The claim ‘lactose-free‘ cannot be used in labeling and advertising of plant-based food products – since it is a common characteristic of the entire category – and the ICQRF in Italy is beginning to activate official controls and administrative sanctions for this purpose.
1) ‘Freefrom’, the current rules in the European Union.
Voluntary label claims regarding the absence of certain ingredients, nutrients or substances-so-called ‘free from,‘ or ‘without…’-are subject, as appropriate, to specific rules and/or the general criteria of fairness of consumer information. (1)
1.1) Specific Rules.
Specific rules apply to several voluntary ‘free from’ type claims. And they may deviate from the general criteria in the following paragraph to the extent that they contain detailed requirements. Some examples to follow:
- Nutrition and Health Claims Regulation (EC) No 1924/06 applies to a number of nutrition claims such as ‘calorie-free, ‘fat-free,’ ‘saturated fat-free,’ ‘sugar-free,’ ‘no addedsugar,’ ‘sodium/salt-free,’ ‘no sodium/added salt‘ (2,3)
- Gluten Free Regulation (EU) No 828/2014 applies to the terms ‘gluten-free’ and ‘very low gluten’. (4)
1.2) General criteria
In the absence of EU rules – or member state regulations, in non-harmonized matters, as long as they are subject to regular notification to the European Commission (5) – ‘free from‘ claims are subject to the general criteria of fairness and transparency set out in the Food Information Regulation (EU) No 1169/11, Articles 7 and 36.
The general criteria apply to claims without special regulations (e.g., ‘glyphosate-free‘, ‘pesticide residue-free‘, ‘antibiotic-free‘, ‘palm oil-free‘, ‘nitrite-free. See notes 6,7,8,9), in some cases even to those subject to specific rules. (10) News must be ‘accurate and clear, easily understood by the consumer‘ and unambiguous.
2) Fairness of consumer information
Food Information Regulation
(EU) No 1169/11 expresses the general criteria of fairness of consumer information including through the express prohibitions of:
- Misleading the consumer about the essential characteristics of the food (e.g. nature, identity, properties, composition, quantity, shelf life, country of origin or place of provenance, the method of manufacture or production (EU Reg. 1169/11, Art. 7.1.a),
- attribute to the foodstuff ‘effects or properties it does not possess‘ (Art. 7.1.b),
- suggest ‘that the food possesses special characteristics, when in fact all similar foods possess the same characteristics, particularly by explicitly highlighting the presence orabsence of certain ingredients and/or nutrients‘ (Art. 7.1.c),
- make to imply ‘through appearance, description or illustrations, the presence of a particular food or ingredient, while in fact a component naturally present or an ingredient normally used in that food has been replaced with a different component or ingredient‘ (Art. 7.1.d).
3) ‘Lactose-free’, ‘lactose-free‘. No specific rules
Nutrition and Health Claims
Regulation (EC) No 1924/06 – in excluding the terms ‘lactose-free‘ and ‘lactose-free‘ from its scope of application – had provided for their regulation in the context of foods for particular nutritional use. Admitting, pending harmonized standards, the adoption and/or permanence of national standards in this regard (reg. EC 1924/06, recital 22).
Food for Specific Groups
Regulation (EU) No 609/2013 (FSG), on the other hand, excluded gluten-free foods from the special regime to which they were previously subject. The Italian Celiac Disease Association (AIC) with the support of the European Confederation of Celiac Patients and the professional support of the writer, however, succeeded in getting reg. EU 828/14. (4) While ‘lactose-free’ still lacks appropriate regulation at the European level.
3.1) ‘Lactose-free‘ Ministry of Health circulars in Italy.
The Ministry of Health in Italy, as noted, has adopted a number of circulars regarding the use of the terms ‘lactose-free,’ ‘lactose-reduced,’ ‘naturally lactose-free ,’ and ‘naturally lactose-reduced. Prescribing, in the latter two cases, that the words ‘contains galactose‘ or ‘contains galactose in an amount less than…’ also be indicated on the label. (11)
Italian ministerial circulars theorize that the various labels ‘lactose-free‘ and the like should be reserved for ‘milk and milk products.’ Moreover, this limitation is unconstitutional and unenforceable, for two essential reasons:
- Circulars do not have the force of law. Therefore, they cannot impose or prohibit anything, outside the sole scope of the personnel of the department to which they belong, subject to special legislative delegations,
- documents do not appear to have been notified to Brussels, as they should have been, and are therefore unenforceable. (5) Food business operators can therefore follow health-relevant claims (‘contains galactose‘ where appropriate), but remain bound only to the general criteria established in the European Union regarding, in particular, the fairness of consumer information (see supra, para. 2).
