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Why you should buy this report?

Italy has the largest probiotic supplement market in Europe and is forecasted to grow to US$722.56 million by 2025, making the probiotics market in Italy, a lucrative industry for any manufacturer or distributor to be a part of.

This report is a comprehensive resource for studying end-to-end regulations on probiotics in Italy.

The objective of this report is to enable a Regulatory go-to-market strategy and ensure compliance.

Table of Contents
  1. LIST OF ABBREVIATIONS
  2. REGULATORY STATUS
    1. Governing Regulatory Body
    2. Governing Laws
  3. PRODUCT DEFINITION AND CLASSIFICATION
    1. Product Definition
  4. REGISTRATION REQUIREMENTS
    1. Product Registration/Notification Process
    2. Documents to be Submitted for Registration/Notification
    3. Submission Format/Delivery Mode
    4. Registration/Notification Fee
    5. Registration Timeline
  5. FOOD MICRO-ORGANISMS AND THE EU NOVEL FOOD REGULATION
  6. INGREDIENTS AND THEIR LIMITS
    1. Probiotics
    2. Quantity of Micro-organisms
    3. List of Vitamins and Minerals
  7. LABELING REQUIREMENTS
    1. General Labeling Requirements
    2. Regulatory Controls on Label in the European Union
    3. Requirements for Front Pack of Labeling
    4. Requirements for Trademark/Brand Name
    5. Requirements for Pictorial Graphics on the Label
    6. Requirements for Details of Manufacturer/Importer/Distributor on the Label
    7. Requirements for Quantitative Ingredient Declaration (QUID) on the Label
    8. Requirements for List of Ingredients and Exemptions
    9. Requirements for Allergen Labeling
    10. Requirements for Country of Origin on the Label
    11. Requirements for Date Marking on the Label (shelf life, best before, manufacturing date)
    12. Requirements for Net Weight Declaration on the Label
    13. Requirements for Traceability Code/Lot Number/Batch Number Declaration on the Label
    14. Requirements for Nutritional Information on the Label
    15. Requirements for Making Claims on the Label (nutritional claims, health claims and marketing claims)
    16. Requirements for Instructions for Use on the Label
    17. Requirement for Multilingual (multi-language) Labeling
    18. Requirement for Font Size on the Table
    19. Labelling Requirements of Health Claims
  8. CLAIMS
    1. Probiotic Claims
    2. Authorization of Probiotic Claims
    3. Type of Claims Allowed/Prohibited
    4. Additional Process for Approval of New Claim
  9. ADVERTISING AND PROMOTIONS
  10. IMPORT REGULATIONS
  11. LOCAL AGENT REQUIREMENTS
  12. POST MARKETING AUTHORIZATION
    1. Validity of Registration Certificate
    2. Variations
    3. Renewal of Product Registration
  13. REFERENCES
  14. ANNEXURE
Summary
  • Product definition and classification criteria in Italy
  • Information on product registration and governing laws
  • Precise information on documentation required, health authority fees, timelines for registration and submission format
  • Regulations applicable on labeling, claims and advertising
  • Information on import regulations, and the requirement/qualification of a legal representative

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