It is established that the more a brand has build a concept and a territory, the more the consumer will rely on the products. Before the R&D and regulatory processes, companies should make a research and analysis of the concept and brand position. The goal is to strengthen the characteristics leading to value and differentiation, upgrading purchase decision and fidelity. From the moment a precise product brief has been validated, the R&D and Regulatory teams can be ensured to develop a long lasting product.
Scientific substantiation (efficacy and safety data) and innovative ingredients (novel or not)
Regulatory constraints (country, dosage…)
Existing patent applications
Technical and economical constraints
Consumer expectations in term of product efficacy as a whole or each of its constituents (pineapple and sliming, caffeine and energy…)
3) Intellectual property
Lead time: from 2 to 4 months
This optional step is strongly recommended to secure your invention and/ or its formula for a health application, differentiate from competitors and to market an exclusive product for this application. An application or manufacturing patent gives an extra value to the product in terms of communication. It is an alternative for a specific health claim which could be hard to obtain. Patent refers to innovation, originality, research, efficacy of the product, characteristics which have a strong impact on consumers. In addition, it is the best existing alternative in the legal arsenal, for its easy going investment in commercial & legal matters as well as for the protection of its upcoming health claim. Feasibility, complexity and costs vary in accordance with the level of protection: local or international patent.
4) Quality control
Lead time: from 1 to 3 months
Sourcing (i.e research of raw materials) is based on strict quality criteria that meet the requirements of the quality charter and standards. A quality charter must be set up by the supplier so that he guarantees quality of raw materials in terms of specifications (Latin name, plant part, ratio, active substance, contaminants, microbiology, residual solvent…), traceability,… but also about conducting its own studies (efficacy, safety) or price or availability. Raw materials must have constant specifications according to seasonality and among several batches.
5) Manufacturing development
Lead time: from 2 to 4 months
Manufacturing development is made up of two steps:
On lab scale: to define the accurate quantitative formulation of the product (excipient content) and to anticipate on possible interactions between the components and between packaging and content.
On industrial scale: to approve industrial feasibility of the product and to conduct stability study. This step enables to define a production process and the quality control made, before, during and at the end of a product production in order to meet the regulatory requirements. The manufacturing process is commonly asked in various files as health claim application, novel food application…
6) Characterization of the product
Lead time: from 6 to 36 months
Responding to the requirements of several files as health claim or novel food applications, the characterization of the product consists in four main criteria:
Identification and dosage of active components, through validated analytical methods, depending on the matrix in the product and on many batches (variability study) : standardization of the product.
Validation of the stability: follow-up of physical and chemical parameters during and at the end of the Best Before Date in the sales condition of the product.
If necessary, the validation of the in vitro mechanism of action (in all cases: test recommended beforehand of investments in in vivo and clinical studies).
Bioavailability study of active components tatement of claim.
7) Safety validation
Lead time: 1 to 6 months depending on study type
While these safety data is required by the European authorities within the framework of the Novel Food file, this is not the case for the health claim file request. Obviously, both safety and efficacy of a health & nutrition product should be substantiated. Various tests can be performed by specialized laboratories such as in vitro tests (mutagenicity, genotoxicity …) and on animals (acute/ subchronic toxicity studies, teratogenesis…). EFSA clearly stated its recommendations on this subject. This complementary step contributes to ensure the product safety.
8) Regulatory conformity
Lead time: 1 to 4 months
In the background of a permanent evolution of the regulatory requirements of health & nutrition products, it is important to follow the regulatory evolution within the European countries (lists of plants, regulatory texts and regularly exchange with authorities). This mandatory regulatory step allows:
Notification / registration of the product to the competent administrations of the member states. It allows getting the authorization of marketing (tacit or notified)/ allocation of a registration number in accordance with the target countries.
Analysis and validation of communications tools (brochure, leaflet, website,…)
9) Efficacy studies
Lead time: from 12 months to 36 months depending on the application
The European authority expects from industrials some basic rules in the setting up of clinical trial protocols on their products:
The study must be representative of the target population for which the claim is intended
The effect of the product must be beneficial for human health
Markers of efficacy must be biologically and analytically validated
The sample size must be calculated on the basis of appropriate statistical hypothesis This significant investment in terms of experience, lead time and cost can bring an actual competitive advantage, through the achievement of a specific product claim.
10) Health claim
Lead time: 18 months
The constitution and submission to EFSA of the health claim application (in art.13.5 or 14) substantiating the efficacy of your product is the last and optimal stage of its development. The evaluation by EFSA is based on 3 main criteria: characterization of the product, the health relationship and scientific evidences substantiating the efficacy of the product. When you get a positive scientific opinion from EFSA and a regulatory validation by the EC, you are allowed to communicate on the product with its own claim in the whole European Union (27 member states!). Conversely, competitors will use generic claims which will homogenize the market.
11) Launch of the product
Lead time: from 1 to 3 months
Now your product is efficient, safe, innovative and compliant, you can claim on its efficacy and it is ready to be launched on the market supported by your communication and brand strategy.
NOL Data Solution is an essential tool for anyone interested in food Regulatory matters in Europe.
Nestle Health Science
The NOL datasolution is my 'go to' source for accessing regulatory information for the EU. It's straightforward design makes locating the documentation I'm looking for quick and easy. Thanks to Nutraveris for consolidating this important data in a single, user-friendly format!
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