に関しての補足説明資料(服部メンバー提出資料)(PDF:381KB)

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資料2
ᇹ‫ׅ‬ᠾᕤႇ᥵Сࡇটᛩ˟
Ტßφ˳ႎᛯໜàƴ᧙ƠƯƷᙀឱᛟଢ᝻૰Უ
࠯঺࠰உଐ
஌ᢿ ήᨺ
2
zß
ß᫢‫ۀܤ‬᛽բ᳸‫إܫ‬ԓᅆàƷᛢ᫆
3
᫢‫ۀܤ‬ǁƷ᛽բƷᆔ᫏
క ˑ
᪮᛽բ zૼᙹ҄ӳཋ
zᢘဇਘ‫ٻ‬
zǤȳȝȸȈȈȬȩȳ
ǹဎᛪ
zᮄʼ᫏အᎹሁƷؕ
แ͌ᚨ‫ܭ‬
᪮᛽բ z୤‫ؕܭ‬แᚨ‫ܭ‬ᠾᕤƷ
ᚸ̖
ͳ ᎋ
ǿǤȠǯȭȃǯС
ࡇƕᚨ‫ܭ‬ƞǕƯƓ
ǓŴß᛽բ᳸ሉ
ဎàLJưƷ஖᧓Ƹ
࠰᧓
ᲢˬƠŴဎᛪᎍƷdzȡ
ȳȈ‫ࣖݣ‬஖᧓ƸᨊƘᲣ
ǿǤȠǯȭȃǯС
ࡇƸᚨ‫ܭ‬ƞǕƯƍ
Ƴƍ
4
ß᫢‫ۀܤ‬᛽բ᳸‫إܫ‬ԓᅆàƷ්Ǖ
ĭ
‫ܤ‬
‫ۀ‬
961ᡫ‫إ‬
ෞ ᝲ ᎍ ࠻
ң
ᜭ
ඥ
ˋ
৖
ዓ
Ɩ
‫ܫ‬
‫إ‬
ԓ
᫢ Լ ᘓ ဃ
Ў ᅹ ˟
ᅆ
ဎ
ȑȖdzȡ
ሉ
ᕤ
᫢
‫ݙ‬
ᠾ
ᕤ
ȷ
ѣ
ཋ
ᕤ
ᢿ
˟
Ĭ
բ
᛽
ĭ
‫ۀ‬
‫ݦ‬
Ĭ ᧉ Ĭ
ᛦ
௹
˟
ᢿ
˟
‫ ݦ‬ĭ
ᧉ
ᛦ
௹ Ĭ
˟
࠴
ʙ
˟
᫢
‫ܤ‬
᫢
Լ
‫ܤ‬
μ
‫ۀ‬
Ճ
˟
Į
Į
᫢
᫢‫ۀܤ‬᛽բ᳸
ą Ĭ ᢿ˟ச‫ݙ‬ᜭдƷ‫ئ‬ӳ ß᫢‫ۀܤ‬ሉဎàЭƴȑȖdzȡܱ଀
᫢‫ۀܤ‬ሉဎ
ĭ ଏƴᚸ̖୿ƕ˺঺ƞǕƯƍǔƕŴᡙьư൒ࣱᚾ᬴঺ጚƕ੩ЈƞǕƯƍ
ǔ‫ئ‬ӳ Į സသᚾ᬴঺ጚƷLjƕ੩ЈƞǕƯƍǔ‫ئ‬ӳ
5
‫ݙ‬ᜭ᫁ࡇ
᧏͵᫁ࡇሁ
ᠾᕤ‫ᧉݦ‬ᛦ௹˟ z ᢿ˟ưನ঺
z ؕஜᲴᠾᕤᢿ˟உ
ᚸ̖ᢿ˟
z ӳᚘᲴᠾᕤஉ
ᠾᕤ‫ᧉݦ‬ᛦ௹˟ z ᢿ˟‫ݙ‬ᜭኽௐŴૼƨƳ൒ࣱᚾ᬴঺ጚ੩Ј
ᠾᕤŴᚸ̖୿ᚸ̖дᲢ‫׎‬ϋưႇ᥵ƷƳƍ
࠴ʙ˟
୤‫ؕܭ‬แᚨ‫ܭ‬ᠾᕤᲣሁƴƭƍƯᚸ̖
᫢Լ‫ܤ‬μ‫ۀ‬Ճ˟
z ؕஜᲴ‫͵᧏ׅ‬உ
z ࠴ʙ˟ᚸ̖ኽௐŴȑȖdzȡኽௐሁƴƭƍƯ
ᚸ̖
z ᢘဇਘ‫ٻ‬Ტ˺ཋസသᚾ᬴঺ጚƷLjƕૼƨƴ
੩ЈᲣƷᚸ̖
᫢‫ۀܤ‬ư#&+ᚨ‫ܭ‬ฎLjƷᠾᕤƷ#4H&ƸŴƲƷെ᨞ư
ᚸ̖ƢǔƷƔᲹ
6
ᚸ̖ཞඞ
ሉဎƞǕƨᠾᕤૠᲤ
࠰ ࠰ ࠰
Ძ᪮᛽բకˑᲝ
ᢿ˟Ɣǒ‫ݙ‬ᜭ
࠴ʙ˟Ɣǒ‫ݙ‬ᜭ
᫢‫ۀܤ‬ƷLjư‫ݙ‬ᜭ
Წ᪮᛽բకˑ
ᲤӷɟଐƴီƳǔకˑưᙐૠሉဎƞǕƯƍǔ‫ئ‬ӳƸßᲫàƱƠƯǫǦȳȈŵ
Ო᪮᛽բకˑƴƭƍƯNjӷ଺ƴ᛽բƞǕƯƍǔ‫ئ‬ӳǛԃljŵ
ᲞßɟਙЪᨊàƓǑƼßཎ‫ܭ‬ᠾᕤàƸԃLJƳƍŵ
7
zß
ß‫إܫ‬ԓᅆ᳸ؕแ͌‫୼٭‬àLJưƷ
ᛢ᫆
8
