유럽연합의 승인된 식품첨가물 재평가프로그램 규칙
κഃೞ೫
ᮁᩑ⧊(European Union: EU)᮹ ᮁ᮹⫭
(European Parliament: EP)᪡ ᯕᔍ⫭(Council) ۵ EUᬕᩢ᳑᧞(Treaty on the Functioning of the European Union: TFEU) ᱽ᳑(Ǎ EC
᳑᧞ ᱽ᳑)ᨱ Ḳ⧪᭥ᬱ⫭(European
Commission)a ᱽᦩ⦹Ł, Ğᱽᔍ⫭᭥ᬱ⫭
(Economic and Social Committee)a ᯱྙ᮹č
ᮥ ᱽ⦹ᩍ ษಉࡽ ‘⣩℉aྜྷᨱ š⦽ ☖⧊
Ƚ⊺’)ᮥ TFEU ᱽ᳑(Ǎ EC᳑᧞ ᱽ᳑) ᮹ ᱩ₉ᨱ ₥┾⦹ᩡᮝ໑, ᯕ ☖⧊Ƚ⊺ᮡ
֥ ᝁȽ ᱽᱶࡽ ᯕ⬥ ₉ಡᨱ Ùℱ
֥)ŝ ֥)ᨱ }ᱶࡹᨕ ᝅ⧪ࡹŁ ᯩ݅. ə ญŁ ၵಽ ᯕ ☖⧊Ƚ⊺ ᱽ᳑ᨱ EU ԕ
ᨱᕽ᮹ ‘ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ
Ƚ⊺’)ᯕ ֥ᨱ ₥┾ࡹᨕ ֥ ᬵ ᯝ ᯕᱥᨱ ᯕၙ ᰍ⠪aࡽ ⣩℉aྜྷ, ֥
ᬵ ᯝʭḡ əญŁ ֥ ᬵ ᯝʭḡ ᰍ
⠪aࡹᨕ ⧁ ⣩℉aྜྷᨱ š⦹ᩍ ᖙᇥ⦹ᩍ ℕĥᱢᮝಽ Ƚᮉ⦹Ł ᯩ݅. ᰆᯕ ⦹ӹಽ ☖
⧊ࡽ ᔢ⫊ᨱᕽ EU۵ ⣩℉aྜྷᨱ š⦽ ᔍᬊ
⨩a᪡ ᰍ⠪aᨱ ᝍ⩩ᮥ ʑᬙᯕŁ ᯩ۵ ⩶ᔢ ᯕ݅. ྜྷು EU ⣩℉aྜྷ᮹ ᖁᱶᨱ š⦽ ᭥
⧕ᖒ ⠪a᪡ ⣩℉aྜྷŝ qၙഭ ॒᮹ ᯙ ŝ šಉࡽ ᔍ⧎ᮡ ֥ ₥┾ࡽ ᗭ᭥ ‘⣩℉
aྜྷᨱ š⦽ Ŗ࠺⨩aᱩ₉ Ƚ⊺’)ᨱ ᮹⧕ ᙹ⧪
ࡽ݅. ᦥ௹ᨱᕽ۵ ֥ʭḡ ᰍ⠪aࢁ ᇡᗮ ᕽ ⳑŝ Ⳓ(Annex ⳑ & Annex Ⳓ)ᔢ᮹ ⣩
℉aྜྷ᮹ ᳦ඹෝ ӹᩕ⦹ʑ ᅕ݅۵ ‘ᯙࡽ
) Regulation //EC of the European Parliament and of the Council on food additives (OJ L /).
) Commission Regulation //EU (OJ L /).
) Commission Regulation //EU (OJ L /); Commission Regulation //EU (OJ L /); Commission Regulation //EU (OJ L /).
) Commission Regulation //EU of March setting up a programme for the re-evaluation of approved food additives in accordance with Regulation //EC of the European Parliament and of the Council on food additives (OJ L /).
) Regulation //EC OF the European Parliament and of the Council establishing a common authorization procedure for food additives, food enzymes and food flavourings (OJ L /).
⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺’ᔢ᮹ ⣩℉a
ྜྷ ᰍ⠪a ᱩ₉ᔢ᮹ ԕᬊᮥ ჶᱢ ⊂໕ᨱᕽ ᇥ ᕾ⦹Łᯱ ⦽݅.
λလ഼କྭ๖
କߌਐඨੲୢ &'4"ଭୀࢂ
EU۵ ‘⣩℉aྜྷᨱ š⦽ ☖⧊Ƚ⊺’ / ᱽ᳑ᨱ ᯙࡽ ⣩℉aྜྷ ᰍ⠪
a⥥ಽəఉ Ƚ⊺ᮥ ₥┾⧁ ⦥a ᯩᨩ݅. ᯕ ᨱ Ḳ⧪᭥ᬱ⫭۵ EUᨱᕽ ⣩ᦩᱥᨱ š⦽ ᮁ
⣩ᦩᱥℎ(European Food Safety Author- ity: EFSA)᮹ ᯱྙᮥ Ñℱ šಉ ჶᦩᮥ ᔢᱶ⦹
ᩡŁ,) ֥ ᬵ ᯝ ᮁ᮹⫭(EP)᪡ ᯕᔍ
⫭۵ ‘ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ
⊺’ //EUᮥ ₥┾⦹ᩡ݅.
୍ඌԧ۩ঃଭુ
əߑ ⣩ ‘ᔪᔢ(food colours)’᮹ ᰍ⠪a ۵ ᯕၙ ᬑᖁᙽ᭥ಽ ຝᱡ ᯲ࡽ ၵ ᯩ݅. ᯕ
్⦽ ⣩℉aྜྷᮡ ⣩ŝ⦺᭥ᬱ⫭(Scientific
Committee on Food: SCF))ᨱ ᮹⦽ aᰆ ᪅௹
ࡽ ⠪aᯕʑ ভྙᨱ ✚ᱶ ᔪᔢ᮹ ᰍ⠪a۵ ᯕ
ၙ ᪥ഭࡽ ᔢ┽ᯕ݅.) ੱ⦽ E Nisin, E - Para-hydroxybenzoates᪡ zᮡ ⣩℉aྜྷ
ॅᮡ ‘ᔩಽᬕ ŝ⦺ᱢ ᯱഭ’a Ǎࡹᨩʑ ভྙ
ᨱ ֥ ᯕᱥᨱ ᙹ ֥ ࠺ᦩ ᰍ⠪a ࡹᨩ݅.
ᕽ đŝᱢᮝಽ ᯕॅ ℉aᱽ۵ ᰍ⠪a⧁ ⦥
a ᨧí ࡹᨩ݅.)
୍ඌԧট০ড୨ଭଵࢱୡ׆ஜ
qၙഭ(sweeteners)᮹ Ğᬑᨱ۵ aᰆ ↽ɝ ᨱ ᮁ⣩ᦩᱥℎ(EFSA)ᨱ ᮹⧕ ⠪aࡹᨩᮭ
ᮥ qᦩ⦹ᩍ ้ ษḡสᮝಽ ᰍ⠪aࡹࠥಾ Ƚ ᱶ⦹ᩡ݅.) ᩍʑᨱᕽ ᬑญ۵ ⣩℉aྜྷᨱ ݡ
⦽ ᰍ⠪aa ֥ʭḡ ᪥ഭࢁ äᮝಽ ᩩᔢ
ࡹ۵ ၵ, EUᨱᕽ᮹ ⣩℉aྜྷᨱ ݡ⦽ ᰍ⠪a ۵ ↽ᗭ⦽ ֥ᮥ ᵝʑಽ ᰍ⠪aࡹŁ ᯩᮭᮥ
ᙹ ᯩ݅.
əญŁ ᯙࡽ ⣩℉aྜྷ᮹ ᰍ⠪aෝ ᭥⦽
ᬑᖁᙽ᭥۵ ݅ᮭ᮹ ‘ʑᵡ’ᨱ ᖅᱶࡽ݅.
ⴗ ⣩ŝ⦺᭥ᬱ⫭(SCF) ੱ۵ ᮁ⣩ᦩᱥℎ (EFSA)᮹ ⣩℉aྜྷᨱ ݡ⦽ ↽᳦⠪aᱱᮝ ಽᇡ░᮹ ‘ᔩಽᬕ ŝ⦺ᱢ ɝÑ᮹ a܆ᖒ’, əญ
) ʡࢱᙹ, 「EU⣩ჶ」 (❭ᵝ: ⦽ǎ⦺ᚁᱶᅕ, ), ~໕ ₙ᳑.
