Nano regulations in food

How are nanos controlled in food?

By the AVICENN team – Last modification August 2022

The ban on E171, an additive composed of (nano)particles of titanium dioxide, already in force in France since 2020, was extended to the entire European Union in August 2022.

Elsewhere, the regulation of nanos in food is somewhat unclear.

In France, the r-nano register lacks key information that would enable a good understanding of the volumes and uses in food.

At the European level, the labeling of nanos in food, which has been mandatory since the end of 2014, is not respected – whereas since 2016, tests have confirmed the presence of nanos in products sold on supermarket shelves.

Despite the requirement for pre-market authorization for food containing nanos, the knowledge and monitoring of the safety of nanomaterials in food remain very limited, falling short of what civil society and the most risk-aware MEPs have been demanding for years now.

In France, the r-nano register is almost useless to monitor nanos in food

In 2013, France was the first country to have required from manufacturers an “annual declaration of substances in the nanoparticulate state” in order to obtain more information on nanos. However, the data that manufacturers provide to ANSES and that are compiled in the r-nano register are not accessible to the public: most remain hidden, to respect industrial or commercial confidentiality.

In addition, in 2016 and 2017, no reporting was done for E171, the food coloring that contains titanium dioxide nanoparticles. The justification at the time was that this additive contained less than 50% of particles below the 100 nm mark¹E171 has since been banned, in 2019 in France and in 2022 at the European level, the threshold below which the declaration is not mandatory. As a result, there are many nanoparticles used in food that are not declared while “food manufacturing” is the fourth largest sector for nano usage with the highest number of declarations in the r-nano register.

Finally, the traceability of nanomaterials in food is currently incomplete because the r-nano system, as currently designed, does not allow the public or the health authorities to identify the finished products (food and others) in which the declared nanos are incorporated.

Although mandatory throughout Europe, the labeling of nanos in food is not respected

The labeling of nanomaterials in food has been mandatory in Europe since December 2014

Starting in December 2014, consumers should have seen [nano] labeling in food ingredient lists as required by the 2011 “INCO” Regulation on food information for consumers²Regulation (EU) No. 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, published in Official Journal of the European Union of November 22, 2011; this regulation of the European Parliament and the Council was validated after the European Parliament vote on July 6, 2011 (following a request made by the European Parliament as early dating back to 2009³The European Parliament had requested it in its resolution of March 25, 2009 on the proposal for a regulation of the European Parliament and of the Council on novel foods).
The Article 18, paragraph 3, stipulates that from mid-December 2014, “all ingredients that are in the form of manufactured nanomaterials shall be clearly indicated in the list of ingredients. The name of the ingredient shall be followed by the word “nano” in square brackets”.

A law, backed by Ségolène Royal, then Minister of the Environment  and published in the Official Journal on May 10, 2017, restated this labeling obligation⁴Cf. Order of May 5, 2017 setting the conditions for labeling manufactured nanomaterials in foodstuffs, published in the JORF n°0109 of May 10, 2017.

In fact, very few mentions [nano] on the labels…

Despite the 2014 regulations, very few food labels have included the [nano] mention:

The situation is similar in other European countries and associations have made the same assessments: Friends of the Earth Germany, the Italian consumer association Altroconsumo, the Belgian magazine Test santé and the Spanish magazine OCU-Compra Maestra have published similar tests, always with the same observation: several years after it came into force, the labeling obligation [nano] in food is nowhere to be found.

Why are brands keeping quiet about the presence of nanos?

There are several reasons for the brands’ silence: fear of seeing consumers turn away from their products, ignorance (real for some, feigned for others), incomplete or erroneous information from their suppliers and/or their professional branch, etc.

But brands can no longer escape: even those who have attestations from their suppliers (certifying that their ingredients are not nanomaterials) should worry. From a legal stand point, brands are obliged to verify what they put in their products and those who rely on incomplete or erroneous certificates from their suppliers can also be prosecuted.

In France, the National Laboratory of Metrology and Testing (LNE) is the reference laboratory on the subject. The UT2A of Pau is also working on the detection of nanoparticles in food.

