On 6 May 2021, the European Food Safety Authority (“EFSA”) published its updated safety assessment on titanium dioxide as a food additive (E171). EFSA examined new evidence on nanoparticles and found that there was uncertainty about E171’s ability to accumulate in the body and damage genetic material in cells; i.e. genotoxicity. The agency could not calculate an Acceptable Daily Intake (“ADI”), nor could it determine a safe cut-off value for particle size and distribution. On that basis, it could not confirm the safety of E171 in food. However, since it found no evidence of acute toxicity, an immediate ban is not warranted. France previously initiated a national ban in 2019/2020; following EFSA’s revised opinion, the EU is likely to adopt an EU-wide ban early 2022. In this blog, we briefly review the planned EU-level response and the developments in the Netherlands, Germany and the UK.

I. EU

On 18 May 2021, the Commission Working Group on Food Additives discussed EFSA’s revised assessment and its follow-up.  According to a report on the meeting by the Dutch delegation, all Member States indicated they could support a ban on E171. An official from the European Commission has confirmed that the Commission foresees a transitional period to give operators time to phase out the use of this additive in food and replace it where needed. However, reportedly, the Commission wishes for this transition period to be as short as possible. The Member States will provide feedback on this as soon as possible. As a reference, France suggested that a transition period of 8 months was applied without any problems with the French (national) E 171 ban in 2019/2020. The Commission expects to table a proposal by the end of July to be voted on at the Plants, Animals, Food and Feed Standing Committee meeting on Toxicology & Novel Food (SCoPAFF Tox & NF) scheduled for 28 September 2021.  If adopted, the proposal could enter into application at the beginning of 2022.

Titanium dioxide is also permitted as a coloring agent in other products, such as pharmaceuticals, animal feed, food contact materials and care products. The relevant agencies have been informed and will consider for themselves whether the EFSA opinion has consequences for the use of titanium dioxide in their area. For its part, EFSA also concluded on 16 June 2021 that titanium dioxide can no longer be considered safe to use in animal feed.

II. The Netherlands

It is currently unlikely that the Netherlands will impose a national prohibition on the use of titanium dioxide as a food additive.  In the Dutch minutes for the Commission Working Group on Additives on 8 February 2021, the Netherlands reportedly indicated that European legislation exists for a reason and that national bans are undesirable. The National Institute for Public Health and the Environment (“RIVM”) webpage on E171 confirms that any decision on banning titanium dioxide is to be taken at EU-level.

III. Germany

Similarly, there are no developments in Germany that suggest it will adopt a national E171 ban.

The Federal Minister for Food and Agriculture and the Federal Institute for Risk Assessment have both issued press releases on titanium dioxide on 6 May 2021.  Both of them refer to actions to be taken at EU level. Federal Minister Klöckner stated in her press release that she has asked the Commission to take action. The Federal Institute for Risk Assessment also issued a press release stating that it has reached comparable conclusions to the EFSA.  It subsequently updated its Q&A on the additive and indicated it expects action at the EU level.

The emphasis on EU-level action suggests that an initiative at the national level is rather unlikely.

IV. UK

The UK is still considering its stance on the additive, suggesting no immediate national ban is to be expected, but further action cannot be ruled out.

Following the publication of the EFSA opinion, a spokesman for the UK Food Standards Agency (‘’FSA’’) said its independent scientific advisory committees would scrutinize EFSA’s revised assessment alongside existing evidence. This review would inform next steps and future policy.

The FSA also discussed the issue during its board meeting on 26 May 2021, where it concluded it would “put the EFSA opinion through the risk analysis process” and that “devolved administrations have been informed and we are considering implications for Northern Ireland.”

Conclusion

In short, an EU-wide ban on the use of titanium dioxide could be put to a SCoPAFF Tox & NF vote in September 2021 and come into effect by January 2022 with a relatively short transition period of 6 to 9 months. We await the outcome of the UK FSA scrutiny of the EFSA assessment and expect no further national action in the Netherlands and Germany.

 

 

 

 

 

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Photo of Bart Van Vooren Bart Van Vooren

Bart Van Vooren has a broad life sciences practice supporting innovative pharmaceutical, food, medtech and biotech companies on EU regulatory, commercial and strategic policy assignments. He is widely recognized for his expertise on general EU law and procedure, as well as his extensive…

Bart Van Vooren has a broad life sciences practice supporting innovative pharmaceutical, food, medtech and biotech companies on EU regulatory, commercial and strategic policy assignments. He is widely recognized for his expertise on general EU law and procedure, as well as his extensive litigation experience before the EU Court of Justice in dozens of cases.

Over the past seven years, Mr. Van Vooren has developed a niche practice on compliance with the Biodiversity Convention and the Nagoya Protocol, a set of rules to combat bio-piracy worldwide. He has accumulated unique, practical experience in dozens of jurisdictions around the world, and has handled everything from benefit-sharing negotiations, over compliance programs, to inspections by authorities.

Finally, Mr. Van Vooren has an active pro bono practice assisting NGOs defending the human rights of persons with a disability through strategic litigation.