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(Click here to download original
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in WP5.1 or WW6.0)
(Decision 15/30 of the
Governing Council of UNEP of 25 May 1989)
Introduction to the
Guidelines
1. This set of
Guidelines is addressed to Governments with a view to assisting them in the process of
increasing chemical safety in all countries through the exchange of information on
chemicals in international trade. They have been developed on the basis of common elements
and principles derived from relevant existing bilateral, regional and global instruments
and national regulations, drawing upon experience already gained through their preparation
and implementation.
2. The Guidelines are
general in nature and are aimed at enhancing the sound management of chemicals through the
exchange of scientific, technical, economic and legal information. Special provisions have
been included regarding the exchange of information on banned or severely restricted
chemicals in international trade, which call for co-operation between exporting and
importing countries in the light of their joint responsibility for the protection of human
health and the environment at the global level. To this end, all references in these
Guidelines to a Government or Governments shall be deemed to apply equally to regional
economic integration organizations for matters falling within their areas of competence.
3. The Guidelines are
without prejudice to the provisions of particular systems or procedures included in
existing or future national legislation and bilateral, regional and multilateral
instruments for the exchange of information on chemicals; rather, they have been prepared
with a view to assisting States in the process of developing such arrangements.
4. These Guidelines do
not preclude States from instituting broader and more frequent information exchange or
other systems involving consultation with importing countries on banned or severely
restricted chemicals designed to gain experience with alternative procedures.
5. These Guidelines
provide a mechanism for importing countries to formally record and disseminate their
decisions regarding the future importation of chemicals which have been banned or severely
restricted and outlines the shared responsibilities of importing and exporting countries
and exporting industries in ensuring that these decisions are heeded.
6. The importance of
technical and financial assistance to enhance decision-making and training in the safe use
of chemicals is recognized by the Guidelines.
7. These Guidelines are
complementary to existing instruments developed by the United Nations and the World Health
Organization and to the International Code of Conduct on the Distribution and Use of
Pesticides of the Food and Agriculture Organization of the United Nations, which is the
primary guidance for the management of pesticides internationally. These Guidelines should
be implemented in a non-duplicative manner for the different classes of chemicals covered
by existing instruments.
8. Although the
Guidelines have not been prepared specifically to address the situation of developing
countries, they nevertheless provide a framework for the establishment of procedures for
the effective use of information on chemicals in these countries. Implementation of the
Guidelines should thus help them to avoid serious and costly health and environmental
problems due to ignorance about the risks associated with the use of chemicals,
particularly those that have been banned or severely restricted in other States.
PART
I. GENERAL PROVISIONS
1.
Definitions
For the purposes of the
Guidelines:
(a) "Chemical"
means a chemical substance whether by itself or in a mixture or preparation, whether
manufactured or obtained from nature and includes such substances used as industrial
chemicals and pesticides;
(b) "Banned
chemical" means a chemical which has, for health or environmental reasons, been
prohibited for all uses by final governmental regulatory actions;
(c) "Severely
restricted chemical" means a chemical for which, for health or environmental reasons,
virtually all uses have been prohibited nationally by final government regulatory action,
but for which certain specific uses remain authorized;
(d) "International
trade" means export or import of chemicals;
(e) "Export"
and "import" mean, in their respective connotations, the movement of a chemical
from one State to another State, but exclude mere transit operations;
(f)
"Management" means the handling, supply transport, storage, treatment,
application, or other use of a chemical subsequent to its initial manufacture or
formulation;
(g) "Prior informed
consent" (PIC) refers to the principle that international shipment of a
chemical that is banned or severely restricted in order to protect human health or the
environment should not proceed without the agreement, where such agreement exists, or
contrary to the decision, of the designated national authority in the importing country;
(h) "Prior informed
consent procedure " (PIC procedure) means the procedure for formerly obtaining
and disseminating the decisions of importing countries as to whether they wish to receive
future shipments of chemicals which have been banned or severely restricted. A specific
procedure was established for selecting chemicals for initial implementation of the PIC
procedures. These include chemicals which have been previously banned or severely
restricted as well as certain pesticide formulations which are acutely toxic. This is
explained in annex II.
2.
