Search Legislation

Advanced Search

Commission Regulation (EC) No 353/2008Show full title

Commission Regulation (EC) No 353/2008 of 18 April 2008 establishing implementing rules for applications for authorisation of health claims as provided for in Article 15 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council (Text with EEA relevance)

Help about what version

What Version

More Resources

Revised version PDFs

Help about UK-EU Regulation

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.

Close

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.).

Changes to legislation:

There are currently no known outstanding effects by UK legislation for Commission Regulation (EC) No 353/2008. Help about Changes to Legislation

Close

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. Introductory Text

  2. Article 1.Subject matter

  3. Article 2.Scope of the application

  4. Article 3.Specification of the type of health claim

  5. Article 4.Proprietary data

  6. Article 5.Scientific studies

  7. Article 6.Conditions for use

  8. Article 7.Technical rules

  9. Article 7a. Verification of the validity of applications by the Member States

  10. Article 7b. Withdrawal of applications

  11. Article 8.This Regulation shall enter into force on the 20th day...

  12. Signature

    1. ANNEX

      Technical rules for the preparation and presentation of the application for health claims

      1. INTRODUCTION

        1. 1. This Annex applies to health claims related to the consumption...

        2. 2. In cases where some of the data that are required...

        3. 3. The term ‘application’ hereafter means a stand-alone dossier containing the...

        4. 4. One application shall be prepared for each individual health claim;...

        5. 5. The application shall indicate whether health claim concerned or a...

        6. 6. Pertinent scientific data are all human and non-human studies, published...

        7. 7. Journal abstracts and articles published in newspapers, magazines, newsletters or...

      2. GENERAL PRINCIPLES FOR THE SCIENTIFIC SUBSTANTIATION

        1. 1. The application shall contain all scientific data, published and unpublished,...

        2. 2. The application shall contain a comprehensive review of the data...

        3. 3. The substantiation of health claims shall take into account the...

      3. FOOD CHARACTERISTICS

      4. ORGANISATION OF PERTINENT SCIENTIFIC DATA

        1. 1. Scientific data identified shall be organised in the following order:...

        2. 2. Human data shall be classified according to a hierarchy of...

        3. 3. Non-human data shall consist in:

      5. SUMMARY OF PERTINENT SCIENTIFIC DATA

      6. STRUCTURE OF THE APPLICATION

        1. Part 1 — Administrative and Technical Data

          1. 1.1. Table of contents

          2. 1.2. Application form

          3. 1.3. General information

          4. 1.4. Health claim particulars

          5. 1.5. Summary of the application

          6. 1.6. References

        2. Part 2 — Food/Constituent Characteristics

          1. 2.1. Food constituent

          2. 2.2. Food or category of food

          3. 2.3. References

        3. Part 3 — Overall Summary of Pertinent Scientific Data

          1. 3.1. Tabulated summary of all pertinent studies identified

          2. 3.2. Tabulated summary of data from pertinent human studies

          3. 3.3. Written summary of data from pertinent human studies

          4. 3.4. Written summary of data from pertinent non-human studies

          5. 3.5. Overall conclusions

        4. Part 4 — Body of Pertinent Scientific Data Identified

          1. 4.1. Identification of pertinent scientific data

          2. 4.2. Pertinent data identified

        5. Part 5 — Annexes to the Application

          1. 5.1. Glossary/abbreviations

          2. 5.2. Copies/reprints of pertinent published data

          3. 5.3. Full study reports of pertinent unpublished data

          4. 5.4. Other

Back to top

Options/Help

Print Options

Close

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.

Close

Opening Options

Different options to open legislation in order to view more content on screen at once

Close

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
Close

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.

Close

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

The data on this page is available in the alternative data formats listed: