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This English translation of the Act on Regulation of Human Cloning Techniques ( Effective June 6,2001) has been prepared in compliance with the Standard Bilingual Dictionary ( March 2006
edition).
This is an unofficial translation. Only the original Japanese texts of laws and regulations havelegal effect, and the translations are to be used solely as reference material to aid in theunderstanding of Japanese laws and regulations.
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dispute, users should consult the original Japanese texts published in the Official Gazette.

Act on Regulation of Human Cloning Techniques (Act No. 146 of
2000)
Article 1 (Purpose)
The purpose of this Act is, in light of the risk that certain techniques including theCloning Techniques (hereinafter referred to as the “Cloning Techniques, etc.”) among
the techniques for manipulating Embryos or Germ Cells of a human or an Animal
could, depending on the way they are applied, create an individual with the samegene structure as a certain individual (hereinafter referred to as a “Human Clone
Individual”) or an individual which cannot be clearly classified as a human or an
Animal (hereinafter referred to as an “Hybrid Individual”), or artificially create othersimilar individuals, and have a serious influence on the preservation of humandignity, safety for human life and body, and maintenance of public order (hereinafterreferred to as the “Preservation of Human Dignity, etc.”), to prevent creation of
Human Clone Individuals and Hybrid Individuals and to regulate artificial creationof individuals similar to them by means of prohibiting transfer of Embryos producedby the Cloning Techniques or Specified Fusion/Aggregation Techniques among
Cloning Techniques, etc. into a human or Animal uterus, regulating production,
receipt by assignment and import of Embryos created by Cloning Techniques, etc.,
and taking other measures for securing appropriate handling of such Embryos,
thereby ensuring the development of science and technology in harmony with society
and citizens lives.
Article 2 (Definitions)(1) In this Act, the meanings of the terms listed in the following items shall be as-1-

prescribed respectively in those items:(i)Embryo-A cell (except for a Germ Cell) or a cell group which has thepotential to grow into an individual through the process of development in uteroof a human or an Animal and remains at a stage prior to placental formation(ii)

Germ Cell ― A sperm (including a spermatid and a spermatocyte whose

number of chromosomes is equal to the number of chromosomes of the sperm;
the same shall apply hereinafter) and an Unfertilized Egg(iii)

Unfertilized Egg ― An unfertilized ovum and oocyte (limited to an oocyte

whose number of chromosomes is equal to the number of chromosomes of the
ovum)
(iv)

Somatic Cell ― A cell (except for a Germ Cell) taken from an individual(including a dead individual) or a Fetus (including a dead Fetus) belonging to theclass Mammalia, or a cell produced by division of such a cell, excluding an
Embryo or a cell constituting an Embryo(v)

Embryonic Cell ― A cell taken from an Embryo or a cell produced bydivision of such a cell, excluding an Embryo(vi)

Human Fertilized Embryo ― An Embryo produced by fertilization between ahuman Sperm and a human Unfertilized Egg (including each Embryo which is
produced successively by single or multiple splitting of such an Embryo and is
not a Human Split Embryo)(vii)

Fetus ― A cell group lying in utero of a human or an Animal which has thepotential to grow into an individual through the process of development in utero
and has begun formation of a placenta, and which shall include the placenta andother appendages(viii) Human Split Embryo ― An Embryo produced by splitting ex utero of a
Human Fertilized Embryo or a Human Embryonic Nuclear Transfer Embryo(ix)

Human Embryonic Nuclear Transfer Embryo ― An Embryo produced by

Fusion between a Human Enucleated Egg and a Human Fertilized Embryo or
Human Split Embryo at the one-cell stage or an Embryonic Cell with a cell
nucleus of a Human Fertilized Embryo, Human Split Embryo or Human-Human
Chimeric Embryo(x)

Human Somatic Cell Nuclear Transfer Embryo ― An Embryo produced by

Fusion between a Human Enucleated Egg and a human Somatic Cell with a cell
nucleus (including each Embryo produced successively by single or multiple
splitting of such an Embryo)(xi)

Cloning Techniques ― The techniques for producing a Human Somatic

Nuclear Transfer Embryo(xii)

Human-Human

Chimeric Embryo ― Any ofthefollowing Embryos(including each Embryo produced successively by single or multiple splitting ofsuch an Embryo):-2-

