation

should for now implement those measures.

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(9)

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

the prohibitions laid down 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
substances 1 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 preparations 2.  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 so that

exemptions only apply where a substance fulfils an essential function in a specific application.

(10) Exports of substances covered by the Convention and exports of lindane are regulated by

Regulation (EC) No 304/2003 of the European Parliament and of the Council of
28 January 2003 concerning the export and import of dangerous chemicals 3.

1

2

3

OJ L 33, 8.2.1979, p. 36.  Directive as last amended by Regulation (EC) No 807/2003 (OJ L
122, 16.5.2003, p. 36).
OJ L 262, 27.9.1976, p. 201.  Directive as last amended by Commission
Directive 2004/21/EC (OJ L 57, 25.2.2004, p. 4).
OJ L 63, 6.3.2003, p. 1.  Regulation as amended by Commission Regulation (EC)
No 1213/2003 (OJ L 169, 8.7.2003, p. 27).

                                                
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(11)

 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 possible to prohibit immediately all existing 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 by the end of 2007 at the latest.

(12) 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 production or use of which is still allowed should be

notified to the authorities and properly supervised.  In particular, existing stockpiles which

consist of or contain banned persistent organic pollutants should be managed as waste  as

soon as possible.  If other substances are banned in the future, their stocks should also be

destroyed without delay and no new stockpiles should be built up.  In view of the particular

problems of certain new Member States, adequate financial and technical assistance should be

provided through existing Community financial instruments, such as the Cohesion and

Structural Funds.

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(13)

 In line with the Communication from the Commission on the Community Strategy for
Dioxins, Furans and Polychlorinated Biphenyls (PCBs) 1, 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 as soon as possible with the ultimate aim

of elimination, where feasible.  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 as soon as

possible.  To this end, appropriate tools should be developed in the framework of the

Convention.

(14)

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.

1

OJ C 322, 17.11.2001, p. 2.

                                                
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(15)

 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, unless

other operations are environmentally preferable.  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 a high level of protection, common concentration limits for the

substances in waste should be established before 31 December 2005.

(16) The importance of identifying and separating waste consisting of, containing or contaminated

by persistent organic pollutants at source in order to minimise the spreading of these

chemicals into other waste is recognised.  Council Directive 91/689/EEC of
12 December 1991 on hazardous waste 1 established Community rules on the management of

hazardous waste obliging Member States to take the necessary measures to require that

establishments and undertakings which dispose of, recover, collect or transport hazardous

waste do not mix different categories of hazardous waste or mix hazardous waste with

non-hazardous waste.

1

OJ L 377, 31.12.1991, p. 20.  Directive as amended by Directive 94/31/EC (OJ L 168,
2.7.1994, p. 28).

                                                
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(17) The Convention provides that each Party is to draw up a plan for the implementation of its

obligations under the Convention. Member States should provide opportunities for public

participation in drawing up their implementation plans.  Since the Community and the

Member States share competence in that regard, implementation plans should be drawn up

both at national and Community level. Cooperation and an exchange of information between

the Commission and the authorities of the Member States should be promoted.

(18)

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.

(19) Public awareness of the hazards that persistent organic pollutants pose to the health of present

and future generations as well as to the environment, particularly in developing countries, is

often lacking, and wide-scale information is therefore needed to increase the level of caution

and gain support for restrictions and bans.  In accordance with the Convention, public

awareness programmes on these substances, especially for the most vulnerable groups, as well

as training of workers, scientists, educators, technical and managerial personnel should be

promoted and facilitated, as appropriate.

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(20)

 Upon request and within available resources, the Commission and the Member States should

cooperate in providing appropriate and timely technical assistance designed especially to

strengthen the capacity of developing countries and countries with economies in transition to

implement the Convention.  Technical assistance should include the development and

implementation of suitable alternative products, methods and strategies, inter alia, to the use

of DDT in disease vector control which, under the Convention, can only be used in

accordance with World Health Organisation recommendations and guidelines and when

locally safe, effective and affordable alternatives are not available to the country in question.

(21) 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.  The Commission, in

cooperation with Member States, should develop a common format for Member States'

reports.

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(22) 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.

