Alle dokumenter › Forskrift om grenseverdier for legemiddelrester i næringsmidler fra dyr › Historikk › Endringer

Endringer

Forskrift om grenseverdier for legemiddelrester i næringsmidler fra dyr

2 endring(er) på ledd-nivå.

• Endret vedleggI

  Før: VEDLEGG IMetodologiske prinsipper for den vitenskapelige risikovurderingen nevnt i artikkel 6 i forordning (EF) nr. 470/2009 1 Europaparlaments- og rådsdirektiv 2004/10/EF av 11. februar 2004 om tilnærming av lover og forskrifter om bruk av prinsippene for god laboratoriepraksis og kontroll av deres bruk ved forsøk med kjemiske stoffer (EUT L 50 av 20.2.2004, s. 44). 2 Europaparlaments- og rådsdirektiv 2010/63/EU av 22. september 2010 om vern av dyr som brukes til vitenskapelige formål (EUT L 276 av 20.10.2010, s. 33). 3 Europaparlaments- og rådsforordning (EF) nr. 470/2009 av 6. mai 2009 om framgangsmåter i Fellesskapet for å fastsette grenseverdier for restmengder av farmakologisk virksomme stoffer i næringsmidler av animalsk opprinnelse, om oppheving av rådsforordning (EØF) nr. 2377/90 og om endring av europaparlaments- og rådsdirektiv 2001/82/EF og europaparlaments- og rådsforordning (EF) nr. 726/2004 (EUT L 152 av 16.6.2009, s. 11). 4 Safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001536.jsp&mid=WC0b01ac058002dd38). 5 Kommisjonens gjennomføringsforordning (EU) 2017/12 av 6. januar 2017 om formen på og innholdet i søknader og anmodninger om fastsettelse av grenseverdier for restmengder i samsvar med europaparlaments- og rådsforordning (EF) nr. 470/2009 (EUT L 4 av 7.1.2017, s. 1). 6 Approach to establish a pharmacological acceptable daily intake (ADI) (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001530.jsp&mid=). 7 VICH GL47 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals:laboratory animal comparative metabolism studies (http:///www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001515.jsp&mid=WC0b01ac058002dd37). 8 VICH GL33 Safety studies for veterinary drug residues in human food: general approach to testing (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001480.jsp&mid=WC0b01ac058002dd37.) 9 VICH GL31 Safety studies for veterinary drug residues in human food: repeat-dose (90) toxicity testing (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001478.jsp&mid=WC0b01ac058002dd37.) 10 VICH GL37 Safety of veterinary drugs in human food repeat-dose (chronic) toxicity testing (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001481.jsp&mid=WC0b01ac058002dd37.) 11 VICH GL22 Safety studies for veterinary drug residues in human food: reproduction studies (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001475.jsp&mid=WC0b01ac058002dd37.) 12 VICH GL32 Studies to evaluate the safety of residues of veterinary drugs in human food: developmental toxicity testing (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001479.jsp&mid=WC0b01ac058002dd37.) 13 VICH GL23 Studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001476.jsp&mid=WC0b01ac058002dd37.) 14 VICH GL46 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: metabolism study to determine the quantity and identify the nature of residues (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001516.jsp&mid=WC0b01ac058002dd37.) 15 Review of the Threshold of Toxicological Concern (TTC) approach and development of new TTC decision tree (http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2016.EN-1006/epdf). 16 VICH GL28 Studies to evaluate the safety of veterinary drugs in human: carcinogenicity testing (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001477.jsp&mid=WC0b01ac058002dd37.) 17 OECD Test No 424: Neurotoxicity Study in Rodents (http://www.oecd-ilibrary.org/environment/test-no-424-neurotoxicity-study-in-rodents_9789264071025-en). 18 OECD Test No 426: Developmental Neurotoxicity Study (http://www.oecd-ilibrary.org/environment/test-no-426-developmental-neurotoxicity-study_9789264067394-en). 19 OECD Test No 443: Extended One-Generation Reproductive Toxicity Study (http://www.oecd-ilibrary.org/environment/test-no-443-extended-one-generation-reproductive-toxicity-study_9789264185371-en.) 20 OECD Test No 418: Delayed Neurotoxicity of Organophosphorus Substances Following Acute Exposure (http://www.oecd-ilibrary.org/environment/test-no-418-delayed-neurotoxicity-of-organophosphorus-substances-following-acute-exposure_9789264070905-en.) 21 OECD Test No 419: Delayed Neurotoxicity of Organophosphorus Substances: 28-day Repeated Dose Study (http://www.oecd-ilibrary.org/environment/test-no-419-delayed-neurotoxicity-of-organophosphorus-substances-28-day-repeated-dose-study_9789264070929-en .) 22 VICH GL36 Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to establish a microbiological ADI (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001531.jsp&mid=WC0b01ac058002dd37.) 23 Guidance of the Scientific Committee on Use of the benchmark dose approach in risk assessment (http://www.efsa.europa.eu/en/efsajournal/pub/1150). 24 Approach to establish a pharmacological acceptable daily intake (ADI) (http://www.ema.europa.eu/ema/index.jsp?curl=pages//regulation/general/general_content_001530.jsp&mid=). 25 VICH GL46 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: metabolism study to determine the quantity and identify the nature of residues (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001516.jsp&mid=WC0b01ac058002dd37.) 26 VICH GL49 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: validation of analytical methods used in residue depletion studies (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001513.jsp&mid=WC0b01ac058002dd37.) 27 VICH GL56 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: study design recommendations for residue studies in honey for establishing MRLs and withdrawal periods (http://www.ema.europa.eu//ema/index.jsp?curl=pages/regulation/safety_residues_pharmaceuticals/general_content_001815.jsp&mid=WC0b01ac058002dd37 .) 28 Note for guidance for the assessment of the effect of antimicrobial substances on diary starter cultures (http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500004533&mid=WC0b01ac058009a3dc.)

