1992R2455 — EN — 12.02.1994 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B Council Regulation (EEC) No 2455/92
of 23 July 1992
concerning the export and import of certain dangerous chemicals
(OJ L 251, 29.8.1992, p. 13)
Amended by:
Official Journal
No page date
►M1Commission Regulation (EC) No 41/94 of 11 January 1994 L 8 1 12.1.1994
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Council Regulation (EEC) No 2455/92
of 23 July 1992
concerning the export and import of certain dangerous chemicals
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Havingreg ard to the Treaty establishingthe European Economic
Community, and in particular Article 130s thereof,
Havingreg ard to the proposal from the Commission(1),
Havingreg ard to the opinion of the European Parliament(2),
Havingreg ard to the opinion of the Economic and Social Committee(3),
Whereas Regulation (EEC) No 1734/88 (4) concerns exports and
imports of certain dangerous chemicals;
Whereas an amendment to Regulation (EEC) No 1734/88 is necessary
to implement the ‘prior informed consent' (PIC) procedure;
Whereas, on the occasion of this amendment, Regulation (EEC) No
1734/88 is to be replaced by this Regulation;
Whereas certain provisions of Community legislation, and in particular
Directives 76/769/EEC (5) and 79/117/EEC (6) restrict the marketingand
use of certain dangerous substances and preparations and prohibit theplacingon the market and use of plant protection products containingcertain active substances in the Member States; whereas these provi-sions do not apply to such products when intended for export to thirdcountries;
Whereas Directive 67/548/EEC (
7) specifies the requirements for pack-
aging and labelling of dangerous chemicals when they are intended forexport to third countries; whereas it is necessary to ensure that the rulesapplicable within the Community for the packag ingand labellingofdangerous chemicals should apply to such chemicals when intended forexport;
Whereas international trade in certain chemicals which are banned or
severely restricted in countries of export has caused internationalconcern on the grounds of the protection of man and the environment;
Whereas measures are necessary for the protection of man and the
environment, in both the Community and third countries;
Whereas schemes for notification, information and PIC concerning
international trade in such substances have been set up within theframework of international organizations, namely the Organization forEconomic Cooperation and Development (OECD), the United NationsEnvironment Programme (UNEP) and the Food and Agriculture Organ-ization (FAO);
Whereas the Community and its Member States have actively partici-
pated in the work of these and of other international organizationsrelatingto banned and severely restricted substances; whereas it isappropriate that the Community acts upon the results of this workthrough uniform Community procedures;
(1) OJ No C 17, 25. 1. 1991, p. 16.
(2) OJ No C 305, 25. 11. 1991, p. 112.
(3) OJ No C 191, 22. 7. 1991, p. 17.
(4) OJ No L 155, 22. 6. 1988, p. 2.
(5) OJ No L 262, 27. 9. 1976, p. 201. Directive as last amended by Directive
91/339/EEC (OJ No L 186, 12. 7. 1991, p. 64).
(6) OJ No L 33, 8. 2. 1979, p. 36. Directive as last amended by Directive
91/188/EEC (OJ No L 92, 13. 4. 1991, p. 42).
(7) OJ No L 196, 16. 8. 1967, p. 1. Directive as last amended by Directive
79/831/EEC (OJ No L 259, 15. 10. 1979, p. 10).
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Whereas the exports of chemicals to which this Regulation applies
should be made subject to a common notification procedure whichwould permit the Community to notify third countries with regard tosuch exports;
Whereas it is necessary to inform all the Member States of notifications
received from third countries with regard to imports of substancesbanned or severely restricted under the legislation of those countries;
Whereas the common notification procedures should also provide a
basis for an appropriate exchange of information within the Community,includinginformation on the implementation of the international noti-fication scheme;
Whereas, to this end, the Commission will report to the European
Parliament and the Council and at regular intervals, in particular on anypossible reaction from the country of destination;
Whereas Resolution 88/C 170/1 (
1) invited the Commission to submit
proposals for adaptingReg ulation No 1734/88 with a view to intro-ducinga PIC scheme similar to that established by the UNEP and theFAO;
Whereas it is right that citizens of the Member States should receive no
less protection than that afforded to the citizens of other importingcountries participatingin the international PIC scheme;
Whereas a single contact point for Community interaction with the
international PIC scheme is desirable in order to coordinate and dissem-inate information;
Whereas it is desirable to establish common conditions for the import
and export of substances covered by the PIC scheme;
Whereas Annex 1 lists the chemicals banned or severely restricted in
the Community and whereas this list should be subject to review atintervals, and amendment, as necessary; whereas any such amendmentto Annex I should be made on the basis of proposals from the Commis-sion and should be the subject of a decision by the Council by aqualified majority,
HAS ADOPTED THIS REGULATION:
Article 1
Objectives
1. The purpose of this Regulation is to establish a common system of
notification and information for imports from and exports to thirdcountries of certain chemicals which are banned or severely restrictedon account of their effects on human health and the environment and toapply the international notification and ‘prior informed consent' (PIC)procedure established by the United Nations Environment Programme(UNEP) and the Food and Agriculture Organization (FAO) (
2).
2. The purpose of this Regulation is also to ensure that the provisions
of Directive 67/548/EEC on the classification, packaging and labellingof substances dangerous to man or the environment when they areplaced on the market in the Member States shall also apply to suchsubstances when they are exported from the Member States to thirdcountries.
3. This Regulation does not apply to substances or preparations
imported or exported for the purposes of analysis or scientific researchand development as defined in Article 2, where the quantities involved
(1) OJ No C 170, 29. 6. 1988, p. 1.
(2) London Guidelines for the Exchange of Information on Chemicals in
International Trade, Decision 14/27 of the GoverningCouncil of UNEP of17 June 1987 as amended in May 1989; FAO International Code ofConduct on the Distribution and Use of Pesticides, Rome 1986, asamended in November 1989.
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are sufficiently small that they are unlikely to affect human health or the
environment adversely.
Article 2
Definitions
For the purposes of this Regulation, the following definitions shall
apply:
1.‘chemical subject to notification' means any of the chemical
substances listed in Annex I and preparations containingany ofthese chemicals if the preparation has a labellingoblig ation underCommunity legislation as a result of the presence of the Annex Ichemical;
2.‘chemical subject to the PIC procedure' means each chemical
listed in Annex II, whether by itself or in preparations, whethermanufactured or obtained from nature, unless its concentration in apreparation is insufficient for a labellingrequirement underCommunity legislation.
3.‘banned chemical' means a chemical which has, for health or
environmental reasons, been prohibited for all uses by final govern-mental regulatory action;
4.‘severely restricted chemical' means a chemical for which, for
health or environmental reasons, virtually all uses have beenprohibited by final governmental regulatory action but for whichcertain specific uses remain authorized;
5.‘export' means
(a) the permanent or temporary export of products meetingthe
conditions of Article 9 (2) of the Treaty,
(b) the re-export of products not meetingthe conditions referred to
in (a) which are placed under a customs procedure other thantransit procedure;
6.‘import'means the physical introduction into the customs territory
of the Community of products which are placed under a customsprocedure other than transit procedure;
7.‘prior informed consent' (PIC) means the principle that inter-
national shipment of a chemical which is banned or severelyrestricted in order to protect human health or the environmentshould not proceed without the agreement, where such agreementexists, or contrary to the decision of the designated nationalauthority of the importingcountry;
8.‘reference number' means the number assigned by the Commission
to each chemical subject to notification when it is exported for thefirst time to a third country. This number remains unchanged forevery subsequent export of the same chemical from the Communityto the same third country;
9.‘labelling' means the provision on a label of information related to
the potential hazard to health, safety or the environment from use ofthe chemical. It does not refer to labellingrequirements for thetransport of dangerous goods.
10.‘scientific research and development' means scientific experimen-
tation, analysis or chemical research carried out under controlledconditions; it includes the determination of intrinsic properties,performance and efficacy as well as scientific investigation relatedto product development.
Article 3
Designation of authorities
1. Each Member State shall designate the authority or authorities,
hereinafter referred to as the ‘designated authority' or ‘designatedauthorities', competent for the notification and information procedures
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laid down by this Regulation. It shall inform the Commission of suchdesignation.
2. As far as the participation of the Community in the international
PIC procedure is concerned, the Commission shall act as commondesignated authority with regard to receiving information from thecompetent bodies dealingwith the international PIC procedure and forprovidinginformation to these bodies on common decisions which havebeen taken in close cooperation and consultation with the MemberStates in accordance with the provisions of Article 5.
Article 4
Exports to third countries
1. When a chemical subject to notification is due to be exported from
the Community to a third country for the first time followingthe date asof which ist becomes subject to the provisions of this Regulation, theexporter shall provide the designated authority of the Member State inwhich he is established, no later than 30 days before the export is due totake place, with the information contained in Annex III necessary toenable the designated authority to effect a notification. The designatedauthority shall take the necessary measures to ensure that the appro-priate authorities of the country of destination receive notification of theintended export. Such notification, which shall as far as possible bemade at least 15 days before export, must comply with the requirementsset out in Annex III.
Where the export of a chemical relates to an emergency situation in
which any delay may endanger public health or the environment in theimportingcountry, the provisions referred to above may be waivedwholly or partly at the discretion of the designated authority of theexportingMember State.
The designated authority shall send a copy of the notification to the
Commission, which shall forward it to the designated authorities of theother Member States and to the International Register of PotentiallyToxic Chemicals (IRPTC).
The Commission shall assign a reference number to each notification
received and communicate it immediately to the designated authoritiesof the Member States. It shall periodically publish a list of thesereference numbers in the Official Journal of the European Communities,statingthe chemical concerned and the third country of destination.Until a relevant reference number is published in the Official Journal ofthe European Communities, the exporter shall assume that such anexport has not previously taken place unless he can obtain from thedesignated authority of the Member State in which he is established therelevant reference number previously assigned by the Commission.
2. The designated authority of the relevant Member State shall
inform the Commission as soon as possible of any significant reactionfrom the country of destination. The Commission shall ensure that theother Member States are informed as soon as possible of that country’sreaction.
3. For every subsequent export of the chemical concerned from the
Community to the same third country, the exporter shall ensure that theexport is accompanied by reference to the number of the notificationeither published in the Official Journal of the European Communities orobtained by it from the designated authority of the Member State inwhich he is established pursuant to the fourth subparagraph of para-graph 1.
4. New notification according to paragraph 1 must be given for
exports which take place subsequent to major changes to Communityleg islation concerningthe marketingand use or labellingof thesubstances in question or whenever the composition of the preparationin question changes to such an extent that the labelling of such prepara-tion is altered. The new notification must comply with the requirementsset out in Annex III and must indicate that it is a revision of a previous
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notification. Information to the effect that a new notification is needed
shall be published in the Official Journal of the European Communities.
The Commission shall send new notifications to the designated national
authorities of countries which have received notification of the exportfrom the Community of the substance or preparation in question in thesix months prior to the relevant changes to Community legislation.
5. As regards the transmission of information within the meaning of
paragraph 1, the Member States and the Commission shall take accountof the need to protect the confidentiality of data and ownership in boththe Member States and the countries of destination.
The followingshall not be reg arded as confidential:
— the names of the substance;
— the names of the preparation;— the names of substances in Annex I contained in the preparation and
their percentage in the preparation;
— the names of the main impurities in the substances in Annex I;— the name of the manufacturer or exporter;— information on the precautions to be taken, includingthe categ ory of
danger, the nature of the risk and the relevant warnings;
— physico-chemical data concerningthe substances;— the summary results of the toxicological and ecotoxicological tests;— the possible ways of renderingthe substance harmless;— the information contained in the safety data sheet;— the country of destination.
Article 5
Participation in the international notification and ‘prior informed
consent' (PIC) procedure
1. The Commission shall notify the competent bodies dealingwith
the international PIC procedure of the chemicals which are banned orseverely restricted in the Community (Annex I). It shall provide allrelevant information, especially on the identity of the chemicals, theirdangerous properties, Community labelling requirements and necessaryprecautionary measures. It shall also identify the relevant control actionsand the reasons for them.