) Bernd van der Meulen/Menno van der Velde, European Food Law (Wageningen: Wageningen Academic Publishers, ), pp. ~ ₙ᳑.
) E Tartrazine, E Quinoline Yellow, E Sunset Yellow FCF, E Ponceau R, E Allura Red AC, E Carmoisine, E D lycopeneᮥ ั⦽݅.
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱥྙ ().
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱥྙ ().
Ł ⴘ ֥ ‘EU᮹ ⣩℉aྜྷ ᖎ≉ᨱ š⦽
Ḳ⧪᭥ᬱ⫭᮹ ᅕŁᕽ(Report from the Com- mission on Dietary Food Additive Intake in the EU)’)ᨱ ᮹⦽ ⣩℉aྜྷ᮹ ‘ᔍᬊ ᱶࠥ’᪡
‘ᯙℕי⇽(human exposure)᮹ ᱶࠥ’ᨱ
ᖅᱶࡽ݅. ᇢᮁ bഭᯕᔍ⫭(Nordic Council of Ministers)a ᱽ⇽⦽ ‘ᮁ ֥ ⣩℉a
ྜྷ(Report Food Additives in Europe )’)
ᮡ ᰍ⠪a᮹ ᬑᖁᙽ᭥ෝ ᭥⦽ ⇵aᱢ ੱ۵ ᅕ
∊ᱢᯙ ᱶᅕෝ ᱽŖ⦽݅.)
ுෘฎଭ૬ށۀକߌਐඨੲୢ
&'4"ୀ఼ࢳଭଭ୍ඌԧ
‘⬉ᮉᖒ(efficiency)’ŝ ‘ᝅᱽᱢᯙ ༊ᱢ(prac- tical purposes)’ᮥ ᭥⧕ a܆⦽ ⦽ ᰍ⠪a۵ ə
ॅᯕ ᗮ⦽ ᵝ ʑ܆ᄥ ॒ɪ(ᇡᗮᕽ ⳑ, Ⳓ)ᨱ
⧕ݚ ⣩℉aྜྷ᮹ ə൚ᨱ ᮹⧕ ᙹ⧪ࡹᨕ
⦽݅. ə్ӹ อ᧞ ‘ᔩಽᬕ ᷾Ñ’ᨱ ᮹⧕ ᯙ e᮹ Õv ੱ۵ ᨕਅ ⩶┽ಽु ⣩℉aྜྷ᮹ ᦩᱥᖒ ⠪aᨱ ᩢ⨆ᮥ ᵝ۵ ĞᬑŁ ᱢࡹ۵ Ğᬑᨱ۵ Ḳ⧪᭥ᬱ⫭᮹ ‘ℎ’ᨱ ᮹⦹ᩍ ੱ۵
ᮁ⣩ᦩᱥℎ(ESFA)᮹ ‘ᯱℕ ၽ᮹’ᨱ ᮹⧕
ᮁ⣩ᦩᱥℎᯕ ᙹ⧪⦹ᩍ ⦽݅.) ᩍʑᕽ
ั⦹۵ ⬉ᮉᖒŝ ᝅᱽᱢᯙ ༊ᱢᯕ ᯕၙ ᯙ
ࡽ ⣩℉aྜྷॅᨱ ݡ⦽ ᰍ⠪a᮹ Ğᬑᨱ۵ š ಉ ⫭ᬱǎ, ʑ┡ Ḳ݉, ⣩ᦩᱥʑš, ᮁ᮹⫭
(EP)ӹ ᯕᔍ⫭᮹ ⩲᳑a ⦥⦹݅. ੱ⦽ ᰍ⠪
a eᯕ ฯᯕ ᗭࡹʑ ভྙᨱ šಉ ᱶᅕӹ
⇵a ᱶᅕℎᨱ ᯩᨕᕽ ᝁᗮ⦽ ⩲ಆᯕ Ǎࢁ
ᙹၷᨱ ᨧ݅. ᮁ⣩ᦩᱥℎ(EFSA)ᮡ Ḳ⧪᭥
ᬱ⫭ᨱ ‘ŝ⦺ᱢ č⧕’ෝ ᱽ⦹۵ ‘ᯱྙ ʑǍ’
ಽᕽ᮹ ᩎ⧁ᮥ ᙹ⧪⦹Ł ᯩʑ ভྙᨱ, อ᧞ ‘ᔩ ಽᬕ ŝ⦺ᱢ ᷾Ñ’)a ӹ┡ӹ໕ Ḳ⧪᭥ᬱ⫭᮹
ℎᯕӹ ᮁ⣩ᦩᱥℎ(ESFA)ᯕ wŁ ᯩ۵
‘᭥⧕ᖒ ⠪a(risk assessment)’۵ ᯱℕ ǭ⦽
ᮥ ☖⧕ ᯕ్⦽ ⣩℉aྜྷᨱ ݡ⧕ᕽ ᰍ⠪aෝ
ᝅ⧁ ᙹ ᯩ݅۵ ᮹ၙᯕ݅.
୍ඌԧଭ׆ࢫ࣡լ
⣩℉aྜྷ ᰍ⠪a᮹ ʑ⦽(deadlines)ᮡ ᇡᗮ ᕽ Iŝ ᇡᗮᕽ IIᨱ ʑᰍࡽ ᬑᖁᙽ᭥ᨱ ᖅ ᱶࡹ໑, ‘ᱶݚᖒ’ᯕ ᯙᱶࡹ۵ Ğᬑᨱ۵ ⣩℉
aྜྷᨱ ݡ⦽ ᰍ⠪aa ḡᩑࢁ ᙹ ᯩ݅.) əญ Ł ‘ᔍᦩᯕ ၽᔾ⦹۵ Ğᬑ’ᨱ ੱ۵ ‘ᰍ⠪a᮹ ᝅ⧪ᮥ ᬱอ⦹í’ ⦹ʑ ᭥⦹ᩍ ✚ᱶ }ᄥ ⣩
℉aྜྷ ੱ۵ ⣩℉aྜྷ ə൚ᨱ ݡ⦽ ᰍ⠪a
) COM() final.
) Food Additives in Europe , EUԕ ᯙࡽ ⣩℉aྜྷᨱ ݡ⦽ ᦩᱥᖒ⠪a ⩥⫊, Nordic Council of Ministers, TemaNord :.
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱥྙ ().
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱥྙ ().
) van der Meulen/van der Velde, supra note , p. . ) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱥྙ ().
ʑ⦽᮹ ᖅᱶᮡ ၙ௹ᨱ ᖅᱶࢁ ᙹࠥ ᯩ݅.) ᷪ ⴗ ᰍ⠪a᮹ ‘ᬱอ⦽ ḥ⧪’ ੱ۵ ⴘ ⩥ᰍ ⣩
ᦩᱥᖒ᮹ ᭥⧕ᖒ ⠪aᨱᕽ ऽ్ӽ ‘ᝁ᳦ ᭥⧕
ᗭ’a ၽᔾ⦽ Ğᬑᨱ ᯕ్⦽ ᗭෝ aḥ
⣩℉aྜྷᨱ ݡ⦽ Ǎℕᱢᯙ ᰍ⠪aෝ ᭥⦽ ʑ⦽
᮹ Ğᬑ ฯᮡ eᯕ ᗭࢁ ᙹ ᯩᮭᮥ ᮹
ၙ⦽݅.
୍ඌԧୣఙւߛୀ߹୪վଭண૬ নԳ
‘⬉ŝᱢᯙ’ ᰍ⠪aᱩ₉ෝ ᭥⦹ᩍ ᮁ⣩
ᦩᱥℎ(EFSA)ᯕ ᰍ⠪a šಉ ᯕ⧕šĥᯱॅ᮹
‘༉ु ᯱഭॅ’ᮥ ⫮ा⦹۵ äᮡ ๅᬑ ᵲ⦹
݅. ੱ⦽ ‘⇵aᱢᯙ ᯱഭ’a ⣩℉aྜྷ᮹ ᰍ
⠪a ᪥ഭᨱ ⦥⦽ Ğᬑᨱ šಉ ᯕ⧕šĥᯱॅ
ᨱí۵ ‘ᔍᱥ ☖ᅕ’ࡹᨕ ⦽݅.) ᕽ ⣩
℉aྜྷ ᯙ᮹ ᮁḡ(continuity)ᨱ šᝍᯕ ᯩ۵ ᔍᨦᯱ۵ ⣩℉aྜྷ ᰍ⠪a᪡ šಉࡽ ༉ु ᯱ ഭ(data)ෝ ᱽ⇽⧕ ⦹໑, ᔍᨦᯱ۵ a܆⦽ ⦽ ᱥℕᱢᯙ ᱶᅕ(information collectively)ෝ ᱽŖ
⧕ ⦽݅.) əญŁ ᮁ⣩ᦩᱥℎ(EFSA)ᮡ
ᰍ⠪a⧁ ༉ु ⣩℉aྜྷᨱ ݡ⦽ ᯱഭෝ ⦹ӹ ᯕᔢ Ŗ}⧕ ⦽݅. ⣩℉aྜྷᨱ ݡ⦽ ʑᚁ
ᱢ ၰ ŝ⦺ᱢᯙ ᱶᅕ۵ ᰍ⠪aᨱ ⦥ᙹᱢᯕŁ,
✚⯩ ⣩℉aྜྷᨱ šಉࡽ ‘ࠦᖒᯱഭ’᪡ ‘ᯙℕ י⇽’ᯕ ⇵ᱶࡹ۵ ᯱഭ۵ ᱽࡽ ʑ⦽ ԕᨱ ᮁ
⣩ᦩᱥℎ(EFSA)᮹ ᯕ⧕šĥᯱᨱí ᱽ⇽
ࡹᨕ ⦽݅.)