(a) An Embryo produced as a result of aggregation of two or more of Human
Fertilized Embryos, Human Split Embryos, Human Embryonic Nuclear
Transfer Embryos or Human Somatic Cell Nuclear Transfer Embryos(including an Embryo produced as a result of aggregation of such an Embryoand either a Human Somatic Cell or an Embryonic Cell of a Human Fertilized
Embryo, Human Split Embryo, Human Embryonic Nuclear Transfer Embryo
or Human Somatic Cell Nuclear Transfer Embryo)(b) An Embryo produced as a result of aggregation of a Human Fertilized
Embryo, Human Split Embryo, Human Embryonic Nuclear Transfer Embryo,or Human Somatic Cell Nuclear Transfer Embryo and either a human Somatic
Cell or an Embryonic Cell of a Human Fertilized Embryo, Human Split
Embryo, Human Embryonic Nuclear Transfer Embryo or Human Somatic Cell
Nuclear Transfer Embryo(xiii) Human-Animal Hybrid Embryo ― Any of the following Embryos (including
each Embryo produced successively by single or multiple splitting of such an
Embryo):(a) An Embryo produced by fertilization between a human Germ Cell and an
Animal Germ Cell(b) An Embryo produced by Fusion between a human or Animal Enucleated Egg
and an Embryo at the one-cell stage described in (a) or an Embryonic Cell witha cell nucleus of an Embryo described in (a)(xiv)

Human-Animal Clone Embryo ― Any of the following Embryos (including

each Embryo produced successively by single or multiple splitting of such an
Embryo):(a) An Embryo produced by Fusion between an Animal Enucleated Egg andeither a human Somatic Cell or a Human Fertilized Embryo, Human Split
Embryo, Human Embryonic Nuclear Transfer Embryo or Human Somatic Cell
Nuclear Transfer Embryo at the one-cell stage or an Embryonic Cell with acell nucleus of a Human Fertilized Embryo, Human Split Embryo, Human
Embryonic Nuclear Transfer Embryo, Human Somatic Cell Nuclear Transfer
Embryo or Human-Human Chimeric Embryo(b) An Embryo produced by Fusion between a Human Enucleated Egg and an
Embryo at the one-cell stage described in (a) or an Embryonic Cell with a cell
nucleus of an Embryo described in (a)(xv)

Human-Animal Chimeric Embryo ― Any of the following Embryos which is

not a Human-Human Chimeric Embryo, Animal Embryo or Animal-Human
Chimeric Embryo (including each Embryo produced successively by single ormultiple splitting of such an Embryo):(a) An Embryo produced as a result of aggregation of two or more Embryos(including an Embryo produced as a result of aggregation of such an Embryo-3-and a Somatic or Embryonic Cell)(b) An Embryo produced as a result of aggregation of an Embryo and a Somaticor Embryonic Cell(c) An Embryo produced by Fusion between an Embryonic Cell with a cell
nucleus of an Embryo listed in (a) or (b) and a human or Animal Enucleated
Egg
(xvi)

Specified Fusion/Aggregation

Human-Animal

HybridTechniques ― Techniques

Embryo,Human-Animal

to

Clone

produce a
Embryoor

Human-Animal Chimeric Embryo(xvii) Animal ― An individual except for a Human belonging to the class
Mammalia(xviii) Animal Embryo ― Any of the following Embryos (including each Embryo
produced successively by single or multiple splitting of such an Embryo):(a) An Embryo produced by fertilization between an Animal sperm and an
Animal Unfertilized Egg(b) An Embryo produced by Fusion between an Animal Enucleated Egg andeither an Animal Somatic Cell or an Embryo at the one-cell stage described in(a) or an Embryonic Cell with a cell nucleus of an Embryo described in (a)(c) An Embryo produced as a result of aggregation of two or more Embryos listedin (a) or (b) (including an Embryo produced as a result of aggregation of suchan Embryo and either an Animal Somatic Cell or an Embryonic Cell of an
Embryo listed in (a) or (b))(d) An Embryo produced as a result of aggregation of an Embryo listed in (a) or(b) and either an Animal Somatic Cell or an Embryonic Cell of an Embryo
listed in (a) or (b)(xix)