(23) When Annexes to this Regulation are amended to implement any listings of an additional,

intentionally produced persistent organic pollutant in the Protocol or in the Convention, it

should be included in Annex II, instead of Annex I, only in exceptional cases and when duly

justified.

(24) The measures necessary for the implementation of this Regulation should be adopted in

accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures
for the exercise of implementing powers conferred on the Commission 1.

(25)

In order to ensure transparency, impartiality and consistency at the level of enforcement

activities, 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, since non-compliance can result in damage

to human health and the environment.  Information on infringements of the provisions of this

Regulation should be made public, where appropriate.

1

OJ L 184, 17.7.1999, p. 23.

                                                
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(26) 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,

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.

(27)

In the light of the above, Directive 79/117/EEC should be amended,

HAVE ADOPTED THIS REGULATION:

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Article 1

Objective and scope

1.

Taking into account, in particular, the precautionary principle, the objective of this Regulation

is to protect human health and the environment from persistent organic pollutants by prohibiting,

phasing out as soon as possible, or restricting the production, placing on the market and use of

substances subject to the Stockholm Convention on Persistent Organic Pollutants, hereinafter "the

Convention", or the 1998 Protocol to the 1979 Convention on Long-Range Transboundary

Air Pollution on Persistent Organic Pollutants, hereinafter "the Protocol", and by minimising, with a

view to eliminating where feasible as soon as possible, releases of such substances, and by

establishing provisions regarding waste consisting of, containing or contaminated by any of these

substances.

2.

Articles 3 and 4 shall not apply to waste consisting of, containing or contaminated by any

substance listed in Annexes I or II.

Article 2

Definitions

For the purposes of this Regulation:

(a)

"placing on the market" means supplying or making available to third persons against

payment or free of charge.  Imports into the customs territory of the Community shall also be

deemed to be placed on the market;

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(b)

"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;

(c)

"substance" is as defined in Article 2 of Council Directive 67/548/EEC 1;

(d)

"preparation" is as defined in Article 2 of Directive 67/548/EEC;

(e)

"waste" is as defined in Article 1(a) of Council Directive 75/442/EEC 2;

(f)

"disposal" is as defined in Article 1(e) of Directive 75/442/EEC;

(g)

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

Article 3

Control of production, placing on the market and use

1.

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.

1

2

Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and
administrative provisions relating to the classification, packaging and labelling of dangerous
substances (OJ P 196, 16.8.1967, p. 1).  Directive as last amended by Council
Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).
Council Directive 75/442/EEC of 15 July 1975 on waste (OJ L 194, 25.7.1975, p. 39).
Directive as last amended by  Regulation (EC) No 1882/2003 of the European Parliament and
of the Council (OJ L 284, 31.10.2003, p. 1).

                                                
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2.

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.

3. Member States and the Commission shall, within the assessment and authorisation schemes

for existing and new chemicals and pesticides under the relevant Community legislation, take into

consideration the criteria set out in paragraph 1 of Annex D to the Convention and take appropriate

measures to control existing chemicals and pesticides and prevent the production, placing on the

market and use of new chemicals and pesticides, which exhibit characteristics of persistent organic

pollutants.

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.

2.

Article 3 shall not apply in respect of substances occurring as a constituent of articles

produced before or on the date of entry into force of this Regulation until six months after the date

of its entry into force.

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Article 3 shall not apply in the case of a substance occurring as a constituent of articles already in

use before or on the date of entry into force of this Regulation.

However, immediately upon becoming aware of articles referred to in the first and second

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.

3. 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)

an annotation has been entered in the relevant Annex expressly to the effect that such

production and use of that substance may be permitted;

(b)

the manufacturing process will transform the substance into one or more other substances that

do not exhibit the characteristics of a persistent organic pollutant;

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(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, as shown through assessment of that
closed system in accordance with Commission Directive 2001/59/EC 1.

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

1.

The holder of a stockpile, which consists of or contains any substance listed in Annex I or

Annex II, for which no use is permitted, shall manage that stockpile as waste and in accordance

with Article 7.

1

Commission Directive 2001/59/EC of 6 August 2001 adapting to technical progress for the
28th time Council Directive 67/548/EEC on the approximation of the laws, regulations and
administrative provisions relating to the classification, packaging and labelling of dangerous
substances (OJ L 225, 21.8.2001, p. 1).

