Cartagena_PROTOCOLe.doc CARTAGENA PROTOCOL ON BIOSAFETY to the convention on biological diversity

《生物多样性公约》的卡塔赫纳生物安全议定书

The Parties to this Protocol,

本议定书缔约方，

Being Parties to the Convention on Biological Diversity, hereinafter referred to as "the Convention",

作为《生物多样性公约》(以下简称《公约》)的缔约方，

Recalling Article 19, paragraphs 3 and 4, and Articles 8 (g) and 17 of the Convention,

忆及《公约》第19条第3和第4款、第8(g)条和第17条，

Recalling also decision II/5 of 17 November 1995 of the Conference of the Parties to the Convention to develop a Protocol on biosafety, specifically focusing on transboundary movement of any living modified organism resulting from modern biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity, setting out for consideration, in particular, appropriate procedures for advance informed agreement,

又忆及《公约》缔约方大会1995年11月17日第II/5号决定要求订立一项生物安全议定书，其具体侧重点应为凭借现代生物技术获得的、可能对生物多样性的保护和可持续使用产生不利影响的任何改性活生物体的越境转移问题，特别是着手拟定适宜的提前知情同意程序，以供审议，

Reaffirming the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development,

重申《关于环境与发展的里约宣言》原则15中所规定的预先防范办法，

Aware of the rapid expansion of modern biotechnology and the growing public concern over its potential adverse effects on biological diversity, taking also into account risks to human health,

意识到现代生物技术扩展迅速，公众亦日益关切此种技术可能会对生物多样性产生不利影响，同时还需顾及对人类健康构成的风险，

Recognizing that modern biotechnology has great potential for human well-being if developed and used with adequate safety measures for the environment and human health,

认识到如能在开发和利用现代生物技术的同时亦采取旨在确保环境和人类健康的妥善安全措施，则此种技术可使人类受益无穷，

Recognizing also the crucial importance to humankind of centres of origin and centres of genetic diversity,

亦认识到起源中心和遗传多样性中心对于人类极为重要，

Taking into account the limited capabilities of many countries, particularly developing countries, to cope with the nature and scale of known and potential risks associated with living modified organisms,

考虑到许多国家、特别是发展中国家此方面能力有限，难以应付改性活生物体所涉及的已知和潜在风险的性质和规模，

Recognizing that trade and environment agreements should be mutually supportive with a view to achieving sustainable development,

认识到贸易协定与环境协定应相辅相成，以期实现可持续发展，

Emphasizing that this Protocol shall not be interpreted as implying a change in the rights and obligations of a Party under any existing international agreements,

强调不得将本议定书解释为缔约方根据任何现行国际协定所享有的权利和所承担的义务有任何改变，

Understanding that the above recital is not intended to subordinate this Protocol to other international agreements,

认为上述陈述无意使本议定书附属于其他国际协定，

Have agreed as follows:

兹协议如下：

Article 1

第1条

OBJECTIVE

目标

In accordance with the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, the objective of this Protocol is to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements.

本议定书的目标是依循《关于环境与发展的里约宣言》原则15所订立的预先防范办法，协助确保在安全转移、处理和使用凭借现代生物技术获得的、可能对生物多样性的保护和可持续使用产生不利影响的改性活生物体领域内采取充分的保护措施，同时顾及对人类健康所构成的风险并特别侧重越境转移问题。

Article 2

第2条

GENERAL PROVISIONS

一般规定

1. Each Party shall take necessary and appropriate legal, administrative and other measures to implement its obligations under this Protocol.

1. 每一缔约方应为履行本议定书为之规定的各项义务采取必要和适当的法律、行政和其他措施。

2. The Parties shall ensure that the development, handling, transport, use, transfer and release of any living modified organisms are undertaken in a manner that prevents or reduces the risks to biological diversity, taking also into account risks to human health.

2. 各缔约方应确保在从事任何改性活生物体的研制、处理、运输、使用、转移和释放时，防止或减少其对生物多样性构成的风险，同时亦应顾及对人类健康所构成的风险。

3. Nothing in this Protocol shall affect in any way the sovereignty of States over their territorial sea established in accordance with international law, and the sovereign rights and the jurisdiction which States have in their exclusive economic zones and their continental shelves in accordance with international law, and the exercise by ships and aircraft of all States of navigational rights and freedoms as provided for in international law and as reflected in relevant international instruments.

3. 本议定书的任何规定不得以任何方式妨碍依照国际法所确立的各国对其领海所拥有的主权以及国际法所规定的各国对其专属经济区及其大陆架所拥有的主权和管辖权，亦不得妨碍所有国家的船只和航空器依照国际法和有关国际文书所享有的航行权和航行自由。

4. Nothing in this Protocol shall be interpreted as restricting the right of a Party to take action that is more protective of the conservation and sustainable use of biological diversity than that called for in this Protocol, provided that such action is consistent with the objective and the provisions of this Protocol and is in accordance with that Party's other obligations under international law.

4. 不得将本议定书中的任何条款解释为限制缔约方为确保对生物多样性的保护和可持续使用采取比本议定书所规定的更为有力的保护行动的权利，但条件是此种行动须符合本议定书的各项目标和条款并符合国际法为缔约方规定的各项其他义务。

5. The Parties are encouraged to take into account, as appropriate, available expertise, instruments and work undertaken in international forums with competence in the area of risks to human health.

5. 鼓励各缔约方酌情考虑到具有在人类健康风险领域内开展活动权限的各国际机构所掌握的现有专门知识、所订立的文书和所开展的工作。

Article 3

第3条

USE OF TERMS

用语

For the purposes of this Protocol:

为本议定书的目的:

(a) "Conference of the Parties" means the Conference of the Parties to the Convention;

(a) “缔约方大会”是指《公约》的缔约方大会；

(b) "Contained use" means any operation, undertaken within a facility, installation or other physical structure, which involves living modified organisms that are controlled by specific measures that effectively limit their contact with, and their impact on, the external environment;

(b) “封闭使用”是指在一设施、装置或其他有形结构中进行的涉及改性活生物体的任何操作，且因对所涉改性活生物体采取了特定控制措施而有效地限制了其与外部环境的接触及其对外部环境所产生的影响；

(c) "Export" means intentional transboundary movement from one Party to another Party;

(c) “出口”是指以从一缔约方向另一缔约方的有意越境转移；

(d) "Exporter" means any legal or natural person, under the jurisdiction of the Party of export, who arranges for a living modified organism to be exported;

(d) “出口者”是指属于出口缔约方管辖范围之内并安排出口改性活生物体的任何法人或自然人；

(e) "Import" means intentional transboundary movement into one Party from another Party;

(e) “进口”是指从一缔约方进入另一缔约方的有意越境转移；

(f) "Importer" means any legal or natural person, under the jurisdiction of the Party of import, who arranges for a living modified organism to be imported;

(f) “进口者”是指属于进口缔约方管辖范围之内并安排进口改性活生物体的任何法人或自然人；

(g) "Living modified organism" means any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology;

(g) “改性活生物体”是指任何具有凭借现代生物技术获得的遗传材料新异组合的活生物体；

(h) "Living organism" means any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids;

(h) “活生物体”是指任何能够转移或复制遗传材料的生物实体，其中包括不能繁殖的生物体、病毒和类病毒；

(i) "Modern biotechnology" means the application of:

(i) “现代生物技术”是指下列技术的应用:

a. In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or

a. 试管核酸技术，包括重新组合的脱氧核糖核酸(DNA)和把核酸直接注入细胞或细胞器， 或

b. Fusion of cells beyond the taxonomic family,

b. 超出生物分类学科的细胞融合，

that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection;

此类技术可克服自然生理繁殖或重新组合障碍，且并非传统育种和选种中所使用的技术；

(j) "Regional economic integration organization" means an organization constituted by sovereign States of a given region, to which its member States have transferred competence in respect of matters governed by this Protocol and which has been duly authorized, in accordance with its internal procedures, to sign, ratify, accept, approve or accede to it;

(j) “区域经济一体化组织”是指由一个特定区域的主权国家所组成的组织，它已获得其成员国转让的处理本议定书所规定事项的权限、且已按照其内部程序获得正式授权可以签署、批准、接受、核准或加入本议定书；

(k) "Transboundary movement" means the movement of a living modified organism from one Party to another Party, save that for the purposes of Articles 17 and 24 transboundary movement extends to movement between Parties and non-Parties.

(k) “越境转移”是指从一缔约方向另一缔约方转移改性活生物体，但就第17第条和第24条的目的而言，越境转移所涉范围当予扩大到缔约方与非缔约方之间的转移。

Article 4

第4条

SCOPE

范围

This Protocol shall apply to the transboundary movement, transit, handling and use of all living modified organisms that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.

本议定书应适用于可能对生物多样性的保护和可持续使用产生不利影响的所有改性活生物体的越境转移、过境、处理和使用，同时亦顾及对人类健康构成的风险。

Article 5

第5条

PHARMACEUTICALS

药物

Notwithstanding Article 4 and without prejudice to any right of a Party to subject all living modified organisms to risk assessment prior to the making of decisions on import, this Protocol shall not apply to the transboundary movement of living modified organisms which are pharmaceuticals for humans that are addressed by other relevant international agreements or organisations.

尽管有第4条的规定，在不损害缔约方在其就进口问题作出决定之前对所有改性活生物体进行风险评估的权利的情况下，本议定书不应适用于由其他有关国际协定或组织予以处理的、用作供人类使用的药物的改性活生物体的越境转移。

Article 6

第6条

TRANSIT AND CONTAINED USE

过境和封闭使用

1. Notwithstanding Article 4 and without prejudice to any right of a Party of transit to regulate the transport of living modified organisms through its territory and make available to the Biosafety Clearing-House, any decision of that Party, subject to Article 2, paragraph 3, regarding the transit through its territory of a specific living modified organism, the provisions of this Protocol with respect to the advance informed agreement procedure shall not apply to living modified organisms in transit.

