- Latest available (Revised)
- Point in Time (31/01/2020)
- Original (As adopted by EU)
Commission Regulation (EC) No 429/2008Show full title
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:
What Version
Advanced Features
- Show Geographical Extent(e.g. England, Wales, Scotland and Northern Ireland)
- Show Timeline of Changes
More Resources
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.
This item of legislation originated from the EU
Legislation.gov.uk publishes the UK version. EUR-Lex publishes the EU version. The EU Exit Web Archive holds a snapshot of EUR-Lex’s version from IP completion day (31 December 2020 11.00 p.m.).
Status:
Point in time view as at 31/01/2020.
Changes to legislation:
There are currently no known outstanding effects for the Commission Regulation (EC) No 429/2008, Division 1..
Changes to Legislation
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
1.SECTION I: SUMMARY OF THE DOSSIERU.K.
1.1.Public summary according to Article 7(3)(h) of Regulation (EC) No 1831/2003U.K.
The applicant shall submit a summary indicating the main features of the additive concerned. The summary shall not contain any confidential information and shall be structured as follows:
1.1.1.ContentsU.K.
(a)
name of the applicant(s);
(b)
identification of the additive;
(c)
method of production and method of analysis;
(d)
studies on safety and efficacy of the additive;
(e)
proposed conditions for use; and
(f)
proposal for post-market monitoring.
1.1.2.DescriptionU.K.
(a)
name and address of the applicant(s)
This information shall be provided in all cases, independent of the type of feed additive authorisation (holder-specific or non-holder specific). When a dossier is submitted by a group of applicants, the name of each of them shall be indicated.
(b)
identification of the additive
The identification of the additive shall contain a summary of the information required according to Annex II or III, depending on the type of the feed additive authorisation. In particular: name of the additive, proposed classification by category and functional group, target species/animal categories and doses.
(c)
method of production and method of analysis
The manufacturing process shall be described.
The general procedures of the analytical methods to be used for the analysis for the official controls of the additive as such, in premixtures, and in feedingstuffs, as required in this Annex and Annex III shall be described. If appropriate, on the basis of the information submitted in this Annex and Annex III, the procedure of the method(s) to be used for the analysis for the official controls of the additives or its metabolites in food of animal origin shall be included.
(d)
studies on safety and efficacy of the additive
The conclusion regarding the safety and efficacy of the additive based on the different studies performed shall be given. The results of the studies may be included in a tabular form to support the conclusion of the applicant(s). Only studies required according to Annex III shall be indicated in the summary.
(e)
proposed conditions for use
The proposal for conditions of use shall be provided by the applicant(s). In particular the applicant shall describe the level of use in water or feed, together with the detailed conditions of use in complementary feedingstuffs. Information is also required where other methods of administration or incorporation in feed or water are used. Any specific conditions for use (e.g. incompatibilities), specific labelling requirements and animal species for which the additive is intended shall be described.
(f)
proposal for post-market monitoring
This part shall only relates to additives, which according to point (g) of Article 7(3) of Regulation (EC) No 1831/2003, do not belong to categories shown as (a) or (b) in Article 6(1) of the same Regulation and to additives falling within the scope of Community legislation relating to the marketing of products consisting of, containing or produced from GMOs.
1.2.Scientific summary of the dossierU.K.
A scientific summary including details of each part of the documents submitted to support the application, according to this Annex and Annex III shall be submitted. This summary shall include the conclusions made by the applicant(s).
The summary must follow the order of this Annex and address all the different parts with reference to the relevant pages of the dossier.
1.3.List of documents and other particularsU.K.
The applicant must identify the number and titles of volumes of documentation submitted in support of the application. A detailed index with reference to volumes and pages shall be added.
1.4.List of parts of the dossier requested to be treated as confidential, where necessaryU.K.
The list shall make reference to the relevant volumes and pages of the dossier.
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
The Schedules 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?
Legislation is available in different versions:
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As adopted by EU): The original version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.
Point in Time: This becomes available after navigating to view revised legislation as it stood at a certain point in time via Advanced Features > Show Timeline of Changes or via a point in time advanced search.
See additional information alongside the content
Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Opening Options
Different options to open legislation in order to view more content on screen at once
More Resources
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as adopted version that was used for the EU Official Journal
- lists of changes made by and/or affecting this legislation item
- all formats of all associated documents
- correction slips
- links to related legislation and further information resources
Timeline of Changes
This timeline shows the different versions taken from EUR-Lex before exit day and during the implementation period as well as any subsequent versions created after the implementation period as a result of changes made by UK legislation.
The dates for the EU versions are taken from the document dates on EUR-Lex and may not always coincide with when the changes came into force for the document.
For any versions created after the implementation period as a result of changes made by UK legislation the date will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. For further information see our guide to revised legislation on Understanding Legislation.
More Resources
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as adopted version that was used for the print copy
- correction slips
Click 'View More' or select 'More Resources' tab for additional information including:
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- links to related legislation and further information resources
All content is available under the Open Government Licence v3.0 except where otherwise stated. This site additionally contains content derived from EUR-Lex, reused under the terms of the Commission Decision 2011/833/EU on the reuse of documents from the EU institutions. For more information see the EUR-Lex public statement on re-use.