2013 was a decisive year for the European dietary supplements industry.
While the EU was preparing to implement the Food Information Regulation (FIR – Regulation (EU) No. 1169/2011), another topic increasingly came into focus: the composition and quality of ingredients.
The industry faced a new era of regulatory compliance, transparency, and scientific scrutiny.
1. The legal framework: Directive 2002/46/EC and FIC
In 2013, the composition of dietary supplements was determined by two central EU regulations:
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Directive 2002/46/EC (Dietary Supplements Directive):
It specified which vitamins, minerals, and other substances with nutritional or physiological effects may be used in dietary supplements – including the approved chemical forms (e.g., ascorbic acid for vitamin C). -
Regulation (EU) No. 1169/2011 (FIC):
Originally focused on food labeling, it also made a complete disclosure of ingredients and clear allergen labeling mandatory for dietary supplements.
Together, these regulations laid the foundation for greater safety, traceability, and consumer trust.
2. Vitamins and minerals: Only approved forms
By 2013, the EU had largely harmonized its positive list of approved nutrient compounds.
Manufacturers had to ensure that only authorized chemical forms of vitamins and minerals were used.
At the same time, the trend towards organically bound, bioavailable forms and synergistic combinations (e.g., vitamin D3 + calcium, magnesium + zinc) prevailed.
3. The grey area of “other substances”
Besides vitamins and minerals, many bioactive substances – such as plant extracts, amino acids, enzymes, and probiotics – remained a regulatory grey area.
In 2013, the EU had still not adopted a unified list of permitted substances.
Instead, national regulations applied, for example in Germany, France, and Italy.
A significant step was the BELFRIT project, a joint initiative of these three countries to develop a list of permitted plant substances for dietary supplements.
👉 Impact:
Many manufacturers began aligning with the strictest national standards to prepare for future EU harmonization.
4. Safety and quality assessment by EFSA
In 2013, the European Food Safety Authority (EFSA) intensified its work on ingredient evaluation:
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Establishment of upper safe intake levels (ULs) for vitamins and minerals
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Examination of the toxicology and efficacy of plant ingredients
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Strict evaluation of health and efficacy claims
👉 Result:
Manufacturers increasingly had to scientifically validate their formulations and use high-quality, standardized raw materials.
5. Transparency and the beginning of the “clean label” trend
With the upcoming LMIV, the complete labeling of all ingredients – including carriers, additives, and allergens – became mandatory.
Already in 2013, many brands began modernizing their labels and publishing transparent ingredient information.
Short, understandable ingredient lists became a quality feature – and triggered the now established clean label trend.
Conclusion: 2013 – The year of ingredient responsibility
2013 marked the beginning of a new awareness in the dietary supplements industry.
Regulators demanded scientific evidence and clear declaration, while consumers demanded honesty and quality.
The result:
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Formulations became cleaner,
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Raw material sources became more traceable,
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and labeling became more transparent.
2013 was the year when the EU industry took responsibility for every ingredient.
Transparency became the new competitive advantage.