2. The Commission shall forward forthwith to the Member States
information which it receives regarding chemicals subject to the PICprocedure and the decisions of third countries regarding the impositionof bans or import conditions on these chemicals. The Commission shallevaluate in close cooperation with the Member States the risks posed bythe chemicals. The Commission shall take its decision, includinginterim decisions, in accordance with the procedure laid down in Article21 of Directive 67/548/EEC. It shall then inform the IRPTC whetherimport into the Community of each ot the chemicals is allowed, prohib-ited or restricted.
When such a decision is taken, the followingprinciples shall be
observed:
(a) in the case of a substance or preparation banned by Community
legislation: import consent for the banned use shall be refused;
(b) in the case of a substance or preparation severely restricted by
Community legislation: import consent shall be subject to condi-tions; the appropriate conditions shall be decided on a case by casebasis;
(c) in the case of a substance or preparation not banned or severely
restricted by Community legislation: import consent shall notnormally be refused; however, if the Commission, in consultationwith Member States, considers that a proposal should be made tothe Council to ban or severely restrict a substance or preparation notproduced in the Community, interim import conditions, set on acase by case basis, may be imposed until the Council has taken adecision on the proposed severe restriction or permanent ban.
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In the case of a substance or preparation banned or severely restricted
by legislation of one or more Member State, the Commission shall, atthe written request of the Member State concerned, prepare its decisionon the reply to be made to the IRPTC, takinginto consideration thatMember State’s bans or severe restrictions.
The Commission shall, whenever practicable, make use of existing
Community procedures and shall ensure that the response does notconflict with existingCommunity leg islation.
3. Annex II shall comprise the following:
(a) the international list of banned and severely restricted chemicals
subject to the PIC procedure established by the UNEP and FAO;
(b) a list of the countries participatingin the PIC scheme;
and
(c) the decisions of these countries (includingthe Community Member
States) regarding the import of the chemicals listed in (a) above.
The Commission shall immediately notify the Member States of infor-
mation which it receives regarding changes to the above. It shall period-ically publish these changes in the Official Journal of the EuropeanCommunities.
4. The exporter shall be required to comply with the decision of the
country of destination participatingin the PIC procedure.
5. If a participatingimportingcountry does not make a response or
responds with an interim decision which does not address importation,the status quo with respect to imports of the chemical should continue.This means that the chemical should not be exported without theexplicit consent of the importingcountry, unless it is a pesticide whichis registered in the importing country or is a chemical the use orimportation of which has been allowed by other action of the importingcountry.
Article 6
Infringements
Member States shall take appropriate legal or administrative action in
the event of infringement of the provisions of this Regulation.
Article 7
Packaging and labelling
1. Dangerous chemicals which are intended for export shall be
subject to the measures on packag ingand labellingestablished pursuantto Directive 67/548/EEC or, as appropriate, of other Directives coveringdangerous preparations(
1) as are applicable in the Member State from
which the goods are to be exported or in which they have beenproduced. This obligation shall be without prejudice to any specificrequirements of the importingthird country. The label need complywith the requirements of the importingthird country only if suchrequirements ensure that the label has all the health, safety and environ-ment-related information which Community use would require.
2. The information on the label shall as far as practicable be given in
the language(s), or in one or more of the principal languages, of thecountry of destination or of the area of intended use.
(1) Directive 78/631/EEC (OJ No L 206, 29. 7. 1978, p. 13), as last amended
by Directive 84/299/EEC (OJ No L 144, 30. 5. 1984, p. 1).Directive 88/379/EEC (OJ No L 187, 16. 7. 1988, p. 14), as last amendedby Directive 90/492/EEC (OJ No L 275,5. 10. 1990, p. 35).
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Article 8
Notification from third countries
1. Where the designated authority of a Member State receives a
notification from the competent authority of a third country concerningthe export to the Community of a chemical the manufacture, use,handling, consumption, transport and/or sale of which is subject toprohibition or substantial legal restriction under that country’s legisla-tion, it shall send forthwith to the Commission a copy of that noti-fication, together with all relevant information.
2. The Commission shall forward forthwith to the Member States
any notification received either directly or indirectly, together with allavailable information.
3. The Commission shall periodically evaluate the information
received via the Member States or directly from third countries and, ifnecessary, submit appropriate proposals to the Council.
