Il claim 'lactose-free' cannot be used on the label and advertising of plant-based food products - as this is a characteristic common to the entire category - and the NIPAAF (Agri-Food and Forestry Environmental Police Investigative Unit) in Italy is starting to activate official controls and administrative sanctions for this purpose expected.
1) 'Free from', the rules in force in the European Union
Voluntary indications on the label relating to the absence of certain ingredients, nutrients or substances – so-called 'free from', or 'senza ...' – are subject, according to the case, to specific rules and/or to the general criteria of fairness of information to the consumer. (1)
1.1) Specific rules
Specific rules apply to various voluntary indications of the type 'free from '. And they can derogate from the general criteria referred to in the following paragraph, to the extent that they contain detailed prescriptions. Some examples to follow:
- il Nutrition and Health Claims Regulation (EC) No 1924/06 applies to a number of nutrition claims which 'without calories, 'fat-free,without saturated fat,sugar free,with no added sugar', 'sodium/salt free,no sodium/salt added(2,3)
- il Gluten Free Regulation (EU) No 828/2014 applies to the indications 'gluten free' and 'very low gluten content'. (4)
1.2) General criteria
In the absence of EU rules - or regulations of the Member States, in non-harmonised matters, provided that they are subject to regular notification to the European Commission (5) - the indications 'free from' are subject to the general criteria of loyalty and transparency indicated in Food Information Regulation (EU) No 1169/11, articles 7 and 36.
The general criteria apply to wordings without a specific discipline (e.g. 'without glyphosate,without pesticide residues', 'without antibiotics,without palm oil,without nitrites'. See notes 6,7,8,9), in some cases also to those subject to specific rules. (10) The news must be 'precise and clear, easily understandable for the consumer' and unambiguous.
2) Loyalty of information to the consumer
Food Information Regulation (EU) No 1169/11 expresses the general criteria of loyalty of information to the consumer also through the express prohibitions of:
- mislead the consumer regarding the essential characteristics of the food (e.g. nature, identity, properties, composition, quantity, shelf life, country of origin or place of provenance, manufacturing or production method (EU regulation 1169/11, art. 7.1.a),
- attribute to the foodstuff 'effects or properties that it does not possess' (art. 7.1.b),
- to suggest 'that the food has particular characteristics, when in reality all similar foods have the same characteristics, in particular by explicitly highlighting the presence orabsence of certain ingredients and/or nutrients' (art. 7.1.c),
- make understood 'by the appearance, description or illustrations, the presence of a particular food or an ingredient, when in fact a naturally occurring component or an ingredient normally used in that food has been replaced with a different component or a different ingredient' (art. 7.1.d).
3) 'Lactose-free,lactose free'. No specific rules
Nutrition and Health Claims Regulation (EC) No 1924/06 – in excluding from its scope the wordings 'lactose-free' and 'lactose-free' – had foreseen their discipline in the context of foods for particular nutritional uses. Admitting, pending harmonized standards, the adoption and/or permanence of national standards in this regard (reg. CE 1924/06, recital 22).
Food for specific groups Regulation (EU) No 609/2013 (FSG) instead excluded gluten-free foods from the special regime to which they were previously subjected. The Italian Celiac Association (AIC) with the support of the European confederation of celiac patients and the professional support of the writer, has nevertheless managed to obtain the adoption of the reg. EU 828/14. (4) While the 'lactose-free' is still without specific discipline at European level.
3.1) 'Lactose-free', the circulars of the Ministry of Health in Italy
The Ministry of Health in Italy, as we have seen, has adopted some circulars regarding the use of the words 'lactose-free,low in lactose,naturally lactose free e It is naturally low in lactose'. Prescribing, in the last two hypotheses, to also indicate the words on the label 'contains galactose' or 'contains less galactose than…'. (11)
Ministerial circulars Italians theorize that the various wordings 'lactose-free' and the like should be reserved for 'milks and dairy products'. This limitation is also unconstitutional and unenforceable, for two essential reasons:
- the circulars have no legal effect. They cannot therefore impose or forbid anything, outside the scope of the personnel of the dicastery to which they belong, without prejudice to specific legislative delegations,
- the documents do not appear to have been notified to Brussels, as required, and are therefore inapplicable. (5) Food business operators can therefore follow the indications of health relevance ('contains galactose', where appropriate), but remain bound only to the general criteria established in the European Union as regards in particular the loyalty of information to the consumer (see supra, by. 2).
