Maven has extensive experience in setting up and implementing labeling process, creation of Core Patient Information Leaflet (Core PIL) and auditing existing labeling setups.
Europe – Clean Label
In Europe, the following regulations have been drafted to help and guide the manufacturers with production and labeling of clean label products.
- Food Information Regulation (Regulation (EU) 1169/2011) – The regulation is applicable to all food products for labeling as well as advertising. It emphasizes on conveying fair information to the consumers. In simpler words, the information on label should not be misleading.
- Health Claims Regulation (Regulation (EC) 1924/2006 on nutrition and health claims made on food) – Established in 2007, the regulation covers nutrition and health claims for food products across the EU. It is applicable to the nutrition and health claims used for communicating information commercially.
- Flavoring and Additive Regulation (Regulation (EC) 1334/2008 and Regulation (EC) 1333/2008) – The regulation defines what exactly comes under flavoring and additives. Products coming under the category of “no colorings”, “no preservatives” or “no flavorings” must adhere to the guidelines of these regulations.
US – Nutrition Facts Label
The demand for clean labels is in line with the efforts of the Food and Drug Administration (FDA) to help the consumers understand the food products better with the new Nutrition Fact Label in the US.
Enforced from July 2018, the new nutrition fact label ensures that the label reflects latest scientific information of the product. The revised rule suggests some format changes in the label, which are required to be followed by the food product manufacturers.
The concept of clean label is now moving from labeling to processing, i.e., the process and the production must also adhere to the clean label concept. Despite the hype, the concept of a clean label is still considered to evolve more. Meanwhile, it is advisable for manufacturers to consult a Regulatory expert to understand and implement the concepts more accurately with the possible information on food ingredients. Be up-to-date. Be compliant.
Maven Expertise:
- Global labeling management
- Create, review and update Investigational Brochure (IB)
- Create, review and update Developmental Core Data Sheet (DCDS)
- Create, review and update Company Core Data Sheet (CCDS)/Reference Safety Information (RSI)
- Detailed literature search & review to substantiate labeling content
- Create, review and update Clinical Overviews (CO)/Justification documents (JD)
- Quality Check (QC) of Core labels (IB, DCDS, CCDS, RSI, CO/JD)
- Tracking and implementation of labeling Changes
- Label Content Change Control Management
- HA query Management
- Preparation of label justification documents
- Global deviation management
- Proofreading and departmental Quality Control (QC)
- Labeling operations (packaging, bottle labeling and artwork systems)
- Technical/SPL
- Core to local label harmonization
- Local label safety alignment with reference label
- Assess safety & non-safety updates across markets
- Creation of core patient information leaflet (Core PIL)
- Identify internal and external signal detection and innovator label changes (signal management)
- Assess the safety updates and signals from one region/country and their impact on other regions/countries
Cosmetic Labeling :
USA
The U.S. the Food and Drug Administration controls the Cosmetics labeling under the Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA)
Principle Display Panel
A principle display panel consists of information which indicates the nature as well as the use of the product. The information is conveyed through a common name or an illustration. The label also informs about the net contents of the cosmetic product.
Information Panel
The following information must be mentioned on the information panel:
- In case the distributor and the manufacturer of the product are different, it must be clearly mentioned on the label.
- Material facts must be mentioned on the label to ensure there are no misleading labeling practices.
- If the cosmetic may harm the consumers, the product label must bear the respective warnings and precautions.
- The product must provide an extensive list of the ingredients used in the cosmetic product
European Union (EU)
In the EU, the cosmetic labeling requirements are regulated under EU Cosmetics Regulation 1223/2009.
- Purpose of the cosmetic product
- Name and address of the responsible person
- In case of imported product, the origin country must be mentioned on the label
- The net content of the ingredients of the product
- Usability duration of the product
- Precautions
- Product identification or batch number
- List of ingredients
INDIA
the Central Drug Standard Control Organization (CDSCO) regulates beauty products under the overarching regulations governed by Drug and Cosmetic Act 1940 & Rules 1945 vide Gazette Notification G.S.R 426(E)
The manufacturers, their authorized agents and subsidiaries in India, and any other importers can apply for issuing a registration certificate for the import of cosmetics in India by uploading necessary documents through SUGAM portal. The application for registration i.e. Form 42 with required documents are submitted to CDSCO, followed by obtaining Registration certificate i.e. Form 43 within 3-6 months and has three-year validity of the registration.
MAVEN also provides authorized agent services and help in procuring SUGAM portal membership and uploading form 42 alongside all the necessary documents
Formulation Review
Cosmetics Claims and Substantiation Services
Labeling Review as per Drugs & Cosmetics Rules Act
Dossier Compilation
Registration with the CDSCO
SUGAM Portal Membership
Authorized Agent Services
Medical Devices Labeling
Food/Dietary Supplements Labeling
- Create, update & review contraindications, warnings, precautions
- Development and review of nutritional and Health claims
- Development and review of Nutritional Declarations
- Creation and review of product labels for Food and Dietary Supplements
- Creation, updating and reviewing of, core food supplement labels (Core Summary of Food Product Characteristics)
- Creation of Company Core Data Sheet(CCDS)/Core Safety Information(CSI)
- Preparation and tracking of Dear Doctor or Dear HCP letters