What about controls and sanctions from the public authorities?

“Community inspections” were carried out in France in 2017, as well as in three other European Union Member States (Greece, Lithuania, Portugal) to verify the implementation of the INCO regulation (i.e. [nano] labeling)¹⁰Health and food audits and analysis – Programme 2017, DG Health, page 29.

France is the Member State that has been the most proactive in controlling the [nano] labeling obligation in food. At the end of November 2017, it presented its approach to the INCO Regulation expert committee at the EU level and committed to making its analytical methods available to other member states.

From the end of 2017 to the end of 2018, the DGCCRF (fraud repression) presented partial results of its analyses, which confirmed those published by the associations mentioned above: in almost all of the food products tested, nanoparticles were detected and, except for rare cases, these did not have any [nano] label.

The association Agir pour l’Environnement then strongly criticized the inertia of the authorities: “By not taking immediate action against the manufacturers, the public authorities continue to cover those known to be using nanos and allow them to continue to gain time, as they have done for years on this subject. It is the game of “leave no trace, can’t get traced” that will continue! This new form of judicial procrastination is truly scandalous!”¹¹Cf. DGCCRF confirms the massive presence of nanos in food, Agir pour l’Environnement, November 14, 2017.

The DGCCRF then took a harder line¹²The DGCCRF has presented its results in several forums:
– November 10, 2017, at workshop 8 of the Etats généraux de l’alimentation: see Des nanoparticules non mentionnées sur les étiquettes des aliments, Ouest-France, November 14, 2017
– On December 14, 2017, at the ANSES “nano and health” dialogue committee.
– On the morning of January 16, 2018, at the National Consumer Council (CNC) (see. the press release from the Ministry of the Economy), then in the afternoon to Avicenn, Agir pour l’Environnement and France Nature Environnement.
– On March 29, 2018, at LNE’s “nanomaterials and cosmetics” technical day
– On April 10, 2018, during a roundtable discussion, organized by the Ministry of Economy, bringing together professionals on the presence of nanoparticles in food products
– On November 26, 2018, at the ANSES “nano and health” dialogue committee (on the food component only) insisting that companies for which analyses show a failure to comply with the labeling obligation are liable to be prosecuted. The DGCCRF can transmit files to the Public Prosecutor’s Office so that legal proceedings can be initiated, with requests to bring labeling into compliance and possible criminal proceedings (5th class offences: ~ €1500), and even, in the case of deliberate concealment of the presence of nanos in the product, penalties of up to 2 years imprisonment and a fine of €300,000 (article L454-1 of the Consumer Code).

AVICENN has repeatedly questioned the DGCCRF to know what analyses were conducted after 2018 on nanos in food, but has not yet received an answer on this point.

Labeling under the influence of lobbies

While the labeling requirement is certainly a step in the right direction, it remains of limited value and is not sufficient.

Existing pre-market safety monitoring of nanomaterials in food

Several European regulations explicitly provide for the traceability and safety of nanomaterials potentially used by the food industry.

Marketing Authorization (MA) required for nanos under the 2015 Novel Foods Regulation

The second version of the Novel Foods Regulation, voted in October 2015 by the European Parliament¹⁵Legislative resolution on the proposal for a regulation of the European Parliament and of the Council on novel foods (COM(2013)0894 – C7-0487/2013 – 2013/0435(COD)), European Parliament, 28 October 2015: the final text validated by the Council of the EU is the Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods of 25 November 2015 now covers “foods that consist of engineered nanomaterials” defined as follows:

“intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have above the order of 100 nm but retain properties that are characteristic of the nanoscale. Properties that are characteristic of the nanoscale include:
i) those related to the large specific surface of the materials considered; and/or
(ii) specific physicochemical properties that are different from those of the non-nanoform of the same material.”

This definition may evolve in order to be adjusted “to technical and scientific progress or to definitions agreed at international level”. The use of a delegated act will allow the European Parliament to have a say in how the definition is updated.

Foods that contain engineered nanomaterials (nano-foods) fall within the scope of novel foods, even if the ingredients are already known.

There must now be a Marketing Authorization application (MA) for “manufactured nanomaterials”.

The European Consumers’ Organisation (BEUC)¹⁶EU Parliament votes in new novel food rules – or did it?“, NutraIngredients, 29 October 2015 and Green MEPs Michèle Rivasi and José Bové¹⁷Food safety: Novel foods, The Parliament deaf to the concerns of Europeans, Michèle Rivasi and José Bové, 28 October 2015 would have liked the Parliament to go further in its demands in order to provide a stricter framework for the marketing of nanomaterials in food, notably by adopting a broader definition and requesting a moratorium on the presence of nanoparticles in food until an adequate European health and environmental assessment procedure has been developed.

The case of additives (and the ban on E171)

Food additives are covered by another European regulation of 2008. It stipulates that the European Food Safety Agency (EFSA) must carry out a new evaluation of previously authorized additives whose particle size has been modified by the use of nanotechnology¹⁸Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives mentions nanos twice:
– In the “recital” 13 : “A food additive already authorised under this Regulation and prepared using manufacturing methods or starting materials significantly different from those referred to in the Authority’s risk assessment or different from those provided for in the specifications shall be submitted by the Authority for evaluation. “Significantly different” could mean inter alia (…) a change in particle size, including the use of nanotechnology.”
-In section 12: “Where, in the case of a food additive already included in a Community list, there is a significant change in the production methods or raw materials used, or where there is a change in particle size, for example through the use of nanotechnology, the additive produced with these new methods or raw materials is considered to be a different additive and a new entry or a change in the specifications in the Community lists is required before it can be placed on the market”..

The re-evaluation program for additives authorized before 2009¹⁹See in particular:
– Commission Regulation (EU) No 257/2010 of 25 March 2010 establishing a programme for the re-evaluation of approved food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives
– Food additives re-evaluation work programme, Paolo Colombo, Senior Scientific Officer – Food Additives Team, Food Ingredients and Packaging (FIP) Unit, EFSA, 28 April 2014
– Re-evaluation of food additives: tentative work programme 2016, EFSA, 2016 (?) therefore now takes this criterion into account. The two most common additives known to contain a significant proportion of nanoparticles are:

• E551, composed of silica amorphous (SiO₂Silicon dioxide, classified among food additives as an anti-caking agent) was authorized, including in nano form for precisely defined uses (powdered foodstuffs, sugar, salt, seasoning, rice…) in 2009²⁰Guidance for submission for food additive evaluations, EFSA Journal, 10(7):2760, 2012 (p.15) ; a new EFSA opinion was published in 2018 stating that there were not enough data to conclude on the safety or toxicity of this additive. A call for data was opened by EFSA between October 2018 and May 2020. There will be no new call for additional data and if no conclusive data can be obtained, the current authorization of this food additive would be revised based on EFSA’s current scientific opinion and the additive could be removed from the European Union’s list of authorized additives. In the meantime, scientific publications on the harmful effects of this additive are accumulating.
  
• E171, composed of titanium dioxide (TiO₂ an additive used as a coloring agent in food and medicines) has been banned in France in 2020 and at the European level in 2022 (at the end of a long process in which researchers, NGOs and French public authorities played a significant role, prompting EFSA to reconsider its last evaluation published in 2016²¹See Food colours: titanium dioxide marks re-evaluation milestone, EFSA, 14 September 2016 (press release) and Re-evaluation of titanium dioxide (E 171) as a food additive, EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), EFSA Journal, 14 September 2016 (“scientific opinion”) according to which E171 did not pose a health concern to consumers).

Nearly a decade after its 2012 guidelines for the evaluation of food additives²²Guidance for submission for food additive evaluations, EFSA Journal, 10(7):2760, 2012 (p.15) concerning the specific information required for the characterization of nanomaterials, EFSA published in 2021 two new sets of very important guidelines (“Guidance”)²³Guidance on risk assessment of nanomaterials in the food and feed chain: animal and human health, June 2021: this guidance provides a roadmap to progressively roll out and assist in the assessment of nanomaterials; Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles, June 2021: this guidance addresses conventional materials that contain a fraction of small particles but do not meet the definition of engineered nanomaterials before organizing a workshop in 2022 to provide further clarification on these various aspects²⁴Stakeholders workshop on small particles and nanoparticles in food, EFSA, 31 March – 1 April 2022.