ß‫إܫ‬ԓᅆ᳸ؕแ͌‫୼٭‬àƷ஖᧓
ဎ
ȵஉ
1᳸2
ȵஉ
ኖ1࠰Ფ
4᳸5
ȵஉ
ᕤ
᫢
‫ݙ‬
ᢿ
˟
‫ݙ‬
ᜭ
6᳸7
ȵஉ
‫ܫ‬
‫إ‬
ԓ
ᅆ
6ȵஉ
Ფ᫢‫ۀܤ‬ᢿ˟‫ݙ‬ᜭ1‫ׅ‬Ʊˎ‫ܭ‬
ؕ
แ
͌
Ъ
ᨊ
጑
‫ݱ‬
#4H&੩క
4᳸5
ȵஉ
᫢
‫ܤ‬
‫ۀ‬
ሉ
ဎ
ᢿ
˟
‫ݙ‬
ᜭ
᫢
‫ܤ‬
‫ۀ‬
᛽
բ
ᛪ
6᳸8
ஜ
Ⴞ
ǁ
᝻
૰
ᡛ
˄
ᛢ ᫆
z ૼƨƳസသؕแ଀ᘍࢸŴ᫢ԼᘓဃඥᢌӒᲢസသؕแ͌
ឬᢅᲣǛਔƘƓƦǕ
Ტᙲ‫׆‬Უ
9ᠾᕤƷ̅ဇ଺஖Ʊ˺ཋƷӓᆫ଺஖ƷᨠƨǓ
9ᠾငཋь߻ԼƷᧈ஖᧓්ᡫ
9
ß‫إܫ‬ԓᅆ᳸ؕแ͌‫୼٭‬àƷ஖᧓
'7
ҾЩᲫ࠰ᲢˬƠŴவˑƴǑƬƯƸஇ‫࠰ٻ‬LJưࡨᧈӧᲣ
Article 15 Inclusion of new or modified MRLs in Annexes II and III
Where a temporary MRL is set as provided for in paragraph 1(b), it shall be deleted from
Annex
III by a Regulation one year after the date of the inclusion or noninclusion in Annex I to
Directive 91/414/EEC of the active substance concerned, in accordance with the procedure
referred to in Article 45(2) of this Regulation. However, where one or more Member States so
request,
it may be maintained for an additional year pending confirmation that any scientific
studies necessary for supporting an application for setting a MRL have been undertaken. In
where such confirmation is provided, the temporary MRL shall be maintained for a
cases
further two years, provided that no unacceptable safety concerns for the consumer have
been identified.
