Case 1 - Rye bread with a 7% fibre claim: national threshold versus harmonised nutrition claim rules
A Danish bakery, Rugbrod ApS, has sold packaged rye bread in Member State X since 2022. Its label states 'high fibre'. Analysis shows 7.0 g of fibre per 100 g. X's Food Safety Act, adopted in 2023, provides that bread may be described as 'high fibre' only if it contains at least 9 g of fibre per 100 g; products below that threshold may not be placed on the market with that description, and the authority may order withdrawal of the consignment. Acting on a complaint from domestic millers, X's food authority orders withdrawal of 14,000 packs and a recall of the packs already sold. Rugbrod observes that Regulation (EC) No 1924/2006 sets the 'high fibre' threshold at 6 g per 100 g and that its bread is lawfully marketed in Denmark. X answers that the measure protects consumers, applies equally to domestic producers, and that the bread could be relabelled. X did not notify the 2023 Act to the Commission. The packaging is identical in all Member States.
1. Can Rugbrod rely on Regulation 1924/2006 and/or Articles 34 and 36 TFEU to challenge the withdrawal and the recall? Identify the decisive test and apply it.
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1. Characterise the measure. The Act does not ban rye bread as such, but it conditions marketing under a particular description on a 9 g threshold and arms the authority with a power of withdrawal. That is a product-related marketing requirement applying to all traders, so it is a classic measure of equivalent effect: it restricts access to the market of X and requires the imported product to meet a second set of requirements (Dassonville; Cassis de Dijon).
2. Identify the decisive test - harmonisation displaces Article 34. The bread is a food, and nutrition claims such as 'high fibre' are exhaustively regulated. Regulation (EC) No 1924/2006 harmonises the use of nutrition and health claims (Article 1(2)) and its Annex lays down the condition for 'high fibre': at least 6 g of fibre per 100 g. Where the EU legislature has fixed the matter, national rules are not assessed against Article 34 and Article 36 but against the harmonising measure; a Member State cannot unilaterally add a stricter threshold. If X wanted a stricter national rule after harmonisation, the route was Article 114(4)–(6) TFEU, with notification and Commission approval - not national legislation.
3. Apply. At 7.0 g the bread meets the EU threshold. The 9 g rule therefore contradicts the Regulation and cannot be saved by consumer protection: the EU legislature has already made the scientific and policy assessment, and a Member State may not substitute its own. Even on an Article 34 analysis, the measure would fail proportionality because a full withdrawal of compliant product is not the least restrictive means.
4. The recall. The Regulation prohibits the claim, not the product. At most, X may require relabelling; ordering recall of 14,000 packs that are safe and lawful in Denmark is disproportionate and, in substance, a quantitative restriction.
Conclusion: the withdrawal and recall decisions are incompatible with the Regulation read with Article 34 TFEU and must be set aside, subject at most to a relabelling requirement.
2. Does X's failure to notify the 2023 Act to the Commission matter? What are the consequences if the Act is a technical regulation?
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1. Is the Act a technical regulation? Under Directive (EU) 2015/1535, a technical regulation includes product requirements and rules on labelling, marking and packaging whose observance is compulsory for marketing. A rule that reserves the description 'high fibre' to products above a national threshold, backed by withdrawal powers, plainly affects the marketing and labelling of the product. It is therefore, in principle, notifiable under Article 5.
2. The exemption X would invoke. The Directive does not require notification where a Member State merely implements binding Union acts. That defence fails here: reproducing the 6 g threshold of Regulation 1924/2006 would be implementation; replacing it with 9 g is a national policy choice that departs from the harmonised rule, so it cannot be treated as implementation.
3. The consequence of non-notification. Where a technical regulation has been adopted without notification, it is inapplicable in proceedings brought against individuals, whether criminal, civil or administrative (CIA Security, C-194/94; Unilever Italia, C-443/98). The national court must therefore disapply the 9 g threshold of its own motion if necessary, with the result that the withdrawal decision has no legal basis. X cannot rely on the urgency procedure retroactively: a Member State may only use the urgent procedure where it has notified the Commission and given reasons, which was not done.
4. Practical consequence. Even if the Act were validly in force, it could not justify withdrawing compliant product. Non-notification adds an independent, and decisive, ground of inapplicability. Rugbrod can raise both grounds - the substantive conflict with the Regulation and the procedural defect - before the national court, which must give effect to the Regulation and disapply the national rule.