  Etter: VEDLEGG IMetodologiske prinsipper for den vitenskapelige risikovurderingen nevnt i artikkel 6 i forordning (EF) nr. 470/2009 1 Europaparlaments- og rådsdirektiv 2004/10/EF av 11. februar 2004 om tilnærming av lover og forskrifter om bruk av prinsippene for god laboratoriepraksis og kontroll av deres bruk ved forsøk med kjemiske stoffer (EUT L 50 av 20.2.2004, s. 44). 2 Europaparlaments- og rådsdirektiv 2010/63/EU av 22. september 2010 om vern av dyr som brukes til vitenskapelige formål (EUT L 276 av 20.10.2010, s. 33). 3 Europaparlaments- og rådsforordning (EF) nr. 470/2009 av 6. mai 2009 om framgangsmåter i Fellesskapet for å fastsette grenseverdier for restmengder av farmakologisk virksomme stoffer i næringsmidler av animalsk opprinnelse, om oppheving av rådsforordning (EØF) nr. 2377/90 og om endring av europaparlaments- og rådsdirektiv 2001/82/EF og europaparlaments- og rådsforordning (EF) nr. 726/2004 (EUT L 152 av 16.6.2009, s. 11). 4 Safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market ( http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001536.jsp&mid=WC0b01ac058002dd38). 5 Kommisjonens gjennomføringsforordning (EU) 2017/12 av 6. januar 2017 om formen på og innholdet i søknader og anmodninger om fastsettelse av grenseverdier for restmengder i samsvar med europaparlaments- og rådsforordning (EF) nr. 470/2009 (EUT L 4 av 7.1.2017, s. 1). 6 Approach to establish a pharmacological acceptable daily intake (ADI) ( http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001530.jsp&mid=). 7 VICH GL47 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals:laboratory animal comparative metabolism studies ( http:///www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001515.jsp&mid=WC0b01ac058002dd37). 8 VICH GL33 Safety studies for veterinary drug residues in human food: general approach to testing ( http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001480.jsp&mid=WC0b01ac058002dd37.) 9 VICH GL31 Safety studies for veterinary drug residues in human food: repeat-dose (90) toxicity testing ( http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001478.jsp&mid=WC0b01ac058002dd37.) 10 VICH GL37 Safety of veterinary drugs in human food repeat-dose (chronic) toxicity testing ( http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001481.jsp&mid=WC0b01ac058002dd37.) 11 VICH GL22 Safety studies for veterinary drug residues in human food: reproduction studies ( http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001475.jsp&mid=WC0b01ac058002dd37.) 12 VICH GL32 Studies to evaluate the safety of residues of veterinary drugs in human food: developmental toxicity testing ( http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001479.jsp&mid=WC0b01ac058002dd37.) 13 VICH GL23 Studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing ( http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001476.jsp&mid=WC0b01ac058002dd37.) 14 VICH GL46 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: metabolism study to determine the quantity and identify the nature of residues ( http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001516.jsp&mid=WC0b01ac058002dd37.) 15 Review of the Threshold of Toxicological Concern (TTC) approach and development of new TTC decision tree ( http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2016.EN-1006/epdf). 16 VICH GL28 Studies to evaluate the safety of veterinary drugs in human: carcinogenicity testing ( http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001477.jsp&mid=WC0b01ac058002dd37.) 17 OECD Test No 424: Neurotoxicity Study in Rodents ( http://www.oecd-ilibrary.org/environment/test-no-424-neurotoxicity-study-in-rodents_9789264071025-en). 18 OECD Test No 426: Developmental Neurotoxicity Study ( http://www.oecd-ilibrary.org/environment/test-no-426-developmental-neurotoxicity-study_9789264067394-en). 19 OECD Test No 443: Extended One-Generation Reproductive Toxicity Study ( http://www.oecd-ilibrary.org/environment/test-no-443-extended-one-generation-reproductive-toxicity-study_9789264185371-en.) 20 OECD Test No 418: Delayed Neurotoxicity of Organophosphorus Substances Following Acute Exposure ( http://www.oecd-ilibrary.org/environment/test-no-418-delayed-neurotoxicity-of-organophosphorus-substances-following-acute-exposure_9789264070905-en.) 21 OECD Test No 419: Delayed Neurotoxicity of Organophosphorus Substances: 28-day Repeated Dose Study ( http://www.oecd-ilibrary.org/environment/test-no-419-delayed-neurotoxicity-of-organophosphorus-substances-28-day-repeated-dose-study_9789264070929-en .) 22 VICH GL36 Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to establish a microbiological ADI ( http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001531.jsp&mid=WC0b01ac058002dd37.) 23 Guidance of the Scientific Committee on Use of the benchmark dose approach in risk assessment ( http://www.efsa.europa.eu/en/efsajournal/pub/1150). 24 Approach to establish a pharmacological acceptable daily intake (ADI) ( http://www.ema.europa.eu/ema/index.jsp?curl=pages//regulation/general/general_content_001530.jsp&mid=). 25 VICH GL46 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: metabolism study to determine the quantity and identify the nature of residues ( http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001516.jsp&mid=WC0b01ac058002dd37.) 26 VICH GL49 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: validation of analytical methods used in residue depletion studies ( http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001513.jsp&mid=WC0b01ac058002dd37.) 27 VICH GL56 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: study design recommendations for residue studies in honey for establishing MRLs and withdrawal periods ( http://www.ema.europa.eu//ema/index.jsp?curl=pages/regulation/safety_residues_pharmaceuticals/general_content_001815.jsp&mid=WC0b01ac058002dd37 .) 28 Note for guidance for the assessment of the effect of antimicrobial substances on diary starter cultures ( http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500004533&mid=WC0b01ac058009a3dc.)