Animal-Human Clone Embryo ― Any of the following Embryos (including

each Embryo produced successively by single or multiple splitting of such an
Embryo):(a) An Embryo produced by Fusion between a Human Enucleated Egg and either
an Animal Somatic Cell or an Animal Embryo at the one-cell stage or an
Embryonic Cell with a cell nucleus of an Animal Embryo(b) An Embryo produced by Fusion between an Animal Enucleated Egg andeither an Embryo at the one-cell stage described in (a) or an Embryonic Cellwith a cell nucleus of an Embryo described in (a)(xx)

Animal-Human

Chimeric

Embryo ― Any ofthefollowing Embryos(including each Embryo produced successively by single or multiple splitting ofsuch an Embryo):(a) An Embryo produced as a result of aggregation of two or more
Animal-Human Clone Embryos (including an Embryo produced as a result of
aggregation of such an Embryo and a Somatic or Embryonic Cell)-4-(b) An Embryo produced as a result of aggregation of one or more
Animal-Human Clone Embryos and one or more Animal Embryos or Somaticor Embryonic Cells(c) An Embryo produced as a result of aggregation of one or more Animal
Embryos and Human Somatic Cells or Embryonic Cells of a Human Fertilized
Embryo, Human Split Embryo, Human Embryonic Nuclear Transfer Embryo,
Human Somatic Cell Nuclear Transfer Embryo, Human-Human Chimeric
Embryo, Human-Animal Hybrid Embryo, Human-Animal Clone Embryo,
Human-Animal Chimeric Embryo or Animal-Human Clone Embryo (including
an Embryo produced as a result of aggregation of such an Embryo and either
an Animal Somatic Cell or an Embryonic Cell of an Animal Embryo)(d) An Embryo produced by Fusion between a Human or Animal Enucleated Egg
and an Embryonic Cell with a cell nucleus of an Embryo listed in (a) to (c)inclusive(xxi)

Fusion ― Production of a single cell through combination of more than one

cell without fertilization, which includes transfer of the nucleus of a single cell toanother enucleated cell(xxii) Enucleation ― Removal of the nucleus from a cell or destruction of thenucleus of a cell(xxiii) Human Enucleated Egg ― An enucleated human Unfertilized Egg or an
enucleated Human Fertilized Embryo or Human Split Embryo at the one-cell
stage(xxiv) Animal Enucleated Egg ― An enucleated Animal Unfertilized Egg or an
enucleated Animal Embryo at the one-cell stage(2) With regard to application of the provisions shown in Column A of the following
table, an Embryo or cell shown in Column B of the same table shall be regarded as
an Embryo or cell shown in Column C of the same table which is mentioned in thesaid provisions.
Column A

Column B(i)

Article 2(1)(viii)

Human Split Embryo(ii)

Article 2(1)(ix)

Human

Embryonic

Column C
Human Fertilized Embryo
Nuclear Human Fertilized Embryo

Transfer Embryo(iii)

Article 2(1)(x)Human Somatic Cell Nuclear Human Somatic Cell
Tran sferEm bryoattheone-cell stage, or Embryonic
Cell of a Human Somatic Cell
Nuclear Transfer Embryo(iv)

Article2(1)(xii) E m b r y o n i c(a) and (b)CellHuman-Human

-5-

of

a Embryonic

C h i m e r i c Human

Cell

Somatic

of

a

Cell

Embryo(v)

Nuclear Transfer Embryo

Article 2(1)(xiii) Human-Animal Hybrid Embryo Embryo described in (a)
(b)

(vi)
(vii)

Article 2(1)(xiv) Human-Animal Clone Embryo

HumanSomatic

Cell(a)

Nuclear Transfer Embryo

Article 2(1)(xiv) Human-Animal Clone Embryo

Embryo described in (a)(b)(viii) A r t i c l e

Animal Embryo

Embryo described in (a)2(1)(xviii)(b)(ix)

ArticleEmbryonic Cell of an Animal Embryonic2(1)(xviii)(c) and Embryo

Cell

of

an

Embryo described in (a)

(d)
(x)

Article 2(1)(xix) Animal-Human Clone Embryo

Animal Embryo

(a)
(xi)

