II
(Non-legislative acts)
REGULATIONS
COMMISSION REGULATION (EU) 2022/63
of 14 January 2022
amending Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the
Council as regards the food additive titanium dioxide (E 171)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008on food additives(1), and in particular Article 10(3) thereof,
Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings(2), and in particular Article 7(5) thereof,
Whereas:
(1)Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for u in foods and
their conditions of u.
(2)Annex III to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for u in food
additives, food enzymes, food flavourings, nutrients and their conditions of u.
(3)Titanium dioxide (E 171) is a substance authorid as a colour in certain foods, in accordance with Annex II to
Regulation (EC) No 1333/2008.
(4)Pursuant to Article 3(1) of Regulation (EC) No 1331/2008, the Union list of food additives may be updated either on
the initiative of the Commission or following an application.
(5)Article 32(1) of Regulation (EC) No 1333/2008 provides that all food additives that were already permitted in the
Union before 20 January 2009are subject to a new risk asssment by the European Food Safety Authority (‘the Authority’).
(6)On 14 September 2016, the Authority published a scientific opinion on the re-evaluation of the safety of titanium
dioxide (E 171) as a food additive(3)concluding that the margins of safety calculated in the opinion would not be of concern. Nevertheless, the Authority recommended additional toxicological testing, an extended 90-day study or a multigeneration or extended-one generation reproduction toxicity study according to the current OECD guidelines, in order to be able to establish a health-bad guid
休休有容ance value (acceptable daily intake – ADI) for titanium dioxide (E 171). The Authority also recommended amendments to the Union specifications for titanium dioxide (E 171) by introducing a characterisation of the particle size distribution and the percentage of particles in the nanoscale prent in titanium dioxide (E 171) ud as a food additive, and revising the maximum limits for impurities of toxic elements.
(1)OJ L 354, 31.12.2008, p. 16.
(2)OJ L 354, 31.12.2008, p. 1.
(7)On 30 January 2017, the Commission launched a public call for scientific and technological data on titanium
dioxide (E 171), targeting the data needs identified in the scientific opinion on the re-evaluation of this substance as
a food additive.
(8)On 2 October 2017and 29 June 2018, in view of the recommendations made by the Authority, business operators
made a proposal for the amendment of the specifications for titanium dioxide (E 171) and submitted the necessary data. On 7 August 2018, the Commission requested the Authority to provide a scientific opinion on whether the data provided adequately support the propod amendment of the specifications for titanium dioxide (E 171). (9)On 12 July 2019, the Authority published a scientific opinion on the propod amendments of the specifications for
titanium dioxide (E 171) ud as a food additive. The Authority concluded on additional parameters related to particle size distribution to be included in the specifications and recommended a revision of the definition of the food additive titanium dioxide (E 171) in the Union specifications. The Authority also concluded that, bad on the propod change in the specifications, revisiting the toxicological databa on titanium dioxide (E 171) as a food additive should conquently be conducted in line with the data requirements specified in the 2018 ‘Guidance on risk asssment of the application of nanoscience and nanotechnologies in the food and feed chain’(4).
(10)On 6 March 2020, the Commission requested the Authority to asss the safety of the food additive titanium dioxide
(E 171), taking into account the propod amendments of the specifications, the data from an extended one
generation reproductive study submitted by a consortium of interested business operators in reply to the public call for data launched in 2017 as well as all new relevant data available since the completion of the re-evaluation of titanium dioxide (E 171) in 2016, including the data considered to be in line with the data requirements specified in the 2018 Guidance on nanotechnology.
(11)On 6 May 2021, the Authority published a scientific opinion on the safety asssment of titanium dioxide (E 171) as
a food additive(5). In light of the opinion on the propod amendments of the specifications and following the 2018
Guidance on nanotechnology, the opinion also takes into account, in addition to all new relevant data, the data on the potential genotoxicity of titanium dioxide nanoparticles published before 2016, that had not previously been identified as relevant for the 2016 re-evaluation. In its opinion the Authority indicated that, bad on all the evidence available, a concern for genotoxicity could not be ruled out, and given the many uncertainties, it concluded that titanium dioxide (E 171) can no longer
be considered safe when ud as a food additive. The Authority neither identified nor recommended any new studies that could alleviate the genotoxicity concern and other remaining uncertainties.
(12)In light of the conclusion of the 2021 Authority’s opinion about the safety of titanium dioxide (E 171) when ud as
a food additive, it is appropriate to remove the authorisation to u titanium dioxide (E 171) in foods. Accordingly,
titanium dioxide (E 171) may no longer be ud in foods. As titanium dioxide (E 171) would no longer be authorid for u in foods, it is also appropriate to remove the reference to it from the entry on the u of potassium aluminium silicate (E 555) as a carrier laid down in Part 1 of Annex III to Regulation (EC) No 1333/2008.
(13)However, given that the Authority did not identify an immediate health concern linked to titanium dioxide (E 171)
ud as a food additive and in order to allow for a smooth transition, it is appropriate that foods that contain titanium dioxide (E 171) ud in accordance with the rules applicable before the date of entry
into force of this Regulation may be placed on the market until six months after that date. Tho foods may then continue to be marketed until their date of minimum durability or ‘u by’ date.
(4)EFSA Journal 2018;16(7):5327.
(14)Directive 2009/35/EC of the European Parliament and of the Council(6)restricts the u of colours in human and
veterinary medicinal products to tho authorid in accordance with Regulation (EC) No 1333/2008 on food additives, for which specifications are laid down in Commission Regulation (EU) No 231/2012(7). Us of excipients other than colours in medicinal products are subject to the Union rules on medicinal products and are evaluated as part of the overall benefit risk profile of a medicinal product.
