Issuance Date: September 5, 2022

Titanium Dioxide

EU Statement of Compliance forFood Contact Materials for Paper

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 product identified as:
Ti-Pure™ Titanium Dioxide Pigments for Paper
Grade: R-900
Color Index Name: White 6.
Color index Number: 77891
has the following status relative to food contact
regulations in Europe:
European Union:
Ti-Pure™ titanium dioxide pigments grades are producedaccording 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.
Presuming appropriate processing following theGood Manufacturing Practices Regulation (EC) n°
2023/2006, the above listed Ti-Pure™ titanium dioxide
pigment complies with Regulation (EC) n° 1935/2004
as amended, and can be used in the countries of theEuropean Union for the manufacturing of materials andarticles according to article 3 of Regulation (EC)n° 1935/2004.
In absence of EU harmonised legislation for paper andboard materials and articles foreseen to come into
contact with food, the existing material specific legislationin the different EU Member states applies. An overview ofthe EU Member State legislation is shown below:

European Legislation
Comply with the following regulatory requirements:
Germany – BfR: BfR Recommendation XXXVI (includingXXXVI/1 and XXXVI/2) (Paper and Board for FoodContact), dated April 1st 2022. BfR Recommendation
LII. Fillers, section 3 ( purity requirements) dated June
1st 2019.
Netherlands: “Commodities Act (Packaging and UtensilsDecree)” of Jan 1st 2017, as last amended on April 26th2022, Chapter II Paper and cardboard & 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 forHg 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
10 days at 60 °C, no polymer matrix)1.
Ionic aluminum migration under the prescribedsevere testing conditions, exceeded the migration
limit of 1 mg/kg food of ionic aluminum. As these aretests performed directly on pigment, they are highlyprecautionary. When incorporated in polymer in the formof an article the migration is substantially lower1.
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 withfood stuffs simulated by 3% acetic acid, should belimited to conditions 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
for compliance with the ionic aluminum migration limit of
1 mg/ kg food.

Additional information

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.
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 tocome into contact with food stuff; including:• The general provisions outlined in Chapter 1, 2 and 3;
and• The provisions for paper and cardboard outlined inChapter 9: no specific requirements for pigments
In 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.
Council of Europe: Resolution AP (2002)1 “Paper andboard materials and articles intended to come into
contact with foodstuffs”, Technical Document No. 1,
List 1 of additives covers titanium dioxide as well as thesubstances used in coatings on pigments.
The above resolution was adopted by the Committeeof Ministers, in its composition restricted to theRepresentatives of Austria, Belgium, Cyprus, Denmark,Finland, France, Germany, Ireland, Italy, Luxembourg,
The Netherlands, Norway, Portugal, Slovenia, Spain,
Sweden and Switzerland. It recommends that concerned
governments take into account in their national laws andregulations the principles and/or the analytical methods
and/or the inventory lists set out in these resolutions.
UK: Statutory Instrument 2012 No. 2619: The Materials
and Articles in Contact with Food (England) Regulations
2012, updated by statutory instrument 2019 No. 704(European Union Exit regulations)

Specification of Use
There are no Specifications of Use for any of thesubstances in 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 whenharmonized legislation is promulgated.
Notes
Severe Metals Migration Testing in the Absence ofPolymer Matrix

1

Metal migration testing from pigment was performed
following the principals of EN 13130:2004; however,in the absence of a polymer matrix. Briefly, the pigment
to food simulant concentration was calculated using
the prescribed plastic article surface area to foodsimulant ratio of 6 dm2 to 1000 ml food simulant andthe standard assumption that migration comes fromthe first 0.25 mm of the surface of said article. For thiscalculation, a mass fraction loading of 25% was used
for the pigment content. Testing was performed using
conditions considered as severe for complying inserted
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 higherversus tests performed in non-polar polymers (LDPE) andtypically in the range order of magnitude greater thansimilar testing results obtained from studies performedin polar polymers that swell in the 3% acetic acid foodsimulant for the same time/temperature regiment (e.g.,polyacrylamide).
Table 1. Comparison of Al migration data for the method
above versus standard testing protocols
Test itemConditions

TiO2 pigment(no polymer)

25% TiO2 inLDPE

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

4 hours at
4 hours at
100 °C
100 °C followed
4 hoursfollowed by 10by 10 days
at 100 °Cdays
at 60 °Cat 60 °C

Food simulant 3% Acetic acid 3% Acetic acid
Al migration

57 mg/kg food

0,066 mg/kg
food

25% TiO2 in
25% TiO2 in
Polyacrylamide Polyacrylamide

3% Acetic acid 3% Acetic acid
>1 mg/kg food

0,64 mg/kg
food

Ti-Pure™

Titanium Dioxide

End-Use Testing

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 the manufacture of any medical device forimplantation in the human body without prior writtenagreement of Chemours.

Manufacturers using the above products for thefabrication of paper materials and articles intended
to come into contact with food, must comply withthe general principles or regulatory requirement thatthese materials and articles should not, by reasonof their coloration, pose a risk to human health orbring about either a deterioration in the organoleptic
characteristics or other unacceptable changes to thefood which they come into contact with. Colorants
should be sufficiently integrated within the papermaterials and articles so as to preclude migration
into foodstuffs under normal conditions of use, asdetermined by an appropriate method.

Further questions should be directed toTiO2ProductStewardship@chemours.com

The present review only refers to food-contact
applications.

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.

This document expires 2 years after issuance date. After that time, customers should contact Chemours for updated information.
© 2022 The Chemours Company FC, LLC. Ti-Pure™ and any associated logos are trademarks or copyrights of The Chemours Company FC, LLC.
Chemours™ and the Chemours Logo are trademarks of The Chemours Company.

C-11390-2 0922

For more information, visit tipure.com