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瑙h锛氭鐩熴€佺編鍥芥坊鍔犲墏鏍囧噯娉曡

鎵弿浜岀淮鐮� 鍒嗕韩濂藉弸鍜屾湅鍙嬪湀
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椋熷搧娣诲姞鍓傛槸鍔犲伐椋熷搧杩囩▼涓笉鍙己灏戠殑鍩烘枡锛屼笘鐣屽悇鍥介兘鍗佸垎閲嶈椋熷搧娣诲姞鍓備骇鍝佽川閲忓拰浣跨敤鐨勫畨鍏ㄧ鐞嗭紝娣卞叆浜嗚В鍥藉唴澶栭鍝佹坊鍔犲墏鐨勬爣鍑嗘硶瑙勶紝瀵逛簬鍚勪紒涓氶鍝佸嚭鍙c€佸浗鍐呮坊鍔犲墏鏂板搧绉嶇敵璇峰強鎵╁ぇ浣跨敤鑼冨洿鍏锋湁閲嶈鎰忎箟銆傞鍝佷紮浼寸綉鏁寸悊浜咶AO/WHO銆佹鐩熴€佺編鍥�3涓粍缁囨垨鍥藉鐨勬坊鍔犲墏闄愰噺銆佽川閲忚鏍煎拰璇勪及鎶ュ憡锛屾暀澶у杞绘澗鍏ラ棬娣诲姞鍓傛爣鍑嗘硶瑙勩€� 


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² 娉曡姒傝堪

娉曡锛圗C锛�1331/2008瑙勫畾浜嗛鍝佹坊鍔犲墏銆侀叾鍒跺墏鍜岄鏂欑殑涓€鑸鎵圭▼搴忥紱娉曡锛圗C锛�1332/2008瑙勫畾浜嗛鍝佺敤閰跺埗鍓傜殑绠$悊锛涙硶瑙勶紙EC锛�1333/2008瑙勫畾浜嗛櫎浜嗛叾鍒跺墏鍜岄鏂欎互澶栫殑椋熷搧娣诲姞鍓傜殑绠$悊锛涙硶瑙勶紙EC锛�1334/2008鍒欒瀹氫簡鍏充簬椋熷搧鐢ㄩ鏂欎互鍙婇鍝佷腑鍏锋湁棣欐枡鐗规€х殑椋熷搧閰嶆枡鐨勭鐞嗭紱娉曡(EU) No 231/2012瑙勫畾浜嗘坊鍔犲墏鐨勮川閲忚鏍笺€�

² 娉曡璇﹁В

椋熷搧娣诲姞鍓備笉鍖呮嫭鑳跺熀銆佹皑鍩洪吀鍙婂叾鐩愶紙闄や簡鏃犳妧鏈繀瑕佹€х殑璋锋皑閰搞€佺敇姘ㄩ吀銆佸崐鑳辨皑閰稿拰鑳辨皑閰稿強鍏剁洂锛夈€侀叒铔嬬櫧鍙婇叒铔嬬櫧閰哥洂绛�11椤广€傦紙EC锛�1333/2008涓嶅寘鎷惀鍏诲己鍖栧墏銆佸姞宸ュ姪鍓傘€侀绮鹃鏂欍€�

锛圗C锛�1333/2008鍏卞寘鍚�6绔�35鏉�5涓檮褰曘€�

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2銆侀檮褰曗叀鍖呮嫭Part A銆丅銆丆銆丏銆丒5閮ㄥ垎锛�

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2)Part B 缃楀垪浜嗘墍鏈夐鍝佹坊鍔犲墏鍚嶇О鍙婂叾E number锛屽ぇ鑷村垎涓虹潃鑹插墏銆佺敎鍛冲墏銆佺潃鑹插墏鍜岀敎鍛冲墏浠ュ鐨勬坊鍔犲墏3閮ㄥ垎銆�

3锛塒art C鍒嗕负Group鈪犮€丟roup鈪★紙鍏佽鎸夌敓浜ч渶瑕侀€傞噺浣跨敤鐨勯鐢ㄧ潃鑹插墏锛夈€丟roup 鈪紙缁撳悎浣跨敤鏈夋渶澶ч檺閲忕殑椋熺敤鐫€鑹插墏)銆丟roup鈪�(澶氱緹鍩虹被鍖栧悎鐗╋級浠ュ強鍏朵粬璋冭妭缁勫悎浣跨敤鐨勬坊鍔犲墏锛屽灞辨ⅷ閰稿強鍏剁洂绫伙紙E200-E203)銆�

4锛塒art D鏄鍝佸垎绫荤郴缁燂紝娆х洘鍏卞皢椋熷搧鍒嗕负18涓ぇ绫伙紝涓庝腑鍥藉垎绫绘瘮杈冪浉浼硷紝姣旇緝鐗规畩鐨�1锛�“0.”鏄寚鍚勭被椋熷搧銆�2锛�“18.”绗�01-17绫绘病鏈夎鐩栫殑鍔犲伐椋熷搧锛屼笉鍖呮嫭濠村辜鍎块鍝併€�

5锛塒art E 鎸夐鍝佺被鍒垪鍑轰簡璇ラ鍝佽兘浣跨敤鐨勯鍝佹坊鍔犲墏銆佹渶澶ч檺閲忋€佸娉ㄥ強渚嬪鏉′欢銆�

3銆侀檮褰曗參鍖呭惈浜嗙敤浜庨鍝佹坊鍔犲墏銆侀鍝佺敤閰躲€侀鍝佺敤棣欐枡鍜岃惀鍏荤礌涓殑椋熷搧娣诲姞鍓傚拰杞戒綋鐨勫悕鍗曞強闄愰噺锛屽叡鍒嗕负6閮ㄥ垎锛屽叾涓璸art 6瀹氫箟浜�7涓猼able锛岀被浼间簬闄勫綍鈪′腑鐨刧roup銆�

Part 5鍒嗕负A銆丅涓よ妭锛孲ection A 瑙勫畾浜嗛櫎浜嗛檮褰曗叀 part E涓�13.1鎵€鍒楀┐骞煎効椋熷搧钀ュ吇绱犱互澶栫殑钀ュ吇绱犵敤椋熷搧娣诲姞鍓傘€侀檺閲忋€佸彲浠ユ坊鍔犳坊鍔犲墏鐨勮惀鍏荤礌绛夛紱section B 瑙勫畾浜嗛檮褰曗叀 part E涓�13.1鎵€鍒楀┐骞煎効椋熷搧钀ュ吇绱犱互澶栫殑钀ュ吇绱犵敤椋熷搧娣诲姞鍓傘€侀檺閲忋€佸彲浠ユ坊鍔犳坊鍔犲墏鐨勮惀鍏荤礌銆�

4銆侀檮褰曗叄鏄煇浜涙垚鍛樺浗浠嶇姝㈢敤浜庝紶缁熼鍝佺殑娣诲姞鍓傜殑鍥藉銆侀鍝佺被鍒€佹坊鍔犲墏绉嶇被銆�

5銆侀檮褰曗叅鏍规嵁article 24 瑕佹眰娣诲姞鏌愪簺椋熺敤鐫€鑹插墏蹇呴』鏍囨敞闄勫姞淇℃伅銆�

(EC) No 1334/2008锛�http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1482392582136&uri=CELEX:02008R1334-20160818

² 璐ㄩ噺瑙勬牸鍜岃瘎浼版姤鍛�

娣诲姞鍓傝川閲忚鏍硷細鍖呮嫭E number銆佸悇绉嶅悕绉般€佸垎瀛愬紡銆佸垎瀛愰噺銆佹娴嬫柟娉曘€佹劅瀹樻€х姸銆佺悊鍖栨寚鏍囥€�

(EU) No 231/2012锛�http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1482392768173&uri=CELEX:02012R0231-20161103

娣诲姞鍓傝瘎浼版姤鍛婏細鍙互鍦ㄥ垪琛ㄩ噷鎼滅储锛屼篃鍙互鐩存帴鍦‥FSA瀹樼綉鎸夌収娣诲姞鍓傚悕绉拌繘琛屾悳绱€€�

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缇庡浗

² 娉曡姒傝堪

缇庡浗灏嗚壊绱犲拰鍏朵粬椋熷搧娣诲姞鍓傚垎寮€绠$悊锛岃繘琛屼笉鍚岃瀹氥€�

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椋熷搧娣诲姞鍓傚垎鐩存帴椋熷搧娣诲姞鍓傘€佹绾х洿鎺ラ鍝佹坊鍔犲墏鍜岄棿鎺ラ鍝佹坊鍔犲墏銆�

鐩存帴椋熷搧娣诲姞鍓傦紙PART 172锛夊寘鎷鍝侀槻鑵愬墏銆佽鑶滃墏銆佺壒娈婅喅椋熷拰钀ュ吇寮哄寲鍓傘€佹姉缁撳墏銆侀鏂欏強鐩稿叧鐗╄川锛岃兌鍩哄強閰嶆枡銆佸鍔熻兘娣诲姞鍓傜瓑9鑺�,璇︾粏瑙勫畾浜嗘瘡绉嶉鍝佹坊鍔犲墏闇€瑕佽揪鍒扮殑璐ㄩ噺瑙勬牸鏍囧噯銆佸厑璁镐娇鐢ㄧ殑椋熷搧鑼冨洿鍙婁娇鐢ㄩ檺閲忋€佷负浜嗕繚璇侀鍝佹坊鍔犲墏鐨勫畨鍏ㄤ娇鐢ㄥ簲娉ㄦ剰鐨勪簨椤圭瓑鍐呭銆�

娆$骇鐩存帴椋熷搧娣诲姞鍓傦紙PATR 173)鏄湪椋熷搧鐨勭敓浜у姞宸ヨ繃绋嬩腑鍔犲叆銆佷絾涓嶅湪缁堜骇鍝佷腑鍙戞尌鍔熻兘浣滅敤鐨勯鍝佹坊鍔犲墏,濡傞叾鍒跺墏銆佺瀛愪氦鎹㈡爲鑴傜瓑锛岀被浼间簬涓浗鐨勫姞宸ュ姪鍓傘€�

闂存帴椋熷搧娣诲姞鍓傦紙PATR 172-178锛夋槸涓嶉€氳繃鐩存帴娣诲姞銆佽€屾槸閫氳繃杩佺Щ杩涘叆椋熷搧鐨勯鍝佹坊鍔犲墏,濡傞鍝佸寘瑁呮潗鏂欑墿璐ㄣ€�

闄や笂杩拌瀹氬锛屽湪GRAS鐗╄川鍚嶅崟涓紝杩樺寘鎷簡澶氱鐗瑰畾鍔熻兘椋熷搧娣诲姞鍓傜墿璐紝濡傞槻鑵愬墏銆佽惀鍏荤礌銆佹姉缁撳墏銆佸悎鎴愰鏂欑墿璐ㄣ€佽灟鍚堝墏銆佺ǔ瀹氬墏銆�

² 缇庡浗椋熷搧鍒嗙被

缇庡浗椋熷搧鍏卞垎涓�43澶х被锛屾病鏈変簩绾у垎绫汇€�

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² 娉曡璇﹁В

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² 璐ㄩ噺瑙勬牸鍜岃瘎浼版姤鍛�

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