Ref. Ares(2019)3000909 - 06/05/2019
Vice-President Jyrki Katainen
European Commission
Rue de la Loi 200
B – 1049 Brussels
Ref.: BEUC-L-2019-097/
Brussels, 3rd May 2019
Subject: Civil society organisations demand the removal of E171 from the EU list
of permitted food additives
Dear Vice-President,
We are writing regarding the notification by France of a decree suspending the placing on
the French market of foodstuffs containing the food additive titanium dioxide (E171) as of
January 2020 over concerns about its safety for consumers. The measure will be examined
at a meeting of the Standing Committee on Plants, Animals, Food and Feed taking place
on 13 May 2019.
Because all Europeans deserve the same high level of protection,
the undersigned
organisations call on the European Commission to follow suit and put forward a
legislative proposal removing E171 from the EU list of permitted food additives.
In the meantime,
we urge you not to raise any objections or initiate any legal
proceedings against the French measure. Ahead of the European elections, any move
to challenge or delay the French measure would risk sending the wrong signal to EU
citizens, who expect the EU to put their health and safety first.
Indeed, the French decree is based on the precautionary principle after the French food
safety agency, ANSES recently confirmed that significant uncertainties remain as to the
health effects for consumers of the additive E171.
According to EU legislation, a food additive may only be authorised if its use is safe,
technologically justified, and if it does not mislead, but on the contrary benefits, the
consumer:
E171 meets none of these conditions.
• Safety: As clearly emerged from the ANSES report, scientific uncertainties and data
gaps remain, which do not allow lifting concerns over the potential toxicity of E171 for
consumers. The 2016 opinion by the European Food Safety Authority, EFSA on E171
also pointed at a lack of data hindering the full safety risk assessment of the additive.
…/…
…/…
2
The European Commission
should therefore
apply the precautionary principle and
propose to remove E171 from the EU list of permitted food additives. It is remarkable
that these uncertainties partly result from manufacturers’ failure to provide the
necessary data to conduct the risk assessment. The
‘no data, no market’ approach,
which prevails in the chemicals sector under the REACH legislation, should also apply
to regulated substances in the food area, such as food additives, to prove their safety.
• Technological need: There is no convincing technological need for the use of E171.
Many food manufacturers and retailers operating on the French market have already
removed E171 from their products or are in the process of phasing it out. The move is
even spreading beyond Europe, with some multinational companies having committed
to remove E171 from their food portfolio.
• Benefits and advantages for the consumer: E171 is only used for aesthetic purposes.
It has no nutritional value, nor does it fulfil any beneficial technological function in food
(e.g. extending shelf life).
We therefore urge the European Commission to protect the health of European
consumers and propose to ban the use of E171 in food.
Further detailed information on the reasons behind our request is available as an annex
to this letter. We remain at your disposal to discuss this matter with your services.
Yours sincerely,
BEUC
Center for
ECOS
European
International
Environmental
Environmental
Bureau (EEB)
Law (CIEL)
Health and
Health Environment SAFE – Safe Food
foodwatch international Environment
Justice Support –
Advocacy Europe
Alliance (HEAL)
HEJ Support
Women engage for a
common future (WECF)
Supporting national organisations:
1. Agir pour l'Environnement (FR)
6. Consommation Logement Cadre de
2. Altroconsumo (IT)
vie (CLCV) (FR)
3. Bio Consom'acteurs (FR)
7. Consumentenbond (NL)
4. Bund für Umwelt und Naturschutz
8. EKPIZO (EL)
Deutschland (BUND) (DE)
9. Fédération romande des
5. Comité pour le développement
consommateurs (FRC) (CH)
durable en santé (C2DS) (FR)
10. foodwatch France (FR)
11. Forbrugerrådet Tænk (DK)
ANNEX
On 17 April 2019, France announced
1 that it had adopted a decree to suspend the placing
on the French market of foodstuffs containing the food additive titanium dioxide (TiO2 - E
171) as of 1st January 2020. The decree was published
2 in the French Official Journal on
25 April 2019 and was subsequently notified to the European Commission. The measure
will be examined at a meeting of the Standing Committee on Plants, Animals, Food and
Feed taking place on 13 May 2019.