• Endret vedleggII

  Før: VEDLEGG IIMetodologiske prinsipper for anbefalingene om risikohåndtering nevnt i artikkel 7 i forordning (EF) nr. 470/2009 1 Fett og hud i naturlig forhold for svin 2 Safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001536.jsp&mid=WC0b01ac058002dd38.) 3 Europaparlaments- og rådsdirektiv 2001/82/EF av 6. november 2001 om innføring av et fellesskapsregelverk for veterinærpreparater (EFT L 311 av 28.11.2001, s. 1). 4 Risk characterisation and assessment of maximum residue limits (MRL) for biocides (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001541.jsp&mid=WC0b01ac05804aca04.) 5 Kommisjonsforordning (EU) 2017/880 av 23. mai 2017 om fastsettelse av regler for bruken av en grenseverdi for restmengder som er fastsatt for et farmakologisk virksomt stoff i et bestemt næringsmiddel, på et annet næringsmiddel som stammer fra samme art, og for bruken av en grenseverdi for restmengder som er fastsatt for et farmakologisk virksomt stoff i en eller flere arter, på andre arter, i samsvar med europaparlaments- og rådsforordning (EF) nr. 470/2009 (EUT L 135 av 24.5.2017, s. 1).

  Etter: VEDLEGG IIMetodologiske prinsipper for anbefalingene om risikohåndtering nevnt i artikkel 7 i forordning (EF) nr. 470/2009 1 Fett og hud i naturlig forhold for svin 2 Safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market ( http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001536.jsp&mid=WC0b01ac058002dd38.) 3 Europaparlaments- og rådsdirektiv 2001/82/EF av 6. november 2001 om innføring av et fellesskapsregelverk for veterinærpreparater (EFT L 311 av 28.11.2001, s. 1). 4 Risk characterisation and assessment of maximum residue limits (MRL) for biocides ( http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001541.jsp&mid=WC0b01ac05804aca04.) 5 Kommisjonsforordning (EU) 2017/880 av 23. mai 2017 om fastsettelse av regler for bruken av en grenseverdi for restmengder som er fastsatt for et farmakologisk virksomt stoff i et bestemt næringsmiddel, på et annet næringsmiddel som stammer fra samme art, og for bruken av en grenseverdi for restmengder som er fastsatt for et farmakologisk virksomt stoff i en eller flere arter, på andre arter, i samsvar med europaparlaments- og rådsforordning (EF) nr. 470/2009 (EUT L 135 av 24.5.2017, s. 1).