Article 9
Exchange of information and monitoring
1. Member States shall regularly forward to the Commission infor-
mation on the operation of the notification system provided for in thisRegulation.
2. The Commission shall regularly compile a report on the basis of
the information provided by the Member States and forward it to theEuropean Parliament and the Council. This report shall consist of, interalia, information on participation in international notification and PICsystems on the cover provided by such systems and on how they arecomplied with by third countries.
3. As regards the information supplied pursuant to paragraphs 1 and
2, the Member States and the Commission shall take account of theneed to protect the confidentiality of data and ownership.
Article 10
If a Member State applies, with respect to substances other than those in
Annex I, a national system usingsimilar information procedures inrespect of third countries to those laid down in this Regulation, it shallinform the Commission thereof, specifyingthe substances concerned.
The Commission shall forward this information to the Member States.
Article 11
Updating of Annexes
1. The list of chemicals in Annex I shall be reviewed by the
Commission at regular intervals, particularly in the light of experiencegained in implementing this Regulation, with special regard to informa-tion received pursuant to Article 10, and on the basis of developmentsin Community leg islation concerningmarketingand use and of develop-ments within the framework of the OECD, the UNEP and the FAO. Thelist shall be amended as necessary by decisions taken by the Council byqualified majority on a proposal from the Commission.
In determiningwhether reg ulatory action qualifies as a ban or severe
restriction, the effect of the action on any one of three major usecategories must be considered. These categories are:
(a) plant protection products;
(b) industrial chemicals;
(c) consumer product chemicals
If, for health or environmental reasons, the control action bans or
severely restricts the use of a chemical in any one of these categories ofuse, it will be included in Annex I.
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2. Amendments initiated by the UNEP and the FAO to the list ofchemicals subject to the international PIC procedure and to the PICdecisions of importingcountries (Annex II) shall be adopted in accord-ance with the procedure laid down in Article 21 of Directive 67/548/EEC.
3. The amendments required for adaptingAnnex III to scientific and
technical progress shall be adopted in accordance with the procedurelaid down in Article 21 of Directive 67/548/EEC.
Article 12
1. Regulation (EEC) No 1734/88 is hereby repealed.2. References to Regulation (EEC) No 1734/88 shall be construed as
references to this Regulation.
Article 13
This Regulation shall enter into force three months from the day of its
publication in the Official Journal of the European Communities.
This Regulation shall be binding in its entirety and directly applicable in
all Member States.
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Chemical CAS No (a)EINECS
No (b)Use
(c) categoryUse (d)
limitationANNEX I
List of chemicals banned or severely restricted to certain uses by Community legislation owing to
their effects on heath and the environment
1. Mercuric oxide 21908-53-2 244-654-7 ps r
2. Mercurous chloride (calomel) 10112-91-1 233-307-5 ps r
3. Other inorganiy mercury compunts pb
4. Alkyl mercury compounds ps r
5. Alkoxyalkyl and aryl mercury compounds pb
6. Aldrin 309-00-2 206-215-8 ps r
7. Chlordane 57-74-9 200-349-0 pb
8. Dieldrin 60-57-1 200-484-5 pb
9. DDT 50-29-3 200-024-3 pb
10. Endrin 72-20-8 200-775-7 ps r
11. HCH containingless than 99,0 % of the
gamma isomer608-73-1 210-168-9 pb
12. Heptachlor 76-44-8 200-962-3 pb
13. Hexachlorobenzene 118-74-1 204-273-9 pb
14. Camphechlor (toxaphene) 8001-35-2 232-283-3 pb
15. Polychlorinated biphenyls (PCB), exceptmono- and dichlorinated biphenyls 1336-36-3 215-648-1 ib
16. Polychlorinated terphenyls (PCT) 61788-33-8 262-968-2 ib
17. Preparations with a PCB or PCT contenthiger than 0,01 % by weight ib
18. Tris (2,3-dibromopropyl) phosphate 126-72-7 204-799-9 is r
19. Tris-aziridinyl-phosphinoxide 545-55-1 208-892-5 is r
20. Polybrominated biphenyls (PBB) is r
21. Crocidolite 12001-28-4 is r
22. Nitrofen 1836-75-5 217-406-0 pb
23. 1,2 Dibromoethane 106-93-4 203-444-5 pb
24. Dichloroethane 107-06-2 203-458-1 p b
(a) CAS = Chemical Abstracts Service.