ᮁ⣩ᦩᱥℎ(EFSA)ᨱ ᮹⧕ ᰍ⠪aࢁ
⣩℉aྜྷᮡ ᯕᱥᨱ۵ Ḳ⧪᭥ᬱ⫭ ᔑ⦹ ⣩ŝ
⦺᭥ᬱ⫭(SCF)ᨱ ᮹⧕ ᦩᱥᖒᯕ ⠪aࡹᨕ ᪵
݅. ᕽ ə ᰍ⠪aෝ ᭥⧕ ᱽ⇽ࡹ۵ ᱶᅕ ۵ ⣩℉aྜྷᨱ ݡ⦽ ʑ᳕᮹ ⠪aᨱ ʑⅩ⦽
‘ʑ᳕ ߑᯕ░’ෝ ⡍⧉⧕ ⦽݅. ੱ⦽ ⣩℉
aྜྷᨱ ݡ⦽ ‘ᔩಽᬕ ᯱഭ’۵ ⣩ŝ⦺᭥ᬱ⫭
(SCF)᮹ ษḡส ⠪a ᯕ⬥ಽ ⠪aa a܆⧕Ჭ Ł, ᯕ ᔩಽᬕ ᱶᅕ۵ ᮁ⣩ᦩᱥℎ(ESFA) ᯕ ᰍ⠪aෝ ᪥ഭ⦹ᩍ ↽ᝁ᮹ ᮹čᮥ ⩶ᖒ⧁
ᙹ ᯩࠥಾ ⦹ʑ ᭥⧕ a܆⦽ ⡍ťᱢᮝಽ ᱽŖ
ࡹᨕ ⦽݅. əญŁ ⣩℉aྜྷ ᰍ⠪aෝ ᭥
⧕ ᯕ్⦽ ᱶᅕ۵ a܆⦽ ჵ᭥ᨱᕽ ⧕ݚḡ⋉ᕽ (֥ ᬵ ᯝ ⣩ŝ⦺᭥ᬱ⫭(SCF)᮹
⣩℉aྜྷ⠪aෝ ᭥⦽ ᯱഭᱽ⇽ ḡ⋉ᕽ))ᨱ
ᱽ⇽ࡹᨕ ⦽݅.)
ᮁ⣩ᦩᱥℎ(EFSA)ᮡ ⣩℉aྜྷ᮹ ᰍ
⠪aෝ ᪥ഭ⦹ʑ ᭥⧕ ⇵aᱢᯙ ᱶᅕෝ Ǎ⧁
ᙹ ᯩ݅. ᯕ Ğᬑ ᮁ⣩ᦩᱥℎ(EFSA)ᮡ ᯱ
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱥྙ ().
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱥྙ ().
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱥྙ ().
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱥྙ ().
) Guidance on submission for food additive evaluations by the Scientific Committee on Food. Opinion expressed on July . SCF/CS/ADD/GEN/ final.
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱥྙ ().
ഭᨱ ݡ⦽ ⴗ ‘Ŗ}༉Ḳ’ ੱ۵ ⴘ ⣩℉aྜྷ
ᨱ ݡ⦽ ‘ߑᯕ░ෝ ᱽ⇽⦽ ݚᔍᯱ’ᨱí ᩑ⦹
ᩍ ᳬᮡ eᨱ ⦥⦽ ߑᯕ░ෝ ℎ⧕ ⦽
݅. ᯕ⧕ šĥᯱ۵ ᱶ⧕ḥ ʑe ԕᨱ ℎࡽ ᱶ ᅕෝ ᱽ⇽⧕ ⦹۵ߑ, ə ʑeᮡ ᯕ⧕šĥᯱ
᮹ č⧕ෝ Łಅ⦹ᩍ ᮁ⣩ᦩᱥℎ(EFSA)ᨱ ᮹⧕ ᱶ⧕ḥ݅.) ੱ⦽ ⣩℉aྜྷᨱ š⦽ ☖
⧊Ƚ⊺ //ECᯕ ⣩℉aྜྷᨱ ݡ⦽
ᯙ ‘⪹Ğᱢ ᯙ(environmental factors)’
ᮥ Łಅ⧕ ⦽݅Ł Ƚᱶ⦹Ł ᯩʑ ভྙᨱ ᯕ
⧕šĥᯱ۵ ⣩℉aྜྷ᮹ ᰍ⠪a ℕĥᨱᕽ
⣩℉aྜྷ᮹ ‘ᔾᔑ(production), ᔍᬊ(use), ⠱ʑ
(waste)’ಽᇡ░᮹ ⪹Ğᱢ ᭥⧕ᖒ(environmen-
tal risks)ŝ šಉࡽ äᯕ໕, ᨕਅ ᱶᅕु Ḳ
⧪᭥ᬱ⫭᪡ ᮁ⣩ᦩᱥℎ(EFSA)ᨱ ☖ḡ⧕
⦽݅.)
⦽⠙ ✚ᱶ ⣩℉aྜྷ᮹ ᰍ⠪a᮹ ᪥ഭᨱ ⦥
⦹ᩍ ‘ℎࡽ ᱶᅕ’a ᱽŖࡹḡ ᦫ۵ Ğᬑ,
⣩℉aྜྷᮡ EU᮹ ᯙࡽ ⣩℉aྜྷ ༊ಾ
ᨱᕽ ᔎᱽࢁ ᙹ ᯩࠥಾ ⦹ᩍ,) ⣩℉aྜྷ ᰍ
⠪a šಉ ᯱഭ᮹ ᱽŖ᮹ ᵲᖒᮥ v᳑⦹Ł
ᯩ݅. ⣩℉aྜྷ᮹ ᰍ⠪a ᱩ₉۵ ‘⚍ᖒ
(transparency)’ ᯩí ᯕ⧪ࡹᨕ ⦹Ł, ✚ᱶ ‘ ᱶᅕ᮹ ʑၡᖒ’ᮥ ᅕᰆ⦹۵ Ğᬑa ᦥܭ ᯕ ᔢ ‘ŖŖᱶᅕ Õ(public information require-
ments)’ᨱ ᯕ⧪ࡹᨕ ⦽݅.) ᯕ Ƚ⊺᮹
ၽ⬉ᯝᮥ ʑᵡᮝಽ, ⣩ŝ⦺᭥ᬱ⫭(SCF) ੱ۵
ᮁ⣩ᦩᱥℎ(EFSA)ᨱ ᮹⦹ᩍ ᰍ⠪aࡽ
⣩℉aྜྷᨱ ݡ⦹ᩍ Ḳ⧪᭥ᬱ⫭۵ ᯙࡽ ⣩
℉aྜྷ᮹ ༊ಾᮥ Ŗᱢᮝಽ ᯕᬊ⧁ ᙹ ᯩ݅.) ᯕ Ƚ⊺ᨱ Ƚᱶࡽ ᳑⊹۵ ‘⣩ᔍᜍŝ ࠺ྜྷᅕ Õᨱ š⦽ ᔢᯥ᭥ᬱ⫭(Standing Committee on Food Chain and Animal Health: SCFCAH)’᮹ ᮹čᨱ ෙ äᮝಽ) ᮁ᮹⫭(EP)᪡ ᯕᔍ⫭
᧲ᯱa ༉ࢱ ၹݡ⦹ḡ ᦥܩ⦹ᩡ݅.)
