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
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- LIST OF ABBREVIATIONS
- REGULATORY STATUS
- Governing Regulatory Body
- Governing Laws
- PRODUCT DEFINITION
- REGISTRATION REQUIREMENTS
- Product Registration Process
- Documents to be Submitted
- Submission/Delivery Mode
- Submission Fees
- Timeline
- FOOD MICRO-ORGANISMS AND THE EU NOVEL FOOD REGULATION
- INGREDIENTS AND THEIR LIMITS
- Probiotics
- Vitamins and Minerals
- LABELING REQUIREMENTS
- General Labeling Requirements
- Regulatory controls on label in the European Union
- Requirements for front pack of labeling
- Requirements for trademark/brand name
- Requirements for pictorial graphics on label
- Requirements for details of manufacturer/importer/distributor on the label
- Requirements for Quantitative Ingredient Declaration (QUID) on label
- Requirements for list of ingredients and exemptions
- Requirements for allergen labeling
- Requirements for country of origin on label
- Requirements for date marking on label (shelf life, best before, manufacturing date)
- Requirements for net weight declaration on label
- Requirements for traceability code/ lot number/ batch number declaration on label
- Requirements for nutritional information on label
- Requirements for making claims on label (nutritional claims, health claims, marketing claims)
- Requirements for instructions for use on label
- Requirement for multilingual (multi language) labeling
- Requirement for font size on the table
- Labeling requirements of Health Claims
- Labeling requirements as per Dz.U. 2014. 453
- ADVERTISING AND CLAIMS
- Probiotic Claim
- Authorization of Probiotic claims
- Type of claims allowed/prohibited
- Additional process for approval of new claim
- IMPORT REGULATIONS
- POST MARKETING AUTHORIZATION
- REFERENCES
- ANNEXURE
- Summary
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- 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