Food Industry Regulatory Compliance Consulting Demand in

Picture a supplement brand based outside the EU that ships protein powder and vitamins straight to European consumers from an online store. Orders arrive, parcels move, and then a customs authority pulls products for inspection. EU authorities are now testing exactly this scenario at scale [4]. It explains much of the interest in food industry regulatory compliance consulting.

This article looks at what is driving that interest, what the EU rules actually say about food supplements, and what you can check yourself before you bring in an adviser.

Why compliance support is in demand

The pressure comes from volume and from enforcement. The EU reports that the volume of small packages sent into the EU has doubled every year since 2022 [4]. In 2024, 4.6 billion packages entered the EU market, and at the end of 2025 that volume reached 5.8 billion [4]. Customs authorities are handling this growth while checking whether the goods meet EU product rules [4].

A recent EU-wide control operation put numbers on the problem. In its second phase, 27 customs authorities worked with market surveillance and food safety authorities to run intensive controls from October to December 2025 [4]. They checked products from third-country operators shipping directly to EU consumers, covering cosmetics, personal protective equipment and food supplements [4]. A total of 11 338 pieces were checked, of which 3474 were food supplements [4]. The supplements included protein powder, booster supplements, dietary supplements, herbal preparations and vitamins [4].

The Commission’s finding was blunt: most goods shipped directly to EU consumers from third countries do not comply with EU product rules and safety standards [4]. The United States, China and the United Kingdom were the leading countries of origin for non-compliant food supplements, with the United States holding a marginally larger share [4]. Food supplements are sold through a more diverse range of online platforms than the other categories, but non-compliance was an issue across the entire online food supplement market [4].

Enforcement is not a one-off. Customs say they will keep monitoring e-commerce imports with market surveillance and food safety authorities, and enhanced targeted controls may be decided for products and operators where the risk of non-compliance is particularly high [4]. If you sell into the EU, plan for scrutiny and treat compliance as a cost of market entry rather than an afterthought.

Food supplements are food, and the duty sits with you

Many non-EU brands think of supplements as a product category with its own rulebook. In the EU, the starting point is different. Under the General Food Law Regulation (EC) No 178/2002, food supplements are considered as foodstuffs [3]. Responsibility for their safety lies with the food business operator placing the product on the market [3].

The practical consequence is that the manufacturer, importer, supplier or distributor must ensure that a supplement placed on the market is safe [3]. Ask who in your supply chain holds each of those roles, and make sure the answer is written down in your supply agreements. A marketplace listing does not settle the question.

What the harmonised supplement rules cover

The harmonised rules on food supplements sit in Directive 2002/46/EC [1]. Its objective is to protect consumers against potential health risks from food supplements and to ensure they are not given misleading information [1]. The EU describes food supplements as concentrated sources of nutrients or other substances with a nutritional or physiological effect, marketed in dose form such as pills, tablets, capsules or liquids in measured doses [1].

For vitamins and minerals, the Directive works through two lists:

Annex I sets out the harmonised list of vitamins and minerals that may be added for nutritional purposes [1].
Annex II lists the permitted sources from which those vitamins and minerals may be manufactured [1].

The Annex II list has been extended over time by several amending acts, including Commission Regulation (EU) 2017/1203 [1]. The trade of products containing vitamins and minerals not listed in Annex II has been prohibited since 1 August 2005 [1]. If your formula uses a form of a vitamin or mineral that is not on the current list, that is a problem to solve before you ship, not after.

Ingredients beyond vitamins and minerals

Botanicals and other substances are less straightforward. The use of ingredients other than vitamins and minerals, such as botanicals, may be authorised under other specific legislation depending on the nature of the substance [3]. Three routes come up most often:

Substances without a history of safe use in the EU before 1997 are assessed under the novel food rules [3].
Sources of vitamins, minerals and additional substances may also be assessed under Regulation (EC) No 1925/2006 on fortification of foods or Regulation (EC) No 609/2013 on foods for specific groups [3].
Substances added for technological reasons, such as colours, sweeteners or preservatives, are assessed as food additives under Regulation (EC) No 1333/2008 [3].

On additives specifically, only those authorised for use in this food category under Regulation (EC) No 1333/2008 can be added to food supplements [3]. The Commission can also decide to list a substance as prohibited, restricted or under scrutiny, a procedure defined in Article 8 of Regulation (EC) No 1925/2006, with the substances listed in its Annex III [3]. Check any botanical or novel ingredient against these routes early. For herbal products, this is also where identity and adulteration testing becomes relevant to your file, since you need to know what is actually in the material you are placing on the market.

Where the rules are still open

Brands often ask for the maximum dose of each vitamin or mineral in the EU. There is no single answer yet. At present there are no binding maximum and minimum levels for the ingredients of food supplements defined in the EU [3]. Directive 2002/46/EC envisages those levels being set in consultation between the Commission, Member States and stakeholders, but the process is ongoing and no final conclusion has been reached [3]. The Commission has stated that no proposal has been presented because of the complex nature of the issue and the divergent views expressed [1].

This gap does not mean anything goes. EFSA has established tolerable upper intake levels for individual micronutrients for different population groups, and these support the Commission’s work on maximum limits [3]. EFSA also uses them as a reference when it evaluates the safety of nutrient sources added to food supplements [3]. Because EU-level limits are not set, verify the position in each country where you plan to sell.

EU countries may also request notification of a supplement placed on their market for monitoring purposes, in accordance with Article 10 of the Directive [1]. Whether a notification applies in your target country is a basic check that is easy to miss.

Label accuracy matters too. The Commission has published a guidance document on tolerances for checking whether nutrient values declared on a label comply with EU legislation [1]. If your declared values rely on lab results, it is worth confirming how they compare with those tolerances.

Cosmetics follow a different framework

Many brands that sell supplements also sell skin care, so it helps to keep the two regimes separate. Regulation (EC) No 1223/2009 is the main regulatory framework for finished cosmetic products placed on the EU market [2]. Several of its requirements shape market entry:

Manufacturers must follow specific requirements in preparing a product safety report before placing a product on the market [2].
Only cosmetic products for which a legal or natural person is designated within the EU as a responsible person can be placed on the market [2].
Manufacturers notify their products once, through the EU cosmetic products notification portal (CPNP) [2].
The responsible person must notify serious undesirable effects to national authorities [2].
Nanomaterials must be labelled in the list of ingredients with the word “nano” in brackets after the name of the substance [2].

Claims are covered separately. Commission Regulation (EU) No 655/2013 lays down common criteria for the justification of claims used in relation to cosmetic products [2]. Cosmetics were also part of the customs operation described above, with 5772 pieces checked [4]. Treat the two regimes as separate workstreams with separate owners.

A note for brands used to the US approach

FDA states that its guidance documents represent its current thinking on a topic and do not bind FDA or the public [5]. FDA also states that manufacturers can use an alternative approach if it satisfies the applicable statutes and regulations [5]. The EU supplement framework, by contrast, rests on specific legal acts such as Directive 2002/46/EC, with named annexes and lists that your formula either fits or does not [1].

That does not make one system easier than the other. A US-built compliance file is a starting point, not something to relabel for Europe. Cross-check each ingredient and claim against the EU lists, and consult a qualified EU regulatory expert where the position is unclear.

A practical checklist before you ship

Use this list to find gaps before customs or a national authority does:

Name the responsible parties. Identify the manufacturer, importer, supplier and distributor for each product, and record who is responsible for safety [3].
Check every vitamin and mineral source against Annex II of Directive 2002/46/EC [1].
Map each non-vitamin ingredient to its route: novel food, fortification, foods for specific groups, or additive rules [3].
Screen for restricted substances listed under Annex III of Regulation (EC) No 1925/2006 [3].
Review your additives against Regulation (EC) No 1333/2008 [3].
Confirm notification requests in each member state where you plan to sell [1].
Verify identity and contaminant data for botanical raw materials through a suitable laboratory, so your file reflects what is in the product.
Separate your cosmetics workstream, including a responsible person, a safety report and CPNP notification [2].
Keep your consultant’s scope clear. Agree in writing which markets, products and regulations are covered, and revisit it when you change a formula.

Work through the checklist, document your answers, and bring in specialist help where a question falls outside what you can confirm yourself.

Sources

[1] Food supplements (food.ec.europa.eu, accessed 2026-11-02)
[2] Legislation (single-market-economy.ec.europa.eu, accessed 2026-11-02)
[3] Food supplements | EFSA (efsa.europa.eu, accessed 2026-11-02)
[4] Protein powder, sunglasses, moisturiser: what do these products have in common? If you buy them online, they most likely violate EU product standards (taxation-customs.ec.europa.eu, accessed 2026-11-02)
[5] Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements) | FDA (fda.gov, accessed 2026-11-02)

Written by Nour Abochama, Quality & Regulatory Advisor, Care Europe | VP Operations, Qalitex. Learn more about our team

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Food Industry Regulatory Compliance Consulting Demand in the EU