This decree by the French government, which is based on the application of the
precautionary principle, follows the publication by the French agency for food,
environmental and occupational health, ANSES of a report
3 (in French only) which
analysed 25 new studies on E 171's toxicity published since 2017. The report concludes
that significant scientific uncertainties persist as to the health effects for consumers of
exposure to TiO2 via ingestion.
TiO2 is found in many everyday products, as pigment-grade particles for use as whitening
and opacifying agents in paints, cosmetics or food, where it is referred to as E171. It is
widely used in a range of foodstuffs, including confectionery, bakery and sauces. E 171
consists in a mixture of particles of different sizes, including a nanosized fraction. Because
of their extremely small size, nanoparticles can pass through protective body barriers and
get into the liver, lungs or intestines. They can exhibit different properties compared to
their larger sized versions, and as such they can also raise new risks to health and the
environment.
Human oral exposure to TiO2 is estimated to range between 0.2 and 0.4 mg per kg of
body weight in infants and the elderly, and up to 5.5 –10.4 mg per kg b.w. in children,
depending on the exposure scenario. TiO2 intake occurs mostly
via the ingestion of candy,
coffee creamer and sauces, and toothpaste by young children
4.
Tests carried out on the French market by consumer and environmental groups have
unveiled the presence of unlabelled nanoparticles of E 171 in many popular foodstuffs such
as sweets, chewing-gums and cakes frequently consumed by children and other vulnerable
populations
5.
According to EU Regulation (EC) No 1333/2008 on food additives, a food additive may
only be authorised if its use is safe, technologically justified, and if it does not mislead,
but on the contrary benefits, the consumer: E 171 meets none of these conditions.
• Safety: In 2016, the European Food Safety Agency (EFSA) published its scientific
opinion re-evaluation the safety of E 171
6. While it concluded that available data did
not suggest any immediate health concern, EFSA highlighted some data gaps and
uncertainties hindering the full safety re-evaluation of the additive. In particular, the
expert panel in charge of the re-evaluation could not reach definitive conclusions on
the potential reproductive toxicity of E 171, and for that reason did not establish a safe
intake level (Acceptable Daily Intake) for the additive. The Commission subsequently
requested industry
7 to provide additional data and information, notably on the particle
size and particle size distribution of E 171 because of their potential toxicological
importance.
1 Press release issued by the French Ministry of Ecological Transition.
2 Decree from the 17th of April relating to the suspension of the placing on the market of foodstuffs containing
the food additive E 171 (titanium dioxide) published in the French Official Journal on the 25th of April.
3 ANSES scientific opinion on the health risks associated with E 171 ingestion published on 15 April 2019.
4 Dorier M
et al. The food additive E171 and titanium dioxide nanoparticles indirectly alter the homeostasis of
human intestinal epithelial cel s in vitro.
Environ. Sci.: Nano, Advance Article, 2019.
5 Tests carried out by Agir Pour l’Environnement, 60 mil ions de consommateurs and UFC – Que Choisir.
6 EFSA safety re-evaluation of titanium dioxide (E 171) as a food additive.
7 Additional request for data published on DG SANTE website.
However, new studies became available, indicating several potential health risks (incl.
genotoxicity and carcinogenicity) for consumers from oral exposure to E 171. Notably,
a study by the French National Institute for Agricultural Research
8 showed for the first
time that E171 crosses the intestinal barrier in animals and reaches other parts of the
body. Immune system disorders linked to the absorption of the nanoscale fraction of
E171 particles were observed. The researchers also showed that chronic oral exposure
to the additive spontaneously induced precancerous lesions in rats, while
acknowledging that more evidence was needed to extrapolate the results to humans.
In March 2018, the Commission mandated EFSA to evaluate four of these new studies.
In June 2018, EFSA published its evaluation
9, whereby it did not consider the four
studies would warrant re-opening its 2016 scientific opinion. The EFSA expert panel
recognised that the four studies evaluated did highlight some concerns, albeit with
uncertainties. It recommended further research to decrease the level of uncertainties.
Eventually, in a most recent scientific advic
e10 released on 15 April 2019 and taking
into account the latest available evidence on the health effects of E 171
11, the French
food safety agency, ANSES pointed once more at persisting scientific uncertainties and
insufficient data making it impossible to set an ADI for E 171. ANSES recommended to
improve the physicochemical characterization of E 171 in order to allow for the full
assessment of the risks associated with the consumption of this additive. It also
recommended to conduct additional reproductive toxicity and, possibly,
in vivo
genotoxicity studies to better characterise the potential hazards associated with E 171.
