The market size for dietary supplements in the European Union is over $5 billion and is projected to grow through 2026. It is worth noting that in Europe, dietary supplements are regulated by directives, ordinances and regulations. The main document distributing dietary supplements in Europe is Directive 2002/46/EC, which defines “dietary supplements”, lists the permissible minerals and vitamins, and provides labelling instructions. This document contains information on maximum and minimum amounts of ingredients. It is also important to note that each member state of the European Union is allowed to impose additional restrictions on ingredients.
Understanding the intricacies of the required documentation can be difficult, which is why our experts at Millmax have written an article explaining the relevant rules.
The concept of dietary supplements and their regulation in Europe
First, you need to understand the concept of dietary supplements. Bioactive supplements are defined as products containing biologically active substances intended to improve the general condition of the body or maintain health. According to European law, the definition and classification of dietary supplements are regulated by special directives.
According to the European Union Directive 2002/46/EC, a dietary supplement is defined as a product intended to supplement the normal diet and containing one or more biologically active ingredients, including vitamins, minerals, amino acids, fatty acids, plant extracts or other similar substances. Dietary supplements are usually intended to be taken in small amounts as part of a food or drink for additional nutritional purposes.
The European Dietary Supplement Approval and Registration Process
If a dietary supplement requires approval and registration, the process is as follows:
1. Prepare the necessary documents.
The first step in the process is to collate all relevant documentation, including data on the product’s ingredients, manufacturing process, safety, efficacy and stability. Clinical trial results, analytical data, proof of safety and quality of ingredients are required.
2. Choice of Competent Authority.
It is very important that you check the list of competent authorities in the European Union member states and select one option for where you want to introduce your product. Competent authorities are responsible for registering and regulating dietary supplements according to local law.
3. Submit your application.
Before submitting an application for registration of a dietary supplement, the necessary documentation must be prepared as per the regulations of the relevant authorities, which must contain all the relevant information about the said product, such as its ingredients, safety, efficacy and other aspects as specified by the said authorities.
4. Evaluate the document.
The competent authorities will analyze the submitted documentation, which may include an analysis of the product ingredients, the safety of the active ingredients, efficacy and other criteria. At this stage, additional information may be requested or the documentation may be returned in order to correct deficiencies in the submitted documentation.
5. Conducting further testing and research (if necessary)
Competent authorities may require additional clinical or laboratory tests to confirm the effectiveness and health safety of the product in question.
6. Approval issues.
Once the evaluation process is complete, if the results are favorable and all requirements established by the competent authorities are met, the necessary authorisation for the registration of the food additive will be issued, which guarantees that the manufactured product complies with all necessary regulations and can be placed on the European Union market.
7. Post-Registration Regulatory Compliance.
Once registration permission is granted, it is paramount to comply with all requirements and regulations set forth by the competent authorities, which may include mandatory labelling of products, regular reporting, adherence to production and quality standards, etc.
Each of these steps is crucial for a proper and legal entry into the European market, therefore we highly recommend understanding all the nuances and getting expert support in advance.
Quality and Safety Requirements
It is important to realize that manufactured dietary supplements must conform to certain quality and safety standards that protect the health of the consumer and indicate good product quality. The key criteria employed to evaluate the quality and safety of a product are:
Purity and integrity of ingredients, safety of use, quality of manufacturing, mandatory labelling and consumer information, compliance with regulations and standards, clinical studies and efficacy.
The European market is characterised by strict regulations, especially regarding the quality and safety of products intended for human consumption, so producers must take these factors into account at an early stage and present a high-quality product to the relevant authorities.
Practical advice for producers and entrepreneurs
To make the process easier for entrepreneurs, vitamin manufacturer Milmax offers some helpful tips:
Research the laws and requirements.
Before beginning the registration process, it is very important to closely study the relevant European Union legislation as well as the national laws and regulations of the countries in which you plan to introduce your product.
Collaborate with experts.
You can always seek advice from experts familiar with the registration of dietary supplements in Europe. Such experts include regulatory and certification consultants. Their expertise and experience play a key role in correctly assessing your requirements and saving you time and resources.
Prepare comprehensive documentation.
It is advisable to check in advance that all documentation required to meet the requirements of the competent authorities is provided, including information on the product ingredients, safety, efficacy, manufacturing process and other important aspects.
Don’t leave anything to chance. We recommend keeping track of deadlines for submitting documents and processing your registration application.
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Ensuring the production of the highest quality dietary supplements and controlling all stages of production is crucial. Compliance with Good Manufacturing Practice (GMP) standards and other relevant regulations will impress authorities and consumers alike.
Pay attention to trends.
It is crucial that we monitor market trends and stay abreast of changes in European Union laws and regulations, so we can stay up to date with the latest requirements and trends.
Conclusion
Companies that choose to manufacture their own dietary supplements must be aware of the complexities of production and the need to correctly evaluate consumer demand. In addition, they must study the issues of registration and certification of dietary supplements. Business owners are advised to seek advice from experts who can provide valuable advice and help choose the quickest way to obtain 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, significantly simplifying the market entry process and allowing smooth business operations in Europe.