                                                
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2.

The holder of a stockpile greater than 50 kg, consisting of or containing any substance listed

in Annex I or Annex II, and the use of which is permitted 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 this Regulation and of amendments to Annexes I or II and annually thereafter until the deadline

specified in Annex I or II for restricted use.

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, minimisation and elimination

1. 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 into air, water and land in

accordance with their obligations under the Convention and the Protocol.

2.

A Member State shall communicate its action plan on measures to identify, characterise

and minimise with a view to eliminating where feasible as soon as possible the total releases

developed in accordance with its obligations under the Convention, to both the Commission and the

other Member States as part of its national implementation plan, pursuant to Article 8.

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The action plan shall include measures to promote the development and, where it deems

appropriate, shall require the use of substitute or modified materials, products and processes to

prevent the formation and release of the substances listed in Annex III.

3. Member States shall, when considering proposals to construct new facilities or significantly to

modify existing facilities using processes that release chemicals listed in Annex III, without
prejudice to Council Directive 1996/61/EC 1, give priority consideration to alternative processes,

techniques or practices that have similar usefulness but which avoid the formation and release of

substances listed in Annex III.

Article 7

Waste management

1.

Producers and holders of waste shall undertake all reasonable efforts to avoid, where feasible,

contamination of this waste with substances listed in Annex IV.

2.

Notwithstanding Directive 96/59/EC 2, waste consisting of, containing or contaminated by

any substance listed in Annex IV shall be disposed of or recovered, without undue delay and in

accordance with Annex V, part 1 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.

1

2 

Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention
and control (OJ L 257, 10.10.1996, p. 26.  Directive as last amended by Regulation (EC)
No 1882/2003.
Council Directive 96/59/EC of 16 September 1996 on the disposal of polychlorinated
biphenyls and polychlorinated terphenyls (PCB/PCT) (OJ L 243, 24.9.1996, p. 31).

                                                
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In carrying out such a disposal or recovery, any substance listed in Annex IV may be isolated from

the waste, provided that this substance is subsequently disposed of in accordance with the first

subparagraph.

3.

Disposal or recovery operations that may lead to recovery, recycling, reclamation or re-use of

the substances listed in Annex IV shall be prohibited.

4.

By way of derogation from paragraph 2:

(a) waste containing or contaminated by any substance listed in Annex IV may be otherwise

disposed of or recovered in accordance with the relevant Community legislation, provided

that the content of the listed substances in the waste is below the concentration limits to be

specified in Annex IV before 31 December 2005, in accordance with the procedure referred to

in Article 17(2).  Until such time as concentration limits are specified in accordance with such

procedure, the competent authority of a Member State may adopt or apply concentration

limits or specific technical requirements in respect of the disposal or recovery of waste under

this subparagraph;

(b)

a Member State or the competent authority designated by that Member State may, in

exceptional cases, allow wastes listed in Annex V, part 2 containing or contaminated by any

substance listed in Annex IV up to concentration limits to be specified in Annex V, part 2, to

be otherwise dealt with in accordance with a method listed in Annex V, part 2 provided that:

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(i)

the holder concerned has demonstrated to the satisfaction of the competent authority of

the Member State concerned that decontamination of the waste in relation to substances

listed in Annex IV was not feasible, and that destruction or irreversible transformation

of the persistent organic pollutant content, performed in accordance with best

environmental practice or best available techniques, does not represent the

environmentally preferable option and the competent authority has subsequently

authorised the alternative operation;

(ii)

this operation is in accordance with the relevant Community legislation and the

conditions laid down in relevant additional measures referred to in paragraph 6; and

(iii)

the Member State concerned has informed the other Member States and the

Commission of its authorisation and the justification for it.

5.

Concentration limits in Annex V, part 2 shall be established for the purposes of

paragraph 4(b) before 31 December 2005 in accordance with the procedure referred to in

Article 17(2).

Until such time as these concentration limits are established:

(a)

the competent authority may adopt or apply concentration limits or specific technical

requirements in respect of waste being dealt with under paragraph 4(b);

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(b) where waste is being dealt with under paragraph 4(b), the holders concerned shall provide

information on the persistent organic pollutant content of the waste to the competent

authority.

6.

The Commission may, where appropriate, and taking into consideration technical

developments and relevant international guidelines and decisions and any authorisations granted by

a Member State, or the competent authority designated by that Member State in accordance with

paragraph 4 and Annex V, adopt additional measures relating to the implementation of this Article.

The Commission shall define a format for the submission of the information by Member States in

accordance with paragraph 4(b)(iii).  Such measures shall be decided in accordance with the

procedure laid down in Article 17(2).

7.

The Commission shall, before 31 December 2009, review the derogations in paragraph 4 in

the light of international and technical developments, in particular with regard to their

environmental preferability.

Article 8

Implementation plans

1. When preparing their national implementation plans, Member States shall, in accordance with

their national procedures, give the public early and effective opportunities to participate in this

process.

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2.

As soon as a Member State has adopted its national implementation plan in accordance with

its obligations under the Convention, it shall communicate it both to the Commission and to the ´

other Member States.

3. When preparing their implementation plans, the Commission and the Member States shall

exchange information on the content, as appropriate.

4.

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 cooperation, appropriate

programmes and mechanisms, consistent with the state of the art, for the regular provision of

comparable monitoring data on the presence of dioxins, furans and PCBs as identified in Annex III

in the environment.  When establishing such programmes and mechanisms, due account shall be

taken of developments under the Protocol and the Convention.

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Article 10

Information exchange

1.

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, minimisation or

elimination, where feasible, 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.

2.

The Commission and Member States, as appropriate, shall promote and facilitate with regard

to persistent organic pollutants:

(a)

awareness programmes, including relating to their health and environmental effects and their

alternatives and on the reduction or elimination of their production, use and release, especially

for

(i)

(ii)

policy and decision makers,

particularly vulnerable groups;

(b)

the provision of public information;

(c)

training, including workers, scientists, educators and technical and managerial personnel.

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3. Without prejudice to Directive 2003/4/EC of the European Parliament and of the Council of
28 January 2003 on public access to environmental information 1, information on health and safety

of humans and the environment shall not be regarded as confidential.  The Commission and the

Member States that exchange other information with a third country shall protect any confidential

information as mutually agreed.

Article 11

Technical assistance

In accordance with Articles 12 and 13 of the Convention, the Commission and the Member States

shall cooperate in providing appropriate and timely technical and financial assistance to developing

countries and countries with economies in transition to assist them, upon request and within

available resources and taking into account their particular needs, to develop and strengthen their

capacity to fully implement their obligations under the Convention. Such support may also be

channelled through non-governmental organisations.

Article 12

Reporting

1. Member States shall every three years forward to the Commission information on the

application of this Regulation, including information on infringements and penalties.

1

OJ L 41, 14.2.2003, p. 26.

                                                
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2. 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.

3. 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)

summary information compiled from the notifications, concerning stockpiles, received

pursuant to Article 5(2);

(b)

summary information compiled from the release inventories drawn up pursuant to

Article 6(1);

(c)

summary information on the presence of dioxins, furans and PCBs as identified in Annex III

in the environment, as compiled pursuant to Article 9.

4.

As regards the data and information to be provided by Member States pursuant to

paragraphs 1, 2 and 3, the Commission shall develop in advance a common format in accordance

with the procedure referred to in Article 16(2).

5.

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.

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6.

The Commission shall every three years compile a report on the application of this Regulation

and shall integrate it with the information already available in the context of the EPER, as
established by Commission Decision 2000/479/EC 1, and CORINAIR Emission Inventory of EMEP

(Cooperative Programme for Monitoring and Evaluation of the Long-Range Transmission of Air

Pollutants in Europe), and with the information provided by the Member States under paragraphs 1,

2 and 3 to form a synthesis report.  This report shall include information on the use of derogations

as referred to in Article 7(4).  It shall forward a summary of the synthesis report to the European

Parliament and to the Council and make it available to the public without delay.

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.

1

Commission Decision 2000/479/EC of 17 July 2000 on the implementation of a European
pollutant emission register (EPER) according to Article 15 of Council Directive 96/61/EC
concerning integrated pollution prevention and control (IPPC) (OJ L 192, 28.7.2000, p. 36).