1. 尽管有第4条的规定，在不损害过境缔约方对作穿越其领土运输的改性活生物体实行管制以及根据第2条第3款把该缔约方针对穿越其领土运输某种改性活生物体作出的任何决定通知生物安全资料交换所的任何权利的情况下，本议定书中有关提前知情同意程序的规定不应适用于过境的改性活生物体。

2. Notwithstanding Article 4 and without prejudice to any right of a Party to subject all living modified organisms to risk assessment prior to decisions on import and to set standards for contained use within its jurisdiction, the provisions of this Protocol with respect to the advance informed agreement procedure shall not apply to the transboundary movement of living modified organisms destined for contained use undertaken in accordance with the standards of the Party of import.

2. 尽管有第4条的规定，在不损害缔约方在其就进口问题作出决定之前对所有改性活生物体进行风险评估的任何权利、以及针对属其管辖范围之内的封闭使用订立标准的任何权利的情况下，本议定书中有关提前知情同意程序的规定不应适用于那些拟按照进口缔约方的标准用于封闭使用的改性活生物体的越境转移。

Article 7

第7条

APPLICATION OF THE ADVANCE INFORMED AGREEMENT PROCEDURE

提前知情同意程序的适用

1. Subject to Articles 5 and 6, the advance informed agreement procedure in Articles 8 to 10 and 12 shall apply prior to the first intentional transboundary movement of living modified organisms for intentional introduction into the environment of the Party of import.

1. 在不违反第5条和第6条的情况下，第8至第10条和第12条中所列提前知情同意程序应在拟有意向进口缔约方的环境中引入改性活生物体的首次有意越境转移之前予以适用。

2. "Intentional introduction into the environment" in paragraph 1 above, does not refer to living modified organisms intended for direct use as food or feed, or for processing.

2. 以上第1款中所述“有意向环境中引入”并非指拟直接用作食物或饲料或用于加工的改性活生物体。

3. Article 11 shall apply prior to the first transboundary movement of living modified organisms intended for direct use as food or feed, or for processing.

3. 第11条应在拟直接用作食物或饲料或用于加工的改性活生物体首次越境转移之前予以适用。

4. The advance informed agreement procedure shall not apply to the intentional transboundary movement of living modified organisms identified in a decision of the Conference of the Parties serving as the meeting of the Parties to this Protocol as being not likely to have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.

4. 提前知情同意程序不应适用于经作为本议定书缔约方会议的缔约方大会的一项决定认定在亦顾及对人类健康构成的风险的情况下不太可能对生物多样性的保护和可持续使用产生不利影响的改性活生物体的有意越境转移。

Article 8

第8条

NOTIFICATION

通知

1. The Party of export shall notify, or require the exporter to ensure notification to, in writing, the competent national authority of the Party of import prior to the intentional transboundary movement of a living modified organism that falls within the scope of Article 7, paragraph 1.

1. 出口缔约方应在首次有意越境转移属于第7条第1款范围内的改性活生物体之前，通知或要求出口者确保以书面形式通知进口缔约方的国家主管部门。

The notification shall contain, at a minimum, the information specified in Annex I.

通知中至少应列有附件一所列明的资料。

2. The Party of export shall ensure that there is a legal requirement for the accuracy of information provided by the exporter.

2. 出口缔约方应确保订有法律条文，规定出口者所提供的资料必须准确无误。

Article 9

第9条

ACKNOWLEDGEMENT OF RECEIPT OF NOTIFICATION

对收到通知的确认

1. The Party of import shall acknowledge receipt of the notification, in writing, to the notifier within ninety days of its receipt.

1. 进口缔约方应于收到通知后九十天内以书面形式向发出通知者确认已收到通知。

2. The acknowledgement shall state:

2. 应在此种确认中表明：

(a) The date of receipt of the notification;

(a) 收到通知的日期；

(b) Whether the notification, prima facie, contains the information referred to in Article 8;

(b) 通知中是否初步看来列有第8条所述资料；

(c) Whether to proceed according to the domestic regulatory framework of the Party of import or according to the procedure specified in Article 10.

(c) 可否根据进口缔约方的国内规章制度或根据第10条中列明的程序采取下一步行动。

3. The domestic regulatory framework referred to in paragraph 2 (c) above, shall be consistent with this Protocol.

3. 以上第2(c)款所述国内规章制度应与本议定书相一致。

4. A failure by the Party of import to acknowledge receipt of a notification shall not imply its consent to an intentional transboundary movement.

4. 即使进口缔约方未能对通知作出确认，亦不应意味着其对越境转移表示同意。

Article 10

第10条

DECISION PROCEDURE

决定程序

1. Decisions taken by the Party of import shall be in accordance with Article 15.

1. 进口缔约方所作决定应符合第15条的规定。

2. The Party of import shall, within the period of time referred to in Article 9, inform the notifier, in writing, whether the intentional transboundary movement may proceed:

2. 进口缔约方应在第9条所规定的时限内书面通知发出通知者可否在下述情况下进行有意越境转移:

(a) Only after the Party of import has given its written consent; or

(a) 只可在得到进口缔约方的书面同意后；或

(b) After no less than ninety days without a subsequent written consent.

(b)于至少九十天后未收到后续书面同意。

3. Within two hundred and seventy days of the date of receipt of notification, the Party of import shall communicate, in writing, to the notifier and to the Biosafety Clearing-House the decision referred to in paragraph 2 (a) above:

3. 进口缔约方应在收到通知后二百七十天内向发出通知者及生物安全资料交换所书面通报以上第2(a)款中所述决定并表明:

(a) Approving the import, with or without conditions, including how the decision will apply to subsequent imports of the same living modified organism;

(a) 有条件或无条件地核准进口，其中包括说明此项决定将如何适用于同一改性活生物体的后续进口；

(b) Prohibiting the import;

(b) 禁止进口；

(c) Requesting additional relevant information in accordance with its domestic regulatory framework or Annex I; in calculating the time within which the Party of import is to respond, the number of days it has to wait for additional relevant information shall not be taken into account; or

(c) 根据其国内规章条例或根据附件一要求提供更多的有关资料；在计算进口缔约方作出答复所需时间时，不应计入进口缔约方用于等候获得更多的有关资料所需的天数； 或

(d) Informing the notifier that the period specified in this paragraph is extended by a defined period of time.

(d) 通知发出通知者已将本款所列明的期限适当延长。

4. Except in a case in which consent is unconditional, a decision under paragraph 3 above, shall set out the reasons on which it is based.

4. 除非已予以无条件核准， 否则根据以上第3款所作的决定应列出作出这一决定的理由。

5. A failure by the Party of import to communicate its decision within two hundred and seventy days of the date of receipt of the notification shall not imply its consent to an intentional transboundary movement.

5. 即使进口缔约方未能在收到通知后二百七十天内通报其决定，亦不应意味着该缔约方对有意越境转移表示同意。

6. Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of a living modified organism on the conservation and sustainable use of biological diversity in the Party of import, taking also into account risks to human health, shall not prevent that Party from taking a decision, as appropriate, with regard to the import of the living modified organism in question as referred to in paragraph 3 above, in order to avoid or minimize such potential adverse effects.

6. 在亦顾及对人类健康构成的风险的情况下，即使由于在改性活生物体对进口缔约方的生物多样性的保护和可持续使用所产生的潜在不利影响的程度方面未掌握充分的相关科学资料和知识，因而缺乏科学定论，亦不应妨碍该缔约方酌情就以上第3款所指的改性活生物体的进口问题作出决定，以避免或尽最大限度减少此类潜在的不利影响。

7. The Conference of the Parties serving as the meeting of the Parties shall, at its first meeting, decide upon appropriate procedures and mechanisms to facilitate decision-making by Parties of import.

7. 作为本议定书缔约方会议的缔约方大会应在其第一次会议上就旨在便利进口缔约方决策的适当程序和机制作出决定。

Article 11

第11条

PROCEDURE FOR LIVING MODIFIED ORGANISMS INTENDED FOR DIRECT USE AS FOOD OR FEED, OR FOR PROCESSING

关于拟直接作食物或饲料或加工之用的改性活生物体的程序

1. A Party that makes a final decision regarding domestic use, including placing on the market, of a living modified organism that may be subject to transboundary movement for direct use as food or feed, or for processing shall, within fifteen days of making that decision, inform the Parties through the Biosafety Clearing-House.

1. 一缔约方如已针对为供直接作食物或饲料或加工之用而拟予以越境转移的改性活生物体的国内用途、包括投放市场作出最终决定，则应在作出决定后十五天之内通过生物安全资料交换所将之通报各缔约方。

This information shall contain, at a minimum, the information specified in Annex II.

此种通知应至少列有附件二所规定的信息资料。

The Party shall provide a copy of the information, in writing, to the national focal point of each Party that informs the Secretariat in advance that it does not have access to the Biosafety Clearing-House.

该缔约方应将上述信息资料的书面副本提供给事先已告知秘书处它无法通过生物安全资料交换所交流信息资料的每一缔约方的国家联络点。

This provision shall not apply to decisions regarding field trials.

此项规定不应适用于关于实地测试的决定。

2. The Party making a decision under paragraph 1 above, shall ensure that there is a legal requirement for the accuracy of information provided by the applicant.

2. 根据以上第1款作出决定的缔约方应确保订有法律条文，规定申请者所提供的资料必须准确无误。

3. Any Party may request additional information from the authority identified in paragraph (b) of Annex II.

3. 任何缔约方均可从附件二第(b)段中指明的主管部门索要其他资料。

4. A Party may take a decision on the import of living modified organisms intended for direct use as food or feed, or for processing, under its domestic regulatory framework that is consistent with the objective of this Protocol.

4. 缔约方可根据符合本议定书目标的国内规章条例，就拟直接作食物或饲料或加工之用的改性活生物体的进口作出决定。

5. Each Party shall make available to the Biosafety Clearing-House copies of any national laws, regulations and guidelines applicable to the import of living modified organisms intended for direct use as food or feed, or for processing, if available.

5. 每一缔约方如订有适用于拟直接作食物或饲料或加工之用的改性活生物体的进口的任何国家法律、规章条例和准则，应向生物安全资料交换所提供此种资料的副本。

6. A developing country Party or a Party with an economy in transition may, in the absence of the domestic regulatory framework referred to in paragraph 4 above, and in exercise of its domestic jurisdiction, declare through the Biosafety Clearing-House that its decision prior to the first import of a living modified organism intended for direct use as food or feed, or for processing, on which information has been provided under paragraph 1 above, will be taken according to the following:

6. 发展中国家缔约方或经济转型国家缔约方如未订有以上第4款所述的国内规章条例，可在行使其国内司法管辖权时通过生物安全资料交换所宣布，它已根据以上第1款提供了相关资料的、并拟于意在直接作食物或饲料或加工之用的改性活生物体的首次进口之前作出的决定，将根据下列情况作出:

(a) A risk assessment undertaken in accordance with Annex III; and

(a) 根据附件三进行的风险评估；及

(b) A decision made within a predictable timeframe, not exceeding two hundred and seventy days.

(b) 在不超过二百七十天的可预测的时间范围内作出决定。

7. Failure by a Party to communicate its decision according to paragraph 6 above, shall not imply its consent or refusal to the import of a living modified organism intended for direct use as food or feed, or for processing, unless otherwise specified by the Party.

7. 缔约方未能依照以上第6款发出通知不应意味着该缔约方同意或拒绝进口某种拟直接作食物或饲料或加工之用的改性活生物体，除非该缔约方另有明确说明。

8. Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of a living modified organism on the conservation and sustainable use of biological diversity in the Party of import, taking also into account risks to human health, shall not prevent that Party from taking a decision, as appropriate, with regard to the import of that living modified organism intended for direct use as food or feed, or for processing, in order to avoid or minimize such potential adverse effects.

8. 在亦顾及对人类健康构成的风险的情况下，即使由于在改性活生物体对进口缔约方生物多样性的保护和可持续使用产生的潜在不利影响的程度方面未掌握充分的相关科学资料和知识，因而缺乏科学定论，亦不应妨碍进口缔约方酌情就拟直接作食物、饲料或加工之用的该改性活生物体的进口作出决定，以避免或尽最大限度减少此类潜在的不利影响。

9. A Party may indicate its needs for financial and technical assistance and capacity-building with respect to living modified organisms intended for direct use as food or feed, or for processing.

9. 缔约方可表明它在拟直接作食物或饲料或加工之用的改性活生物体方面需要得到的财务和技术援助及其在相关的能力建设方面的需要。

Parties shall cooperate to meet these needs in accordance with Articles 22 and 28.

缔约方应相互合作，以根据第22和第28条满足这些需要。

Article 12

第12条

REVIEW OF DECISIONS

对决定的复审

1. A Party of import may, at any time, in light of new scientific information on potential adverse effects on the conservation and sustainable use of biological diversity, taking also into account the risks to human health, review and change a decision regarding an intentional transboundary movement.

1. 进口缔约方可随时根据对生物多样性的保护和可持续使用的潜在不利影响方面的新的科学资料，并顾及对人类健康构成的风险，审查并更改其已就改性活生物体的有意越境转移作出的决定。

In such case, the Party shall, within thirty days, inform any notifier that has previously notified movements of the living modified organism referred to in such decision, as well as the Biosafety Clearing-House, and shall set out the reasons for its decision.

在此种情形中，该缔约方应于三十天之内就此通知先前曾向其通报此种决定中所述改性活生物体的转移活动的任何发出通知者以及生物安全资料交换所，并应说明作出这一决定的理由。

2. A Party of export or a notifier may request the Party of import to review a decision it has made in respect of it under Article 10 where the Party of export or the notifier considers that:

2. 出口缔约方或发出通知者如认为出现了下列情况，便可要求进口缔约方对其已依照第10条针对该次进口所作出的决定进行复审:

(a) A change in circumstances has occurred that may influence the outcome of the risk assessment upon which the decision was based; or

(a) 发生了可能会影响到当时作出此项决定时所依据的风险评估结果的情况变化；或

(b) Additional relevant scientific or technical information has become available.

(b) 又获得了其他相关的科学或技术信息资料；

3. The Party of import shall respond in writing to such a request within ninety days and set out the reasons for its decision.

3. 进口缔约方应于九十天内对此种要求作出书面回复并说明其所作决定的依据。

4. The Party of import may, at its discretion, require a risk assessment for subsequent imports.

4. 进口缔约方可自行斟酌决定是否要求对后续进口进行风险评估。

Article 13

第13条

SIMPLIFIED PROCEDURE

简化程序

1. A Party of import may, provided that adequate measures are applied to ensure the safe intentional transboundary movement of living modified organisms in accordance with the objective of this Protocol, specify in advance to the Biosafety Clearing-House:

1. 只要已依循本议定书的目标，为确保以安全方式从事改性活生物体的有意越境转移采取了适宜的措施，进口缔约方便可提前向生物安全资料交换所表明:

(a) Cases in which intentional transboundary movement to it may take place at the same time as the movement is notified to the Party of import; and

(a) 向该缔约方的有意越境转移可在何种情况下于向进口缔约方发出转移通知的同时同步进行；以及

(b) Imports of living modified organisms to it to be exempted from the advance informed agreement procedure.

(b) 拟免除对向该缔约方进口的改性活生物体采用提前知情同意程序。

Notifications under subparagraph (a) above, may apply to subsequent similar movements to the same Party.

以上第(a)项中所述通知可适用于其后向同一缔约方进行的类似转移。

2. The information relating to an intentional transboundary movement that is to be provided in the notifications referred to in paragraph 1 (a) above, shall be the information specified in Annex I.

2. 应在以上第1(a)款所述通知中予以提供的有意越境转移资料应为附件一中具体列明的资料。

Article 14

第14条

BILATERAL, REGIONAL AND MULTILATERAL AGREEMENTS AND ARRANGEMENTS

双边、区域及多边协定和安排

1. Parties may enter into bilateral, regional and multilateral agreements and arrangements regarding intentional transboundary movements of living modified organisms, consistent with the objective of this Protocol and provided that such agreements and arrangements do not result in a lower level of protection than that provided for by the Protocol.

1. 缔约方可在符合本议定书目标的前提下，与其他缔约方或非缔约方就有意越境转移改性活生物体问题订立双边、区域及多边协定和安排，但条件是此种协定和安排所规定的保护程度不得低于本议定书所规定的保护程度。

2. The Parties shall inform each other, through the Biosafety Clearing-House, of any such bilateral, regional and multilateral agreements and arrangements that they have entered into before or after the date of entry into force of this Protocol.

2. 各缔约方应通过生物安全资料交换所相互通报各自在本议定书生效日期之前或之后订立的任何此种双边、区域及多边协定和安排。

3. The provisions of this Protocol shall not affect intentional transboundary movements that take place pursuant to such agreements and arrangements as between the parties to those agreements or arrangements.

3. 本议定书的各项条款不得妨碍此类协定或安排的缔约方之间根据此种协定和安排进行的有意越境转移。

4. Any Party may determine that its domestic regulations shall apply with respect to specific imports to it and shall notify the Biosafety Clearing-House of its decision.

4. 任何缔约方均可决定其国内的规章条例适用于对它的某些特定进口，并应向生物安全资料交换所通报其所作决定。

Article 15

第15条

RISK ASSESSMENT

风险评估

1. Risk assessments undertaken pursuant to this Protocol shall be carried out in a scientifically sound manner, in accordance with Annex III and taking into account recognized risk assessment techniques.

1. 依照本议定书进行的风险评估应按附件三的规定并以在科学上合理的方式做出，同时应考虑采用已得到公认的风险评估技术。

Such risk assessments shall be based, at a minimum, on information provided in accordance with Article 8 and other available scientific evidence in order to identify and evaluate the possible adverse effects of living modified organisms on the conservation and sustainable use of biological diversity, taking also into account risks to human health.

此种风险评估应以根据第8条所提供的资料和其他现有科学证据作为评估所依据的最低限度资料，以期确定和评价改性活生物体可能对生物多样性的保护和可持续使用产生的不利影响，同时亦顾及对人类健康构成的风险。

2. The Party of import shall ensure that risk assessments are carried out for decisions taken under Article 10.

2. 进口缔约方应确保为依照第10条作出决定而进行风险评估。

It may require the exporter to carry out the risk assessment.

它可要求出口者进行此种风险评估。

3. The cost of risk assessment shall be borne by the notifier if the Party of import so requires.

3. 如果进口缔约方要求由发出通知者承担进行风险评估的费用，则发出通知者应承担此种费用。

Article 16

第16条

RISK MANAGEMENT

风险管理

1. The Parties shall, taking into account Article 8 (g) of the Convention, establish and maintain appropriate mechanisms, measures and strategies to regulate, manage and control risks identified in the risk assessment provisions of this Protocol associated with the use, handling and transboundary movement of living modified organisms.

1. 缔约方应参照《公约》第8(g)条的规定，制定并保持适宜的机制、措施和战略，用以制约、管理和控制在本议定书风险评估条款中指明的、因改性活生物体的使用、处理和越境转移而构成的各种风险。

2. Measures based on risk assessment shall be imposed to the extent necessary to prevent adverse effects of the living modified organism on the conservation and sustainable use of biological diversity, taking also into account risks to human health, within the territory of the Party of import.

2. 应在必要范围内规定必须采取以风险评估结果为依据的措施，以防止改性活生物体在进口缔约方领土内对生物多样性的保护和可持续使用产生不利影响，同时亦顾及对人类健康构成的风险。

3. Each Party shall take appropriate measures to prevent unintentional transboundary movements of living modified organisms, including such measures as requiring a risk assessment to be carried out prior to the first release of a living modified organism.

3. 每一缔约方均应采取适当措施，防止于无意之中造成改性活生物体的越境转移，其中包括要求于某一改性活生物体的首次释放之前进行风险评估等措施。

4. Without prejudice to paragraph 2 above, each Party shall endeavour to ensure that any living modified organism, whether imported or locally developed, has undergone an appropriate period of observation that is commensurate with its life-cycle or generation time before it is put to its intended use.

4. 在不妨碍以上第2款的情况下，每一缔约方均应做出努力，确保在把无论是进口的还是于当地研制的任何改性活生物体投入预定使用之前，对其进行与其生命周期或生殖期相当的一段时间的观察。

5. Parties shall cooperate with a view to:

5. 缔约方应开展合作，以期:

(a) Identifying living modified organisms or specific traits of living modified organisms that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health; and

(a) 确定可能对生物多样性的保护和可持续使用产生不利影响的改性活生物体或改性活生物体的某些具体特性，同时亦顾及对人类健康构成的风险；和

(b) Taking appropriate measures regarding the treatment of such living modified organisms or specific traits.