μට഼କྭ๖
କߌਐඨੲୢ ଭ ୍ඌԧ ਓਏ ࢫ୍ඌԧ୪ਐඨషԧࢄ
࠺ Ƚ⊺ᮡ ⣩℉aྜྷᨱ š⦽ ☖⧊Ƚ⊺
//EC᮹ ᱽ᳑᮹ Ƚᱶᨱ ᯕ
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱥྙ ().
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱥྙ (); EU۵ ᮁᱥᯱᄡ⩶ᔾྜྷℕ(Genetically Modified Organisms: GMO) ᮹ ⣩ᦩᱥᖒŝ ⪹Ğ᭥⧕ᖒᮥ ᄥࠥ᮹ Ƚჵℕĥᨱ ᮹⧕ šญ⦹Ł ᯩ݅. ʡࢱᙹ, “EU ᮁᱥᯱᄡ⩶ᔾྜྷℕ(GMO)Ƚჵℕ ĥෝ ☖⧕ ᅙ ǎᱽ☖ᔢᨱ ᯩᨕᕽ᮹ ⣩ᦩᱥŝ ⪹Ğᅕ⪙”, 「ǎᱽĞᱽჶᩑǍ」 ᱽǭ ᱽ⪙(.), ~໕.
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱥྙ ().
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱥྙ ().
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱥྙ ().
) EU⣩ʑᅙჶ(General Food Law, Regulation /) ᱽ᳑ᨱ ᮹⧕ ᖅพࡹᨕ ᩎ⧁ᮥ ᙹ⧪⦹Ł ᯩ݅. van der Meulen/van der Velde, supra note , p. ₙ᳑.
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱥྙ ().
ၙ ‘ᯙࡽ ⣩℉aྜྷ’ᨱ ݡ⦽ ᮁ⣩ᦩ ᱥℎ(ESFA)ᨱ ᮹⦽ ᰍ⠪a ⥥ಽəఉᮥ Ƚᱶ
⦹Ł ᯩ݅.) ᷪ ᱥྙᨱᕽ ᨙɪ⧩ॐᯕ Ƚ⊺
//EC ᱽ᳑۵ ᯙࡽ ⣩℉aྜྷ
ᨱ ݡ⦹ᩍ ᰍ⠪aෝ ⧁ ᙹ ᯩ۵ ჶᱢ ɝÑ Ƚᱶ ᮝಽ ֥ ᬵ ᯝᱥᨱ ᯙᯕ ࡹᨩ ⣩
℉aྜྷᮡ ǭ⦽ ᯩ۵ ʑšᨱ ᮹⧕ᕽ ‘ᔩಽᬕ ᭥
⧕ᖒ ⠪a’ෝ ⧁ ᙹ ᯩ݅. Ƚ⊺ //EC ᱽ᳑ ⧎ᨱ ᮁ⣩ᦩᱥℎ(EFSA)ᮥ
ᵲᝍᮝಽ ֥ ᬵ ᯝʭḡ ⣩℉aྜྷᨱ ݡ⦽ ᰍ⠪a ⥥ಽəఉᯕ ₥┾ᯕ ࡹࠥಾ ᩩᱶࡹ
ᨕ ᯩᨩ݅. ࠺ Ƚ⊺᮹ ₥┾ ᮁ⣩ᦩᱥℎ
(EFSA)ᨱ ᮹⧕ ᰍ⠪aa ᯕၙ ᪥ഭࡽ ⣩℉
aྜྷᮡ ݅ ⠪a⦹ḡ ᦫᮝ໑, ᯕॅ ⣩℉a
ྜྷᮡ ᇡᗮᕽⳑ(Annex I)ᨱ ʑᰍࡹᨕ ᯩ݅.)
Ԩઘ۩Թڄ୨ଭ
࠺ Ƚ⊺ᔢ ᯙࡽ ⣩℉aྜྷ, ᔍᨦᯱ, ᯕ⧕š ĥ ᯩ۵ ᔍᨦᯱ, ᬱᅙ ᕽඹ۵ ݅ᮭᮥ ᮹ၙ⦽݅.
(a) ‘ᯙࡽ ⣩℉aྜྷ(approved food addi-
tive)’ᯕ, ֥ ᬵ ᯕᱥᨱ ᯙࡽ
⣩℉aྜྷᮥ ᮹ၙ⦹Ł, ֥ ᬵ ᯝ
ᮁ᮹⫭(EP)᪡ ᯕᔍ⫭ ḡ⋉ //EC ᨱ ӹᩕࡽ ⣩℉aྜྷᮥ ᮹ၙ⦽݅. əญ Ł ⣩ᨱ ᔍᬊ⦹۵ qၙഭᨱ ݡ⦽ ḡ⋉
ᮥ ⡍⧉⦽݅.
- ֥ ᬵ ᯝ ᯕᱥ ḡ⋉ //EC) ᨱ ӹᩕࡽ Ŗᯙ ⣩℉aྜྷ
- ֥ ᬵ ᯝ ᮁ᮹⫭(EP)᮹ ⣩
₊ᔪഭᨱ š⦽ ḡ⋉ //EC) - ੱ۵ ֥ ᬵ ᯝ ᮁ᮹⫭(EP) ḡ
⋉ //EC)ᨱᕽ ⣩℉aྜྷ᮹ ᔪʵ ŝ qၙഭ ᮹ ⣩℉aྜྷᨱ š⦽ ḡ⋉
ᮥ ஜ⦽݅.)
(b) ‘ᔍᨦᯱ(business operator)’۵ Ƚ⊺ / /ECᨱᕽ ⣩ᔍᨦ ☖ᱽ⦹᮹ Ƚ⊺᮹
Õ ᮹ྕෝ ḡŁ ᯩ۵ ༉ु ᯱᩑᯙ ੱ۵ ჶᯙᮥ ᮹ၙ⦽݅.) ᷪ ᔍᨦᯱ۵ ⣩ᔍ ᨦᮥ ☖ᱽ⦹۵ ᯱᩑᯙ ੱ۵ ჶᯙᯕᨕ
⦹Ł, Ƚ⊺ //EC᮹ Ǎෝ ᅕ ᰆ⧁ ₦ᯥᮥ ḡ۵ ᯱᯕᨕ ⦽݅.
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ . ) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ .
) European Parliament and Council Directive //EC of June on sweeteners for use in foodstuffs (OJ L /).
) European Parliament and Council Directive //EC of June on colours for use in foodstuffs (OJ L /).
) European Parliament and Council Directive No //EC of February on food additives other than colours and sweeteners (OJ L /).
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ (a).
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ (b).
(c) ‘ᯕ⧕šĥ ᯩ۵ ᔍᨦᯱ(interested busi- ness operator)’ ᯙ᮹ ḡᗮ(ᮁḡ)ŝ š ಉࡹÑӹ ੱ۵ ᯙࡽ ⣩℉aྜྷŝ šಉ
ࡽ ᯱෝ ั⦽݅.) ᷪ ᯕভ ‘ᯕ⧕šĥ ᯩ ۵ ᔍᨦᯱ’ᨱᕽ ᔍᨦᯱ۵ ᯙࡽ ⣩℉
aྜྷᨱ ݡ⦽ ᔍᨦᮥ ⦹۵ ᯱᯕᨕ ⦹Ł,
ᯙࡽ ⣩℉aྜྷᯕ ᰍ⠪aᨱᕽ ᭥⧕
ᗭa ᯩᨕᕽ ᱽ⦽ࢁ Ğᬑ ⋉⧕ෝ ᯦۵ ᯱ
ෝ ⡍⧉⦹Ł ᯩ݅.
(d) ‘ᬱᅙ ᕽඹ’(original dossier)۵ ֥
ᬵ ᯝ ᯕᱥᨱ ⠪a ၰ ᯙࡽ ⣩℉a
ྜྷᮥ ʑၹᮝಽ ࡽ ᕽඹෝ ᮹ၙ⦽݅.)
ܤਐඨషԧࢄଭ୍ඌԧਏট ০ଭէ୨
ᯕၙ ᯙࡽ ⣩℉aྜྷᮡ ᇡᗮᕽ IIᨱ ʑᰍ
ࡽ ᙽᕽᨱ ݅ᮭŝ zᮡ ʑ⦽ ԕᨱ ᰍ⠪a
ࡹࠥಾ Ƚᱶ⦹Ł ᯩ݅.
(a) ḡ⋉ //ECᨱ ӹᩕࡽ ༉ु ᯙࡽ
⣩ ᔪʵ᮹ ᰍ⠪a۵ ֥ ᬵ ᯝʭ ḡ ᰍ⠪aa ᪥ഭࡹᨕ ⦽݅.)
