Codex Alimentarius: PAL and Reference Doses ready for takeoff

By
Dario Dongo - Andrea Adelmo Della Penna
-
0
88

Allergen risk management in the food sector is about to undergo a global scientific revolution. During the 49th session of the Codex Committee on Food Labelling (CCFL49), held in Ottawa from 11 to 15 May 2026, the adoption of guidelines on the use of precautionary allergen labelling (PAL) was recommended. The real breakthrough lies in the official introduction of Reference Doses (RfD) as globally standardised quantitative thresholds. This reform, intended to update the historic global standard CXS 1-1985, promises to supersede the indiscriminate use of the ‘May contain‘ statement, providing food business operators and enforcement authorities with precise mathematical criteria for the protection of allergic and coeliac consumers.

General Standard for the Labelling of Foods

Standard CXS 1-1985 – General Standard for the Labelling of Pre-Packaged Foods  (Codex Alimentarius, 1985a) is the reference standard of the Codex Alimentarius which forms the basis upon which the legislation of States members of FAO and WHO — including the European Union — has developed and updated its own rules on consumer information on food products (e.g. Regulation EU No 1169/2011).

Alignment with Codex Alimentarius standards and recommendations also gives rise to a presumption of conformity of national (and EU) legislation with the principles of free trade established within the World Trade Organisation (WTO), with specific regard to the agreements on Sanitary and Phytosanitary measures (SPS) and on Technical Barriers to Trade (TBT).

CCFL49

The 49th meeting of the Codex Committee on Food Labelling (CCFL49) finally reached conclusions on several food labelling issues, many of which had not yet gathered sufficient consensus for adoption into the standard. These include:

  • guidelines on the use of precautionary allergen labelling (PAL);
  • indication of the country of harvest for spices and culinary herbs, in addition to the mandatory indication of the country of origin;
  • amendments to the rules on joint presentation and multipack formats;
  • alcoholic beverages labelling;
  • guidelines on the application of additional labelling requirements in emergency situations.

Participants discussed the opportunity to develop a working document on a strategic plan for the CCFL. Some members then proposed initiating new work aimed at harmonising the labelling of alcoholic beverages and small packages, as the fragmentation of rules among FAO and WHO member States generates complexity and obstacles to international trade. In the absence of consensus on these matters, discussions were deferred to a future meeting.

Precautionary Allergen Labelling (PAL)

The guidelines developed by the CCFL serve to promote a harmonised approach to the conditions of use of precautionary labelling in cases of unintentional presence of allergens and substances causing intolerances in foods, following the adoption of best practices aimed at mitigating the risk of cross-contamination (e.g. Code of Practice on Allergen Management for Food Business Operators – CXC 80-2020. Codex Alimentarius, 2020). Competent authorities are called upon to develop education and information programmes for stakeholders on the correct use and understanding thereof.

The decision to use Precautionary Allergen Labelling (PAL) must be based on the outcome of a qualitative risk assessment (presence/absence), potentially supported by a quantitative assessment, such as mg/kg of allergen in the food (Action Level = Reference Dose, RfD), and only where such values are exceeded.

PAL must be:

  • positioned directly below or in proximity to the ingredients list, where present, or in any case in a clearly visible location on the label;
  • preceded by the statement ‘May contain‘ or equivalent terms defined by competent authorities;
  • graphically highlighted with distinctive typefaces, styles or colours, as for allergens (of the same type if also present among the ingredients).

The use of PAL is not compatible with the voluntary statement ‘gluten free‘. Where it is not possible to identify the source of gluten exceeding the action level (RfD), all gluten-containing cereals must be indicated.

pastedGraphic.png

pastedGraphic_1.png
Note. Reference Doses for allergenic foods (a) and for foods containing gluten (b) for the purposes of applying PAL in labelling (source: FAO/WHO)

Country of harvest and country of origin for spices and culinary herbs

CCFL49 considered standard CXS 351-2022 on saffron (Codex Alimentarius, 2022), introducing new provisions regarding the indication of the country of harvest (section 8.2). Participants agreed to introduce the obligation to indicate the country of origin (which coincides with the country of harvest, in accordance with the standard), together with the option to indicate the region and year of harvest.

The Commission also defined the guiding principles that the Committee on Spices and Culinary Herbs (CCSCH) may follow in establishing origin labelling rules applicable to these products:

  • where the country of origin coincides with the country of harvest, a single reference is sufficient to avoid redundancy;
  • where harvesting and processing take place in different countries, the origin is identified as the country in which the product underwent substantial transformation changing its nature;
  • the mere blending of spices or culinary herbs of the same species but of different origins does not qualify as substantial transformation altering the nature of the product. In such cases, origin must be indicated if its omission could mislead the consumer, pursuant to the general rule.

Multipack labelling

New labelling provisions have been proposed for multiple foods sold as a single unit composed of several individually packaged foods, whether identical or different, intended to be consumed together or separately. The outer packaging must bear the mandatory labelling information relating to each container, unless such information is clearly readable and distinguishable on at least one of each type of individually packaged food inside the container, without the need to open it.

Where the information is provided on the outer packaging, the following must be indicated as applicable:

  • separate ingredients lists for each type of individually packaged food making up the pack, or a single ingredients list, depending on the nature of the food (for example, whether the individually packaged foods are intended to be consumed separately or together);
  • alternatively, where it is not possible to easily count the number of individually packaged food items inside the container, the net contents must be indicated on the outer packaging, specifying the total net contents of the pre-packaged food sold as a single unit and/or the number of individually packaged food items by type and their respective net contents;
  • the best-before date or best quality-before date or the use-by date that is earliest must be indicated. Where individually packaged foods bear different types of date marking (e.g. best-before date and use-by date), the earliest date among those relating to foods subject to an expiry date must be indicated.