4) NIPAAF, controls and sanctions on vegetable drinks'lactose-free'
NIPAAF – competent authority in Italy for official controls on consumer information – has (finally) started controls and sanctions on the application of the voluntary 'lactose-free' label on some plant-based food products. Some protest reports from NIPAAF Abruzzo and Molise, Chieti Unit, correctly highlight that
- the wording 'naturally lactose free' in a vegan product, 100% vegetable, constitutes a violation of the reg. EU 1169/11, article 7.1.c (see supra, by. 2).
'Lactose-free' it is in fact a common feature of all the products precisely identified in the category '100% vegetable'and'Vegan'. Products to which, among other things, special sales departments are dedicated. His indication, highlights the NIPAAF, 'could guide the consumer's choice in relation to other vegetable drinks which, correctly, do not use the claim'.
4.1) 'Lactose-free', which products?
Indexing 'lactose-free' can conversely be admitted, according to NIPAAF, 'where the same product containing milk-based ingredients coexists on the market.
As far as non-dairy products are concerned, the claim 'naturally lactose-free' can be used for compound products, such as biscuits, which do not involve the use of milky ingredients (since the substitute with milk is in any case present on the market). That is, again in relation to biscuits, the 'lactose-free' claim could be reported for products which, although using milky ingredients, have no lactose in them'.
5) Provisional conclusions. Dutiful sanctions and official controls to be improved
The violation of the ban on attributing to a food product characteristics common to the category it belongs to (EU regulation 1169/11, article 7.1.c) is subject in Italy to the sanction administrative fine from € 3.000 to € 24.000 (legislative decree 231/17, article 3.1). With reduced payment within 60 days of € 6.000 (the lower amount between double the minimum and one third of the maximum, pursuant to Legislative Decree 231/17, article 37). (12) Or €4.200, if payment is made within 5 days of notification of the sanction.
Official controls however, they should also be oriented towards verifying the correct design and implementation of GMPs (Good Manufacturing Practices), PRPs (Pre-Requisite Programs) and HACCP, by the health authorities. For an effective guarantee of food safety with respect to the risks of cross contamination from allergens (in this case milk proteins and not lactose), especially in public establishments and restaurants. With good memory of the recurring anaphylactic reactions of allergic consumers in Italy. (13)
Dario Dongo
Footnotes
(1) Dario Dongo. 'Free from' on the tab, The ABC. GIFT (Great Italian Food Trade). 24.2.18
(2) Dario Dongo. ABC nutrition facts. GIFT (Great Italian Food Trade). 26.5.18
(3) 'Zero added sugar' fruit drinks? The lawyer Dario Dongo answers. FARE (Food and Agriculture Requirements). 16.6.23
(4) Dario Dongo. claim 'gluten-free', similar wordings are not allowed. GIFT (Great Italian Food Trade). 29.1.21
(5) Any national technical regulation affecting the production and/or marketing of goods and certain categories of services must be notified to Brussels pursuant to directive (EU) 2015/1535 – or pursuant to reg. (EU) 1169/11, when it comes to rules relating to consumer information on food products - under penalty of inapplicability. See Dario Dongo. Headquarters of the establishment and origin decrees, possible actions for damages. FARE (Food and Agriculture Requirements). 20.1.19
(6) Dario Dongo. Without glyphosate, 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, the ministry approves the 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 pursuant to reg. EU 1169/11, article 7.1.c, for example, does not apply to nutrition claims due to the principle of specialty (lex specialis derogat general laws), just as the reg. CE 1924/06 specifically defines the nutritional characteristics required for the use of a specific product nutrition claim
(11) Dario Dongo. Lactose-free, ABC. GIFT (Great Italian Food Trade). 19.11.18
(12) Dario Dongo. Legislative Decree 231/17. ABC calculation of penalties. MiPAAF errors. GIFT (Great Italian Food Trade). 12.3.18
(13) Dario Dongo. Allergy to milk, 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.