75# ᠾᕤƕ̅ဇƞǕƨ଺ໜưᢘඥƴ̅ဇƞǕƯƍǔᨂǓŴ
්ᡫ଺ƴ/4.ƕ‫ݱ‬ƞƘƳƬƯƓǓឬᢅƠƯNjբ᫆Ƴƍ
the channels of trade provision of the FD&C Act addresses the circumstances under which
a food is not unsafe solely due to the presence of a residue from a pesticide chemical for
which the tolerance has been revoked, suspended, or modified by EPA. The channels of
trade provision (section 408(l)(5) of the FD&C Act) states that food containing a residue of
such a pesticide shall not be deemed ``adulterated'' by virtue of the residue, if the residue is
within the former tolerance, and the responsible party can demonstrate to FDA's satisfaction
that the residue is present as the result of an application of the pesticide at a time and in a
manner which were lawful under FIFRA.
http://www.gpo.gov/fdsys/pkg/FR-2014-06-03/html/2014-12819.htm
ଐஜ
ؕแ͌Ǜɦ૾̲ദƢǔ‫ئ‬ӳŴ‫إܫ‬ԓᅆǫஉࢸƴ଀ᘍ
10
z࣯
ࣱ࣯୧ᩧᚸ̖ƷᎋƑ૾
11
ᕤʙȷ᫢Լᘓဃ‫ݙ‬ᜭ˟᫢ԼᘓဃЎᅹ˟ᠾᕤȷѣཋဇҔᕤԼᢿ˟᝻૰Ტ᧏͵Უ
12
zઅ
અӕ᣽ƴ᧙Ƣǔȇȸǿ
ҽဃі΁ᅹ‫ܖ‬ᄂᆮᝲᙀя᣿ ᫢ԼƷ‫࣎ܤ‬ȷ‫ܤ‬μᄩ̬ਖ਼ᡶᄂᆮʙಅ Ტ*࠰ࡇƔǒ৷ቦᲣ
13
zᚸ
ᚸ̖‫ݣ‬ᝋ
μՃᲢബˌɥᲣ࠷‫ݱ‬δᲢ᳸ബᲣ
z഑቟ሁƴƓƍƯŴႆဃ൒ࣱᚾ᬴ᲢᏒδ
ǁƷࢨ᪪ᲣǛఌਗƴ#4H&ƕᚨ‫ܭ‬ƞǕ
Ưƍǔ‫ئ‬ӳŴßɟᑍ‫ک‬ငۡàƷᆔ᫏
ƕᚨ‫ܭ‬ƞǕƯƍǔƜƱƕƋǓLJƢ
ଐஜƴƓƍƯႆဃ൒ࣱᚾ᬴Ǜఌਗƴ
#4H&ƕᚨ‫ܭ‬ƞǕƨ‫ئ‬ӳŴ
¾ଐஜƴƓƍƯNjᆔ᫏ᚨ‫ܭ‬ƞǕǔǂƖư
ƸƳƍƔᲹ
¾અӕ᣽ƱƠƯ‫ک‬ငۡƕ࣏ᙲưƸƳƍƔᲹ
14
୧ᩧᚸ̖‫ݣ‬ᝋᎍ
ᧈ஖୧ᩧᚸ̖
,/24
)GPGTCNRQRWNCVKQP
'7
MI#FWNV
75
z)GPGTCNRQRWNCVKQP