(b) EINECS = European Inventory of ExistingCommercial Chemical Substances.
(c) Use category:
p: plant-protection producti: industrial chemical
(
d) Use limitation:
sr: severe restrictionb: ban
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Chemical Country Final import decisionANNEX II
Chemicals subject to the international PIC procedure and the PIC decisions of importing
countries
[Article 5(3), (a), (b) and (c)]
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Aldrin Angola Prohibit
(EINECS No: 206-215-8) Bhutan Prohibit
(CAS No: 309-00-2) Cape Verde Prohibit
China Prohibit
Cyprus Prohibit
Ecuador Prohibit
Honduras Prohibit
Kenya Prohibit
Mexico Prohibit
Morocco Prohibit
Nicaragua Prohibit
Niger Prohibit
Norway Prohibit
Rwanda Prohibit
Sri Lanka Written approval by Registrar (1)
required
Thailand Permit
Togo Prohibit
Dieldrin Angola Prohibit
(EINECS No: 200-484-5) Bhutan Prohibit
(CAS No: 60-57-1) Cape Verde Prohibit
Central African Republic Prohibit
China Prohibit
Cyprus Prohibit
Ecuador Prohibit
Honduras Prohibit
Morocco Prohibit
Nicaragua Prohibit
Norway Prohibit
Rwanda Prohibit
St. Lucia Prohibit
Thailand Prohibit
Togo Prohibit
DDT Angola Prohibit
(EINECS No: 200-24-3) Cape Verde Prohibit
(CAS No: 50-29-3) Central African Republic Prohibit
Congo Prohibit
Cyprus Prohibit
Ecuador Prohibit
Nicaragua Prohibit
Norway Prohibit
Sri Lanka Prohibit
St. Lucia Prohibit
Dinoseb and dinoseb salts Bhutan Prohibit
(EINECS No: 201-861-7) Cape Verde Prohibit
(CAS No: dinoseb: 88-85-7) China Prohibit
Cyprus Prohibit
Ecuador Prohibit
Honduras Prohibit
Mexico Prohibit
Norway Prohibit
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Chemical Country Final import decision
Sri Lanka Prohibit
St. Lucia Prohibit
Thailand Prohibit
Fluoroacetamide Angola Prohibit
(EINECS No: 211-363-1) Bhutan Prohibit
(CAS No: 640-19-7) Cape Verde Prohibit
China Prohibit
Cyprus Prohibit
Ecuador Prohibit
Morocco Prohibit
Nicaragua Prohibit
Sri Lanka Prohibit
St. Lucia Prohibit
Thailand Prohibit
HCH (mixed isomers) Angola Prohibit
(EINECS No: 210-168-9) Cape Verde Prohibit
(CAS No: 608-73-1) Cyprus Prohibit
Ecuador Prohibit
Honduras Prohibit
Nicaragua Prohibit
Norway Prohibit
Rwanda Prohibit
Sri Lanka Prohibit
St. Lucia Permit
Tanzania Permit
Thailand Prohibit
Togo Prohibit
(1) Registrar of Pesticides,
Department of Agriculture,PO Box 49GetambePeradeniyaSri Lanka
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ANNEX III
Information required pursuant to Article 4
1. Identity of the substance or preparation to be exported:1.1. Substances:
— name in nomenclature of the International Union of Pure and Applied Chemistry,
— other names (usual name, trade name, abbreviation),— EINECS-number and CAS-number, if available,— main impurities of the substance, when particularly relevant
1.2. Preparations:
— trade name or designation of the preparation,
— for each substance listed in Annex I, percentage and details as specified under 1.1.
2. Information on precautions to be taken, including category of danger and risk and safety advice.3. The name address, telephone and telex or fax numbers of the designated authority from which
further information may be obtained.
4. Summary of regulatory restrictions and reasons for them.5. Expected date of first export.6. Reference number.7. Country of destination.8. Use category.9. Estimated amount of the chemical to be exported to the destination country in the next year if
possible.
The above information should be provided on an expert notification form as shown hereafter.
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