(b) 为处理此种改性活生物体或其具体特性采取适当措施。

Article 17

第17条

UNINTENTIONAL TRANSBOUNDARY MOVEMENTS AND EMERGENCY MEASURES

无意中造成的越境转移和应急措施

1. Each Party shall take appropriate measures to notify affected or potentially affected States, the Biosafety Clearing-House and, where appropriate, relevant international organizations, when it knows of an occurrence under its jurisdiction resulting in a release that leads, or may lead, to an unintentional transboundary movement of a living modified organism that is likely to have significant adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health in such States.

1. 每一缔约方均应在获悉已发生下列情况时采取适当措施，向受到影响或可能会受到影响的国家、生物安全资料交换所并酌情向有关的国际组织发出通报：因在其管辖范围内发生的某一事件造成的释放导致了或可能会导致改性活生物体的无意越境转移，从而可能对上述国家内生物多样性的保护和可持续使用产生重大不利影响， 同时亦可能对这些国家的人类健康构成风险。

The notification shall be provided as soon as the Party knows of the above situation.

缔约方应在知悉上述情况时立即发出此种通知。

2. Each Party shall, no later than the date of entry into force of this Protocol for it, make available to the Biosafety Clearing-House the relevant details setting out its point of contact for the purposes of receiving notifications under this Article.

2. 每一缔约方应最迟在本议定书对其生效之日，向生物安全资料交换所提供有关其负责接收根据本条所发通知的联络点的详细情况。

3. Any notification arising from paragraph 1 above, should include:

3. 根据以上第1款发出的任何通知应包括下列内容：

(a) Available relevant information on the estimated quantities and relevant characteristics and/or traits of the living modified organism;

(a) 所涉改性活生物体的估计数量及其相关特性和/或特征的现有相关资料；

(b) Information on the circumstances and estimated date of the release, and on the use of the living modified organism in the originating Party;

(b) 说明发生释放的具体情形和估计的释放日期以及所涉改性活生物体在起源缔约方内的使用情况；

(c) Any available information about the possible adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, as well as available information about possible risk management measures;

(c) 关于可能会对生物多样性的保护和可持续使用产生不利影响和对人类健康构成风险的任何现有资料，以及关于可能采取的风险管理措施的现有资料；

(d) Any other relevant information; and

(d) 任何其他有关资料；

(e) A point of contact for further information.

(e) 可供索取进一步资料的联络点。

4. In order to minimize any significant adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, each Party, under whose jurisdiction the release of the living modified organism referred to in paragraph 1 above, occurs, shall immediately consult the affected or potentially affected States to enable them to determine appropriate responses and initiate necessary action, including emergency measures.

4. 为尽可能减少其对生物多样性的保护和可持续使用的任何重大不利影响，同时亦顾及对人类健康所构成的风险，每一缔约方，如已在其管辖范围内发生以上第1款所述改性活生物体的释放，应立即与受到影响或可能会受到影响的国家进行协商，使它们得以确定适当的应对办法并主动采取必要行动，包括采取各种应急措施。

Article 18

第18条

HANDLING, TRANSPORT, PACKAGING AND IDENTIFICATION

处理、运输、包装和标志

1. In order to avoid adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, each Party shall take necessary measures to require that living modified organisms that are subject to intentional transboundary movement within the scope of this Protocol are handled, packaged and transported under conditions of safety, taking into consideration relevant international rules and standards.

1. 为了避免对生物多样性的保护和可持续使用产生不利影响，同时亦顾及对人类健康构成的风险，每一缔约方应采取必要措施，要求对凡拟作属于本议定书范围内的有意越境转移的改性活生物体，均参照有关的国际规则和标准，在安全条件下予以处理、包装和运输。

2. Each Party shall take measures to require that documentation accompanying:

2. 每一缔约方应采取措施，要求:

(a) Living modified organisms that are intended for direct use as food or feed, or for processing, clearly identifies that they "may contain" living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information.

(a) 拟直接作食物或饲料或加工之用的改性活生物体应附有单据，明确说明其中“可能含有”改性活生物体且不打算有意将其引入环境之中； 并附上供进一步索取信息资料的联络点。

The Conference of the Parties serving as the meeting of the Parties to this Protocol shall take a decision on the detailed requirements for this purpose, including specification of their identity and any unique identification, no later than two years after the date of entry into force of this Protocol;

作为本议定书缔约方会议的缔约方大会应在不迟于本议定书生效后两年就此方面的详细要求、包括对其名称和任何独特标识的具体说明作出决定；

(b) Living modified organisms that are destined for contained use clearly identifies them as living modified organisms; and specifies any requirements for the safe handling, storage, transport and use, the contact point for further information, including the name and address of the individual and institution to whom the living modified organisms are consigned; and

(b) 预定用于封闭性使用的改性活生物体应附有单据，明确将其标明为改性活生物体；并具体说明安全处理、储存、运输和使用的要求，以及供进一步索取信息资料的联络点，包括接收改性活生物体的个人和机构的名称和地址；

(c) Living modified organisms that are intended for intentional introduction into the environment of the Party of import and any other living modified organisms within the scope of the Protocol, clearly identifies them as living modified organisms; specifies the identity and relevant traits and/or characteristics, any requirements for the safe handling, storage, transport and use, the contact point for further information and, as appropriate, the name and address of the importer and exporter; and contains a declaration that the movement is in conformity with the requirements of this Protocol applicable to the exporter.

(c) 拟有意引入进口缔约方的环境的改性活生物体和本议定书范围内的任何其他改性活生物体应附有单据，明确将其标明为改性活生物体；具体说明其名称和特征及相关的特性和/或特点、关于安全处理、储存、运输和使用的任何要求、以及供进一步索取信息资料的联络点，并酌情提供进口者和出口者的详细名称和地址；以及列出关于所涉转移符合本议定书中适用于出口者的规定的声明。

3. The Conference of the Parties serving as the meeting of the Parties to this Protocol shall consider the need for and modalities of developing standards with regard to identification, handling, packaging and transport practices, in consultation with other relevant international bodies.

3. 作为本议定书缔约方会议的缔约方大会应与其他相关的国际机构协商，考虑是否有必要以及以何种方式针对标识、处理、包装和运输诸方面的习惯做法制定标准。

Article 19

第19条

COMPETENT NATIONAL AUTHORITIES AND NATIONAL FOCAL POINTS

国家主管部门和国家联络点

1. Each Party shall designate one national focal point to be responsible on its behalf for liaison with the Secretariat.

1. 每一缔约方应指定一个国家联络点，负责代表缔约方与秘书处进行联系。

Each Party shall also designate one or more competent national authorities, which shall be responsible for performing the administrative functions required by this Protocol and which shall be authorized to act on its behalf with respect to those functions.

每一缔约方还应指定一个或数个国家主管部门，负责行使本议定书所规定的行政职能和按照授权代表缔约方行使此类职能。

A Party may designate a single entity to fulfil the functions of both focal point and competent national authority.

每一缔约方可指定一个单一的实体同时负责履行联络点和国家主管部门这两项职能。

2. Each Party shall, no later than the date of entry into force of this Protocol for it, notify the Secretariat of the names and addresses of its focal point and its competent national authority or authorities.

2. 每一缔约方最迟应于本议定书对其生效之日将其联络点和国家主管部门的名称和地址通报秘书处。

Where a Party designates more than one competent national authority, it shall convey to the Secretariat, with its notification thereof, relevant information on the respective responsibilities of those authorities.

缔约方如果指定了一个以上的国家主管部门，则应将有关这些主管部门各自职责的资料随通知一并送交秘书处。

Where applicable, such information shall, at a minimum, specify which competent authority is responsible for which type of living modified organism.

如果属于此种情况，则此种资料至少应明确说明由哪一主管部门负责何种类别的改性活生物体。

Each Party shall forthwith notify the Secretariat of any changes in the designation of its national focal point or in the name and address or responsibilities of its competent national authority or authorities.

如在其国家联络点的指定方面或在其国家主管部门的名称和地址或职责方面出现任何变更，缔约方应立即就此通知秘书处。

3. The Secretariat shall forthwith inform the Parties of the notifications it receives under paragraph 2 above, and shall also make such information available through the Biosafety Clearing-House.

3. 秘书处应立即向各缔约方通报其根据以上第2款收到的通知，并应通过生物安全资料交换所提供此类信息资料。

Article 20

第20条

INFORMATION SHARING AND THE BIOSAFETY CLEARING-HOUSE

信息交流与生物安全资料交换所

1. A Biosafety Clearing-House is hereby established as part of the clearing-house mechanism under Article 18, paragraph 3, of the Convention, in order to:

1. 兹此建立生物安全资料交换所，作为《公约》第18条第3款所规定的资料交换所机制的一部分，以便：

(a) Facilitate the exchange of scientific, technical, environmental and legal information on, and experience with, living modified organisms; and

(a) 便利交流有关改性活生物体的科学、技术、环境和法律诸方面的信息资料和经验；

(b) Assist Parties to implement the Protocol, taking into account the special needs of developing country Parties, in particular the least developed and small island developing States among them, and countries with economies in transition as well as countries that are centres of origin and centres of genetic diversity.

(b) 协助缔约方履行本议定书，同时顾及各发展中国家缔约方、特别是其中最不发达国家和小岛屿发展中国家、经济转型国家、以及属于起源中心和遗传多样性中心的国家的特殊需要。

2. The Biosafety Clearing-House shall serve as a means through which information is made available for the purposes of paragraph 1 above.

2. 生物安全资料交换所应作为为以上第1款的目的相互交流信息资料的一种手段。

It shall provide access to information made available by the Parties relevant to the implementation of the Protocol.

它应作为连接渠道，提供各缔约方所提交的有关本议定书履行情况的信息资料。

It shall also provide access, where possible, to other international biosafety information exchange mechanisms.