(b) ḡ⋉ //ECᨱ ӹᩕࡽ ᔪʵ ၰ qၙഭ
ᨱ ༉ु ᯙࡽ ⣩℉aྜྷ᮹ ᰍ⠪a
۵ ֥ ᬵ ᯝʭḡ ᪥ഭࡹᨕ ⦽
݅.)
(c) ḡ⋉ //ECᨱ ӹᩕࡽ ༉ु ᯙࡽ q
ၙഭ᮹ ᰍ⠪a۵ ֥ ᬵ ᯝʭḡ
᪥ഭࡹᨕ ⦽݅.)
⦽⠙, ✚ᱶ⦽ ⣩℉aྜྷ ʑ܆॒ɪᮡ ࠺ Ƚ
⊺ ᇡᗮᕽⳒ ᱩᨱ Ǎℕᱢᯙ ʑ⦽ᮥ ⦹ᩍ, ᯕॅ ⣩℉aྜྷᮡ ࠺ɪ᮹ ݅ෙ ⣩℉aྜྷᅕ
݅ ᬑᖁ⦹ᩍ ⠪a⦹ࠥಾ ⦹Ł ᯩ݅.)
əญŁ ࠺ Ƚ⊺ ᱽ᳑ ᱽ⧎ ၰ ᱽ⧎᮹ ᩩ
ಽᕽ, ᦥ௹ᨱᕽ ᅕ۵ ၵ᪡ zᯕ ‘ᔩಽᬕ ŝ
⦺ᱢ ᷾Ñ(new scientific evidence)’a ӹ Ğ ᬑ ᮁ⣩ᦩᱥℎ(EFSA)ᮡ ᨙᱽुḡ ⣩℉
aྜྷ ੱ۵ ⣩℉aྜྷ ə൚᮹ ᬑᖁᙽ᭥ෝ Ḳ⧪
᭥ᬱ⫭᮹ ℎ ੱ۵ ᮁ⣩ᦩᱥℎ(EFSA)᮹
ᯱℕ ၽ᮹ᨱ ᮹⧕ ᰍ⠪aෝ ᯲⧁ ᙹ ᯩ݅. ᯕ ۵ ⣩℉aྜྷ ᰍ⠪a ᝅᨱ ᯩᨕᕽ᮹ ⬉ᮉ ᖒŝ ᝅᱽᱢᯙ ༊ᱢᮥ ݍᖒ⦹ʑ ᭥⦽ ᬱอ⦽
ႊჶᮥ vǍ⦽ äᮝಽ ᅕᯙ݅. ‘ᔩಽᬕ ŝ⦺ᱢ
᷾Ñ’a ӹ a܆ᖒᮥ ᩩᱶ⦹Ł ᯩ۵ Ğᬑಽ,
(a) ᯙe᮹ Õvᮥ ᭥⧕⧁ a܆ᖒᯕ ᯩ۵ Ğᬑ
᪡ (b) ⣩℉aྜྷ ੱ۵ ⣩℉aྜྷ ə൚᮹ ᦩ ᱥᖒ ⠪aᨱ ᨕਅ ᮝಽु ᩢ⨆ᮥ ၙ⊹۵ Ğ ᬑෝ ॅŁ ᯩᨕ ⣩℉aྜྷ᮹ ᰍ⠪a ‘ᯙe
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ (c).
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ (d).
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ (a).
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ (b).
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ (c).
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ .
Õvᨱ ݡ⦽ ᭥⧕ᖒ’ŝ ‘ᦩᱥᖒ⠪a ႊ’ ᧲
ᯱෝ ๅᬑ ᵲ⦹í ݅Ł ᯩ݅.)
୍ඌԧୣఙਏԨஂୀ߹ଭՑഠ
ᮁ⣩ᦩᱥℎ(EFSA)ᮡ ᯙࡽ ⣩℉a
ྜྷ᮹ ᰍ⠪a , (a) ⣩ŝ⦺᭥ᬱ⫭(SCF) ੱ۵
ᮁ⣩ᦩᱥℎ(EFSA)᮹ Ⅹʑ ᮹č(original opinion)ŝ ᝅྕᕽඹ(working documents)ෝ á
☁⦹ᩍ) ŝÑ᪡ ⩥ᰍ᮹ ᄡ࠺ᮥ ❭ᦦ⦹໑, (b)
a܆⦽ ⦽ ᬱᅙ ᕽඹ(original dossier)ෝ á☁⦹
ᩍ ⪽ᬊ⦽݅. ᩍʑᨱᕽ ᬱᅙ ᕽඹ ⣩℉a
ྜྷᨱ ݡ⦽ ʑ᳕⠪aᨱ š⦽ ᯱഭෝ ั⦽݅.) əญŁ (c) ᯕ⧕šĥ ᯩ۵ ᔍᨦᯱ ၰ ʑ┡ ᯕ⧕
šĥ ݚᔍᯱa ᱽ⇽⦽ ᯱഭෝ á☁⦹ᩍ) Ųჵ
᭥⦽ ᮹čᮥ ᙹಕ⦹ࠥಾ ⦹Ł ᯩ݅. ӹᦥa (d) Ḳ⧪᭥ᬱ⫭᪡ ⫭ᬱǎᯕ ᯕᬊ⧁ ᙹ ᯩ۵ ᨕਅ
ᯱഭुḡ ᯱഭෝ ⪶ᅕ⦹ᩍ á☁⦹Ł ᰍ⠪aᨱ ၹᩢ⦹ࠥಾ ⦹Ł ᯩ݅.) ੱ⦽ (e) b ⣩℉a
ྜྷ᮹ ษḡส ⠪a ᯕ⬥ᨱ ᯕෝ í⦽ šಉ ྙ
⨭ᮥ ᄥ⦹ࠥಾ ⦹ᩍ) ᔍ⬥ᨱ ၽᔾ⧁ ᙹ ᯩ۵
ྙᱽෝ ᩩႊ⦹۵ ߑᨱࠥ ⯹ᮥ ʑᬙᯕŁ ᯩ݅.
୍ඌԧࠜୀ߹ଭ૬րٛ
ᯕ⧕šĥ ᯩ۵ ᔍᨦᯱ ၰ ʑ┡ ᯕ⧕šĥ ݚ ᔍᯱᇡ░ ᰍ⠪aෝ ᭥⦽ ᯱഭෝ ᙹḲ⦹ʑ ᭥
⧕ᕽ ᮁ⣩ᦩᱥℎ(EFSA)ᮡ ⣩℉aྜྷ
ᨱ ݡ⦽ ᯱഭෝ ℎ⧕ ⦽݅. ᯱഭ ᱽ⇽ᮥ
᭥⦽ ᯝᱶᮥ ⦹۵ߑ ᯩᨕᕽ ᮁ⣩ᦩ ᱥℎ(EFSA)ᮡ ᯕ⧕šĥ ᯩ۵ ᔍᨦᯱ ੱ۵ ᮹
ྕෝ ḡŁ ᯩ۵ ʑ┡ ᯕ⧕ݚᔍᯱᨱí ࠺ Ƚ⊺
᮹ ၽ⬉ ⬥ ᱢᱶ⦽ eᮥ ⨩ᬊ⦹ࠥಾ ⦹Ł ᯩ
݅.) ᷪ, ᯕ⧕šĥ ᯩ۵ ᔍᨦᯱ ၰ ʑ┡ ᯕ⧕š
ĥ ݚᔍᯱಽᇡ░ ᯱഭෝ ʑ ᭥⦹ᩍ ᮁ⣩
ᦩᱥℎ(EFSA)ᮡ ⣩℉aྜྷ᮹ ᯱഭෝ ℎ⧕
⦹Ł, ᯕ⧕šĥ ᯩ۵ ᔍᨦᯱ ၰ ʑ┡ ᯕ⧕š ĥ ݚᔍᯱ۵ ᮁ⣩ᦩᱥℎ(EFSA)᮹ ᰍ⠪a ᨱ ⦥⦽ ᯱഭ᮹ ℎ ᷪb ᱶᅕෝ ᱽ⇽⧕
⦹۵ ᮹ྕෝ ḥ݅. ݅อ, ᯕ ᮹ྕෝ ᯕ⧪⦹
ʑ ᭥⧕ᕽ ࠺ Ƚ⊺᮹ ၽ⬉ ⬥ᨱ ᮁ⣩ᦩᱥ ℎ(EFSA)ᮡ ḡӹ⊹ḡ ᦫ۵ ჵ᭥ ԕᨱᕽ ⧊ญ ᱢᯙ eᮥ ⨩ᬊ⧁ ᙹ ᯩᨕ ⦽݅.
