- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE)
Commission Regulation (EC) No 429/2008Dangos y teitl llawn
Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (Text with EEA relevance)
You are here:
Pa Fersiwn
Rhagor o Adnoddau
Legislation originating from the EU
When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.
Mae hon yn eitem o ddeddfwriaeth sy’n deillio o’r UE
Mae unrhyw newidiadau sydd wedi cael eu gwneud yn barod gan y tîm yn ymddangos yn y cynnwys a chyfeirir atynt gydag anodiadau.Ar ôl y diwrnod ymadael bydd tair fersiwn o’r ddeddfwriaeth yma i’w gwirio at ddibenion gwahanol. Y fersiwn legislation.gov.uk yw’r fersiwn sy’n weithredol yn y Deyrnas Unedig. Y Fersiwn UE sydd ar EUR-lex ar hyn o bryd yw’r fersiwn sy’n weithredol yn yr UE h.y. efallai y bydd arnoch angen y fersiwn hon os byddwch yn gweithredu busnes yn yr UE. EUR-Lex Y fersiwn yn yr archif ar y we yw’r fersiwn swyddogol o’r ddeddfwriaeth fel yr oedd ar y diwrnod ymadael cyn cael ei chyhoeddi ar legislation.gov.uk ac unrhyw newidiadau ac effeithiau a weithredwyd yn y Deyrnas Unedig wedyn. Mae’r archif ar y we hefyd yn cynnwys cyfraith achos a ffurfiau mewn ieithoedd eraill o EUR-Lex. The EU Exit Web Archive legislation_originated_from_EU_p3
Status:
EU_status_warning_original_version
This legislation may since have been updated - see the latest available (revised) version
8.ADDITIVES ALREADY AUTHORISED FOR USE IN FOOD
8.1.Section I: summary of the dossier
The whole of Section I of Annex II applies.
8.2.Section II: identity, characterisation and conditions of use of the additive; methods of analysis
The Section II of Annex II applies as following:
for additives subject to a specific holder of the authorisation, the whole of Section II applies,
for other additives the paragraphs 2.1.2, 2.1.3, 2.1.4, 2.1.4.2, 2.2, 2.3.1, 2.3.2., 2.4.1, 2.4.2, 2.4.4, 2.5, 2.6 apply.
8.3.Section III: studies concerning the safety of the additives
The most recent formal assessments of the safety of the food additive shall be included and shall be supplemented with any subsequently produced data.
For those additives which are authorised as food additives or approved as components for foodstuffs in the European Union without any restriction, studies concerning the safety for the consumer and the workers are generally not necessary.
Subsections 3.1, 3.2 and 3.3 of Annex II shall be provided considering the present knowledge on the safety of these substances when used in food. Accordingly, such substances also used in food can be classified as:
ADI not specified (without an explicit indication of the upper limit of intake, assigned to substances of very low toxicity),
ADI or UL established, or
no ADI allocated (applicable to substances for which the available information is not sufficient to establish their safety).
8.3.1.Studies concerning the safety of use of the additive for the target animals
If the use level as for the feed additive is similar to that used in food, the safety for target species can be assessed based on the in vivo toxicological data available, a consideration of chemical structure and the metabolic capacity of the target species. If the use level in feed is considerably higher than the corresponding use in food, a tolerance study in the target animal may be required, depending on the nature of the substance.
8.3.2.Studies concerning the safety of use of the additive for consumers
If the use as a feed additive results in a higher consumer exposure, or to a different pattern of metabolites than that resulting from use in food, then further toxicological and residue data will be required.
8.3.2.1.Food additives for which an ADI is not specified
Assessment of the safety for consumers is not required, except when the use of the additive in feed leads to a different pattern of metabolites than when used in food.
8.3.2.2.Food additives with an established ADI or UL
Consumer safety must be assessed taking into consideration the additional exposure from feed use, or specific exposure related to metabolites arising from the target species. This can be done by extrapolating residue data from literature.
Where residue studies are necessary, the requirement is limited to a comparison of the tissue or product levels in an untreated group to the group supplemented with the highest dose that is claimed.
8.3.2.3.Food additives for which no ADI is allocated
The reasons why an ADI was not allocated shall be clearly specified. If concerns arise from this, and the use of the additive in feed would contribute to a significant increase in consumer exposure, a full toxicological evaluation is required.