Article 2(1)(xix) Animal-Human Clone Embryo

Embryo described in (a)

(b)
(xii)

ArticleEmbryonic

Cell

2(1)(xx)(c)Animal-Humanof

a n Embryonic

Cell

of

an

C h i m e r i c Animal Embryo

Embryo(xiii) Article 2(1)(xxiii) Human

Embryonic

Nuclear Human Fertilized Embryo

Transfer Embryo or Human
Somatic Cell Nuclear Transfer
Embryo(xiv) Article 2(1)(xxiv) H u m a n - A n i m a l

H y b r i d Animal Embryo

Embryo, Human-Animal Clone
EmbryoorAnimal-Human

Clone Embryo
Article 3 (Prohibited acts)
No person shall transfer a Human Somatic Cell Nuclear Transfer Embryo,
Human-Animal Hybrid Embryo, Human-Animal Clone Embryo or Human-Animal
Chimeric Embryo into a human or Animal uterus.
Article 4 (Guidelines)(1) The Minister of Education, Culture, Sports, Science and Technology (hereinafterreferred to as the “Minister”) shall, in light of the risk that a Human Split Embryo,
Human Embryonic Nuclear Transfer Embryo, Human Somatic Cell Nuclear
Transfer Embryo, Human-Human Chimeric Embryo, Human-Animal Hybrid
Embryo, Human-Animal

Clone Embryo,

Human-Animal

Chimeric Embryo,

Animal-Human Clone Embryo or Animal-Human Chimeric Embryo (hereinafter-6-referred to as a “Specified Embryo”) could, when transferred into a human orAnimal uterus, develop into a Human Clone Individual or Hybrid Individual or anindividual that has a similar influence on the Preservation of Human Dignity, etc.,
establish guidelines on the handling of Specified Embryos (hereinafter referred toas the “Guidelines”) while taking into consideration scientific knowledge related tothe clarification of the phenomenon of life, in order to secure appropriate
production, receipt by assignment or import and subsequent handling of Specified
Embryos (hereinafter referred to as the “Handling of Specified Embryos”).
(2) The Guidelines shall prescribe the following matters:(i)

Matters concerning the requirement of consent by the donor of the Embryos
or cells necessary for production of a Specified Embryo and other requirements
for allowable production of Specified Embryos(ii)

In addition to what is listed in the preceding item, matters concerning therequirements for allowable Handling of Specified Embryos(iii)

In addition to what is listed in the preceding two items, procedures andother matters to be considered in the Handling of Specified Embryos(3) When the Minister intends to establish or change the Guidelines, he or she shallconsult the heads of the relevant administrative organs and hear the opinions of
the Council for Science and Technology Policy in advance.
(4)

When the Minister establishes or changes the Guidelines, he or she shallannounce such establishment or change without delay.
Article 5 (Compliance obligation)
The Handling of Specified Embryos shall be conducted in accordance with the
Guidelines.
Article 6 (Notification of production, receipt by assignment or import of Specified
Embryo)(1) A person who intends to produce, receive by assignment or import a Specified
Embryo shall notify the following matters to the Minister pursuant to theprovisions of an Ordinance of the Ministry of Education, Culture, Sports, Scienceand Technology (hereinafter referred to as an “Ordinance of MEXT”):(i)

The name and domicile and, in the case of a juridical person, the name of its
representative(ii)

The type of the Embryo to be produced, to be received by assignment, or to

be imported(iii)

The purpose of production, receipt by assignment or import and, in the caseof production, its method(iv)

The scheduled date of production, receipt by assignment or import

-7-

(v)

The method of the handling after the production, receipt by assignment orimport(vi)

In addition to what is listed in the preceding items, matters specified by an

Ordinance of MEXT
(2)

If a person who has made the notification under the preceding paragraphintends to change any matters pertaining to the notification, he or she shall notify
such change to the Minister pursuant to the provisions of an Ordinance of MEXT.
Article 7 (Order to change or abolish the plan, etc)
(1) Where the notification under paragraph 1 or 2 of the preceding Article has been
made, if the Minister finds that the Handling of the Specified Embryo pertaining to
the notification does not conform to the Guidelines, he or she may, within sixty
days from the date of acceptance of the notification, order the person who hasmade the notification to change or abolish the plan concerning the method of thesaid Handling of the Specified Embryo or to take other necessary measures.
(2)