࠺ Ƚ⊺ ᱽ᳑ ᱽ⧎ᨱ ᨙɪࡽ ᯱഭᨱ۵ ݅ᮭ
᮹ ᯱഭࠥ ⡍⧉ࡽ݅. (a) ⣩ŝ⦺᭥ᬱ⫭(SCF)
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ . ) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ (a).
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ (b).
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ (c).
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ (d).
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ (e).
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ .
ੱ۵ ᮁ⣩ᦩᱥℎ(EFSA) ੱ۵ ⣩℉a
ྜྷᨱ ݡ⦽ పᨦʑǍ(FAO)/ᖙĥᅕÕʑǍ
(WHO) ⧊࠺ᱥྙa᭥ᬱ⫭(Expert Committee
on Food Additives: JECFA)ᨱ ᮹⧕ ⠪aࡹ۵ ᬱᅙ ᕽඹಽᇡ░᮹ ᩑǍ ᅕŁᕽ,) (b) ᯕᱥᨱ
⣩ŝ⦺᭥ᬱ⫭(SCF) ੱ۵ ⧊࠺ᱥྙa᭥ᬱ⫭
(JECFA)ᨱ ᮹⧕ á☁ࡹḡ ᦥܩ⦽ šಉ ⣩℉
aྜྷ᮹ ᦩᱥᖒᨱ š⦽ ᯱഭᨱ ݡ⦽ ᱶᅕ,) (c)
᯦ᯱ Ⓧʑ᪡ šಉࡽ ྜྷญ ⪵⦺ᱢ ✚ᖒ ၰ ᗮᖒ ᨱ ݡ⦽ ᱶᅕෝ ⡍⧉⦹ᩍ ⩥ᰍ ᔍᬊࡹŁ ᯩ۵
⣩℉aྜྷ᮹ ᖙ༊(ᩕÑ)ᨱ ݡ⦽ ᱶᅕ,) (d) ᱽ
᳑ Ŗᱶᨱ ݡ⦽ ᱶᅕ,) (e) ⣩᮹ đᱶ(⠙⨆)ᮥ
᭥⧕ ᔍᬊ⧁ ᙹ ᯩ۵ ᇥᕾ ႊჶᨱ ݡ⦽ ᱶᅕ,) (f) ⣩ᨱᕽ ⣩℉aྜྷᨱ ݡ⦽ ᯙℕי⇽ᨱ ݡ
⦽ ᱶᅕ. ᩩෝ ॅᨕ, ᗭእ ➉▕ ၰ ᬊࠥ, ᝅᱽ ᔍ ᬊ ᙹᵡ ၰ ↽ݡ ᔍᬊ ࠥ, ᗭእ᮹ ኩࠥ ၰ ⋉
⧕ᨱ ᩢ⨆ᮥ ၙ⊹۵ ʑ┡ ᯙ,) (g) ᮭᨱ᮹ ၹ᮲ ၰ ⊹ᖒ) đǎ ⣩℉aྜྷ᮹ ᰍ⠪aෝ
᭥⦽ ᯱഭ۵ ᔢʑ᮹ ᯱഭෝ ⡍⧉⦹ᩍ ᮁ⣩
ᦩᱥℎ(EFSA)ᯕ ℎ⦹۵ ༉ु ᯱഭෝ ⡍⧉⦹
۵ äᮝಽ ᯕ⧕⧁ ᙹ ᯩ݅.
ୀ߹୪ౢଭଭࡿ
ᯕ⧕šĥ ᯩ۵ ᔍᨦᯱ ၰ ʑ┡ ᯕ⧕šĥ ݚ ᔍᯱ۵ ᮁ⣩ᦩᱥℎ(EFSA)ᨱ ᮹⧕ ᯱഭ ᱽ⇽ᮥ ℎᮥ ၼᮥ Ğᬑ, ᮁ⣩ᦩᱥℎ
(EFSA)ᨱ ᮹⧕ ᖅᱶࡽ ʑe ԕᨱ ࠺ Ƚ⊺ ᱽ
᳑()ᨱᕽ ᨙɪࡽ ⣩℉aྜྷ᮹ ᰍ⠪a᪡ š ಉࡽ ᯱഭෝ ᱽ⇽⧕ ⦽݅. ᯕ⧕šĥ ᯩ۵ ᔍ ᨦᯱ ၰ ʑ┡ ᯕ⧕šĥ ݚᔍᯱ۵ ⣩℉aྜྷ
᮹ ⠪aෝ ᭥⦽ ᱽ⇽ḡ⋉ᕽ)ᨱ ᮁ⣩
ᦩᱥℎ(EFSA)ᨱ ᮹⧕ Ǎࡹ۵ ᯱഭෝ ↽ݡ⦽
ࠥಽ ᱽŖ⧕ ⦽݅.) əญŁ ᮹ ᯕ⧕šĥ
ᯩ۵ ᔍᨦᯱॅᮡ a܆⦽ Ğᬑ ‘Ŗ࠺ᮝಽ’ ᯱഭ
ෝ ᱽ⇽⧁ ᙹ ᯩ݅.) ⦽⠙ อ᧞ ᰍ⠪a ḥ⧪ ᵲ ᨱ ✚ᱶ ⣩℉aྜྷ᮹ ᰍ⠪aᨱ ‘⇵aᱢᯙ ᱶ ᅕ’a ⦥⦹݅Ł ❱݉ࢁ Ğᬑ, ᮁ⣩ᦩᱥ ℎ(EFSA)ᮡ ᯕ⧕šĥ ᯩ۵ ᔍᨦᯱᨱí ‘⇵a ᱢᯙ ᱶᅕ’ෝ Ǎ⦹Ñӹ ʑ┡ ᯕ⧕šĥ ݚᔍ
ᯱෝ Ⅹℎ⦹ᩍ ᯱഭ᮹ Ŗ}༉Ḳᮥ ☖⧕ ‘⇵a ᱢᯙ ᱶᅕ’ෝ ᱽ⇽⦹í ⧁ ᙹ ᯩ݅.)
əߑ ᮁ⣩ᦩᱥℎ(EFSA)ᨱ ᮹⧕ ᖅᱶ
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ (a).
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ (b).
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ (c).
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ (d).
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ (e).
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ (f).
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ (g).
) Guidance on submission for food additive evaluations by the Scientific Committee on Food. Opinion expressed on July . SCF/CS/ADD/GEN/ final.
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ . ) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ .
ࡽ ʑ⦽ ԕᨱ ᱽ⇽⦹ḡ ᦫ۵ ᱶᅕ۵ ᰍ⠪aᨱ ᕽ Łಅ⦹ḡ ᦫᮝӹ, ᩩᱢᮝಽ ə ᱶᅕa
⣩℉aྜྷ᮹ ᰍ⠪aᨱ ‘ᵲ⦽ ᱶᅕ’ᯙ Ğᬑᨱ ۵ ษq⦽ᮥ չĉᕽ ᱽ⇽ࡽ ᱶᅕෝ ᙹᬊ⦹ʑ ಽ ⦹۵ Ḳ⧪᭥ᬱ⫭᮹ ࠺᮹a ᯩ݅໕ ᮁ⣩
ᦩᱥℎ(EFSA)ᮡ ⧕ݚ ᱶᅕෝ ᱽ⇽ၼᮡ äᮝಽ đᱶ⧁ ᙹ ᯩࠥಾ ⦹ᩍ,) ⣩℉aྜྷ ᰍ⠪aෝ
᭥⦽ ᯱഭ ᱽ⇽ᨱ ᯩᨕᕽ อᱥᮥ ʑ⦹Ł ᯩ݅.
Ҿᮝಽ ℎࡽ ᱶᅕa ᖅᱶࡽ ʑ⦽ ԕᨱ ᮁ
⣩ᦩᱥℎ(EFSA)ᨱ ᱽ⇽ࡹḡ ᦫ۵ Ğᬑ,
⧕ݚ ⣩℉aྜྷᮡ Ƚ⊺ //EC᮹ ᱽ
᳑()ᨱ ᱶ⧕ḥ ᱩ₉ᨱ EU ⣩℉aྜྷ
༊ಾᨱᕽ ᔎᱽࢁ ᙹ ᯩࠥಾ ⧉ᮝಽ៉) ᯱഭ ᱽ
⇽᮹ ᮹ྕෝ ๅᬑ ᨥĊ⦹í Ƚᮉ⦹Ł ᯩ݅.