                                                
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Article 14

Amendment of Annexes

1. Whenever a substance is listed in the Convention or the Protocol, the Commission shall,

where appropriate, amend Annexes I to III accordingly, in accordance with the procedure referred

to in Article 16(2).

Whenever a substance is listed in the Convention or the Protocol, the Commission shall, where

appropriate, amend Annex IV in accordance with the procedure referred to in Article 17(2).

2. Modifications to the existing entries in Annexes I to III, 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).

3. Modifications to the existing entries in Annex IV and modifications to Annex V, including

their adaptation to scientific and technical progress, shall be adopted by the Commission in

accordance with the procedure referred to in Article 17(2).

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.

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Article 16

Committee for general matters

1.

The Commission shall be assisted by the Committee established by Article 29

of Directive 67/548/EEC for all matters under this Regulation except for those relating to waste.

2. Where reference is made to this paragraph, Articles 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 set at three months.

3.

The Committee shall adopt its rules of procedure.

Article 17

Committee for waste matters

1.

The Commission shall be assisted by the Committee established by Article 18 of

Directive 75/442/EEC, for matters relating to waste under this Regulation.

2. Where reference is made to this paragraph, Articles 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 set at three months.

3.

The Committee shall adopt its rules of procedure.

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Article 18

Amendments to Directive 79/117/EEC

In Part B of the Annex to Directive 79/117/EEC, "Persistent Organochlorine compounds", items 1

to 8 shall be deleted.

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 Strasbourg, 29 April 2004.

For the European Parliament

The President

P. COX

For the Council

 The President

M. McDOWELL

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LIST OF SUBSTANCES SUBJECT TO PROHIBITIONS

ANNEX I

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

-

-

-

-

-

-

-

-

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Polychlorinated
Biphenyls (PCB)

1336-36-3
and others

215-648-1
and others

50-29-3

200-024-3

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

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

Member States may allow the
existing production and use of
DDT as a closed-system
site-limited intermediate for the
production of dicofol until
1 January 2014, in accordance
with Article 4(3) of this
Regulation.

The Commission shall review this
exemption by 31.12.2008 in the
light of the outcome of the
evaluation in the framework of
Directive 91/414/EEC 1.

1

Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection
products on the market (OJ L 230, 19.8.1991, p. 1).

                                                
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Part B – Substances listed only in the Protocol

SUBSTANCE

CAS No

EC No

Chlordecone

143-50-0

205-601-3

Hexabromobiphenyl

36355-01-8

252-994-2

-

-

SPECIFIC EXEMPTION ON
INTERMEDIATE USE OR
OTHER SPECIFICATION

HCH, including
lindane

608-73-1,
58-89-9

210-168-9,
200-401-2

By way of derogation,
Member States may allow the
following uses

(a) until 1.9.2006:

– Professional remedial and

industrial treatment of lumber,
timber and logs;

– Indoor industrial and

residential applications;

(b) until 31.12.2007:

– Technical HCH for 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 for use as public
health and veterinary topical
insecticide.

                                        
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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

CONDITIONS OF
RESTRICTION

                                        
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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) 1
_______________
1

For the purpose of emission
inventories, the following four
compound indicators shall be used:
benzo(a)pyrene, benzo(b)
fluoranthene, benzo(k)fluoranthene
and indeno(1,2,3-cd)pyrene.

                                        
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LIST OF SUBSTANCES SUBJECT TO WASTE MANAGEMENT PROVISIONS

SET OUT IN ARTICLE 7

ANNEX IV

CONCENTRATION LIMIT
REFERRED TO IN
ARTICLE 7(4)(a), ppm
(parts per million)

SUBSTANCE

CAS No

EC No

Aldrin

Chlordane

Dieldrin

Endrin

Heptachlor

309-00-2

57-74-9

60-57-1

72-20-8

76-44-8

Hexachlorobenzene

118-74-1

206-215-8

200-349-0

200-484-5

200-775-7

200-962-3

200-273-9

Mirex

Toxaphene

Polychlorinated
Biphenyls (PCB)
DDT
(1,1,1-trichloro-2,2-
bis(4-chlorophenyl)
ethane)
Chlordecone