If the Minister finds that the contents of the matters pertaining to thenotification under paragraph 1 or 2 of the preceding Article are reasonable, he or
she may shorten the period prescribed in the preceding paragraph. In this case, theMinister shall give notice of the shortened period to the person who has made thenotification, without delay.
Article 8 (Limitation on execution)
A person who has made the notification under Article 6, paragraph 1 or 2 shall not
produce, receive by assignment or import the Specified Embryo pertaining to thenotification, or change any matters pertaining to the notification until sixty days (ifthe notice under the second sentence of paragraph 2 of the preceding Article has been
served, the period pertaining to the notice) have passed from the date of acceptanceof the notification.
Article 9 (Notification of production of Specified Embryo by chance cause)
A person who has made the notification under Article 6, paragraph 1 shall, in thecase the Specified Embryo pertaining to the notification has produced a different typeof Specified Embryo by a chance cause, promptly notify the following matters to the
Minister pursuant to the provisions of an Ordinance of MEXT; provided, however,that this shall not apply to the case where such produced Specified Embryo isimmediately disposed of:(i)

The name and domicile and, in the case of a juridical person, the name of its
representative(ii)

The type of the produced Embryo(iii)

The date of the production

-8-

(vi)

In addition to what is listed in the preceding three items, matters specified

by an Ordinance of MEXT
Article 10 (Record)(1)

A person who has made the notification under Article 6, paragraph 1 or thepreceding Article shall make a record of the following matters with regard to theSpecified Embryo pertaining to the notification, pursuant to an Ordinance of
MEXT:
(i)

The type of the Embryo which has been produced, received by assignment orimported(ii)

The date of production, receipt by assignment or import(iii)

The process of the handling after production, receipt by assignment orimport(iv)

In addition to what is listed in the preceding three items, matters specified

by an Ordinance of MEXT
(2) The record prescribed in the preceding paragraph shall be preserved pursuant to
the provisions of an Ordinance of MEXT.
Article 11 (Notification of assignment, etc. of Specified Embryo)
A person who has made the notification under Article 6, paragraph 1 or Article 9
shall, in the case he or she has assigned, exported, destroyed or disposed of theSpecified Embryo pertaining to the notification, notify the following matters to the
Minister without delay, pursuant to the provisions of an Ordinance of MEXT:(i)

The name and domicile and, in the case of a juridical person, the name of its
representative(ii)

The type of the Embryo which has been assigned, exported, destroyed or

disposed of(iii)

The date of the assignment, export, destruction or disposal and, in the caseof destruction or disposal, the manner of destruction or disposal(iv)

In addition to what is listed in the preceding three items, matters specified

by an Ordinance of MEXT
Article 12 (Order to take measures with regard to the Handling of Specified Embryo)
If the Minister finds that the Handling of a Specified Embryo by a person who hasmade the notification under Article 6, paragraph 1 or Article 9 does not conform to
the Guidelines, he or she may order the person who has made the notification to
discontinue or improve the method of the Handling of the Specified Embryo or totake other necessary measures.
Article 13 (Protection of personal information)-9-

A person who has made the notification under Article 6, paragraph 1 or Article 9
shall endeavor to take necessary measures for the prevention of leakage of Personal
Information (information about an individual, which can identify the specificindividual by name, date of birth or other description contained in such information[including information that can be compared with other information and thereby
identify the specific individual]; hereinafter the same shall apply in this Article) of
the donor of the Embryos or cells used for producing the Specified Embryo pertaining
to the notification, and for the proper management of the Personal Information.
Article 14 (Collection of report)
The Minister may, within the limit necessary for enforcement of this Act, ask aperson who has made the notification under Article 6, paragraph 1 or Article 9 toreport on the state of the Handling of the Specified Embryo pertaining to thenotification and of other necessary matters.
Article 15 (Entry and Inspection)(1) The Minister may, within the limit necessary for enforcement of this Act, haveofficials of the ministry enter the office or research facility of a person who hasmade the notification under Article 6, paragraph 1 or Article 9, inspect documents
and other necessary materials of the said person, and ask questions of the persons
concerned.
(2) When an official enters the office or research facility pursuant to the provisionsof the preceding paragraph, he or she shall carry a certificate for identification andproduce it upon request of the persons concerned.
(3) The authority under paragraph 1 shall not be construed as that approved for the
purpose of criminal investigation.
Article 16 (Penal Provisions)
A person who has violated the provisions of Article 3 shall be punished by
imprisonment with work for not more than ten years or a fine of not more than ten
million yen, or both.
Article 17
A person who falls under any of the following items shall be punished by
imprisonment with work for not more than one year or a fine of not more than one
million yen:(i)A person who has, without making the notification under Article 6,paragraph 1 or by making false notification, produced, received by assignment orimported a Specified Embryo(ii)