ฅլැ୨࣪ଭ୪ౢ
⣩℉aྜྷ᮹ ᰍ⠪a ℕĥ ԕᨱᕽ ᯕ⧕šĥ
ᯩ۵ ᔍᨦᯱ ၰ ʑ┡ ᯕ⧕šĥ ݚᔍᯱ۵ ⣩
℉aྜྷ᮹ ᔾᔑ, ᔍᬊ, ⠱ʑಽ ᯙ⦽ ᨕਁ⦽ ⪹Ğ
᭥⧕ᖒ(environment risks)ŝ šಉࡽ ༉ु ᱶᅕ
ෝ ᮁ⣩ᦩᱥℎ(EFSA)ŝ Ḳ⧪᭥ᬱ⫭ᨱ ☖ ḡ⧕ ⦽݅.) ᩍʑᕽ ั⦹۵ ⪹Ğ᭥⧕ᖒᮡ
⪹Ğᨱ ݡ⦽ ⣩℉aྜྷ᮹ ‘ᝁ᳦ ᭥⧕ ᗭ’ෝ
᮹ၙ⦽݅.
୨୨࣪ଭणࢤଭ࣪ୋրુ
ᯕ⧕šĥ ᯩ۵ ᔍᨦᯱ ੱ۵ ݅ෙ ᯕ⧕šĥ ᯩ ۵ ݚᔍᯱ᮹ ‘Ğᰢಆ’ᯕ ᯩ۵ ḡ᭥ᨱ ‘ᵲݡ⦽
ᗱ⧕’ෝ ӝ⋁ ᙹ ᯩ۵ ᱶᅕ᮹ Ŗ}۵ ‘እၡ’ಽ
ᮁḡࢁ ᙹ ᯩ݅.) ᷪ ᮁ⣩ᦩᱥℎ(EFSA) ᮹ ᯱഭ ℎ ੱ۵ ᯱഭ᮹ ༉Ḳ ॒ᮡ Ŗ}ᱢᮝ ಽ ᯕᨕᲙ ⧉ᯕ ᬱ⊺ᯕŁ, ᯕ۵ ᭥ᨱᕽ ᨙ ɪᮥ ⧩ॐᯕ ᮁ⣩ᦩᱥℎ(ESFA)᮹ ⚍ᖒ
(transparency)ŝ šಉࡽ ၝq⦽ ྙᱽᯕ݅. ⩥
ᰍ۵ ᮁ⣩ᦩᱥℎ(EFSA)᮹ ⚍ᖒ ⪶ᅕෝ
᭥⦹ᩍ ᮁ⣩ᦩᱥℎᰆᯕ ⣩ᨱ ݡ⦽ ⫭᮹
ෝ ᔾᵲĥ⦹ᩍ ႊᘂᮝಽ ᅕԙ ᱢᯕ ᯩ݅. ᮁ
⣩ᦩᱥℎ᮹ ⚍ᖒ ⪶ᅕ۵ ๅᬑ ᵲ⦽ ྙ ᱽᯕŁ, ‘Ğᰢಆ’ ᯩŁ ‘ᵲݡ⦽ ᗱ⧕᮹ ᬑಅ’a
ᯩ۵ ᩩᱢᯙ Ğᬑᨱ ᱶᅕ۵ እၡಽ ⧁ ᙹ ᯩ
݅. ə్ӹ (a) ᯕ⧕šĥa ᯩ۵ ᔍᨦ ᬕᩢᯱ᮹ ᯕŝ ᵝᗭ, (b) ⪵⦺ྜྷḩ᮹ ⋎ŝ ྜྷḩᨱ ݡ
⦽ ⪶⦽ ᖅ, (c) ✚ᱶ⣩ ੱ۵ ⣩ჵ᭥ᨱ ᕽ᮹ ྜྷḩ᮹ ᔍᬊᨱ ݡ⦽ ᱶᅕ, (d) ྜྷḩ᮹ ᦩᱥ ᖒ ⠪aᨱ šಉࡽ ᱶᅕ, (e) ⣩ᇥᕾႊჶ(ॅ))
॒᮹ šಉ ᱶᅕ۵ ᨕਁ⦽ ᔢ⫊ᨱᕽࠥ ʑၡಽ eᵝࡹḡ ᦥܩ ⦽݅.
⦽⠙ ࠺ Ƚ⊺ ᱽ᳑ ᱽ⧎᮹ ༊ᱢᨱ ᯕ
⧕šĥ ᯩ۵ ᔍᨦᯱ ၰ ʑ┡ ᯕ⧕šĥ ݚᔍᯱ
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ . ) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ . ) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑.
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ . ) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ .
۵ əॅᯕ እၡಽ៉ ≉ɪࡹʑෝ ၵŁ ᱽŖ
⦹۵ ᱶᅕ۵ ‘⢽’⧁ ᙹ ᯩᮝӹ, ݉ ᱶݚᖒᯕ
ᯩ۵ Ğᬑᨱอ ᩩ ᔍᮁᨱ ⧕ݚࡽ݅.) əญ Ł ᮁ⣩ᦩᱥℎ(EFSA)᮹ ᱽᦩᨱ ↽
᳦ᱢᮝಽ Ḳ⧪᭥ᬱ⫭۵ šಉᯱॅŝ ⩲᮹ ⬥ᨱ ᯕ⧕šĥ ᯩ۵ ᔍᨦᯱ ၰ ʑ┡ ᯕ⧕šĥ ݚᔍ
ᯱ᮹ ᱶᅕෝ ‘እၡ’ಽ ᮁḡ⦹í ⧁ ᙹ ᯩŁ, Ḳ
⧪᭥ᬱ⫭۵ ᯕෝ ᮁ⣩ᦩᱥℎ(EFSA)ŝ ⫭ ᬱǎॅᨱí ☖ḡ⦽݅.) əߑ ᯕ۵ ᮁ⣩
ᦩᱥℎ(EFSA)᮹ ᩎ⧁ ᙹ⧪ᔢ᮹ ⦽ĥෝ ᙹ
ᯩ۵ Ƚᱶᯕ݅. ᮁ⣩ᦩᱥℎᮡ ⣩℉aྜྷ
᮹ ᦩᱥᖒᨱ ݡ⦽ ŝ⦺ᱢ č⧕ෝ ᱽ⦹۵ ᱥ
ྙᖒᮥ w⇹ ʑǍᯕḡอ, ᱥྙᖒ᮹ ∊ᇥ⦽ ᩎ
⧁ ᙹ⧪ᨱ ᯩᨕ ᮹Ǎᝍᯕ ݅ᗭ ᯩŁ, ᮁ
⣩ᦩᱥℎᮡ ᭥⧕ᖒ ⠪aอᮥ ⧁ ᙹ ᯩʑ ভྙ
ᨱ ࠦพᱢ ʑǍ۵ ᱱᨱᕽ ݅ᗭ ᮹ྙᯕ ᯩ݅.
đǎ ᮁ⣩ᦩᱥℎᮡ ᭥⧕ᖒᨱ ݡ⧕ ⠪aෝ
⦹ḡอ ‘šญ’ෝ ⧁ ᙹ ᨧᮭᮥ ᙹ ᯩ݅. ᯕ
⧕šĥ ᯩ۵ ᔍᨦᯱ ၰ ʑ┡ ᯕ⧕šĥ ݚᔍᯱ
᮹ ᱶᅕෝ šญ⧕ ⧉ᮡ ᭥⧕ᖒ šญಽᕽ Ḳ
⧪᭥ᬱ⫭᮹ ᗭš ǭ⦽ᯕ݅. ᮁ⣩ᦩᱥℎᮡ
Ḳ⧪᭥ᬱ⫭᮹ ᯱྙᨱ ᮲⦹Ñӹ ŝ⦺ᱢ č⧕ෝ
ᱽ⦹Ł ᭥⧕ᖒᮥ ⠪a⦹ᩍ šಉ ᯱഭෝ Ḳ
⧪᭥ᬱ⫭ᨱ ᱽ⇽⦹໕ Ḳ⧪᭥ᬱ⫭a šญ⦹۵
⩶┽ᯕ݅.)
