Foodlaw-Reading
Dr David Jukes, The University of Reading, UK
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Commission Daily News, 8 October 2021
Today, Member States approved the European Commission's proposal to ban the use of Titanium Dioxide (E171) as a food additive from 2022. Titanium Dioxide is used as a colorant in a number of products such as chewing gum, pastries, food supplements, soups and broths. Commissioner Stella Kyriakides, in charge of Health and Food Safety, said: “The safety of our food and the health of our consumers is not negotiable. Today, we act decisively with our Member States, based on sound science, to remove a risk from a chemical used in food”.
The Commission's proposal is based on a scientific opinion by the European Food Safety Authority, which concluded that E171 could no longer be considered as safe when used as a food additive, in particular due to the fact that concerns regarding genotoxicity cannot be ruled out. Unless an objection is adopted by the end of the year by either the Council or the European Parliament, the text will enter into force in early 2022. This will then kick-off a 6-month phasing out period after which a full ban will apply in food products.
The Commission has added the following Questions and Answers to their Food Additives – Re-evaluation page:
Questions & Answers on titanium dioxide
A selection of the most frequently asked questions through the re-evaluation process:
On what have the Member States voted on 7 October and what are the next steps?
The Member States have expressed a favourable opinion, in the context of a Standing Committee on Plants, Animals, Food and Feed, on a proposal by the European Commission to withdraw the authorisation to use a food additive (Titanium dioxide /Ti02 also known as E171) in food products.
In the coming weeks, the Council and the European Parliament will have the possibility to give feedback on the draft Regulation during what is called the “scrutiny period” (two months to consider whether there are any grounds to object to the draft Regulation).
The Commission services will also inform the WTO members on the draft Regulation through the SPS notification system.
When can we expect the Regulation to enter into force?
If there is no objection from the Council or the Parliament, the Regulation is expected to be adopted and published at the beginning of 2022.
Will there be a phasing-out period for the food products already on the market which contain the food additive and who will control this?
At the moment, E171 is widely used as a colour in a number of foods such as cakes and pastries, confectionary or food supplements.
In order to mitigate the potential impact of the Regulation on food business operators, transitional measures are foreseen to allow them to continue placing on the market food containing E 171 for a limited period of time, while they are working on the reformulation of their products.
Therefore, the Regulation allows to place on the market foods containing titanium dioxide, in accordance with the conditions given by the currently applicable legislation, until six months after the Regulation enters into force. Those foods may then continue to be marketed until their date of minimum durability or ‘use by’ date.
Surveillance of the markets is under the competence and responsibility of Member States’ food safety authorities.
What is the scientific basis for this decision?
The Commission prepared its proposal on the basis of a scientific opinion from EFSA, published on 6 May 2021, which concluded that E171 can no longer be considered as safe when used as food additive. This conclusion was reached using all available evidence along with all the uncertainties, in particular the fact that a genotoxicity concern could not be ruled out.
EFSA did not conclude that E171 is genotoxic, but it was not able to establish a maximum Acceptable Daily Intake (ADI) for this food additive, in particular due to possible concerns with respect to genotoxicity, and thus concluded that the safety of the product cannot be confirmed.
Genotoxicity is the ability for a substance or any other toxic agent to damage DNA, the genetic material of cells, which may in turn, as a possible consequence, lead to cancer.
This assessment took into account new data that were not available when EFSA re-evaluated E 171 in 2016, and made use, for the first time, of the 2018 EFSA Guidance on nanotechnology.
Moreover, EFSA also searched for studies performed specifically with titanium dioxide nanoparticles.
This led to the identification of almost 10,000 different studies, which have been individually screened and, when relevant, taken into account in the safety assessment of E 171.
Titanium dioxide is also used in medicines. What is foreseen for medicines containing E171?
In line with the applicable legislation and on the basis of the European Medicines Agency (EMA) analysis on the use of titanium dioxide in medicines published 8 October 2021, the Regulation foresees that titanium dioxide remains for the time being on the list of authorised additives to allow its use in medicinal products as a colour. One of the reasons for that decision is to avoid shortages of medicinal products containing the colourant as this could impact public health, animal health and welfare. The replacement of titanium dioxide will also require investigation and testing of suitable alternatives to ensure that quality, safety and efficacy of medicines is not affected negatively.
A review clause is foreseen in the draft Regulation according to which the Commission is to re-evaluate the situation within 3 years after the date of entering into force of the Regulation, on the basis of an updated assessment by the EMA.
This gives a clear sign that the pharmaceutical industry should make any possible efforts to accelerate the research and development of alternatives to replace titanium dioxide in both new and already authorised products, and to submit the necessary changes to the terms of the marketing authorisations concerned.
For previous news item on this topic, see:
