Our services for the registration of specialized (including sports) and infant food products include:
- State registration of specialized and infant food, milk formula and infant herbal beverages of domestic and foreign production;
- Preliminary laboratory testing;
- Amending the Marketing Authorisation Certificate (place of manufacture, product name, marketing authorisation holder, shelf life, etc.);
- Voluntary certification;
- For domestic developers — selection of the manufacturing site, development of technical specifications.
According to Customs Union Technical Regulation TR CU 021/2011 entitled On Food Safety, specialized food products and sports and infant food (Including drinking water for infant food) shall be subject to state registration and inclusion in the Customs Union unified registry of marketing authorisation certificates.
Specialized Food Products are food products for which there are requirements regarding the content and/or ratio of the individual substances or all substances and components, and/or the content and/or ratio of the individual substances in such food products has been changed relative to their natural content, and/or substances or components not originally present (other than food additives and flavorings) have been included, and/or the manufacturer claims that they have therapeutic and/or prophylactic properties, and which are intended for the safe use of these food products by certain categories of people;
Infant foods include milk formula, food products for children, and paediatric herbal teas. Such products can be intended for infants and toddlers aged 0 to 3 years, preschoolers aged 3 to 6 years, or school-age children aged 6 years or older, and must meet the relevant physiological needs of the child’s body and not harm the health of a child of the appropriate age;
Sports Nutrition – Specialized food products of a given chemical composition, of increased nutritional value and/or of targeted effectiveness, that consist of a combination of products or are presented as individual types, and that have a specific effect on increasing human adaptive capacity for physical and neuro-emotional stress;
All of the above products are subject to state registration and inclusion in the Customs Union registry of marketing authorisation certificates.
We offer complex solution of the problem of infant, specialized sports nutrition registration
- Perform an initial evaluation of the dossier and provide client consultation
- Determine whether laboratory testing is required prior to applying for marketing authorisation
- Evaluate the completeness of the materials submitted and their compliance with registering agency requirements
- Calculate the cost of registration and come to an agreement with the client
- Translate and certify documents (for foreign products)
- Compile and complete the dossier in accordance with regulatory requirements (see the Regulatory Framework section)
- Submit the dossier and samples for the state registration evaluation
- Submit additional materials, respond to reviewer questions, and monitor the pre-registration evaluation process
- Obtain the expert findings
- Submit the application and dossier
- Monitor the evaluation status, coordinate with the reviewers, supply supplemental materials, and respond to questions
- Obtain the marketing authorisation certificate and transfer it to the client
- List of documents and data required to register domestically produced infant food
- Llist of documents and data required to register foreign-produced infant food
- Regulatory framework
The list of documents and data required for the registration of mineral water and energetic beverages
Legal and regulatory framework.
- ТР ТС 021/2011 «О безопасности пищевой продукции»
- ТР ТС 022/2011 «Пищевая продукция в части ее маркировки»
- ТР ТС 027/2012 «О безопасности отдельных видов специализированной пищевой продукции, в том числе диетического лечебного и диетического профилактического питания»
- ТР ТС 029/2012 «Требования безопасности пищевых добавок, ароматизаторов и технологических вспомогательных средств»
- ТР ТС 005/2011 «О безопасности упаковки»
- Единые санитарно-эпидемиологические и гигиенические требования к товарам, подлежащим санитарно-эпидемиологическому контролю(надзору)
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Telephone №1: +7 (495) 120-11-64
Telephone №2: +7 (495) 120-11-59
Telephone №3: +7 (903) 748-60-35 (English — speaking consultant)