Ḳ⧪᭥ᬱ⫭, ᮁ⣩ᦩᱥℎ(EFSA)ŝ ⫭ᬱ ǎॅᮡ ᮁ᮹⫭(EP), ᯕᔍ⫭, Ḳ⧪᭥ᬱ⫭᮹
ྙᕽᨱ ݡ⦽ ݡᵲᱢ ᱲɝ(ᯝၹᯙᩕ௭ǭ)ᨱ š
⦽ ֥ ᬵ ᯝ ᮁ᮹⫭᪡ ᯕᔍ⫭a ₥
┾⦽ Ƚ⊺ //EC)ᨱ ‘ᯙe᮹ Õ v, ࠺ྜྷ᮹ Õv ੱ۵ ⪹Ğᮥ ᅕ⪙’⦹ʑ ᭥⧕
⦥⦽ Ğᬑෝ ᱽ⦹Ł ࠺ Ƚ⊺ ⦹ᨱᕽ ᱲᙹ
ࡽ ᱶᅕ᮹ ‘እၡ’ᮥ ᱢᱩ⯩ ᅕᰆ⦹ʑ ᭥⧕ ⦥
⦽ ᳑⊹ෝ ≉⧕ ⦽݅.) đǎ ᯙeÕvŝ
⪹Ğᅕ⪙a ⣩℉aྜྷ ᰍ⠪a᮹ ᵝࡽ ༊ᱢᯥ
ᮥ ᙹ ᯩ݅.
ࡦۍഉࠫෘ
࠺ Ƚ⊺ ᱽ᳑ᨱ ֥ᇡ░ ֥ʭ ḡ ๅ֥ ᬵᨱ ᮁ⣩ᦩᱥℎ(EFSA)ᮡ Ḳ
⧪᭥ᬱ⫭᪡ ⫭ᬱǎॅᨱí ⣩℉aྜྷ ᰍ⠪a
⥥ಽəఉ᮹ ḥ⧪ŝᱶᮥ ☖ḡ⦹ᩍ) EU Ŗ࠺
ᰆ ԕᨱᕽ᮹ ⣩ᦩᱥᮥ ᅕᰆ⦹۵ ߑᨱ ⯹ᮥ
ʑᬙᯕí ࡽ݅.
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ . ) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ .
) Raymond O’Rourke, European Food Law (London: Sweet & Maxwell, ), pp. ~.
) Regulation / of the European Parliament and of the Council of May regarding public access to European Parliament, Council and Commission documents (OJ L /).
) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑ . ) ᯙࡽ ⣩℉aྜྷ ᰍ⠪a⥥ಽəఉ Ƚ⊺, ᱽ᳑.
ν೫
Ų᮹ಽᕽ᮹ ⣩℉aྜྷᮡ ⣩ ᅙ௹᮹ Ǎᖒ ᖒᇥᯕ ᦥܭ äᮝಽᕽ ⣩ᨱ ℉aࡹÑӹ ⪝
᯦ࡹ۵ ྜྷḩಽᕽ ᯝၹᱢᮝಽ ⣩᮹ ‘ᱽ᳑·ᮁ
☖Ⱂᅕ᳕’ᨱ ᯩᨕᕽ ‘૽ಘ⦽ ᔍᬊ༊ᱢ’ᮥ a ḡŁ ⣩ᨱ ℉aࡹ۵ ⪵⦺ྜྷḩᮥ ั⦽݅. ᱶ ᔢᱢᯙ ⣩℉aྜྷᮡ ⣩᮹ ‘ᱽ᳑Ⱂᮁ☖Ⱂ ᅕ᳕’ ॒ ŝᱶᨱᕽ ᅕ☖ ‘ᗭప’ᮝಽ ᔍᬊࡹ۵ äᯕ ᯝၹᱢᯕ໑, ‘ŖᵲᅕÕ’ᨱ ᮁ⧕⦽ ྜྷḩᯕ ӹ ⣩᭥ᔾჶᨱ ᭥ၹࡹ۵ ᯝℕ᮹ ྜྷḩᮡ ᱽ
⦹Ł ᯩ݅. ᦿᨱᕽ ᔕ⠕ᅙ ၵ᪡ zᯕ Ŗ࠺ᰆ ℕᱽෝ w⇹ EU۵ ᮁ ԕᨱᕽ᮹ ⣩ᦩᱥᖒ
ᮥ ⪶ᅕ⦹ʑ ᭥⦹ᩍ) Ŗ࠺᮹ ⣩℉aྜྷ ᰍ⠪
aᨱ š⦽ ჶಚᮥ ษಉ⦹ᩍ Ƚᱽ⦹Ł ᯩ݅. ✚
⯩ ᯙࡽ ⣩℉aྜྷ᮹ ᰍ⠪aෝ ᭥⦽ ℕĥᱢ ᯙ ᯝᱶᮥ ☖⦽ šญෝ ☖⧕ ᩎԕᨱᕽ᮹ ບᮥ
Ñญ᮹ ᦩᱥᖒ ⪶ᅕᨱ ᝍ⩩ᮥ ʑᬙᯕŁ ᯩ݅.
ᯕ۵ ⣩᭥ʑ(food crisis)a ၽᔾ⧩ᮥ Ğᬑᨱ
⧕đ₦ᮥ vǍ⦹۵ ႊᨱᕽ ჸᨕӹ ᔍᱥᨱ ᅕ
݅ ℕĥᱢᮝಽ EU ᩎԕ ⣩℉aྜྷ᮹ ᦩᱥᖒ
ᮥ šญ⦽݅۵ ߑᨱ ⓑ ᮹ၙa ᯩ݅. ᬑญӹ
᮹ Ğᬑ ⣩᭥ᔾჶ ᱽ᳑ᨱᕽ ⣩℉aྜྷᮥ
⣩᮹ ᱽ᳑, aŖ, ⪝⧊, ⋉ල ʑ┡᮹ ႊჶᨱ ᮹⦹ᩍ ᔍᬊࡹ۵ ྜྷḩಽ ᱶ᮹⦹Ł, ᱽ᳑ᨱᕽ ḡᱶ⦽ ℉aྜྷ᮹ ʑᵡ·ȽĊᨱ ⧊ݚ⦽ äᮥ ᔍ ᬊ⦹ᩍ ⦹໑, ᯕॅ᮹ }ᄥ ʑᵡ·ȽĊᮡ ᱽ
᳑ᨱ ᮹Ñ⦹ᩍ ‘⣩℉aྜྷ Ŗᱥ’ᨱ Ł⦹ࠥ
ಾ ⦹Ł ᯩᨕ, ᔍᬊࡹ۵ ༉ु ℉aྜྷᮡ ‘⣩℉
aྜྷ Ŗᱥ’ ᔢ᮹ ʑᵡ·ȽĊŝ ᯝ⊹⦹í ᱽ᳑ࡹ
Ł ᔍᬊࡹᨕᲙ ⦽݅. əญŁ ᯕ۵ ⣩᮹᧞
⣩ᦩᱥෝ ᵲᝍᮝಽ šญ⦹Ł ᯩ۵ߑ, ǎᱽ☖
ᔢݡᨱ ᬑญӹ ǎၝ᮹ ⣩ᦩᱥᖒᮥ ᅕ݅
⪶ᅕ⦹ʑ ᭥⦹ᩍ EUa ⣩℉aྜྷ᮹ ᰍ⠪a
ෝ ჶᱢᮝಽ ℕĥᱢᮝಽ v⪵⦹Ł ᯩॐᯕ ǎԕ ᱢᮝಽ ⣩℉aྜྷ᮹ ᦩᱥᖒᮥ ᅕ݅ ℕĥᱢᮝ ಽ šญ⧁ ⦥a ᯩ݅.
ť ˃ ս
֝֝ઘ۩࣑֗ୢࢂ۩Գॷ
ఞճࢂෝ
ʡࢱᙹ, “EU ᮁᱥᯱᄡ⩶ᔾྜྷℕ(GMO)Ƚჵℕĥෝ ☖⧕ ᅙ ǎᱽ☖ᔢᨱ ᯩᨕᕽ᮹ ⣩ᦩᱥŝ ⪹Ğᅕ⪙”, 「ǎᱽĞᱽ ჶᩑǍ」 ᱽǭ ᱽ⪙, .
ʡࢱᙹ, 「EU⣩ჶ」, ⦽ǎ⦺ᚁᱶᅕ, .
PSRF Mathijsen, A Guide to European Union Law, Sweet
& Maxwell, .
Bernd van der Meulen/Menno van der Velde, European Food Law, Wageningen Academic Publishers, . Raymond O’Rourke, European Food Law, Sweet & Max-
well, .
Guidance on submission for food additive evaluations by the Scientific Committee on Food. Opinion expressed on July . SCF/CS/ADD/GEN/ final.
) PSRF Mathijsen, A Guide to European Union Law (London: Sweet & Maxwell, ), p. .