General principles
(a) Both States of
export and States of import should protect human health and the environment against
potential harm by exchanging information on chemicals in international trade;
(b) In their activities
with regard to chemicals, States should act, in so far as is applicable, in accordance
with principle 21 of the Declaration of the United Nations Conference on the Human
Environment;
(c) States taking
measures to regulate chemicals with a view to protecting human, animal or plant life or
health, or the environment, should ensure that regulations and standards for this purpose
do not create unnecessary obstacles to international trade;
(d) States should ensure
that governmental control measures or actions taken with regard to an imported chemical
for which information has been received in implementation of the Guidelines are not more
restrictive than those applied to the same chemical produced for domestic use or imported
from a State other than the one that supplied the information;
(e) States with more
advanced systems for the safe management of chemicals should share their experience with
those countries in need of improved systems;
(f) Both States of
import and States of export should, as appropriate, strengthen their existing
infrastructures and institutions in the following way:
(i) Establishing and
strengthening legislative and regulatory systems and other mechanisms for improving
control and management of chemicals. This may include development of model legislation or
regulations, in light of these Guidelines and other relevant guidelines prepared by other
organizations;
(ii) Creating national
registers of toxic chemicals, including both industrial chemicals and pesticides;
(iii) Preparing and
updating manuals, directories and documentation for better utilization of facilities for
information collection and dissemination at the country level and to on-line facilities at
the regional level.
3.
Exemptions
These Guidelines should
not apply to:
(a) Pharmaceuticals,
including narcotics, drugs and psychotropic substances;
(b) Radioactive
materials;
(c) Chemicals imported
for the purposes of research or analysis in quantities not likely to affect the
environment or human health;
(d) Chemicals imported
as personal or household effects, in quantities reasonable for these uses;
(e) Food additives.
1/
4.
Effects on other
instruments
(a) States should take
the necessary measures with regard to implementation of these Guidelines.
(b) The provisions of
these Guidelines do not affect the obligations of States deriving from any relevant
international agreement to which they are or may become party.
5.
Institutional
arrangements
5.1 UNEP and FAO should
develop an information exchange system to ensure that designated national authorities of
importing and exporting countries have a single contact point for obtaining information
and communicating decisions on chemicals subject to the PIC procedure;
5.2 UNEP should share
with FAO the operational responsibility for the implementation of the PIC procedure and
jointly manage and implement common preparation on PIC guidance documents, mechanisms for
information sharing, and creation of data bases;
5.3 UNEP should
collaborate with FAO in reviewing the implementation of the PIC procedure, including
participation, responses, and violations of importing country decisions;
5.4 For purposes of
international communications, each State should designate a national governmental
authority (or authorities) competent to perform the administrative functions related to
the exchange of information and decisions regarding importation of chemicals included in
the PIC procedure; 2/
5.5 The designated
national authority should be authorized to communicate, directly or as provided by
national law or regulation, with designated national authorities of other States and with
international organizations concerned, to exchange information, to make and communicate
decisions regarding chemicals included in the PIC procedure and to submit reports at the
request of such States or organizations or on its own initiative;
5.6 States should ensure
that designated national authorities have sufficient national resources to assume
responsibility with regard to implementation of these Guidelines;
5.7 States should as
soon as possible make available the name and address of their designated national
authority to the International Register of Potentially Toxic Chemicals (IRPTC), as well as
subsequent changes;
5.8 A register of
designated national authorities should be maintained, regularly updated, and disseminated
by IRPTC;
5.9 IRPTC should, in
addition:
(a) Co-ordinate the
network of designated national authorities;
(b) Develop
recommendations on practices and procedures, and such joint programmes and measures as may
be required to make the Guidelines effective;
(c) Maintain liaison
with other concerned intergovernmental and non-governmental organizations;
(d) Keep under review
the implementation of these Guidelines, on the basis of periodic reports from designated
national authorities and provide biennial reports on the effectiveness of the Guidelines
and suggestions for their improvement.
PART II
- NOTIFICATION AND INFORMATION REGARDING BANNED AND SEVERELY
RESTRICTED CHEMICALS AND
OPERATION OF THE PIC PROCEDURE
6.
Notification of
control action
(a) States having taken
control action to ban or severely restrict a chemical as defined in these Guidelines
should notify IRPTC. IRPTC will disseminate these notifications as provided in these
Guidelines;
(b) The purpose of the
notification regarding control action is to give competent authorities in other States the
opportunity to assess the risks associated with the chemical, and to make timely and
informed decisions thereon, taking into account local environmental, public health,
economic and administrative conditions, and with regard to existing information on
toxicology, safety and regulatory aspects;
(c) The minimum
information to be provided for this purpose should be:
(i) The chemical
identification/specification of the chemical;
(ii) A summary of the
control action taken and of the reasons for it. If the control action bans or restricts
certain uses but allows other uses, such information should be included;
(iii) The fact that
additional information is available, and the indication of the contact point in the State
of export to which a request for further information should be addressed;
(d) To the extent
practicable, the designated national authority issuing the notification should provide
information concerning alternative measures, such as, for example, integrated pest
management procedures, non-chemical alternatives and impact mitigation measures;
(e) Notification of
control action should be provided as soon as practicable after the control action is
taken.3/ For chemicals banned or severely restricted before the
implementation of these Guidelines, an inventory of prior control actions should be
provided to IRPTC, unless such information has already been provided and circulated by
IRPTC to all designated national authorities.
7.
Operation of the
PIC procedure
7.1
Determination of
participation in the PIC procedure
PIC is a procedure which
operates in addition to information exchange and export notification. Those countries
which elect to participate in the PIC procedure will have the opportunity to record their
decisions regarding future imports of banned or severely restricted chemicals in a formal
way.
(a) Countries may
participate in the information exchange procedures under these Guidelines without
participating in the PIC procedure;
b) All exporting
countries are expected to participate in the PIC procedure by respecting the decisions of
importing countries;
(c) IRPTC should invite
countries to participate in the PIC procedure with respect to imports. Designated national
authorities should reply indicating whether their country will participate. If there is no
reply a follow-up letter should be sent 60 days after the first invitation. If there is no
response, IRPTC should take additional steps to obtain a decision. If after that, there is
still no response then it will be assumed that the country does not wish to participate in
the procedure;
(d) A country may
designate one competent body to handle both industrial chemicals and pesticides or may
designate separate competent bodies for each;
(e) A country may elect
at any time to participate or not participate in the PIC procedure by communicating its
decision to IRPTC;
(f) IRPTC should make
available on request a list of countries who have elected to participate, countries which
have elected not to participate and countries which did not respond.
7.2
Identification of
chemicals for inclusion in the PIC procedure
(a) As provided in
paragraph 9, IRPTC will notify each participating country of each chemical that is the
subject of a notification of a final government control action and that meets the
definitions as being banned or severely restricted for environmental or human health
reasons for a decision under its conditions of use as to whether that country wishes to
permit use and importation of the chemical. An informal consultative process may be used
to assist IRPTC in determining whether the control action meets the definitions of the
Guidelines;
(b) As provided in
paragraph 9, IRPTC should send qualifying control actions, along with PIC decision
guidance documents, to the appropriate designated national authority or authorities in
each participating country for decision. 4/
7.3
Response to
notification of control action for chemicals identified for inclusion in the PIC procedure
(a) The designated
national authority in each participating importing country shall make an initial response
to IRPTC within 90 days. A response may take either of two forms:
(i) A final decision to
permit use and importation, to prohibit use and importation or to permit importation only
under specified stated conditions;
(ii) An interim response
which may be:
a. A statement that
importation is under active review but that final decision has not yet been reached;
b. A request for further
information; and/or
c. A request for
assistance in evaluating the chemical.
An interim response may
also contain a statement permitting importation with or without stated specified
conditions or prohibiting importation during the interim period until a final decision is
made;
(b) The designated
national authority shall use the form provided to make such response; 5/
(c) IRPTC should send
reminders to countries as necessary to encourage a response and should facilitate the
provision of technical assistance where requested;
(d) If a participating
importing country does not make a response or responds with an interim decision that does
not address importation, the status quo with respect to importation of the chemical
should continue. This means that the chemical should not be exported without the explicit
consent of the importing country, unless it is a pesticide which is registered in the
importing country or is a chemical the use or importation of which has been allowed by
other governmental action of the importing country;
(e) If a country takes a
unilateral action which affects the status quo with respect to a chemical, it must
so notify IRPTC to make IRPTC aware of the decision. Such a unilateral action will be
interpreted as superseding any previous decision it has made with respect to the chemical;
(f) When an importing
country takes a final or interim decision which affects the status quo, it should
also communicate this decision to the national competent import control actions under its
authority.
7.4
Dissemination of
information
(a) IRPTC will inform
designated national authorities of decisions taken by participating importing countries in
a timely fashion and should also make these available to industry and other interested
parties on request, preferably through a computer data base. This information should also
be included in the regular updates of the United Nations Consolidated List of Products
whose Consumption and/or Sale have been Banned, Withdrawn or Severely Restricted by
Governments. Semi-annually, IRPTC will notify all Governments in writing of the status of
the decisions by importing countries;
(b) Governments of
exporting countries shall, upon receipt of importing countries' decisions, transmit them
to their industry.
8.
