Issuance Date: August 11, 2024

Titanium Dioxide

EU Statement of Compliance forFood Contact Materials for Coatings

The Chemours Company, 1007 Market Street,Wilmington, DE 19801 USA, which manufactures
and then imports the following products into the EU
via Chemours Belgium BV, hereby declares that thecomposition of our products identified as:
Ti-Pure™ Titanium Dioxide Pigments for Coatings
Grades: R-900, and, R-960
Color Index Name: White 6.
Color Index Number: 77891
have the following status relative to food contact
regulations in Europe:
European Union
Ti-Pure™ titanium dioxide pigments grades are produced
according to our quality management system, which
complies with the requirements of the Regulation (EC)n° 2023/2006, on good manufacturing practice formaterials and articles intended to come into contactwith food.

European Legislation
Comply with the following regulatory requirements:
Germany: “BfR Empfehlung” (BfR recommendations) IX
purity of colorants for plastics other polymers used incommodities; (purity criteria), dated June 1st 2019
Netherlands: “Commodities Act (Packaging and UtensilsDecree)” of Jan 1st 2017, as last amended on April 26th2022, Chapter X Coatings & XI Colorants and pigments.
Section 3 (Purity criteria on pigment/colorants), section
4.a (requirements for the pigmented end product ):Except for aluminum, none of the elements listed in
section 4.a are intentionally added, but trace amounts ofcertain elements may be present.
With the exception of ionic aluminum, section 4.a
substances are below the listed SML’s (except for
Hg where the LOQ is 0,01 mg/kg) in accordance with
migration testing performed directly on pigment under
severe testing conditions for metals migration (3% acetic
acid food simulant, 4 hours at 100 °C followed by 10days at 60 °C, no polymer matrix)1.

Presuming appropriate processing following the Good
Manufacturing Practices Regulation (EC) n° 2023/2006,
the above listed Ti-Pure™ titanium dioxide pigmentscomply with Regulation (EC) n° 1935/2004 as amended,
and can be used in the countries of the European Union
for the manufacturing of materials and articles according
to article 3 of Regulation (EC) n° 1935/2004.

Ionic aluminum migration under the prescribed severe
testing conditions, exceeded the migration limit of 1 mg/kg food of ionic aluminum. As these are tests performed
directly on pigment, they are highly precautionary. When
incorporated in polymer in the form of an article themigration is substantially lower1.

In absence of EU harmonised legislation for coatings
foreseen to come into contact with food, the existingmaterial specific legislation in the different EU Member
states applies. An overview of the EU Member Statelegislation is shown below:

The migration of aluminum ions from non-polar polymers
is typically less than 0.1 mg/kg food. However, uses inpolar polymers, where swelling occurs in contact with foodstuffs simulated by 3% acetic acid, should be limited toconditions that do not exceed the Al SML of
1 mg/kg food.

Ti-Pure™

Titanium Dioxide

Hence we advice that materials and articles producedwith these grades in polar polymers should be verified forcompliance with the ionic aluminum migration limit of
1 mg/ kg food.

UK: Statutory Instrument 2012 No. 2619: The Materialsand Articles in Contact with Food (England) Regulations
2012, updated by statutory instrument 2019 No. 704(European Union Exit regulations)

There are no known sources of Primary Aromatic Amines(PAA) in the production process of titanium dioxide, andhence PAA are not expected to be present.

Additional information

Switzerland: DFI Swiss Ordinance 817.023.21 of
16 December 2016, as amended and last updated on Dec.
1st 2020, on materials and articles foreseen to come into
contact with food stuff; including:• The general provisions outlined in Chapter 1, 2 and 3; and• The provisions applicable to printing inks outlined inChapter 12, annex 10 (List of permitted substances forthe production of packging inks, and related requirements).
Annex 10:
− Titanium dioxide is listed under substance nr.2217,column 5: use as a pigment (C) and additive (AD),column 6: classification of the substance - part A.
− Remark: In line with section 1.3.2. Definitions
and explanations relating to lists I-V of column 5,additives used in the production of pigments do not
require to be listed.
• The provisions applicable to coatings and varnishes
outlined in Chapter 13a, annex 13:− Following substances are not intentionally added ,not tested for but to the best of our knowledge notbelieved present: BADGE, BFDGE, NOGE, BPAIn accordance with the principle of mutual recognition asoutlined in Art.34 – 36 of the Treaty on the functioning of
the European Union (TFEU), the incomplete complianceof a product with legislation in one EU member state,
does still allow the product to be placed on the market in
the European Union on the basis of its full compliance inat least one Member State of the European Union.
As a consequence, compliance is granted in the following
countries which do not have additional positive lists ofsubstances: Austria, Belgium, Bulgaria, Croatia, Cyprus,
Czech Republic, Denmark, Estonia, France, Finland,Greece, Hungary, Ireland, Italy, Latvia, Lithuania,Luxembourg, Malta, Poland, Portugal, Romania, Slovakia,Slovenia, Spain, Sweden and Norway.
Council of Europe: Resolution AP (2004)1 “Coatings
intended to come into contact with foodstuffs”, TechnicalDocument No. 1, List 1 of additives covers titanium dioxide
as well as the substances used in coatings on pigments.

