Why you should buy this report?

The demand for health and immunity-boosting products such as probiotics is expected to grow at a healthier pace due to more and more Polish citizens opting for preventive healthcare practices, and understanding the importance of health and diet.

This report is a comprehensive resource for studying end-to-end regulations on probiotics in Poland, where the food & supplements market is growing rapidly over the years.

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
  4. REGISTRATION REQUIREMENTS
    1. Product Registration Process
    2. Documents to be Submitted
    3. Submission/Delivery Mode
    4. Submission Fees
    5. Timeline
  5. FOOD MICRO-ORGANISMS AND THE EU NOVEL FOOD REGULATION
  6. INGREDIENTS AND THEIR LIMITS
    1. Probiotics
    2. 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 label
    6. Requirements for details of manufacturer/importer/distributor on the label
    7. Requirements for Quantitative Ingredient Declaration (QUID) on label
    8. Requirements for list of ingredients and exemptions
    9. Requirements for allergen labeling
    10. Requirements for country of origin on label
    11. Requirements for date marking on label (shelf life, best before, manufacturing date)
    12. Requirements for net weight declaration on label
    13. Requirements for traceability code/ lot number/ batch number declaration on label
    14. Requirements for nutritional information on label
    15. Requirements for making claims on label (nutritional claims, health claims, marketing claims)
    16. Requirements for instructions for use on label
    17. Requirement for multilingual (multi language) labeling
    18. Requirement for font size on the table
    19. Labeling requirements of Health Claims
    20. Labeling requirements as per Dz.U. 2014. 453
  8. ADVERTISING AND CLAIMS
    1. Probiotic Claim
    2. Authorization of Probiotic claims
    3. Type of claims allowed/prohibited
    4. Additional process for approval of new claim
  9. IMPORT REGULATIONS
  10. POST MARKETING AUTHORIZATION
  11. REFERENCES
  12. ANNEXURE
Summary
  • Product definition and governing laws in Poland
  • Information on product registration
  • Precise information on documentation required, ingredients and their limits, submission fees, timelines for registration and submission mode
  • Regulations applicable on labeling, claims and advertising
  • Information on import regulations, and the requirement/qualification of a legal representative

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