它还应在可能情况下作为连接渠道，接通其他国际生物安全资料交流机制。

3. Without prejudice to the protection of confidential information, each Party shall make available to the Biosafety Clearing-House any information required to be made available to the Biosafety Clearing-House under this Protocol, and:

3. 在不妨碍对机密资料实行保密的情况下，每一缔约方应向生物安全资料交换所提供本议定书要求向生物安全资料交换所提供的任何信息以及下列方面的信息和资料：

(a) Any existing laws, regulations and guidelines for implementation of the Protocol, as well as information required by the Parties for the advance informed agreement procedure;

(a) 为履行本议定书而制订的任何现行法律、条例和准则，以及各缔约方为实施提前知情同意程序而要求提供的信息和资料；

(b) Any bilateral, regional and multilateral agreements and arrangements;

(b) 有关任何双边、区域及多边协定和安排的信息和资料；

(c) Summaries of its risk assessments or environmental reviews of living modified organisms generated by its regulatory process, and carried out in accordance with Article 15, including, where appropriate, relevant information regarding products thereof, namely, processed materials that are of living modified organism origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology;

(c) 在其实行管制过程中根据第15条对改性活生物体进行风险评估或环境审查的结论摘要，其中应酌情包括有关其产品(即源于改性活生物体并经过加工的材料，其中含有凭借现代生物技术获得的可复制性遗传材料的可检测到的新异组合)的资料；

(d) Its final decisions regarding the importation or release of living modified organisms; and

(d) 其针对改性活生物体的进口或释放作出的最终决定；

(e) Reports submitted by it pursuant to Article 33, including those on implementation of the advance informed agreement procedure.

(e) 它依照第33条提交的报告，包括有关提前知情同意程序实施情况的报告。

4. The modalities of the operation of the Biosafety Clearing-House, including reports on its activities, shall be considered and decided upon by the Conference of the Parties serving as the meeting of the Parties to this Protocol at its first meeting, and kept under review thereafter.

4. 作为本议定书缔约方会议的缔约方大会应在其第一次会议上审议并决定生物安全资料交换所的运作方式，包括关于其各项活动的报告，并于其后不断予以审查。

Article 21

第21条

CONFIDENTIAL INFORMATION

机密资料

1. The Party of import shall permit the notifier to identify information submitted under the procedures of this Protocol or required by the Party of import as part of the advance informed agreement procedure of the Protocol that is to be treated as confidential.

1. 进口缔约方应准许发出通知者指明，在按照本议定书的程序所提交的或进口缔约方作为本议定书提前知情同意程序的一部分而要求提交的资料中，应将哪些资料视为机密性资料。

Justification shall be given in such cases upon request.

在指明机密性资料时，应根据要求说明理由。

2. The Party of import shall consult the notifier if it decides that information identified by the notifier as confidential does not qualify for such treatment and shall, prior to any disclosure, inform the notifier of its decision, providing reasons on request, as well as an opportunity for consultation and for an internal review of the decision prior to disclosure.

2. 进口缔约方如果决定，经发出通知者指明为机密性资料的资料不符合机密资料条件，则应就此与发出通知者进行协商，并应在公开有关资料之前将其决定通报发出通知者，同时根据要求说明理由，且在资料予以公开之前提供进行协商和对该决定进行内部审查的机会。

3. Each Party shall protect confidential information received under this Protocol, including any confidential information received in the context of the advance informed agreement procedure of the Protocol.

3. 缔约方应对其根据本议定书收到的机密性资料保密，包括对其在本议定书提前知情同意程序范畴内收到的任何机密资料保密。

Each Party shall ensure that it has procedures to protect such information and shall protect the confidentiality of such information in a manner no less favourable than its treatment of confidential information in connection with domestically produced living modified organisms.

每一缔约方均应确保建立关于对此种资料实行保密的程序，而且对此种资料的保密程度不应低于其对国内制造的改性活生物体的有关机密资料的保密程度。

4. The Party of import shall not use such information for a commercial purpose, except with the written consent of the notifier.

4. 除非发出通知者以书面形式表示同意，否则进口缔约方不得将此种资料用于商业目的。

5. If a notifier withdraws or has withdrawn a notification, the Party of import shall respect the confidentiality of commercial and industrial information, including research and development information as well as information on which the Party and the notifier disagree as to its confidentiality.

5. 如果发出通知者撤回或已经撤回通知，进口缔约方仍应为商业和工业资料保密，其中包括关于研究和研制工作的资料以及该缔约方与发出通知者之间未能对其机密性取得一致看法的那些资料。

6. Without prejudice to paragraph 5 above, the following information shall not be considered confidential:

6. 在不损害以上第5款的情况下，下述资料不得视为机密性资料：

(a) The name and address of the notifier;

(a) 发出通知者的名称和地址；

(b) A general description of the living modified organism or organisms;

(b) 关于改性活生物体的一般性说明；

(c) A summary of the risk assessment of the effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health; and

(c) 关于在顾及对人类健康构成的风险的情况下对生物多样性的保护和可持续使用的影响作出的风险评估结果摘要；以及

(d) Any methods and plans for emergency response.

(d) 任何应急方法和计划。

Article 22

第22条

CAPACITY-BUILDING

能力建设

1. The Parties shall cooperate in the development and/or strengthening of human resources and institutional capacities in biosafety, including biotechnology to the extent that it is required for biosafety, for the purpose of the effective implementation of this Protocol, in developing country Parties, in particular the least developed and small island developing States among them, and in Parties with economies in transition, including through existing global, regional, subregional and national institutions and organizations and, as appropriate, through facilitating private sector involvement.

1. 各缔约方应开展合作，以有效履行本议定书为目的，通过诸如现有的全球、区域、分区域和国家机构和组织和酌情通过促进私人部门的参与等方式，协助发展中国家和经济转型国家缔约方、特别是其中最不发达国家和小岛屿发展中国家逐步建立和/或加强生物安全方面的人力资源和体制能力，包括生物安全所需的生物技术。

2. For the purposes of implementing paragraph 1 above, in relation to cooperation, the needs of developing country Parties, in particular the least developed and small island developing States among them, for financial resources and access to and transfer of technology and know-how in accordance with the relevant provisions of the Convention, shall be taken fully into account for capacity-building in biosafety.

2. 为执行以上第1款的规定，应依照《公约》中的相关条款，在生物安全的能力建设方面充分考虑到各发展中国家缔约方、特别是其中最不发达国家和小岛屿发展中国家对资金以及对获得和转让技术和专门知识的需求。

Cooperation in capacity-building shall, subject to the different situation, capabilities and requirements of each Party, include scientific and technical training in the proper and safe management of biotechnology, and in the use of risk assessment and risk management for biosafety, and the enhancement of technological and institutional capacities in biosafety.

在能力建设方面开展的合作应根据每一缔约方的不同情况、能力和需要进行，包括在对生物技术进行妥善、安全管理方面和为促进生物安全而进行风险评估和风险管理方面提供科学技术培训，并提高生物安全方面的技术和体制能力。

The needs of Parties with economies in transition shall also be taken fully into account for such capacity-building in biosafety.

在此种生物安全能力建设中还应充分考虑到经济转型国家缔约方的需要。

Article 23

第23条

PUBLIC AWARENESS AND PARTICIPATION

公众意识和参与

1. The Parties shall:

1. 缔约方应：

(a) Promote and facilitate public awareness, education and participation concerning the safe transfer, handling and use of living modified organisms in relation to the conservation and sustainable use of biological diversity, taking also into account risks to human health.

(a) 促进和便利开展关于安全转移、处理和使用改性活生物体的公众意识及教育活动和参与，同时顾及对人类健康构成的风险，以利于生物多样性的保护和可持续使用。

In doing so, the Parties shall cooperate, as appropriate, with other States and international bodies;

各缔约方在开展此方面工作时应酌情与其他国家和国际机构开展合作；

(b) Endeavour to ensure that public awareness and education encompass access to information on living modified organisms identified in accordance with this Protocol that may be imported.

(b) 力求确保公众意识和教育活动的内容包括使公众能够获得关于可能进口的、根据本议定书确定的改性活生物体的资料。

2. The Parties shall, in accordance with their respective laws and regulations, consult the public in the decision-making process regarding living modified organisms and shall make the results of such decisions available to the public, while respecting confidential information in accordance with Article 21.

2. 各缔约方应按照其各自的法律和规章，在关于改性活生物体的决策过程中征求公众的意见，并在不违反关于机密资料的第21条的情况下，向公众通报此种决定的结果。

3. Each Party shall endeavour to inform its public about the means of public access to the Biosafety Clearing-House.

3. 每一缔约方应力求使公众知悉可通过何种方式公开获得生物安全资料交换所的信息和资料。

Article 24

第24条

NON-PARTIES

非缔约方

1. Transboundary movements of living modified organisms between Parties and non-Parties shall be consistent with the objective of this Protocol.

1. 缔约方与非缔约方之间进行的改性活生物体的越境转移应符合本议定书的目标。

The Parties may enter into bilateral, regional and multilateral agreements and arrangements with non-Parties regarding such transboundary movements.

各缔约方可与非缔约方订立关于此种越境转移的双边、区域和多边协定及安排。

2. The Parties shall encourage non-Parties to adhere to this Protocol and to contribute appropriate information to the Biosafety Clearing-House on living modified organisms released in, or moved into or out of, areas within their national jurisdictions.

2. 各缔约方应鼓励非缔约方遵守本议定书并向生物安全资料交换所提供改性活生物体在属其国家管辖的地区内释放及其出入情况的相关信息和资料。

Article 25

第25条

ILLEGAL TRANSBOUNDARY MOVEMENTS

非法越境转移

1. Each Party shall adopt appropriate domestic measures aimed at preventing and, if appropriate, penalizing transboundary movements of living modified organisms carried out in contravention of its domestic measures to implement this Protocol.

1. 每一缔约方应在其国内采取适当措施，防止和酌情惩处违反其履行本议定书的国内措施的改性活生物体越境转移。

Such movements shall be deemed illegal transboundary movements.

此种转移应视为非法越境转移。

2. In the case of an illegal transboundary movement, the affected Party may request the Party of origin to dispose, at its own expense, of the living modified organism in question by repatriation or destruction, as appropriate.

2. 在发生非法越境转移事件时，受到影响的缔约方可要求起源缔约方酌情以运回本国或以销毁方式处置有关的改性活生物体，所涉费用自理。

3. Each Party shall make available to the Biosafety Clearing-House information concerning cases of illegal transboundary movements pertaining to it.

3. 每一缔约方应向生物安全资料交换所提供涉及到本国的非法越境转移案件的信息和资料。

Article 26

第26条

SOCIO-ECONOMIC CONSIDERATIONS

社会-经济因素

1. The Parties, in reaching a decision on import under this Protocol or under its domestic measures implementing the Protocol, may take into account, consistent with their international obligations, socio-economic considerations arising from the impact of living modified organisms on the conservation and sustainable use of biological diversity, especially with regard to the value of biological diversity to indigenous and local communities.

1. 缔约方在按照本议定书或按照其履行本议定书的国内措施作出进口决定时，可根据其国际义务，考虑到因改性活生物体对生物多样性的保护和可持续使用的影响而产生的社会-经济因素，特别是涉及到生物多样性对土著和地方社区所具有的价值方面的社会-经济因素。

2. The Parties are encouraged to cooperate on research and information exchange on any socio-economic impacts of living modified organisms, especially on indigenous and local communities.

2. 鼓励各缔约方开展合作，针对改性活生物体所产生的任何社会-经济影响、特别是对土著和当地社区的影响进行研究和交流信息。

Article 27

第27条

LIABILITY AND REDRESS

赔偿责任和补救

The Conference of the Parties serving as the meeting of the Parties to this Protocol shall, at its first meeting, adopt a process with respect to the appropriate elaboration of international rules and procedures in the field of liability and redress for damage resulting from transboundary movements of living modified organisms, analysing and taking due account of the ongoing processes in international law on these matters, and shall endeavour to complete this process within four years.

作为本议定书缔约方会议的缔约方大会应在其第一次会议上发起一个旨在详细拟定适用于因改性活生物体的越境转移而造成损害的赔偿责任和补救方法的国际规则和程序的进程，同时分析和参照目前在国际法领域内就此类事项开展的工作，并争取在四年时间内完成这一进程。

Article 28

第28条

FINANCIAL MECHANISM AND RESOURCES

财务机制和财政资源

1. In considering financial resources for the implementation of this Protocol, the Parties shall take into account the provisions of Article 20 of the Convention.

1. 在考虑履行本议定书所需财政资源时，缔约方应考虑到《公约》第20条的规定。

2. The financial mechanism established in Article 21 of the Convention shall, through the institutional structure entrusted with its operation, be the financial mechanism for this Protocol.

2. 应由受委托负责按照《公约》第21条设立的财务机制的运作的机构充任本议定书的财务机制。

3. Regarding the capacity-building referred to in Article 22 of this Protocol, the Conference of the Parties serving as the meeting of the Parties to this Protocol, in providing guidance with respect to the financial mechanism referred to in paragraph 2 above, for consideration by the Conference of the Parties, shall take into account the need for financial resources by developing country Parties, in particular the least developed and the small island developing States among them.

3. 对于本议定书第22条中所述及的能力建设，作为本议定书缔约方会议的缔约方大会在就以上第2款中提及的财务机制提出指导意见供缔约方大会审议时，应考虑到各发展中国家缔约方、特别是其中最不发达国家和小岛屿发展中国家的对财政资源的需求。

4. In the context of paragraph 1 above, the Parties shall also take into account the needs of the developing country Parties, in particular the least developed and the small island developing States among them, and of the Parties with economies in transition, in their efforts to identify and implement their capacity-building requirements for the purposes of the implementation of this Protocol.

4. 在以上第1款所涉范畴内，各缔约方亦应考虑到各发展中国家缔约方和经济转型国家缔约方、特别是其中最不发达国家和小岛屿发展中国家在为履行本议定书而努力确定和开展能力建设活动方面的各种需要。

5. The guidance to the financial mechanism of the Convention in relevant decisions of the Conference of the Parties, including those agreed before the adoption of this Protocol, shall apply, mutatis mutandis, to the provisions of this Article.

5. 缔约方大会在其各项相关决定、包括在本议定书获得通过之前作出的决定中向《公约》财务机制提供的指导，应在细节上作必要修改后适用于本条的规定。

6. The developed country Parties may also provide, and the developing country Parties and the Parties with economies in transition avail themselves of, financial and technological resources for the implementation of the provisions of this Protocol through bilateral, regional and multilateral channels.

6. 为履行本议定书的条款，发达国家缔约方亦可通过双边、区域和多边渠道提供财政和技术资源，而发展中国家缔约方和经济转型国家缔约方则可利用这些渠道获得财政和技术资源。

Article 29

第29条

CONFERENCE OF THE PARTIES SERVING AS THE MEETING OF THE PARTIES TO THIS PROTOCOL

作为本议定书缔约方会议的缔约方大会

1. The Conference of the Parties shall serve as the meeting of the Parties to this Protocol.

1. 缔约方大会应作为本议定书的缔约方会议。

2. Parties to the Convention that are not Parties to this Protocol may participate as observers in the proceedings of any meeting of the Conference of the Parties serving as the meeting of the Parties to this Protocol.

2. 非本议定书缔约方的《公约》缔约方可作为观察员出席作为本议定书缔约方会议的缔约方大会的任何一次会议。

When the Conference of the Parties serves as the meeting of the Parties to this Protocol, decisions under this Protocol shall be taken only by those that are Parties to it.

在缔约方大会作为本议定书的缔约方会议时，涉及本议定书的决定仅应由本议定书各缔约方作出。

3. When the Conference of the Parties serves as the meeting of the Parties to this Protocol, any member of the bureau of the Conference of the Parties representing a Party to the Convention but, at that time, not a Party to this Protocol, shall be substituted by a member to be elected by and from among the Parties to this Protocol.

3. 在缔约方大会作为本议定书缔约方会议时，主席团中代表届时尚不是本议定书缔约方的《公约》缔约方的任何成员应由本议定书缔约方从议定书各缔约方中另行选举出一名成员予以替代。

4. The Conference of the Parties serving as the meeting of the Parties to this Protocol shall keep under regular review the implementation of this Protocol and shall make, within its mandate, the decisions necessary to promote its effective implementation.

4. 作为本议定书缔约方会议的缔约方大会应定期审查本议定书的履行情况，并应在其任务范围内作出促进其有效履行的必要决定。

It shall perform the functions assigned to it by this Protocol and shall:

它应履行本议定书为其指派的任务并应：

(a) Make recommendations on any matters necessary for the implementation of this Protocol;

(a) 就履行本议定书的任何必要事项提出建议；

(b) Establish such subsidiary bodies as are deemed necessary for the implementation of this Protocol;

(b) 设立它认为属履行本议定书所必需的任何附属机构；

(c) Seek and utilize, where appropriate, the services and cooperation of, and information provided by, competent international organizations and intergovernmental and non-governmental bodies;

(c) 酌情争取和利用有关国际组织及政府间和非政府机构提供的服务、合作和信息；

(d) Establish the form and the intervals for transmitting the information to be submitted in accordance with Article 33 of this Protocol and consider such information as well as reports submitted by any subsidiary body;

(d) 确定应根据本议定书第33条提交资料的形式及间隔时间，并审议由任何附属机构提交的资料和报告；

(e) Consider and adopt, as required, amendments to this Protocol and its annexes, as well as any additional annexes to this Protocol, that are deemed necessary for the implementation of this Protocol; and

(e) 视需要审议并通过它认为属履行本议定书所必需的、对本议定书及其附件提出的修正和本议定书的任何其他增列附件；

(f) Exercise such other functions as may be required for the implementation of this Protocol.

(f) 行使履行本议定书所需的其他职能。

5. The rules of procedure of the Conference of the Parties and financial rules of the Convention shall be applied, mutatis mutandis, under this Protocol, except as may be otherwise decided by consensus by the Conference of the Parties serving as the meeting of the Parties to this Protocol.

5. 除非作为本议定书缔约方会议的缔约方大会以协商一致方式另外作出决定，缔约方大会的议事规则和《公约》的财务细则应在细节上作必要修改后适用于本议定书。

6. The first meeting of the Conference of the Parties serving as the meeting of the Parties to this Protocol shall be convened by the Secretariat in conjunction with the first meeting of the Conference of the Parties that is scheduled after the date of the entry into force of this Protocol.

6. 作为本议定书缔约方会议的缔约方大会第一次会议应由秘书处结合缔约方大会预定于本议定书生效之日后召开的第一次会议召集举行。

Subsequent ordinary meetings of the Conference of the Parties serving as the meeting of the Parties to this Protocol shall be held in conjunction with ordinary meetings of the Conference of the Parties, unless otherwise decided by the Conference of the Parties serving as the meeting of the Parties to this Protocol.

作为本议定书缔约方会议的缔约方大会的其后各次常会应每年结合缔约方大会的常会举行，除非作为本议定书缔约方会议的缔约方大会另有决定。

7. Extraordinary meetings of the Conference of the Parties serving as the meeting of the Parties to this Protocol shall be held at such other times as may be deemed necessary by the Conference of the Parties serving as the meeting of the Parties to this Protocol, or at the written request of any Party, provided that, within six months of the request being communicated to the Parties by the Secretariat, it is supported by at least one third of the Parties.

7. 作为本议定书缔约方会议的缔约方大会的非常会议应于作为本议定书缔约方会议的缔约方大会认为必要的其他时间举行，或根据任何缔约方的书面请求举行，但这一请求须在秘书处向各缔约方作出通报后六个月内获得至少三分之一缔约方的支持。

8. The United Nations, its specialized agencies and the International Atomic Energy Agency, as well as any State member thereof or observers thereto not party to the Convention, may be represented as observers at meetings of the Conference of the Parties serving as the meeting of the Parties to this Protocol.

8. 联合国、其各专门机构和国际原子能机构以及它们的非《公约》缔约方的任何会员国、成员国或观察员皆可作为观察员出席作为本议定书缔约方会议的缔约方大会。

Any body or agency, whether national or international, governmental or non-governmental, that is qualified in matters covered by this Protocol and that has informed the Secretariat of its wish to be represented at a meeting of the Conference of the Parties serving as a meeting of the Parties to this Protocol as an observer, may be so admitted, unless at least one third of the Parties present object.

任何组织或机构，无论是国家或国际、政府或非政府性质的组织或机构，只要在本议定书所涉事项方面具有资格、且已通知秘书处它愿意作为观察员出席作为本议定书缔约方会议的缔约方大会，均可被接纳参加会议，除非至少有三分之一的出席缔约方表示反对。

Except as otherwise provided in this Article, the admission and participation of observers shall be subject to the rules of procedure, as referred to in paragraph 5 above.

除非本条中另有规定，观察员的接纳和参加应遵守以上第5款中述及的议事规则。

Article 30

第30条

SUBSIDIARY BODIES

附属机构

1. Any subsidiary body established by or under the Convention may, upon a decision by the Conference of the Parties serving as the meeting of the Parties to this Protocol, serve the Protocol, in which case the meeting of the Parties shall specify which functions that body shall exercise.

1. 根据《公约》或在《公约》下设立的任何附属机构可依照作为本议定书缔约方会议的缔约方大会作出的决定为本议定书提供服务。 在此种情形中，缔约方会议应明确规定该机构应行使哪些职能。

2. Parties to the Convention that are not Parties to this Protocol may participate as observers in the proceedings of any meeting of any such subsidiary bodies.

2. 非本议定书缔约方的《公约》缔约方可作为观察员出席议定书附属机构的任何会议。

When a subsidiary body of the Convention serves as a subsidiary body to this Protocol, decisions under the Protocol shall be taken only by the Parties to the Protocol.

当《公约》的附属机构作为本议定书的附属机构时，涉及本议定书的决定仅应由本议定书的缔约方作出。

3. When a subsidiary body of the Convention exercises its functions with regard to matters concerning this Protocol, any member of the bureau of that subsidiary body representing a Party to the Convention but, at that time, not a Party to the Protocol, shall be substituted by a member to be elected by and from among the Parties to the Protocol.

3. 当《公约》的附属机构就涉及本议定书的事项行使其职能时，该附属机构主席团中代表届时尚不是本议定书缔约方的《公约》缔约方的任何成员应由本议定书缔约方从议定书各缔约方中另行选举出一名成员予以替代。

Article 31

第31条

SECRETARIAT

秘书处

1. The Secretariat established by Article 24 of the Convention shall serve as the secretariat to this Protocol.

1. 依照《公约》第24条设立的秘书处应作为本议定书的秘书处。

2. Article 24, paragraph 1, of the Convention on the functions of the Secretariat shall apply, mutatis mutandis, to this Protocol.

2. 《公约》中有关秘书处职能的第24条第1款应在细节上作必要修改后适用于本议定书。

3. To the extent that they are distinct, the costs of the secretariat services for this Protocol shall be met by the Parties hereto.

3. 为本议定书提供的秘书处服务所涉费用可分开支付时，此种费用应由本议定书各缔约方予以支付。

The Conference of the Parties serving as the meeting of the Parties to this Protocol shall, at its first meeting, decide on the necessary budgetary arrangements to this end.

作为本议定书缔约方会议的缔约方大会应为此目的在其第一次会议上做出必要的预算安排。

Article 32

第32条

RELATIONSHIP WITH THE CONVENTION

与《公约》的关系

Except as otherwise provided in this Protocol, the provisions of the Convention relating to its protocols shall apply to this Protocol.

除非本议定书另有规定，《公约》中有关其议定书的规定应适用于本议定书。

Article 33

第33条

MONITORING AND REPORTING

监测与汇报

Each Party shall monitor the implementation of its obligations under this Protocol, and shall, at intervals to be determined by the Conference of the Parties serving as the meeting of the Parties to this Protocol, report to the Conference of the Parties serving as the meeting of the Parties to this Protocol on measures that it has taken to implement the Protocol.

每一缔约方应对本议定书为之规定的各项义务的履行情况进行监测，并应按作为本议定书缔约方会议的缔约方大会所确定的时间间隔，就其为履行本议定书所采取的措施向作为本议定书缔约方会议的缔约方大会作出汇报。

Article 34

第34条

COMPLIANCE

遵守

The Conference of the Parties serving as the meeting of the Parties to this Protocol shall, at its first meeting, consider and approve cooperative procedures and institutional mechanisms to promote compliance with the provisions of this Protocol and to address cases of non-compliance.

作为本议定书缔约方会议的缔约方大会应在其第一次会议上审议并核准旨在促进对本议定书各项规定的遵守并对不遵守情事进行处理的合作程序和体制机制。

These procedures and mechanisms shall include provisions to offer advice or assistance, where appropriate.

这些程序和机制应列有酌情提供咨询意见或协助的规定。

They shall be separate from, and without prejudice to, the dispute settlement procedures and mechanisms established by Article 27 of the Convention.

它们应独立于、且不妨碍根据《公约》第27条订立的争端解决程序和机制。

Article 35

第35条

ASSESSMENT AND REVIEW

评估和审查

The Conference of the Parties serving as the meeting of the Parties to this Protocol shall undertake, five years after the entry into force of this Protocol and at least every five years thereafter, an evaluation of the effectiveness of the Protocol, including an assessment of its procedures and annexes.

作为本议定书缔约方会议的缔约方大会应于本议定书生效五年后、且其后至少应每隔五年对其有效性进行评价，其中包括对其程序和附件作出评估。

Article 36

第36条

SIGNATURE

签署

This Protocol shall be open for signature at the United Nations Office at Nairobi by States and regional economic integration organizations from 15 to 26 May 2000, and at United Nations Headquarters in New York from 5 June 2000 to 4 June 2001.

本议定书应自2000年5月15日至26日在联合国内罗毕办事处、并自2000年6月5日至2001年6月4日在纽约联合国总部开放供各国和各区域经济一体化组织签署。

Article 37

第37条

ENTRY INTO FORCE

生效

1. This Protocol shall enter into force on the ninetieth day after the date of deposit of the fiftieth instrument of ratification, acceptance, approval or accession by States or regional economic integration organizations that are Parties to the Convention.

1. 本议定书应自业已成为《公约》缔约方的国家或区域经济一体化组织交存了第五十份批准、接受、核准或加入文书之日后第九十天起生效。

2. This Protocol shall enter into force for a State or regional economic integration organization that ratifies, accepts or approves this Protocol or accedes thereto after its entry into force pursuant to paragraph 1 above, on the ninetieth day after the date on which that State or regional economic integration organization deposits its instrument of ratification, acceptance, approval or accession, or on the date on which the Convention enters into force for that State or regional economic integration organization, whichever shall be the later.

2. 对于在本议定书依照以上第1款生效之后批准、接受或核准或加入本议定书的国家或区域经济一体化组织，本议定书应自该国或该区域经济一体化组织交存其批准、接受、核准或加入文书之日后第九十天起生效，或自《公约》对该国或该区域经济一体化组织生效之日起生效，以两者中较迟者为准。

3. For the purposes of paragraphs 1 and 2 above, any instrument deposited by a regional economic integration organization shall not be counted as additional to those deposited by member States of such organization.

3. 为以上第1和第2款的目的，区域经济一体化组织所交存的任何文书不应视为该组织的成员国所交存文书之外的额外文书。

Article 38

第38条

RESERVATIONS

保留

No reservations may be made to this Protocol.

不得对本议定书作任何保留。

Article 39

第39条

WITHDRAWAL

退出

1. At any time after two years from the date on which this Protocol has entered into force for a Party, that Party may withdraw from the Protocol by giving written notification to the Depositary.

1. 自本议定书对一缔约方生效之日起两年后，该缔约方可随时向保存人发出书面通知，退出本议定书。

2. Any such withdrawal shall take place upon expiry of one year after the date of its receipt by the Depositary, or on such later date as may be specified in the notification of the withdrawal.

2. 任何此种退出均应在保存人收到退出通知之日起一年后生效，或在退出通知中可能指明的一个更晚日期生效。

Article 40

第40条

AUTHENTIC TEXTS

作准文本

The original of this Protocol, of which the Arabic, Chinese, English, French, Russian and Spanish texts are equally authentic, shall be deposited with the Secretary-General of the United Nations.

本议定书的正本应交存于联合国秘书长，其阿拉伯文、中文、英文、法文、俄文和西班牙文文本均同为作准文本。

IN WITNESS WHEREOF the undersigned, being duly authorized to that effect, have signed this Protocol.

下列签署人，经正式授权，在本议定书上签字，以昭信守。

DONE at Montreal on this twenty-ninth day of January, two thousand.

二〇〇〇年一月二十九日订于蒙特利尔。

Annex I

附件一

INFORMATION REQUIRED IN NOTIFICATIONS UNDER ARTICLES 8, 10 AND 13

根据第8、第10和第13条发出通知所需提供的资料

(a) Name, address and contact details of the exporter.

(a) 出口者的名称、地址和详细联络方式。

(b) Name, address and contact details of the importer.

(b) 进口者的名称、地址和详细联络方式。

(c) Name and identity of the living modified organism, as well as the domestic classification, if any, of the biosafety level of the living modified organism in the State of export.

(c) 改性活生物体的名称和标识；如果出口国订有国内改性活生物体生物安全程度分类制度，列出其所属类别。

(d) Intended date or dates of the transboundary movement, if known.

(d) 如已知越境转移的拟定日期，列出这一日期。

(e) Taxonomic status, common name, point of collection or acquisition, and characteristics of recipient organism or parental organisms related to biosafety.

(e) 与生物安全相关的受体生物体或亲本生物体的生物分类状况、通用名称、收集点或获取点及其特性。

(f) Centres of origin and centres of genetic diversity, if known, of the recipient organism and/or the parental organisms and a description of the habitats where the organisms may persist or proliferate.

(f) 如已知受体生物体和/或亲本生物体的起源中心和遗传多样性中心，列出此种中心，并说明有关生物体可赖以存活或增生的各种生境。

(g) Taxonomic status, common name, point of collection or acquisition, and characteristics of the donor organism or organisms related to biosafety.

(g) 与生物安全相关的供体生物体的生物分类状况、通用名称、收集点或获取点及其特性。

(h) Description of the nucleic acid or the modification introduced, the technique used, and the resulting characteristics of the living modified organism.

(h) 介绍说明引入改性活生物体的核酸或改变、所使用的技术其及由此而产生的特性。

(i) Intended use of the living modified organism or products thereof, namely, processed materials that are of living modified organism origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology.

(i) 改性活生物体或其产品（即源于改性活生物体并经过加工的材料，其中含有凭借现代生物技术获得的可复制性遗传材料的可检测到的新异组合）的预定用途。

(j) Quantity or volume of the living modified organism to be transferred.

(j) 拟予转移的改性活生物体的数量或体积。

(k) A previous and existing risk assessment report consistent with Annex III.

(k) 先前和目前根据附件三进行风险评估的报告。

(l) Suggested methods for the safe handling, storage, transport and use, including packaging, labelling, documentation, disposal and contingency procedures, where appropriate.

(l) 建议酌情用于安全处理、储存、运输和使用的方法，其中包括包装、标志、单据、处置和应急程序。

(m) Regulatory status of the living modified organism within the State of export (for example, whether it is prohibited in the State of export, whether there are other restrictions, or whether it has been approved for general release) and, if the living modified organism is banned in the State of export, the reason or reasons for the ban.

(m) 在出口国内对此种改性活生物体实行管制的现状(例如它是否已在出口国被禁止，是否对它实行了其他限制，或是否已核准其作一般性释放)；如果此种改性活生物体已在出口国被禁止，说明予以禁止的理由。

(n) Result and purpose of any notification by the exporter to other States regarding the living modified organism to be transferred.

(n) 出口者就拟予转移的改性活生物体向其他国家发出通知的结果和目的。

(o) A declaration that the above-mentioned information is factually correct.

(o) 有关上述资料内容属实的声明。

Annex II

附件二

INFORMATION REQUIRED CONCERNING LIVING MODIFIED ORGANISMS INTENDED FOR DIRECT USE AS FOOD OR FEED, OR FOR PROCESSING UNDER ARTICLE 11

按照第11条需提供的关于拟直接作食物或饲料或加工 之用的改性活生物体的资料

(a) The name and contact details of the applicant for a decision for domestic use.

(a) 要求就其国内使用事项作出决定的申请者的名称和详细联络方式。

(b) The name and contact details of the authority responsible for the decision.

(b) 负责作出此种决定的主管部门的名称和详细联络方式。

(c) Name and identity of the living modified organism.

(c) 改性活生物体的名称和标识。

(d) Description of the gene modification, the technique used, and the resulting characteristics of the living modified organism.

(d) 关于改性活生物体的基因改变、所采用的技术及其由此而产生的特性的说明。

(e) Any unique identification of the living modified organism.

(e) 改性活生物体的任何独特鉴别方式。

(f) Taxonomic status, common name, point of collection or acquisition, and characteristics of recipient organism or parental organisms related to biosafety.

(f) 与生物安全相关的受体生物体或亲本生物体的生物分类状况、通用名称、收集点或获取点及其特性。

(g) Centres of origin and centres of genetic diversity, if known, of the recipient organism and/or the parental organisms and a description of the habitats where the organisms may persist or proliferate.

(g) 如已知受体生物体和/或亲本生物体的起源中心和遗传多样性中心，列出此种中心，并说明有关生物体可赖以存活或增生的各种生境。

(h) Taxonomic status, common name, point of collection or acquisition, and characteristics of the donor organism or organisms related to biosafety.

(h) 与生物安全相关的供体生物体的生物分类状况、通用名称、收集点或获取点及其特性。

(i) Approved uses of the living modified organism.

(i) 改性活生物体已获核准的用途。

(j) A risk assessment report consistent with Annex III.

(j) 根据附件三编制的风险评估报告。

(k) Suggested methods for the safe handling, storage, transport and use, including packaging, labelling, documentation, disposal and contingency procedures, where appropriate.

(k) 建议酌情用于安全处理、储存、运输和使用的方法， 其中包括包装、标志、单据、处置和应急程序。

Annex III

附件三

RISK ASSESSMENT

风险评估

Objective

目标

1. The objective of risk assessment, under this Protocol, is to identify and evaluate the potential adverse effects of living modified organisms on the conservation and sustainable use of biological diversity in the likely potential receiving environment, taking also into account risks to human health.

1. 本议定书所规定的风险评估的目标是确定和评价改性活生物体在可能的潜在接收环境中对生物多样性的保护和可持续使用产生的不利影响，同时亦顾及对人类健康构成的风险。

Use of risk assessment

风险评估的用途

2. Risk assessment is, inter alia, used by competent authorities to make informed decisions regarding living modified organisms.

2. 风险评估的结果，除其他外，系供主管部门就改性活生物体作出知情决定。

General principles

一般原则

3. Risk assessment should be carried out in a scientifically sound and transparent manner, and can take into account expert advice of, and guidelines developed by, relevant international organizations.

3. 应以科学上合理和透明的方式进行风险评估，并可计及相关的国际组织的专家意见及其所订立的准则。

4. Lack of scientific knowledge or scientific consensus should not necessarily be interpreted as indicating a particular level of risk, an absence of risk, or an acceptable risk.

4. 缺少科学知识或科学共识不应必然地被解释为表明有一定程度的风险、没有风险、或有可以接受的风险。

5. Risks associated with living modified organisms or products thereof, namely, processed materials that are of living modified organism origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology, should be considered in the context of the risks posed by the non-modified recipients or parental organisms in the likely potential receiving environment.

5. 应结合存在于可能的潜在接收环境中的未经改变的受体或亲本生物体所构成的风险来考虑改性活生物体或其产品(即源于改性活生物体并经过加工的材料，其中含有凭借现代生物技术获得的可复制性遗传材料的可检测到的新异组合)所涉及的风险。

6. Risk assessment should be carried out on a case-by-case basis.

6. 风险评估应以具体情况具体处理的方式进行。

The required information may vary in nature and level of detail from case to case, depending on the living modified organism concerned, its intended use and the likely potential receiving environment.

所需资料可能会因所涉改性活生物体、其预定用途和可能的潜在接收环境的不同而在性质和详细程度方面彼此迥异。

Methodology

方法

7. The process of risk assessment may on the one hand give rise to a need for further information about specific subjects, which may be identified and requested during the assessment process, while on the other hand information on other subjects may not be relevant in some instances.

7. 在风险评估进程中一方面可能会需要提供可在评估进程中予以确定和要求提供的关于具体对象的进一步资料；另一方面关于其他对象的资料在某些情况下则可能不相关。

8. To fulfil its objective, risk assessment entails, as appropriate, the following steps:

8. 为实现其目标，有必要在风险评估工作中酌情采取下列步骤:

(a) An identification of any novel genotypic and phenotypic characteristics associated with the living modified organism that may have adverse effects on biological diversity in the likely potential receiving environment, taking also into account risks to human health;

(a) 鉴别与在可能的潜在接收环境中可能会对生物多样性产生不利影响的改性活生物体相关的任何新异基因型和表型性状，同时亦顾及对人类健康构成的风险；

(b) An evaluation of the likelihood of these adverse effects being realized, taking into account the level and kind of exposure of the likely potential receiving environment to the living modified organism;

(b) 在顾及到所涉改性活生物体暴露于可能的潜在接收环境的程度和暴露类型的情况下，评价产生这些不利影响的可能性；

(c) An evaluation of the consequences should these adverse effects be realized;

(c) 评价一旦产生此种不利影响而可能会导致的后果；

(d) An estimation of the overall risk posed by the living modified organism based on the evaluation of the likelihood and consequences of the identified adverse effects being realized;

(d) 根据对所认明的产生不利影响的可能性及其后果进行的评价，估计改性活生物体所构成的总体风险；

(e) A recommendation as to whether or not the risks are acceptable or manageable, including, where necessary, identification of strategies to manage these risks; and

(e) 就所涉风险是否可以接受或可设法加以管理的问题提出建议，包括视需要订立此类风险的管理战略；

(f) Where there is uncertainty regarding the level of risk, it may be addressed by requesting further information on the specific issues of concern or by implementing appropriate risk management strategies and/or monitoring the living modified organism in the receiving environment.

(f) 在风险程度无法确定的情况下，可要求针对令人关注的具体问题提供进一步资料，或采用适宜的风险管理战略和/或在接收环境中对所涉改性活生物体进行监测。

Points to consider

供考虑的要点

9. Depending on the case, risk assessment takes into account the relevant technical and scientific details regarding the characteristics of the following subjects:

9. 风险评估应视具体情况计及与以下诸项的特性相关的详细的科学技术资料:

(a) Recipient organism or parental organisms.

(a) 受体生物体或亲本生物体。

The biological characteristics of the recipient organism or parental organisms, including information on taxonomic status, common name, origin, centres of origin and centres of genetic diversity, if known, and a description of the habitat where the organisms may persist or proliferate;

受体生物体或亲本生物体的生物特性，如有有关生物分类状况、通用名称、起源、起源中心和遗传多样性中心诸方面的资料，应提供此种资料，并附上有关所涉生物体可赖以存活或增生的各种生境的说明；

(b) Donor organism or organisms.

(b) 供体生物体。

Taxonomic status and common name, source, and the relevant biological characteristics of the donor organisms;

供体生物体的生物分类状况和通用名称、来源及有关的生物特性；

(c) Vector.

(c) 媒体。

Characteristics of the vector, including its identity, if any, and its source or origin, and its host range;

媒体的特性，包括其可能的标识及其来源或起源，以及其宿主范围；

(d) Insert or inserts and/or characteristics of modification.

(d) 植入和/或改变的特点。

Genetic characteristics of the inserted nucleic acid and the function it specifies, and/or characteristics of the modification introduced;

所植入的核酸的遗传特性及其特定功能，和/或所引入的改变的特点；

(e) Living modified organism.

(e) 改性活生物体。

Identity of the living modified organism, and the differences between the biological characteristics of the living modified organism and those of the recipient organism or parental organisms;

改性活生物体的标识，以及有关改性活生物体的生物特性与受体生物体或亲本生物体的生物特性之间的差别；

(f) Detection and identification of the living modified organism.

(f) 改性活生物体的发现和鉴别。

Suggested detection and identification methods and their specificity, sensitivity and reliability;

建议采用的发现和鉴别方法及其特殊性、敏感性和可靠性；

(g) Information relating to the intended use.

(g) 与预定用途相关的资料。

Information relating to the intended use of the living modified organism, including new or changed use compared to the recipient organism or parental organisms; and

与改性活生物体的预定用途相关的资料，其中包括与受体生物体或亲本生物体相比属于新的或经改变的用途；

(h) Receiving environment.

(h) 接收环境。

Information on the location, geographical, climatic and ecological characteristics, including relevant information on biological diversity and centres of origin of the likely potential receiving environment.

关于所处位置、地理、气候和生态诸方面特点的资料，其中包括有关可能的潜在接收环境的生物多样性和起源中心的相关资料。