z+PHCPVU
z%JKNFTGP
z;QWVJ
z#FWNVU
z(GOCNGU
z‫׎‬ൟ࠯‫ר‬
z᭗ᱫᎍᲢബˌɥᲣ
z‫ک‬ငۡ
z‫ݱ‬δᲢ᳸ബᲣ
ଐஜ
ჺ஖୧ᩧᚸ̖
z ;QWPIEJKNFTGP
z 9QOCPQH
EJKNFDGCTKPICIG
z )GPGTCNRQRWNCVKQP
z 6QFFNGTU
z 9QOCPQHEJKNF
DGCTKPIRQVGPVKCN
z #FWNVQHIGPGTCN
RQRWNCVKQP
z)GPGTCNRQRWNCVKQP
z+PHCPVU
z%JKNFTGP
z;QWVJ
z#FWNVU
z(GOCNGU
zμՃᲢബˌɥᲣ
z࠷‫ݱ‬δᲢ᳸ബᲣ
15
z᫢
᫢ԼɶƷᠾᕤസသᙹСƴƭƍƯ
16
ᧈ஖୧ᩧᚸ̖ƴƓƚǔ᫢ԼЎ᫏
ᧈ஖୧ᩧᚸ̖ƴƓƚǔ᫢ԼЎ᫏Ƹؕஜႎƴ
̾К˺ཋǛ‫ݣ‬ᝋƱƠƯƍǔƕŴɟᢿƷ˺ཋ
ƴƓƍƯƸßƦƷ˂ƷŨŨàƱƠƯЎ᫏
ؕแ͌௒Ӹ
ᛆ࢘˺ཋӸ
ƦƷ˂ƷǢȖȩȊᅹ᣼ᓔ ƨƔƳŴᓔᑶŴƠǖƳŴƸƳƬƜǓȸŴ
ƻǖƠLJƳ ˂
ƦƷ˂ƷȦȪᅹ᣼ᓔ ǒƬƖǐƏŴƴǜƴƘƷᑻȷᒚŴǏǓƶ ˂
ƦƷ˂ƤǓᅹ᣼ᓔ
ƤǓŴƋƠƨƹ ˂
ƦƷ˂ƷƳƢᅹ᣼ᓔ ƱƏƕǒƠŴƠƠƱƏŴȏȐȍȭŴȑȗȪǫ ˂
ƦƷ˂ƏǓᅹ᣼ᓔ
ƱƏƕǜŴƴƕƏǓŴǁƪLJŴ๱ཋဇƢƍƔ ˂
ƦƷ˂Ʒ᣼ᓔ
ƣƍƖŴǕǜƜǜŴNjǍƠŴƦǒᝃᲢဃᲣŴ
ச঺༌ƦǒᝃŴƨǒƷᑻ ˂
ƦƷ˂ƷƔǜƖƭ
ƖǜƔǜŴdžǜƔǜŴǏƣŴƍǑƔǜŴƔDžƢŴ
ƢƩƪ ˂
ƦƷ˂Ʒௐܱ
ƍƪơƘŴƋƚƼŴǪȪȸȖ ˂
ហ‫܌‬Ჴࣱ࣯୧ᩧᚸ̖ƴƓƚǔे‫ܭ‬ᚸ̖‫ݣ‬ᝋ˺ཋŴ໋ᑥᲴ‫ݣ‬ᝋ‫ٳ‬
17
ᛢ᫆Ĭ ᧈ஖୧ᩧƱჺ஖୧ᩧᚸ̖ƴƓƚǔᚸ̖‫ݣ‬ᝋ
˺ཋƷᎋƑ૾
ཎƴŴßƦƷ˂Ʒ᣼ᓔàƴƓƍƯƸŴ˺ཋ൑ƷസသͼӼǛLJƬƨƘ
ᎋॾƠƯƍƳƍƨNJŴᢅйƳؕแ͌ƕᚨ‫ܭ‬ƞǕƯƍǔ‫ئ‬ӳƕƋǔŵ
‫׎‬ϋႇ᥵
ßƣƍƖᲢƞƱƍNjᲢᓶ௡ᲣᲣàŴßǕǜƜǜàưႇ᥵
ƣƍƖ
ǕǜƜǜ
#‫ئב‬
$‫ئב‬
‫׎‬ᨥෙ‫ؕٳ‬แ ǹǤǹȁȣȸȉᲢRROᲣ
ƣƍƖ
ǕǜƜǜ
ǹǤǹȁȣȸȉ
ƦƷ˂ȇȸǿƷƳƍ˺ཋ
ྵཞƷؕแ͌
ᲢRROᲣ
Ჯ
˺സȇȸǿƔǒ
ؕแ͌ᲢRROᲣ
Ჭ
Ჯ
Ტ̊ᲴNjǍƠŴƦǒᝃᲢဃᲣᲣ
18
ᛢ᫆ĭ ǰȫȸȗႇ᥵ǛƓƜƳƬƯƍǔ‫ئ‬ӳƷؕแ
͌ᚨ‫ܭ‬ƷᎋƑ૾
z ß᩼ኽྶǢȖȩȊᅹᓶᓔ᫏àưႇ᥵ƱƳƬƯƍǔ‫ئ‬ӳ
ƜLJƭƳ
LjƣƳ
ȁȳDzȳǵǤ
DZȸȫŴƦƷ˂ᴉᴤᴶ
ᴯᴝᅹ᣼ᓔ
ƜLJƭƳ
LjƣƳ
ȁȳDzȳǵǤ
DZȸȫŴƨƔƳ
#‫ئב‬
Ყ
ྵཞƷؕแ͌
ᚨ‫૾ܭ‬ඥ
Ჭ
Ჯ
$‫ئב‬
Ყ
૾Ӽࣱ
᩼ኽྶǢȖȩȊᅹᓶᓔ᫏ưႇ᥵ƢǔƨNJƷ˺ཋą
ƜLJƭƳŴLjƣƳƓǑƼ࢘ᛆ˺ཋ፭Ʒ˺ཋ
1'%&%CNEWNCVQTưᚘምƠƨኽௐ