The market for dietary supplements in the European Union exceeds $5 billion and is forecast to grow until 2026. It is noteworthy that in Europe, food supplements are regulated by directives, ordinances and regulations. The key document responsible for their circulation in Europe is Directive 2002/46/EC, which defines "food supplement", lists permissible minerals and vitamins, and provides instructions on their labelling. The document contains information on the maximum and minimum quantities of ingredients. It is also important to note that each member state of the European Union is permitted to set additional restrictions on ingredients.
It is challenging to comprehend the intricacies of the requisite documentation. To that end, Millmax experts have authored an article that elucidates the pertinent rules.
The concept of dietary supplements and their regulation in Europe
It is first necessary to gain an understanding of the concept of dietary supplements. Biologically active supplements are defined as products containing biologically active substances with the intention of improving the general condition of the body or maintaining its health. According to European legislation, the definition and classification of dietary supplements are regulated by special directives.
In accordance with the European Union Directive 2002/46/EC, dietary supplements are defined as products that are intended to supplement the normal diet and contain one or more bioactive ingredients, including vitamins, minerals, amino acids, fatty acids, plant extracts and other similar substances. They are generally intended to be consumed in small quantities as part of food or beverages to provide additional nutrition.
Authorisation and registration process for dietary supplements in Europe
Should authorisation and registration of a dietary supplement be required, the procedure will be as follows:
1. The preparation of required documentation.
The initial stage of the process involves the collation of all pertinent documentation, including data on the product's composition, manufacturing processes, safety, efficacy and stability. Clinical trial results, analytical data, proof of safety and the quality of ingredients will be required.
2. Selection of a competent authority.
It is of the utmost importance to become acquainted with the list of competent authorities in the European Union states and select one of the options where you wish to introduce your product. The competent authority is responsible for the registration and regulation of dietary supplements in accordance with local legislation.
3. Application submission.
Prior to the submission of an application for the registration of a dietary supplement, it is necessary to prepare the requisite documentation in accordance with the stipulations of the relevant authority. This should include all pertinent information regarding the product in question, including its composition, safety, efficacy, and any other aspects that may be specified by the aforementioned authority.
4. Documentation assessment.
The competent authority will analyse the documentation provided. This may include an analysis of the composition of the product, the safety of its active ingredients, efficacy and other criteria. At this stage, additional information may be required or documents may be returned to correct deficiencies in the submitted material.
5. Conducting further tests and studies (if necessary)
The competent authority may require additional clinical testing or laboratory tests to confirm the efficacy and health safety of the product in question.
6. Authorisation issue.
Upon completion of the evaluation process, if the outcome is favourable and all the requisite conditions set forth by the competent authority are met, the requisite authorisation for the registration of the food additive is issued. This authorisation serves to guarantee that the product manufactured will comply with all the necessary regulations and can be placed on the market of the European Union.
7. Post-registration regulatory compliance.
Once authorisation for registration has been granted, it is of the utmost importance to adhere to all requirements and regulations set forth by the competent authorities. This may include the mandatory labelling of products, regular reporting, and compliance with production and quality standards.
Each of these steps is crucial for a competent and legal entry into the European market. Therefore, it is highly recommended to familiarise oneself with all the nuances and to obtain expert support in advance.
Quality and safety requirements
It is crucial to acknowledge that a manufactured dietary supplement must adhere to specific quality and safety standards that safeguard consumer health and signify a superior level of product quality. Crucial criteria that are employed to assess the quality and safety of the product include:
- purity and integrity of ingredients;
- safety of use;
- quality of production;
- mandatory labelling and consumer information;
- compliance with regulations and standards;
- clinical studies and efficacy.
The European market is characterised by a high level of regulatory control regarding the quality and safety of products, particularly those intended for human consumption. Producers must therefore consider these factors at an early stage and present quality products to the relevant authorities.
Pragmatic advice for producers and entrepreneurs
In order to facilitate the processes for entrepreneurs, vitamins manufacturer Millmax has provided a number of helpful tips:
- Research the legislation and requirements.
It is of the utmost importance to meticulously examine the pertinent European Union legislation and the national laws and regulations of the countries into which one plans to introduce one's products prior to the registration process.
- Cooperation with the professionals.
It is always possible to seek advice from professionals who are well versed in the registration of dietary supplements in Europe. Such professionals include regulatory and certification consultants. Expertise and experience will play an important role in correctly assessing the requirements and saving time and resources.
- Prepare comprehensive documentation.
It is advisable to ascertain in advance that all necessary documentation has been provided, which must fulfil the requirements of the competent authority. This includes information on product composition, safety, efficacy, manufacturing processes and other important aspects.
You should not leave everything to chance. It is advisable to maintain a record of the deadlines for submitting documentation and processing the application for registration.
It is of significant importance to ensure the production of dietary supplements of the highest quality and to exercise control over all stages of production. Compliance with Good Manufacturing Practice (GMP) standards and other relevant regulations will send a positive signal to the competent authority and consumers.
- Keep an eye on the trends.
It is of the utmost importance to monitor market trends and to remain apprised of any changes to European Union legislation and regulations. This enables one to remain current with the latest requirements and developments.
Conclusions
The companies that have elected to manufacture their own food supplements must be aware of the intricacies of production and the necessity of correctly assessing consumer demand. In addition, they must study the issue of registration and certification of dietary supplements. Business owners may wish to seek advice from specialists who will be able to provide valuable advice and help them choose the fastest way of obtaining the necessary documentation.
Millmax contract manufacturing offers a comprehensive range of services to assist novice entrepreneurs in the product development and production process. In addition to providing technical and technological support, the company also assists in obtaining the necessary documentation, which greatly simplifies the market entry process and enables smooth operations in Europe.