4) ICQRF, controls and penalties on ‘lactose-free‘ vegetable beverages
ICQRF — Italy’s competent authority for official controls on consumer information — has (finally) initiated checks and sanctions on the application of the voluntary ‘lactose-free’ label on some plant-based food products. Some dispute reports from ICQRF Abruzzo and Molise, Chieti Unit, correctly point out that.
- the words ‘naturally lactose-free‘ in a vegan, 100% plant-based product constitutes a violation of reg. EU 1169/11, Article 7.1.c (see supra, para. 2).
‘Lactose-free‘ is in fact a common feature of all products precisely identified in the ‘100% plant-based‘ or ‘vegan‘ category. Products to which, among other things, special sales departments are dedicated. Its indication, the ICQRF points out, ‘could guide consumer choice in relation to other vegetable beverages that, correctly, do not use the claim.’
4.1) ‘Lactose-free‘, which products?
‘Lactose-free‘ indexing may conversely be allowed, according to ICQRF, ‘where the same product containing milk-based ingredients coexists on the market.
Regarding non-milk products, the claim ‘naturally lactose-free’ can be used for composite products, e.g., cookies, that do not involve the use of milk ingredients (as the substitute with milk is still on the market). That is, again in relation to cookies, the claim ‘lactose-free’ could be reported for products that, while using dairy ingredients, have delactose in them’.
5) Interim conclusions. Penalties due and official controls to be improved
Violation of the prohibition against attributing to a food product characteristics common to the category to which it belongs (EU Reg. 1169/11, Article 7.1.c) is subject in Italy to an administrative fine ranging from € 3,000 to € 24,000 (Legislative Decree 231/17, Article 3.1). With reduced payment within 60 days of €6,000 (the lesser of twice the minimum and one-third of the maximum, pursuant to Legislative Decree 231/17, Article 37). (12) That is, by €4,200, where payment is made within 5 days of notification of the penalty order.
However, official controls should also be oriented toward verifying the proper design and implementation of GMPs(Good Manufacturing Practices), PRPs(Pre-Requisites Programs) and HACCP, by health authorities. For effective assurance of food safety with respect to the risks of cross-contamination by allergens (in this case, milk protein, not lactose), particularly in public and catering establishments. With good memory of the recurrent anaphylactic reactions of allergic consumers in Italy. (13)
Dario Dongo
Notes
(1) Dario Dongo. ‘Free from ‘ in labeling, The ABC. GIFT (Great Italian Food Trade). 24.2.18
(2) Dario Dongo. ABC nutritional claims. GIFT (Great Italian Food Trade). 26.5.18
(3) ‘Zero added sugar’ fruit drinks? Attorney Dario Dongo replies. FARE(Food and Agriculture Requirements). 16.6.23
(4) Dario Dongo. Claim ‘gluten-free’, similar wording not allowed. GIFT (Great Italian Food Trade). 29.1.21
(5) Any national technical regulations that affect the production and/or marketing of goods and certain categories of services must be notified to Brussels under Directive (EU) 2015/1535 – or under Reg. (EU) 1169/11, when it comes to rules on consumer information on foodstuffs – under penalty of inapplicability. V. Dario Dongo. Establishment location and origin decrees, possible damages actions. FARE (Food and Agriculture Requirements). 20.1.19
(6) Dario Dongo. Glyphosate-free, zero residues, values and rules. GIFT (Great Italian Food Trade). 10.11.18
(7) Dario Dongo, Andrea Adelmo Della Penna. Antibiotic-free poultry farming, the Italian way. GIFT (Great Italian Food Trade). 14.12.20
(8) Dario Dongo. Palm oil-free, ministry approves label. GIFT (Great Italian Food Trade). 5.8.17
(9) Marta Strinati. Nitrites and nitrates in cured meats. Market study and analysis. GIFT (Great Italian Food Trade). 30.4.22
(10) The prohibition in reg. EU 1169/11, Article 7.1.c, for example, does not apply to nutrition claims because of the principle of specialty(lex specialis derogat legi generali), precisely because reg. EC 1924/06 specifically defines the nutritional characteristics required for the use of an appropriate nutrition claim
(11) Dario Dongo. Lactose-free, ABC. GIFT (Great Italian Food Trade). 19.11.18
(12) Dario Dongo. Legislative Decree. 231/17. ABC penalty calculation. MiPAAF Errors. GIFT (Great Italian Food Trade). 12.3.18
(13) Dario Dongo. Milk allergy, one death and one recall. The ‘lactose-free’ issue. GIFT (Great Italian Food Trade). 18.4.22
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.