Finally, ANSES reiterated its previous conclusions
12 pertaining to products containing
nanomaterials in general, namely that worker, consumer and environmental exposure
to such products should be minimised, notably by promoting safer alternatives free
from nanomaterials, so long as uncertainties remain over their safety.
Considering these uncertainties and data gaps, which prevent the complete risk
assessment of E 171 and do not allow lifting remaining concerns over its potential
toxicity for consumers, the precautionary principle should apply, and E 171 should be
removed from the EU list of permitted food additives.
It is remarkable that the French government partly justified
13 its decision to suspend
the use of E 171 over manufacturers’ failure to provide the necessary data to conduct
the risk assessment. The ‘no data, no market’ principle, which prevails in the chemicals
sector under the REACH legislation, must equally apply to regulated substances in the
food area, such as food additives, in order to prove their safety. In December 2018,
EFSA recognised
14 that the additional data submitted by industry is still not
satisfactory.
8 Bettini
et al. Food-grade TiO2 impairs intestinal and systemic immune homeostasis, initiates preneoplastic
lesions and promotes aberrant crypt development in the rat colon,
Scientific Reports, 7:40373.
9 EFSA evaluation of four new studies on the potential toxicity of titanium dioxide used as a food additive (E
171)
10 ANSES scientific opinion on the health risks associated with E 171 ingestion published on 15 April 2019.
11 The most recent evidence on the health effects of E 171 includes notably the fol owing studies:
- Gender difference in hepatic toxicity of titanium dioxide nanoparticles after sub-chronic oral exposure in
Sprague‐Dawley rats, Chen Z et al.,
Journal of Applied Toxicology, 2019: the study examined female and
male rats administrated with TiO2 nanoparticles oral y at doses of 0, 2, 10 and 50 mg/kg body weight per
day for 90 days. It found significant hepatic toxicity that could be induced by sub-chronic oral exposure to
TiO2 nanoparticles.
- Exposure to Titanium Dioxide Nanoparticles During Pregnancy Changed Maternal Gut Microbiota and
Increased Blood Glucose of Rat, Mao Z et al.,
Nanoscale Research Letters, 14:26, 2019: the study pointed
out that TiO2 nanoparticles induced the alteration of gut microbiota during pregnancy and increased the
fasting blood glucose of pregnant rats, which might increase the potential risk of gestational diabetes of
pregnant women.
- The food additive E171 and titanium dioxide nanoparticles indirectly alter the homeostasis of human
intestinal epithelial cel s in vitro, Dorier M et al.,
Environ. Sci.: Nano, Advance Article, 2019: the study found
that TiO2 moderately but significantly dysregulates several features that contribute to the protective
function of the intestine.
12 https://www.anses.fr/en/content/assessment-risks-associated-nanomaterials
13 Press release issued by the French Ministry of Ecological Transition.
14 Minutes of the 18 December 2018 meeting of the EFSA Scientific Panel on Food Additives and Flavourings’
Working Group on specifications of food additives
• Technological need: There is no convincing technological need for the use of E 171. As
a result of political and public pressure, many food manufacturers and retailers
operating on the French market have already removed E 171 from their products or
are in the process of phasing it out
15. Over at least 150 foodstuffs which used to contain
E 171 have been reformulated to become ‘E 171 free’ in a very short period of tim
e16.
Smaller producers, who might arguably face greater technological hurdles than bigger
operators, have been offered support from their professional organisations to get rid
of E 171 in their products
17. And the move is even spreading beyond Europe
18, with
some multinational companies having committed to remove E 171 from their food
portfolio.
• Benefits and advantages for the consumer: E 171 is only used for aesthetic purposes.
It has no nutritional value, nor does it fulfil any beneficial technological function in food
(e.g. extending shelf life).
15 May 2018 update by Agir pour l’Environnement.
16 Online inventory (non-exhaustive) by Agir Pour l’Environnement.
17 April 2018 press release by the French Ministry of Economy and Finance.
18 Press release by the US consumer group, the Center for Food Safety reporting on Mars announcement to
phase out artificial food colours, including E 171, from food products.