Information
regarding exports
(a) If an export of a
chemical banned or severely restricted in the State of export occurs, the State of export
should ensure that necessary steps are taken to provide the designated national authority
of the State of import with relevant information; 6/
(b) The purpose of
information regarding exports is to remind the State of import of the original
notification regarding control action and to alert it to the fact that an export will
occur or is occurring;
(c) The minimum
information to be provided for this purpose should be:
(i) A copy of, or
reference to, the information provided at the time of notification of control action;
(ii) Indication that an
export of the chemical concerned will occur or is occurring;
(iii) An estimate of the
quantity to be exported annually as well as any shipment-specific information that might
be available;
(d) States should
endeavour to ensure that, to the extent possible, information regarding exports provided
or received in implementation of these guidelines is forwarded to the State of final
destination and to IRPTC;
(e) Provision of
information regarding exports should take place when the first export following the
control action occurs, and should recur periodically or in the case of any significant
development of new information or condition surrounding the control action. It is the
intention that, in so far as possible, the information should be provided prior to export.
Where the chemical has been banned or severely restricted before the adoption of these
Guidelines, the "first export following the control action" should be considered
to be the first export after adoption of these Guidelines.
9.
Channels of
notification and information
(a) Notifications of
control actions should be addressed to IRPTC for transmission to designated national
authorities;
(b) Participating
importing countries should send their response on the prescribed forms to IRPTC for
appropriate dissemination;
(c) PIC decision
guidance documents will be transmitted by IRPTC to designated national authorities in
participating importing countries for their decision and response and to designated
national authorities in other countries for their information;
(d) Information on
exports should be addressed to the national authority designated for this purpose in the
State of import.
10.
Feedback
Designated national
authorities of States of import should provide to IRPTC, for the purpose of periodic
review pursuant to paragraph 5.9 (d), a summary of action taken as a result of
notifications and information received pursuant to paragraphs 6, 7.3 and 8 and information
on any difficulties which they have experienced in using these Guidelines.
11.
Confidential data
(a) States undertaking
information exchange in implementation of these Guidelines should establish internal
procedures for the receipt, handling and protection of confidential and proprietary
information received from other States;
(b) States receiving
notifications and information regarding exports should be responsible for the protection
of proprietary rights and the confidentiality of data received under these Guidelines when
claimed by the State supplying the information.
12.
Functions of
designated national authorities
(a)
Control
action. It should be the function of designated national authorities, with regard to
control action taken by States to ban or severely restrict a chemical:
(i) To provide
notification to IRPTC, in accordance with these Guidelines, that such control action has
been taken;
(ii) To receive from
IRPTC notification that such action has been taken in other States, and to ensure its
prompt transmittal to all other national authorities concerned;
(iii) To receive from
the United Nations the regular updates of the United Nations Consolidated List of Products
Whose Consumption and/or Sale have been Banned, Withdrawn or Severely Restricted by
Governments;
(v) To respond to
notifications of control action in accordance with paragraph 7.3 of these Guidelines,
including response to the lists to be circulated in accordance with paragraph 7.2 and
annex II;
(b)
Imports. It
should be the function of designated national authorities, with regard to imports of
banned or severely restricted chemicals:
i) To receive from
States of export information on exports, and to ensure the prompt transmittal of such
information to all other authorities concerned in the State of import;
ii) To transmit to
States of export requests for further information as required;
(iii) To provide
feedback information to IRPTC on action taken as a result of notifications and information
received and on any difficulties experienced in the exchange of data with States of
exports;
(iv) To advise and
assist import control authorities so that they can take appropriate import control actions
under their authority;
(v) To strengthen
national decision-making procedures and import control mechanisms;
(vi) To ensure that
decisions apply uniformly to all sources of import and to domestic production of chemicals
for domestic use;
(vii) To encourage that
chemicals subject to PIC be purchased only from sources in exporting countries which are
participants in that procedure;
(c)
Exports.
It should be the function of designated national authorities, with regard to exports of
banned or severely restricted chemicals:
(i) To ensure the
issuance or transmittal of information on exports;
(ii) To respond to
requests for information from other States, especially as regards sources of precautionary
information on safe use and handling of the chemicals concerned;
(iii) To communicate PIC
decisions to their export industry;
(iv) To implement
appropriate procedures, within their authority, designed to ensure that exports do not
occur contrary to the PIC decisions of participating importing countries;
(d)
Other
functions. Designated national authorities should also consider the need:
(i) To provide
information regarding applicable national regulations for the management of banned or
severely restricted chemicals;
(ii) To ensure the
provision of appropriate precautionary information to persons using or handling the
chemicals concerned;
(iii) To keep records of
notifications and information received, issued and transmitted which could be open for
public inspection in accordance with national law, except for information classified as
confidential or proprietary;
(iv) To keep records of
imports and exports of banned and severely restricted chemicals.
PART III. -
GENERAL
INFORMATION EXCHANGE AND PROVISION OF TECHNICAL ASSISTANCE REGARDING CHEMICALS
13.
Information,
advice and assistance
(a) For the
protection of human health and the environment, States should facilitate:
(i) The exchange of
scientific information (including toxicological and safety data) and technical, economic
and legal information concerning the management of chemicals, particularly through
designated national governmental authorities and through intergovernmental organizations
as appropriate;
(ii) The provision upon
request of technical advice and assistance concerning the management of chemicals to other
States, on a bilateral or multilateral basis, taking into account the special needs of
developing countries.
b) With regard to the
export of chemicals, States of export should ensure that, where appropriate, information,
advice and assistance is provided to States of import concerned regarding the sound
management of such chemicals, including appropriate precautionary information;
(c) With regard to the
use of imported chemicals, States of import should, on the basis of notification and
information provided by States of export, take the necessary measures to ensure that users
are provided with information, advice and assistance for the sound management of such
chemicals, including appropriate precautionary information;
(d) As far as
practicable, precautionary information should be provided in the principal language or
languages of the State of import and of the area of intended use, and should be
accompanied by suitable pictorial and/or tactile aids and labels.
14.
Classification,
packaging and labelling
(a) States should
recognize that classification, packaging and labelling are important elements in
information exchange on chemicals in international trade, and that it is desirable that
chemicals exported from their territories are subject to no less stringent requirements of
classification, packaging and labelling than comparable products destined for use in the
State of export;
(b) In the development
and implementation of existing and future internationally harmonized procedures for the
classification, packaging and labelling of chemicals in international trade, States should
take into account the special circumstances surrounding the management of chemicals in
developing countries.
(c) In the absence of
other standards in the State of import, States should ensure that the classification,
packaging and labelling of chemicals exported from their territories conform to recognized
and, where appropriate, internationally harmonized procedures and practices for ensuring
the protection of human health and the environment during use of these chemicals.
15.
Technical
assistance
(a) IRPTC should
encourage funding agencies, such as the development banks and the United Nations
Development Programme, and bilateral donors to provide training, technical assistance and
funding for institutional strengthening and should further encourage other United Nations
organizations to strengthen their activities related to safe management of chemicals;
(b) States with more
advanced chemical regulatory programmes should provide technical assistance to other
countries in developing infrastructure and capacity to manage chemicals within their
countries, including implementation of the provisions of these Guidelines. Developing
countries with more advanced systems should be particularly encouraged to provide
technical assistance to other developing countries with no, or less advanced, systems of
chemical management. To the extent possible, donor countries and institutions and
recipient countries should inform IRPTC of all such technical assistance activities;
(c) Special attention
should be devoted by technical assistance and funding authorities to those countries
without any regulatory procedures on chemicals in developing a regime for their control;
(d) Essential
elements of technical assistance needed by developing countries for the management of
chemicals include:
(i) Strengthening
existing infrastructure and institutions;
(ii) Provision for the
interchange of experts, including short missions, from developed countries to developing
countries and vice versa and in particular from one developing country to another for the
purpose of:
a. Sharing each other's
experience and exchanging ideas;
b. Advising on analysis
of information on chemical risks and benefits, conducting environmental impact assessment,
and disposing of unusable products safely;
c. Sharing information
on new products and alternatives;
d. Ascertaining research
and development requirements for local pesticide efficacy studies and development of
alternatives;
e. Assisting one another
in dealing with practical difficulties in implementing these Guidelines;
(iii) Training to
include:
a. Technical workshops
on a local, regional and international level;
b. Awareness campaigns
on the safe management of chemicals for industrial and agricultural workers, customs
officials and doctors;
c. Opportunities for
decision makers in developing countries to study systems in countries which have been
successfully implementing these Guidelines.
FOOTNOTES
1/
It is open to States to apply these Guidelines to pharmaceuticals and food additives if
they wish to do so.
2/
States may designate more than one national authority for different purposes, such as for
information exchange and making PIC determinations, or for industrial chemicals and
pesticides. Where more than one national authority is designated, the term
"designated National Authority" in the text of these Guidelines should be
interpreted as referring to the authority responsible for the actions being discussed.
3/
The form attached as annex I should be used for that purpose.
4/
The content of a PIC decision guidance document is outlines in annex III.
5/
The content of a form for importing country response is outlined in annex IV.
6/
The form attached as annex V should be used for that purpose.
Annex I
FORM FOR NOTIFICATION OF CONTROL ACTION
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