Specification of Use
There are no Specifications of Use for any of the substancesin Ti-Pure™ titanium dioxide pigments.
Future Harmonized Legislation
Chemours intends to take all action required to have all
relevant constituents of above mentioned Ti-Pure™ products
covered by appropriate EU positive lists when harmonizedlegislation is promulgated.
Notes
Severe Metals Migration Testing in theAbsence of Polymer Matrix

1

Metal migration testing from pigment was performed
following the principals of EN 13130:2004; however, in theabsence of a polymer matrix. Briefly, the pigment to foodsimulant concentration was calculated using the prescribed
plastic article surface area to food simulant ratio of 6 dm2
to 1000 ml food simulant and the standard assumptionthat migration comes from the first 0.25 mm of the surface
of said article. For this calculation, a mass fraction loadingof 25% was used for the pigment content. Testing wasperformed using conditions considered as severe forcomplying to any time and temperature specification (4 hours
at 100 °C followed by 10 days at 60 °C) in 3% acetic acid.
The results from this method are typically much higher
versus tests performed in non-polar polymers (LDPE) andtypically in the range order of magnitude greater than similar
testing results obtained from studies performed in polar
polymers that swell in the 3% acetic acid food simulant forthe same time/temperature regiment (e.g., polyacrylamide).
TiO2 pigment
25%
TiO2 infor the25%method
TiO2 inTable 1. Comparisonof Al migration
data
Test item(no polymer)
25% TiO2 in LDPE Polyacrylamide Polyacrylamide
above versus standard testing protocols
4 hours at
100 °C followedby 10 days
at 60 °C

4 hours at
100 °C followedby 10 days
at 60 °C

4 hours at
100 °C followed 4 hours
by 10 days
at 100 °C
at 60 °C

Food simulant 3% Acetic acid

3% Acetic acid

3% Acetic acid

Al migration

0,066 mg/kg food >1 mg/kg foodConditions

57 mg/kg food

3% Acetic acid
0,64 mg/kg foodTi-Pure™

Titanium Dioxide

End-Use Testing

The present review only refers to food-contact applications.

Manufacturers using the above products for the fabricationof coatings materials and articles intended to come into
contact with food, must comply with the general principles
or regulatory requirement that these materials and articles
should not, by reason of their coloration, pose a risk tohuman health or bring about either a deterioration in theorganoleptic characteristics or other unacceptable changes
to the food which they come into contact with. Colorants
should be sufficiently integrated within the coatingsmaterials and articles so as to preclude migration into
foodstuffs under normal conditions of use, as determined by
an appropriate method.

Ti-Pure™ products may not be directly added to food,
pharmaceuticals, cosmetics, or cigarette papers/filters for
tobacco products. Ti-Pure™ products may not be used in themanufacture of any medical device for implantation in thehuman body without prior written agreement of Chemours.
Further questions should be directed toTiO2ProductStewardship@chemours.com

CAUTION: Do not use or resell Chemours™ materials in medical applications involving implantation in the human body or contact with internal body fluids or tissues unless agreed to by Seller in a writtenagreement covering such use. For further information, please contact your Chemours representative. These products may not be directly added to food, pharmaceuticals, cosmetics, or cigarette
papers/filters for tobacco products.
For medical emergencies, spills, or other critical situations, call (844) 773-2436 within the United States. For those outside of the United States, call (302) 773-1000. The information set forth
herein is furnished free of charge and based on technical data that Chemours believes to be reliable. It is intended for use by persons having technical skill, at their own discretion and risk. The handlingprecaution information contained herein is given with the understanding that those using it will satisfy themselves that their particular conditions of use present no health or safety hazards. Because
conditions of product use are outside our control, Chemours makes no warranties, express or implied, and assumes no liability in connection with any use of this information. As with any material,evaluation of any compound under end-use conditions prior to specification is essential. Nothing herein is to be taken as a license to operate under or a recommendation to infringe any patents.
NO PART OF THIS MATERIAL MAY BE REPRODUCED, STORED IN A RETRIEVAL SYSTEM OR TRANSMITTED IN ANY FORM OR BY ANY MEANS ELECTRONIC, MECHANICAL, PHOTOCOPYING, RECORDING OR OTHERWISEWITHOUT THE PRIOR WRITTEN PERMISSION OF CHEMOURS.

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