Additional exposure from feed use can be extrapolated from residue data from the literature.
Where residue studies are necessary, the requirement is limited to a comparison of the levels in tissues or products in an untreated group with the group supplemented with the highest dose that is claimed.
8.3.3.Studies concerning the safety of use of the additive for users/workers
The whole of the subsection 3.3 of Annex II applies.
Precautionary measures set for handling these substances used in food shall be taken into account when considering user safety for the feed additive.
8.3.4.Studies concerning the safety of use of the additive for the environment
Subsection 3.4 of Annex II is required.
8.4.Section IV: studies concerning the efficacy of the additive
Where the function requested for feed is the same as that used in food, no further demonstration of efficacy might be necessary. Otherwise the requirements for efficacy are as those shown in Section IV of Annex II.
8.5.Section V: post-market monitoring plan
This section of Annex II shall apply under provision of Article 7(3)(g) of Regulation (EC) No 1831/2003.
Options/Help
Print Options
PrintThe Whole Regulation
PrintThe Whole Annex
PrintThis Division only
You have chosen to open the Whole Regulation
The Whole Regulation you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
You have chosen to open Schedules only
Y Rhestrau you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
Mae deddfwriaeth ar gael mewn fersiynau gwahanol:
Y Diweddaraf sydd Ar Gael (diwygiedig):Y fersiwn ddiweddaraf sydd ar gael o’r ddeddfwriaeth yn cynnwys newidiadau a wnaed gan ddeddfwriaeth ddilynol ac wedi eu gweithredu gan ein tîm golygyddol. Gellir gweld y newidiadau nad ydym wedi eu gweithredu i’r testun eto yn yr ardal ‘Newidiadau i Ddeddfwriaeth’.
Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE): Mae'r wreiddiol version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.
Dewisiadau Agor
Dewisiadau gwahanol i agor deddfwriaeth er mwyn gweld rhagor o gynnwys ar y sgrin ar yr un pryd
Rhagor o Adnoddau
Gallwch wneud defnydd o ddogfennau atodol hanfodol a gwybodaeth ar gyfer yr eitem ddeddfwriaeth o’r tab hwn. Yn ddibynnol ar yr eitem ddeddfwriaeth sydd i’w gweld, gallai hyn gynnwys:
- y PDF print gwreiddiol y fel adopted version that was used for the EU Official Journal
- rhestr o newidiadau a wnaed gan a/neu yn effeithio ar yr eitem hon o ddeddfwriaeth
- pob fformat o’r holl ddogfennau cysylltiedig
- slipiau cywiro
- dolenni i ddeddfwriaeth gysylltiedig ac adnoddau gwybodaeth eraill
Rhagor o Adnoddau
Defnyddiwch y ddewislen hon i agor dogfennau hanfodol sy’n cyd-fynd â’r ddeddfwriaeth a gwybodaeth am yr eitem hon o ddeddfwriaeth. Gan ddibynnu ar yr eitem o ddeddfwriaeth sy’n cael ei gweld gall hyn gynnwys:
- y PDF print gwreiddiol y fel adopted fersiwn a ddefnyddiwyd am y copi print
- slipiau cywiro
liciwch ‘Gweld Mwy’ neu ddewis ‘Rhagor o Adnoddau’ am wybodaeth ychwanegol gan gynnwys
- rhestr o newidiadau a wnaed gan a/neu yn effeithio ar yr eitem hon o ddeddfwriaeth
- manylion rhoi grym a newid cyffredinol
- pob fformat o’r holl ddogfennau cysylltiedig
- dolenni i ddeddfwriaeth gysylltiedig ac adnoddau gwybodaeth eraill
Mae’r holl gynnwys ar gael dan Drwydded Llywodraeth Agored v3.0 ac eithrio ble nodir yn wahanol. Yn ychwanegol mae’r safle hwn â chynnwys sy’n deillio o EUR-Lex, a ailddefnyddiwyd dan delerau Penderfyniad y Comisiwn 2011/833/EU ar ailddefnyddio dogfennau o sefydliadau’r UE. Am ragor o wybodaeth gweler ddatganiad cyhoeddus Swyddfa Gyhoeddiadau’r UE ar ailddefnyddio.