Polychlorinated
dibenzo-p-dioxins and
dibenzofurans
(PCDD/PCDF)
HCH, including
lindane
Hexabromobiphenyl

2385-85-5

219-196-6

8001-35-2

232-283-3

1336-36-3
and others
50-29-3

215-648-1

200-024-3

143-50-0

205-601-3

608-73-1,
58-89-9
36355-01-8

210-168-9,
200-401-2
252-994-2

                                        
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ANNEX V

WASTE MANAGEMENT

Part 1 Disposal and recovery under Article 7(2)

The following disposal and recovery operations, as provided for in Annex IIA and IIB of

Directive 75/442/EEC, are permitted for the purposes of Article 7(2) when applied in such a way as

to ensure that the persistent organic pollutant content is destroyed or irreversibly transformed

D9

Physico-chemical treatment,

D10

Incineration on land, and

R1

Use principally as a fuel or other means to generate energy, excluding waste

containing PCBs.

Pre-treatment operation prior to destruction or irreversible transformation pursuant to this Part of

this Annex may be performed, provided that a substance listed in Annex IV that is isolated from the

waste during the pre-treatment is subsequently disposed of in accordance with this Part of this

Annex.  In addition, repackaging and temporary storage operations may be performed prior to such

pre-treatment or prior to destruction or irreversible transformation pursuant to this part of this

Annex.

Part 2 Wastes and operations to which Article 7(4)(b) applies

The following operations are permitted for the purposes of Article 7(4)(b) in respect of the wastes
specified, defined by the six-digit code as classified in Commission Decision 2000/532/EC 1.

1

Commission Decision 2000/532/EC of 3 May 2000 replacing Decision 94/3/EC establishing a
list of wastes pursuant to Article 1(a) of Council Directive 75/442/EEC on waste and Council
Decision 94/904/EC establishing a list of hazardous waste pursuant to Article 1(4) of Council
Directive 91/689/EEC on hazardous waste (OJ L 226, 6.9.2000, p. 3).  Decision as last
amended by Council Decision 2001/573/EC (OJ L 203, 28.7.2001, p. 18).

                                                
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Wastes as classified in Commission
Decision 2000/532/EC

Maximum
concentration limits
of substances listed
in Annex IV

Operation

10

10 01

10 01 14 *

10 01 16 *

WASTES FROM THERMAL
PROCESSES
Wastes from power stations and other
combustion plants (except 19)
Bottom ash, slag and boiler dust from
co-incineration containing dangerous
substances
Fly ash from co-incineration
containing dangerous substances
Wastes from the iron and steel
industry

10 02

Permanent storage
only in:
– safe, deep,
underground, hard
rock formations,
– salt mines or
– a landfill site for
hazardous waste
(provided that the
waste is solidified or
stabilised where
technically feasible as
required for
classification of the
waste in subchapter
19 03 of Decision
2000/532/EC)

whereby the
provisions of Council
Directive
1999/31/EC 1 and
Council Decision
2003/33/EC 2 have to
be adhered to and
whereby it has been
demonstrated that the
selected operation is
environmentally
preferable.

1

2

Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste (OJ L 182, 16.7.1999,
p. 1).  Directive as last amended by Regulation (EC) No 1882/2003.
Council Decision 2003/33/EC of 19 December 2002 establishing criteria and procedures for
the acceptance of waste and landfills pursuant to Article 16 of and Annex II to
Directive 1999/31/EC (OJ L 11, 16.1.2003, p. 27).

                                                
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Wastes as classified in Commission
Decision 2000/532/EC

Operation

Maximum
concentration
limits of substances
listed in Annex IV

10 02 07 *

Solid wastes from gas treatment containing
dangerous substances
Wastes from aluminium thermal metallurgy
Primary production slags
Salt slags from secondary production

10 03
10 03 04 *
10 03 08 *
10 03 09 * Black drosses from secondary production

10 03 21 *

10 03 19 *

10 03 29 *

Flue-gas dust containing dangerous
substances
Other particulates and dust (including
ball-mill dust) containing dangerous
substances
Wastes from treatment of salt slags and
black drosses containing dangerous
substances
Wastes from lead thermal metallurgy
Slags from primary and secondary
production
Dross and skimmings from primary and
secondary production
10 04 04 *
Flue-gas dust
10 04 05 * Other particulates and dust
10 04 06 *