(15)In respon to a request from the Commission, the European Medicines Agency (EMA) provided on 8 September
2021a scientific analysis on the technical purpo of the u of titanium dioxide (E 171) in medicinal
products, the feasibility of replacement and possible timeframes for alternatives. In its conclusions, EMA indicated that titanium dioxide is mainly ud in medicinal products as a colour and opacifier, even if it has multiple functions. It also stresd that titanium dioxide is ud frequently in a number of esntial medicinal products in oral-solid and oral mi-solid dosage forms. EMA also stresd that, from a technical point of view, it should be possible to find alternatives to replace titanium dioxide (E 171)-containing coatings, both as colour and for other us. However, it also underlined that its feasibility is not confirmed at this stage, as replacing titanium dioxide (E 171) would impact in a negative manner the quality, safety and efficacy of medicinal products. EMA highlighted the need to carefully asss alternatives, notably to ensure their compatibility with the various components of individual pharmaceutical products. The replacement of titanium dioxide (E 171) in authorid medicinal products would require an individual review and asssment, possibly requiring bioequivalence studies. Furthermore, EMA concluded that it is difficult at this stage to recommend a preci transition period timeframe for the replacement of titanium dioxide (E 171) ud in medicinal products, as the time needed to reformulate each individual product could take veral years, depending on the complexity of reformulation and studies required. Finally, considering the scale of the u of this excipient and the volume of products impacted, and taking into account global supply chains, EMA stresd that a requirement to replace titanium dioxide (E 171) would almost certainly cau significant medicines shortages on the Union market.
(16)On the basis of the EMA scientific analysis, and in order to avoid shortages of medicinal products that could have
impacts on public health, titanium dioxide (E 171) should remain provisionally on the list of authorid additives to allow its u in medicinal products as a colour, pending the development of adequate alternatives to replace it while ensuring the quality, safety and efficacy of the medicinal products concerned. During this time, titanium dioxide (E 171) should however be included in the list of colours that may not be sold directly to consumers.
(17)It is of critical importance that the pharmaceutical industry makes any possible efforts to accelerate the rearch and
development of alternatives that would be ud as a replacement for titanium dioxide (E 171) in medicinal products, and to submit the necessary variation to the terms of the marketing authorisations concerned. In the abnce of such efforts, competent authorities may request the concerned stakeholders to submit objective and verifiable reason explaining the non-feasibility of the replacement.
(18)The Commission is committed to review the necessity to maintain titanium dioxide (E 171) or oth
erwi delete it
怎么卤猪蹄from the Union list of food additives for exclusive u as a colour in medicinal products within three years after the date of entering into force of this Regulation. This review should be bad on an updated asssment of the EMA to be performed before 1 April 2024. It should take into account the progress made during this period to develop alternatives to titanium dioxide (E 171) in medicinal products both for new products and for replacing it in authorid products, and possible impacts on quality, safety and efficacy, as well as on the availability of medicinal products. Where replacement of titanium dioxide (E 171) in medicinal products has not taken place or been initiated within this period, only objective verifiable reasons related to the lack of feasibility of its replacement should be taken into account.
(19)Annexes II and III to Regulation (EC) No 1333/2008 should therefore be amended accordingly.
(20)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
(6)Directive 2009/35/EC of the European Parliament and of the Council of 23 April 2009 on the colouring matters which may be added
to medicinal products (OJ L 109, 30.4.2009, p. 10).
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(7)Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III
HAS ADOPTED THIS REGULATION:儿童心理教育
Article 1
Annexes II and III to Regulation (EC) No 1333/2008 are amended in accordance with the Annex to this Regulation.
Article 2
Until 7 August 2022, foods produced in accordance with the rules applicable before 7 February 2022
may continue to be placed on the market. After that date, they may remain on the market until their date of minimum durability or ‘u by’ date.
Article 3
The Commission shall, following consultation on the European Medicines Agency, review the necessity to maintain titanium dioxide (E 171) or to delete it from the Union list of food additives for the exclusive u as colour in medicinal products in Part B of Annex II to Regulation (EC) No 1333/2008 within three years after the date of entering into force of this Regulation.
Article 4
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brusls, 14 January 2022.
For the Commission
The President
Ursula VON DER LEYEN
ANNEX
1.Annex II to Regulation (EC) No 1333/2008 is amended as follows:
(a)in point 2 of Part A, point 5 is replaced by the following:
‘5.The colours E 123, E 127, E 160b(i), E 160b(ii), E 161g, E 171, E 173 and E 180 and mixtures thereof may not be sold directly to the consumer.’咏怀古迹
(b)in Part B, point 1 ‘Colours’ is amended as follows:
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1.the entry for the food additive E 171 (Titanium dioxide) is replaced by the following:
2.the following footnote (**) is added after footnote (*):触摸春天
‘(**)Titanium dioxide is not authorid in the food categories listed in Part D and E. The substance is in list B1 becau it is ud in medicinal products in accordance with Directive 2009/35/EC of the European
Parliament and of the Council (OJ L 109, 30.4.2009, p. 10).’;
(c)in Part C, point (2) ‘Group II: Food colours authorid at quantum satis’, the entry for the food additive E 171
(Titanium dioxide) is deleted;
(d)Part E is amended as follows:
1.In category 04.
2.4.1 (Fruit and vegetable preparations excluding compote), the entry concerning the food
additive E 171 (Titanium dioxide) is deleted;
留言板留言大全2.In category 09.2 (Procesd fish and fishery products including molluscs and crustaceans), the three entries
concerning the food additive E 171 (Titanium dioxide) are deleted;
2.In Part 1 of Annex III to Regulation (EC) No 1333/2008, the entry concerning the food additive E 555 (Potassium
aluminium silicate) is replaced by the following:
