Annex II FIC exemptions in food supplements
Which allergen derivatives need no emphasis

Annex II to Regulation (EU) No 1169/2011 (FIC) covers each of the 14 allergens “and products thereof”. For five entries (cereals containing gluten, fish, soybeans, milk, nuts) the same Annex sets out a closed list of exemptions. Only an ingredient that matches the wording of an exemption need not be indicated as an allergen. In food-supplement formulations this mainly means natural tocopherols from soy, fully refined soybean oil, soy-derived phytosterols, wheat-based maltodextrins and glucose syrups, barley-based glucose syrups, lactitol, and fish gelatine used as a carrier for vitamin or carotenoid preparations. Soy lecithin, wheat dextrin, lactose, fish oil, krill oil, glucosamine from crustaceans and a fish-gelatine capsule shell fall outside that catalogue.

1. The default rule: “products thereof” are covered unless the Annex says otherwise

Article 9(1)(c) FIC requires the indication of any ingredient or processing aid listed in Annex II or derived from a substance or product listed there, used in the manufacture or preparation of a food and still present in the finished product, even in an altered form. Every Annex II entry covers the allergen “and products thereof”. The Commission Notice repeats this expressly (point 6): Annex II lists not only the substances and products as such but also products thereof.

Two practical consequences follow:

• Purity alone does not exempt. A highly purified isolate, ester or extract of an allergen is still a “product thereof”. Only the inclusion of that specific derivative in the exemption list removes the duty.
• Exemptions are read narrowly and literally. They are listed by name and sometimes with a defined function (“used as carrier”, “used for making alcoholic distillates”). An ingredient outside that wording falls back under the general rule.

The exemptions did not originate in FIC. They come from Commission Directive 2007/68/EC of 27 November 2007, which, following EFSA opinions, permanently excluded selected derivatives from what was then Annex IIIa to Directive 2000/13/EC. The earlier exclusion under Directive 2005/26/EC was provisional and ran until 25 November 2007. FIC carried the list over into Annex II.

2. The complete list of exemptions and what it means for supplements

The remaining entries (crustaceans, eggs, peanuts, celery, mustard, sesame, lupin, molluscs) have no exemptions at all. Entry 12 (sulphur dioxide and sulphites) works differently: the duty arises above 10 mg/kg or 10 mg/litre of total SO₂, calculated for the product as proposed ready for consumption or as reconstituted according to the manufacturer’s instructions.

3. The allergenicity footnote: a condition that is easy to miss

For wheat-based glucose syrups, wheat-based maltodextrins and fully refined soybean oil, Annex II carries a footnote. The exemption also extends to products thereof “in so far as the process that they have undergone is not likely to increase the level of allergenicity assessed by the Authority for the relevant product from which they originated”. Directive 2007/68/EC contained the same proviso, referring to EFSA.

For a business this means two things. First, the exemption covers the material in the form EFSA assessed, not every further processing step. Second, where further processing is applied (for example additional fractionation or a different process), it is for the operator to show that it has not increased allergenicity. The other exemptions carry no footnote, but their wording binds on its own terms: “natural” D-alpha tocopherol, “fully” refined oil, gelatine “used as carrier”.

4. Common traps in supplement formulations

The following ingredients derive from an Annex II allergen and have no exemption there. On the label they therefore need a clear reference to the allergen’s name and emphasis:

• Soy lecithin (E 322): the soy exemptions cover oil, tocopherols, phytosterols and stanol ester. Lecithin is not among them.
• Wheat dextrin (soluble fibre): the exemption covers wheat-based maltodextrins and glucose syrups, not dextrins. The Notice gives “dextrin (wheat)” as an example (point 11).
• Maltodextrin from an Annex II cereal other than wheat: exemption (b) names wheat only, and for barley only glucose syrups are exempt.
• Oat or barley beta-glucan: these are cereal derivatives without an exemption. Even a product meeting the “gluten-free” conditions of Implementing Regulation (EU) No 828/2014 must indicate and emphasise oats (point 12 of the Notice).
• Lactose as a tablet filler: entry 7 reads “milk and products thereof (including lactose)”. A clear reference to the Annex II name, milk, is required.
• Fish oil, fish collagen, chondroitin from fish cartilage: the fish exemptions cover only fish gelatine in two defined functions.
• A fish-gelatine capsule shell: the exemption covers gelatine “used as carrier for vitamin or carotenoid preparations”. A capsule shell is not a carrier for a vitamin preparation, so it falls outside that wording.
• Krill oil, glucosamine and chitosan from shrimp or crab shells: crustaceans have no exemption at all.
• Green-lipped mussel extract, oyster-shell calcium: molluscs have no exemption, and the purity of the calcium carbonate does not change its status as a “product thereof”.
• Lysozyme (E 1105) and egg hydrolysates: eggs have no exemption. The Notice covers eggs from all farmed birds (point 6).
• Refined peanut (arachis) oil, almond oil: the “fully refined oil” exemption exists only for soy. There is none for peanuts or nuts.

5. Carriers, processing aids and compound ingredients

Article 20 FIC allows certain constituents to be left out of the list of ingredients, including carried-over additives, processing aids and carriers used in quantities strictly necessary (points (b) and (c)). The whole of Article 20 opens, however, with the words “without prejudice to Article 21”. A carrier or processing aid derived from an allergen without an exemption must therefore appear on the label with the allergen’s name, even where it could otherwise be omitted.

This matters in supplements because vitamins, carotenoids and botanical extracts enter the formulation as ready-made preparations with carriers, antioxidants and anti-caking agents. The supplier specification has to show the source of each of them. Without it, there is no way to tell whether a derivative falls within an exemption (e.g. natural tocopherols from soy) or needs emphasis (e.g. soy lecithin in the same preparation).

With compound ingredients, the allergen is emphasised within the compound ingredient (point 17 of the Notice). Where several ingredients come from the same allergen, the third subparagraph of Article 21(1) requires this to be clear for each of them. The Notice (point 21) accepts a single reference, for instance a footnote marker against several items and the note “from wheat” with the word emphasised. That note must, however, be directly linked to the list of ingredients.

6. Micro-organisms grown on an allergen substrate

The Notice (point 6) states that micro-organisms fed on a substrate that is an Annex II food ingredient should not be considered products derived from that substrate. A probiotic strain propagated on a dairy medium, or yeast grown on a cereal substrate, does not thereby become “milk” or “wheat”.

That statement concerns the micro-organisms themselves. If an allergen-derived constituent remains in the strain preparation, such as skimmed milk powder as a cryoprotectant or maltodextrin from a cereal other than wheat as a carrier, that constituent is assessed on its own under Article 9(1)(c) and Articles 20–21. In our view the culture supplier’s certificate should describe the growth medium and the composition of the commercial preparation (carriers, cryoprotectants) separately, because each answers a different question.

7. Form: the Annex II name, emphasis, and no extra “contains” box

• A clear reference to the Annex II name (Article 21(1)(a)). For cereals, the specific cereal must be named (wheat, rye, barley, oats), and spelt and khorasan are tied to the word “wheat” (points 8–9 of the Notice). For nuts, the specific type from entry 8 is named (point 13).
• Typographical emphasis (point (b)): by font, style or background colour. The word corresponding to the allergen is emphasised; in “skimmed milk powder”, emphasising “milk” is enough (point 16).
• No voluntary repetition outside the list of ingredients. According to point 27 of the Notice, citing recital 47 and Article 21(1) read with Article 36(1), allergen information may not be voluntarily repeated outside the list of ingredients, including as “contains: …”, symbols or text boxes. A food supplement always has a list of ingredients, so the “contains” formula of the second subparagraph of Article 21(1) (for foods without a list) does not apply to it.
• Online sales. Article 14(1)(a) requires mandatory food information, allergens included, to be available before the purchase is concluded. The product page in an online shop should therefore carry the same emphasised list as the label.

Sample wording (an example, not an actual product): Ingredients: fish oil (fish); capsule shell: fish gelatine (fish), humectant: glycerol; vitamin E (D-alpha tocopheryl acetate); antioxidant: tocopherol-rich extract; emulsifier: lecithins (soy). If the D-alpha tocopheryl acetate and the tocopherols are natural and soy-derived, point 6(b) of Annex II exempts them. No exemption covers soy lecithin.

8. Can the exemption list be extended?

Article 21(2) FIC requires the Commission to re-examine Annex II systematically and, where necessary, update it by delegated acts. Unlike Directive 2000/13/EC, the Regulation no longer provides a separate procedure for exemption applications (point 33 of the Notice). The Commission nonetheless accepts evidence that certain derived products are not likely to trigger adverse reactions. Such material is prepared following EFSA guidance (EFSA Journal 2013;11(10):3417, point 34 of the Notice). Until Annex II is amended, a manufacturer’s own testing, for example an ELISA result below the limit of quantification, does not create a new exemption.

The same principle works the other way. A test result does not exempt a derivative that has no exemption from emphasis. The duty follows from the ingredient’s origin and its presence in the finished product (Article 9(1)(c)), not from exceeding a threshold. The only threshold in Annex II is the one for sulphites (entry 12).

9. Checklist for a supplement formulation

1. Source map. For each ingredient, carrier, antioxidant and processing aid, establish the source material from the supplier specification.
2. Match against the exemption. Compare name and function with the literal wording of Annex II (e.g. “natural” tocopherol, “fully” refined oil, fish gelatine “used as carrier” for a vitamin or carotenoid preparation).
3. Allergenicity footnote. For wheat-based maltodextrin and glucose syrup and for soybean oil, establish whether further processing goes beyond the footnote condition.
4. Article 20 does not help. A carrier or processing aid from an allergen without an exemption goes on the label with the allergen’s name.
5. Micro-organisms. The growth medium is not the same as the preparation’s composition. Cryoprotectants and carriers are assessed separately.
6. Wording. Give a clear reference to the Annex II name, emphasise it in the list of ingredients and add no “contains” box. Use the same wording on the product page for distance selling.
7. A supplier change means a new assessment. Switching natural tocopherols for a blend with lecithin, or wheat maltodextrin for another one, changes the outcome. In Poland the label is also part of the GIS notification file (see supplement notification procedure at GIS).

Glossary

Product thereof

Any ingredient or processing aid derived from an Annex II allergen, including in an altered form (Article 9(1)(c)). It is covered by default.

Annex II exemption

A derivative named in the Annex that need not be indicated as an allergen. The list is closed and comes from Directive 2007/68/EC.

Allergenicity footnote

The condition attached to wheat-based glucose syrups and maltodextrins and fully refined soybean oil: processing must not increase the allergenicity assessed for the source product.

Carrier (Article 20(c))

A substance used to dissolve, dilute or disperse an ingredient. It may be left out of the list, but “without prejudice to Article 21”.

Notice 2017/C 428/01

Commission guidance on Article 21 and Annex II FIC. It is not binding; only the CJEU can give a binding interpretation.

Conclusion

For allergens, FIC works on the rule “every derivative, unless listed”. The Annex II exemptions are a short, closed list. For supplements the key ones are natural tocopherols and fully refined oil from soy, phytosterols, wheat-based maltodextrins and glucose syrups, barley-based glucose syrup, lactitol and fish gelatine as a carrier for vitamin or carotenoid preparations. Everything outside that wording, including soy lecithin, wheat dextrin, lactose, fish oil, fish collagen, a fish-gelatine capsule shell, krill and crustacean glucosamine, needs a clear reference to the allergen’s name and emphasis in the list of ingredients. The duty also reaches carriers and processing aids, because Article 20 applies “without prejudice to Article 21”. Neither an ELISA result nor the degree of purification creates a new exemption. Only an amendment of Annex II by delegated act can do that.

Primary sources

1. Regulation (EU) No 1169/2011, consolidated version: Articles 9(1)(c), 14(1)(a), 18, 20, 21, 36(1); Annex II with the allergenicity footnote.
2. Commission Delegated Regulation (EU) No 78/2014 of 22.11.2013: amendment of point 1 of Annex II (cereals: spelt and khorasan wheat).
3. Commission Notice of 13.07.2017 (2017/C 428/01), OJ C 428, 13.12.2017, p. 1: points 4, 6, 8–13, 16–17, 21, 27, 33–34.
4. Commission Directive 2007/68/EC of 27.11.2007 (OJ L 310, 28.11.2007, p. 11): permanent exclusions from Annex IIIa to Directive 2000/13/EC.
5. Implementing Regulation (EU) No 828/2014: information on the absence or reduced presence of gluten.
6. Directive 2002/46/EC: food supplements.
7. EFSA Journal 2013;11(10):3417: guidance on applications for allergen exemptions (cited in point 34 of the Notice).