The case of plastic materials and objects in contact with foodstuffs

The European PIM Regulation n°10/2011 states that substances in nanoscale form present in plastic materials and objects in contact with foodstuffs must be subject to a specific authorization procedure by EFSA²⁵Cf. Commission Regulation (EU) No. 10/20111 of 14 January 2011 on plastic materials and articles intended to come into contact with food.

The case of food intended for infants and young children as well as food intended for special medical purposes

In the summer of 2013, the European Parliament examined in a second reading, the proposal for a “Regulation on foods for infants and young children and foods for special medical purposes” that had been under discussion since 2011²⁶European Regulation on foods for infants and young children and foods for special medical purposes, June 2013.

In June 2012, the European Parliament recommended “to exclude nanomaterials from the Union list for the food categories covered by the Regulation as long as the Authority has not provided evidence of their safety, based on appropriate and sufficient testing methods, nutritional value and usefulness for the persons for whom they are intended”.

The adopted text stipulates that “When there is a significant change in the production method of a substance that has been used in accordance with this Regulation or a change in particle size of such a substance, for example through nanotechnology, that substance should be considered different from the one that has been used in accordance with this Regulation and should be re-evaluated under Regulation (EC) No 258/97 (Novel Food) and subsequently under this Regulation“.

This is an important issue since, according to a recent study, children consume two to four times more titanium than adults from sweets containing high levels of titanium dioxide nanoparticles²⁷Titanium Dioxide Nanoparticles in Food and Personal Care Products, Weir A. et al., About. Sci. Technol., 46 (4), pp 2242-2250, 2012; access to the article is not free, but a synthetic presentation as well as the names of the concerned trademarks are available here: http: //www.nanowerk.com/spotlight/spotid=24290.php..

How do organic labels treat nanos?

Unlike GMOs, there is no declared incompatibility between manufactured nanomaterials and organic production at the European level, but this should change from 2022: the text of the new regulation on organic production and labeling of organic products provides for the exclusion of foods containing or consisting of engineered nanomaterials.

The technical difficulties and the cost of detecting nanomaterials have made the “nano-free” guarantee provided by organic labels questionable as ECOCERT learned this the hard way in 2012 in the cosmetics sector.

The technical advances made in recent years should nevertheless lead to further progress in this area.

The challenges for the years to come…

In the months and years to come, these different initiatives or perspectives will continue to provide an opportunity for negotiation and bargaining, particularly around the following issues.

Revision of the definition of nanomaterials

The recommendation of the definition of the term “nanomaterials” has been revised at European level in 2022. It could eventually be integrated into sectoral regulations, particularly with regard to food. When is the deadline? With or without adaptations? Uncertainty prevails…

Standardization of detection and characterization tests for nanomaterials in food

In recent years, significant progress has been made in the detection/characterization of nanomaterials in food and agricultural samples, although the techniques and tools are still limited to a relatively small number of laboratories.

Some brands try to avoid the demands of civil society and public authorities by arguing that there is no standardized method. However, according to the recommendations of the European authorities and the best specialists in the field, it is now impossible to disregard the evidence obtained by electron microscopy laboratories.

Intensified research on the risks of nanos in food and food packaging

The risks related to the presence of nanos in food as well as the migration of nanos (or nano-residues) contained in food packaging to the foodstuffs they contain constitute a major issue for the years to come.

However, research on risks is still too rare. In 2021, Anses published a guide to assess the specific health risk of nanomaterials in food products and, starting in 2022, the proposed method is to be tested by Anses on manufactured nanomaterials. To be continued…

Assessing the real “added value” of the use of nanomaterials in food

The assessment of the real “added value” of the use of nanos in food is crucial; it was a deciding factor in the ban of E171, whose risks were deemed to outweigh the benefits (only visual). The benefit/risk analysis must also be combined with a study of complementary or even alternative solutions, particularly when the benefits do not justify the potential risks.