Supply of foods in emergency situations

The supply of foods in emergency situations was considered as part of the Codex mandate, with particular attention to the safeguarding of safety requirements and the protection of consumer health. Specific guidelines were accordingly developed — to be provided exclusively to national competent authorities — applicable to all types of foods, including those for vulnerable groups such as foods for infants and young children. It is worth recalling that the European Commission has proposed incorporating food emergency management plans into the reform of the Common Agricultural Policy currently under political review.

The CCFL guidance aspires to ensure the safe and adequate supply of foods during emergency phases, through appropriate labelling requirements that are proportionate and based on a risk analysis, on the basis of general decision-making criteria that member States may apply with relative flexibility on a temporary basis. The basic principles of the guidelines concern:

  • authorisation or review of a flexibility measure: assessing whether the level of authority required to provide labelling flexibility is in place, after verifying the absence of risks to consumers (in particular vulnerable ones), collaborating appropriately with all stakeholders to introduce derogatory measures for the time necessary, promoting adequate receipt of information by the general population and sensitive populations, without introducing risks;
  • adoption and monitoring of the flexibility measure: competent authorities must consider that other countries also need to be informed of the flexibility measures adopted by food business operators, where the foods they produce are intended for export to those countries. To facilitate monitoring, traceability must be adequate and appropriate technological measures must be employed for that purpose;
  • conclusion of the flexibility measure: at the end of the measures adopted, competent authorities of other countries and/or the public must be informed of the termination of the temporary measures, upon demonstration by operators. The outcomes of the measures must be considered for the improvement and adoption of future flexibility plans.

EU and Member States’ comments

The European Union and EU Member States (EUMS) welcomed the topics discussed during CCFL49, in which they participated through representatives of the European Commission and national governments. Below is a brief summary of the comments they provided.

Use of PAL

The European Commission finally expressed, after 15 years since the adoption of the Food Information Regulation (EU) No 1169/11, its intention to adopt implementing rules for the use of PAL in food labelling. To that end, it organised a public consultation in early 2026 (Dongo & Della Penna, 2026).

The main EUMS comments concern the adjustment in the use of certain terms, such as ‘food allergens’ or ‘allergenic foods’ (in place of allergens) and the use of the ‘gluten free‘ statement on foods bearing PAL.

The most important comment concerns the separation of wheat from other gluten-containing cereals, such as barley and rye, indicating for the former a specific reference dose for gluten (4.0 mg). With the objective of separating the effects attributable to the presence of proteins causing IgE-immunomodulated allergenic reactions from those of other gluten-containing cereals.

Multipack foods

The views on the proposed amendments were substantially negative, as they could have been introduced in other sections of CXS 1-1985, and their introduction was considered by EUMS as potentially liable to create confusion for consumers.

The main proposed amendments are:

  • introducing the provisions on the ingredients list as part of section 8 – Presentation of Mandatory Information – of the standard, rather than integrating the provisions relating to the ingredients list;
  • indicating the number of individual packages by type on the individual packages of the multipack is considered an unnecessary additional burden.

Labelling of alcoholic beverages

EUMS does not consider it useful to adopt further requirements for alcoholic beverages, as CXS 1-1985 and the guidelines on nutrition labelling (CXG 2-1985) (Codex Alimentarius, 1985b) already contain all that is necessary to meet the labelling requirements for these beverages.

European members of the CCFL did, however, note that the indication of alcoholic strength by volume is not addressed in Codex texts. Since such indication constitutes important information enabling consumers to make informed choices, EUMS supports work relating to the labelling of alcoholic strength on alcoholic beverages, taking into account the existing recommendations of the International Organisation of Vine and Wine (OIV).

EUMS also notes the lack of restrictions on alcoholic beverages in the Guidelines for Use of Nutrition and Health Claims (CAC/GL 23-1997) (Codex Alimentarius, 1997), and is therefore in favour of further work in this direction (in line with the limits established in the Nutrition and Health Claims Regulation EC No 1924/06).

Provisional conclusions

The long-awaited introduction of treaholds (and action levels) for allergens and substances causing intolerances, by the CCFL, provides the basis for harmonising the criteria for the use of PAL in food labelling while simultaneously guaranteeing both vulnerable consumers and food business operators.

The adoption of Reference Doses will finally offer operators and enforcement authorities the possibility of using methods such as VITAL for the precise estimation of risks associated with cross-contamination of foods by allergens, both for labelling purposes and for risk management based on concrete risk analysis.

The implementation of these principles into the national legislation of FAO and WHO member States is now awaited, following the trail blazed by the Netherlands.

Dario Dongo and Andrea Adelmo Della Penna

Bibliography

 

Dario Dongo
+ posts

Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.

FOOD TIMES_ ANDREA ADELMO DELLA PENNA
+ posts

Graduated in Food Technologies and Biotechnologies, qualified food technologist, he follows the research and development area. With particular regard to European research projects (in Horizon 2020, PRIMA) where the FARE division of WIISE Srl, a benefit company, participates.

Related post

Food Times_allergeni etichettatura consultazionePublic consultation on Precautionary Allergen Labelling in the EU Allergen labeling, criteria for exemption of derived substances Food Allergies and PAL, Codex Alimentarius Food safety, ABC operator responsibilities