The registration of food supplements has limitations on the content of labels and fact sheet for consumers that are tightly controlled by regulatory authorities. In order to expand the data on the packaging and insert sheet, there is a voluntary certification procedure which provides imposition of additional warnings on the packaging. It is necessary to provide confirmation of product quality and assessment of efficacy of dietary supplements in optimizing different types of metabolism and normalization and / or improvement in the functional status of organs and systems of human body.
Voluntary certification does not negate the mandatory labels obtained by the state registration of food supplements.
RDG services:
- Checking the package of documents for the voluntary certification of food supplements
- Preparation of literary review of the proper format on the safety and efficacy of food supplements
- Preparation of study documents (projects)
- Organization and conduct of studies of food supplements
- Presentation of the results of the study
- Proposals on variants of slogans, additional warnings on the packaging and insert sheet of food supplements according to the results of tests
- Submission of application for voluntary certification, set of documents
- Support of the application and a set of documents
- Conduct of necessary examinations, laboratory testing, studies
- Analysis of the results obtained in cooperation with an expert of the system of voluntary certification, discussion of decision on the possibility of issuing the certificate of conformity
- Obtaining the certificate of conformity and decision on the use of the mark of conformity
Documents necessary for voluntary certification:
- Results of the use of dietary supplements in the format of research, evidence-based materials confirming the influence on certain symptoms, organs, body systems, etc.
- Layout of packing of food supplements
- Draft of instruction for use
- Certificate of analysis with translation
- Composition with description of active components
- The conclusion of Institute of Nutrition of the RAMS
- State marketing authorization
- Application for certification + annex to the application (№ 1, № 2, № 3)
- Power of Attorney
- The act of sampling from the warehouse
- Samples of the preparation
The document confirming voluntary certification is certificate of voluntary certification that is valid for 1 year. During the validity of the certificate, product can be produced and imported with the text on the packaging and insert sheet which was approved in the course of voluntary certification.
Duration of the procedure of voluntary certification is 1 month.