As the CIRAD and INRA Joint Consultative Ethics Committee for Agricultural Research stated in 2012: “the agricultural, food and environmental problems to which nanotechnologies offer solutions can (…) be solved by adopting other technical scenarios, which seem to leave more autonomy to local populations and make better use of traditional knowledge. (…) Nanotechnologies are not the only technologically innovative solutions; their development can only be encouraged after a comparative assessment, with regard to the desired goals, of other existing or possible solutions²⁸Joint Consultative Ethics Committee for Agricultural Research, CIRAD / INRA, Opinion on nanoscience and nanotechnology, December 2012, p.17 and p.28.

Let’s take the example of packaging for chocolate bars: rather than using packaging coated with aluminum or aluminum oxide nanolayers, brands could use alternative, complementary solutions: raising consumer awareness of the fact that chocolate whitening is not a mold and does not prevent its consumption; modifying the structure of the chocolate to reduce the migration of the lipids responsible for whitening; better control of the crystallization of cocoa butter; tempering;…²⁹Why does chocolate turn white, Pierre Barthélémy, Passeur de sciences, May 10, 2015.

As Didier Schmitt, scientist and coordinator of foresight to the Chief Scientific Advisor and in the office of the European Policy Advisors to the President of the European Commission, pointed out “It is not because things are possible – scientifically – that they should be done; it is not because there is a solution – technological – that there is necessarily a problem to solve. However, the opposite view – the negation of progress – would make us throw away, wrongly, the opportunities with the bath water. We must therefore keep our wits about us and find a balance between what is feasible – the supply – and what we want – the demand. What do we really need?”³⁰Garnishing our plates differently in 2030, Didier Schmitt, Les Echos, August 4, 2014.

The answers that nanotechnologies and nanomaterials could bring to the food sector should not overshadow other solutions for preventing problems – potentially at lower cost, for a greater number of beneficiaries and with wider impact both on the socio-economic level and on the health and environmental level.

Complementary solutions have been tried and tested with good results, including:

• the campaign against food waste
• the development of agroecology³¹See for example:
  – Agriculture and ecology: tensions, synergies and challenges for agronomy, AFA Journal, AE&S, vol.2, n°1, June 2012
  – Agroecology, a transition towards sustainable lifestyles and development, Desertification Working Group (DWG), January 2013
  – The agro-ecological project for France, French government, February 2013
  – UNCTAD, Trade and Environment Review 2013, Wake up before it is too late: Make agriculture truly sustainable now for food security in a changing climate, September 2013
• the combination of scientific knowledge with knowledge accumulated by generations of farmers³²See for example:
  – Vibrant call from FAO chief: let’s change the way we produce food, FAO, June 2015
  – the “Nearer + Healthier + Fairer” campaign of Agronomists and Veterinarians Without Borders
  – Avenues to meet food security. The role of agronomy on solving complexity in food production and resource useSpiertz, J.H.J., European Journal of Agronomy, 43, 2012
  – Agronomy and the food challenge, Synthesis of the AFA Conference-Debate, 2010
• the control of pathogens upstream of the supply chain³³Microflora of raw milk: towards a better knowledge of the microbial ecosystems of milk and their factors of variation, Cécile Laithier, CNAOL, 2011: a synthesis book that popularizes knowledge on the flora of interest, the reservoirs of microflora, the effects of breeding practices on their composition and downstream by the application of elementary rules of hygiene³⁴See, for example, the Household Hygiene sheet published byANSES in February 2013
• the relocation of agriculture and its corollary, the development of short food distribution circuits³⁵Cf. Martine François, Développement des filières courtes de commercialisation : contribution à la souveraineté alimentaire, Possibles, 4 Oct. 2010. Concerning the countries of the South, see for example Les légumes africains comme remède à la malnutrition, SciDev.net, 20 Sept. 2013
• …

Nanotechnological solutions, in the food industry as in other fields, must not make us lose sight of the real needs of the populations to which we must respond in a relevant and responsible way. We must keep in mind that if “common sense is the best shared thing in the world”, collective vigilance is necessary and requires the participation of all. As such, AVICENN intends to continue its citizen’s watch on this.