A person who has, without making the notification under Article 6,- 10 -

paragraph 2 or by making false notification, changed the matters prescribed in
the same paragraph(iii)

A person who has violated the order prescribed in Article 7, paragraph 1(iv)

A person who has violated the order prescribed in Article 12

Article 18
A person who has violated the provisions of Article 8 shall be punished by
imprisonment with work for not more than six months or a fine of not more than five
hundred thousand yen.
Article 19
A person who falls under any of the following items shall be punished by a fine of
not more than five hundred thousand yen:(i)A person who has failed to make the notification under Article 9 or has
made false notification(ii)

A person who has failed to make the record under Article 10, paragraph 1 or

has made a false record(iii)

A person who has violated the provisions of Article 10, paragraph 2(iv)

A person who has failed to make the notification under Article 11 or has

made false notification(v)

A person who has failed to make the report under Article 14 or has made a

false report(vi)

A person who has defied, obstructed or evaded the entry or inspection, or

has failed to make a statement or has made a false statement in response to thequestion under Article 15, paragraph 1
Article 20
When the representative of a juridical person, or an agent, employee or otherworker of a juridical person or individual has committed an act in violation of theprovisions from Article 16 to the preceding Article inclusive with regard to thebusiness of said juridical person or individual, not only the offender shall be punished
but also said juridical person or individual shall be punished by the fine prescribed in
the respective Articles.
Supplementary Provisions
Article 1 (Effective Date)
This Act shall come into force as from the day on which six months from the day of
promulgation have elapsed; provided, however, that the following provisions shallcome into force as from the date described in each item:- 11 -

(i)The provisions of Article 4, paragraph 3 of this Act and Article 3 of the
Supplementary Provisions ― the day of promulgation(ii)

The provisions of Article 4, paragraphs 1, 2 and 4, from Articles 5 to 15

inclusive, from Articles 17 to 19 inclusive and Article 20 (limited to the portion
pertaining to Articles 17 to 19 inclusive) of this Act ― the date specified by a
Cabinet Order within a period not exceeding one year from the day of
promulgation
Article 2 (Review)
The Government shall, within three years of enforcement of this Act, review theprovisions of this Act based on the results of study by the Council for Science andTechnology Policy and others on how Human Fertilized Embryos should be handled
as the emerging potential of human life, while taking into consideration the state ofenforcement of this Act and changes in the circumstances surrounding the Cloning
Techniques, etc., and take necessary measures based on the results of the review.
Article 3 (Transitional measures)With regard to application of the provisions of Article 4, paragraph 3, during theperiod from the day of promulgation of this Act until the day before the effective date
(January 6, 2001) of the Act for Partial Revision of the Cabinet Act (Act No. 88 of
1999), the term “Minister of Education, Culture, Sports, Science and Technology” inthe same paragraph shall be deemed to be replaced with “Prime Minister,” and theterm “Council for Science and Technology Policy” shall be deemed to be replaced with“Council for Science and Technology”.
Article 4 (Partial revision of the Act for Punishment of Organized Crimes, Control of
Crime Proceeds and Other Matters)
A part of the Act for Punishment of Organized Crimes, Control of Crime Proceeds
and Other Matters (Act No. 136 of 1999) shall be revised as follows.
The following item shall be added to the appended table:lxi

An offense prescribed in Article 16 (Transfer of a Human Somatic Clone

Embryo or other Specified Embryo into a human or Animal uterus) of the Act on
Regulation of Human Cloning Techniques, etc. (Act No. 146 of 2000)- 12 -