Solid wastes from gas treatment

10 04 01 *

10 04 02 *

10 04

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10 05
10 05 03 *
10 05 05 *
10 06
10 06 03 *
10 06 06 *

10 08

10 08 08 *

10 08 15 *

10 09

10 09 09 *

16

16 11

16 11 01 *

16 11 03 *

Wastes from zinc thermal metallurgy
Flue-gas dust
Solid waste from gas treatment
Wastes from copper thermal metallurgy
Flue-gas dust
Solid wastes from gas treatment
Wastes from other non-ferrous thermal
metallurgy
Salt slag from primary and secondary
production
Flue-gas dust containing dangerous
substances
Wastes from casting of ferrous pieces
Flue-gas dust containing dangerous
substances 
WASTES NOT OTHERWISE
SPECIFIED IN THE LIST
Waste linings and refractories
Carbon-based linings and refractories
from metallurgical processes
containing dangerous substances
Other linings and refractories from
metallurgical processes containing
dangerous substances

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Wastes as classified in Commission
Decision 2000/532/EC

Maximum
concentration limits
of substances listed
in Annex IV

Operation

17

17 01

17 01 06 *

17 05

17 05 03 *

17 09

17 09 02 *

17 09 03 *

CONSTRUCTION AND DEMOLITION
WASTES (INCLUDING EXCAVATED
SOIL FROM CONTAMINATED SITES)
concrete, bricks, tiles and ceramics
Mixtures of, or separate fractions of
concrete, bricks, tiles and ceramics
containing dangerous substances.
Soil including excavated soil from
contaminated sites, stones and dredging
spoil
Inorganic fraction of soil and stones
containing dangerous substances
Other construction and demolition wastes

Construction and demolition wastes
containing PCB, excluding PCB
containing equipment.
Other construction and demolition wastes
containing dangerous substances

Permanent
storage only in:
– safe, deep,
underground,
hard rock
formations,
– salt mines or
– a landfill site
for hazardous
waste 1
(provided that
the waste is
solidified or
stabilised where
technically
feasible as
required for
classification of
the waste in
subchapter 19 03
of Decision
2000/532/EC)

1

Except in the case of waste containing or contaminated by PCBs above the concentration of
50 ppm.

                                                
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Wastes as classified in Commission
Decision 2000/532/EC

Maximum
concentration limits
of substances listed
in Annex IV

Operation

whereby the
provisions of
Directive
1999/31/EC and
Decision
2003/33 /EC
have to be
adhered to and
whereby it has
been
demonstrated
that the selected
operation is
environmentally
preferable.

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WASTES FROM WASTE
MANAGEMENT FACILITIES, OFF-
SITE WASTE WATER TREATMENT
PLANTS AND THE PREPARATION OF
WATER INTENDED FOR HUMAN
CONSUMPTION AND WATER FROM
INDUSTRIAL USE
Wastes from incineration or pyrolysis of
waste
Solid wastes from gas treatment
Bottom ash and slag containing dangerous
substances
Fly ash containing dangerous substances
Boiler dust containing dangerous
substances
Vitrified waste and waste from
vitrification
Fly ash and other flue-gas treatment
wastes
Non-vitrified solid phase

19

19 01

19 01 07 *

19 01 11 *

19 01 13 *

19 01 15 *

19 04

19 04 02*

19 04 03 *

Permanent storage
only in:
– safe, deep,
underground, hard
rock formations,
– salt mines or
– a landfill site for
hazardous waste
(provided that the
waste is solidified
or stabilised where
technically feasible
as required for
classification of the
waste in
subchapter 19 03 of
Decision
2000/532/EC)

whereby the
provisions of
Directive
1999/31/EC and
Decision
2003/33/EC have
to be adhered to
and whereby it has
been demonstrated
that the selected
operation is
environmentally
preferable.

*

Any waste marked with an asterisk (*) is considered as hazardous waste pursuant to
Directive 91/689/EEC on hazardous waste, and is subject to the provisions of that Directive.