Issuance Date: August 11, 2024

Titanium Dioxide

EU Declaration of Compliance forFood Contact Materials for Plastics

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:

General restriction outlined in Annex II(as last updated by EU 2020/1245)

Ti-Pure™ Titanium Dioxide Pigments for Plastics

With the exception of ionic aluminum, Annex II substances
are below the listed SML’s in accordance with migration
testing performed directly on pigment under severe
testing conditions for metals migration (3% acetic acidfood simulant, 4 hours at 100 °C followed by 10 days at60 °C, no polymer matrix)1.

Grade: R-104, R-105 and R-960
have the following regulatory status relative to the use asadditives in plastics food contact materials:
European Union
The above listed product, as supplied complies with:• Commission Regulation (EC) nº 1935/2004,
as amended by Regulation (EU) 2019/1381.
• Commission Regulation 10/2011/EU on plastic
materials and articles intended to come into contact
with food, as amended.
Colorants in accordance with Article 5.2(b) and Article
6(2) are not required to be listed in the Union list ofauthorised substances (Annex I) when covered in nationallaw. However, the substances present in the above listed
Ti-Pure™ titanium dioxide pigment appear in Annex I andhence the product complies with the Regulation, under
the condition that the finished article meets the following
migration limits.s:
Overall Migration Limit (OML): 10 mg/dm2 (Article 12)
Specific Migration Limits (SML): N/A

Except for aluminum, none of the elements listed in Annex
II are intentionally added, but trace amounts of certain
elements may be present.

Ionic aluminum migration under the prescribedsevere testing conditions, exceeded the migration
limit of 1 mg/kg food of ionic aluminum. As these are
tests 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 with food
stuffs simulated by 3% acetic acid, should be limited toconditions that do not exceed the Al SMLof 1 mg/kg food.
Hence we advice that plastic materials and articles
produced with these grades in polar polymers should beverified for compliance with the ionic aluminum migration
limit of 1 mg/kg food.
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.

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Titanium Dioxide

The products are produced according to our quality
management system, which complies with therequirements of the Regulation (EC) n° 2023/2006, on
good manufacturing practice for materials and articles
intended to come into contact with food.

to colorants for use in polymers coming into contact withfood, as amended.

Presuming appropriate processing following the Good
Manufacturing Practices Regulation (EC) n° 2023/2006,
the above listed Ti-Pure™ titanium dioxide pigments canbe used in the countries of the European Union for themanufacturing of plastic materials and articles according
to article 3 of Regulation (EC) n° 1935/2004.
It remains the responsibility of the end-user to ensure compliance of the finishedarticles with the above-mentioned Migration Limits

Specification of Use
There are no Specifications of Use for any of thesubstances in Ti-Pure™ titanium dioxide pigments.
Status in countries with additional national legislationon colorants:
In addition to being compliant with the requirements inReg. EC n° 10/2011, the above listed Ti-Pure™ pigments
also comply with the following national legislations foradditives used in plastic materials and articles foreseen
to come into contact with food:
Germany: “BfR Empfehlung” (BfR recommendations) IX /purity of colorants for plastics and otherpolymers used in commodities; (purity criteria), dated June
1st 2019.
Italy: “Decreto Ministeriale” (= Ministerial Decree) of 21
March 1973, Art. 12 / purity of colorants for plastics, asamended.
Netherlands: “Commodities Act (Packaging and Utensils
Decree)” of Jan 1st 2017, as last amended on April 26th2022, Chapter I Plastics & XI Colorants and pigments.
Section 3 (Purity criteria on pigment/colorants), section
4.a ( requirements for the pigmented end product ):for comments on migration of elements , see info on
Commission Regulation 10/2011/EU under General
restriction outlined in Annex II (as last updated by EU2020/1245) and 1Severe Metals Migration Testing in
the Absence of Polymer Matrix.
Spain: “Real Decreto” 847/2011, de 17 de junio, Annex II/
Mandatory identification and purity conditions applicable

Switzerland: DFI Swiss Ordinance 817.023.21 of16 December 2016, as amended and last updated onDec. 1st 2020, on materials and articles foreseen to comeinto contact with food stuff; including:• The general provisions outlined in Chapter 1, 2 and 3;and• The provisions applicable to plastics outlined inChapter 5, and substance Specific Migration Limits(SML) listed in Table 1 of Annex 2; on condition thatthe products comply with the Regulation, under thecondition that the finished article meets the following
migration limits:
OML: 10 mg/dm² or 60 mg/kg (food) (Article 12)
SML: not applicable
The above listed Ti-Pure™ meet the general
requirements applicable to pigments and colorants inAnnex 2 Section 2.2 Table 3.8
General restriction outlined in Annex 2 Section 2.3.1:
Please note that above mentioned Ti-Pure™ grade
contains aluminum in oxide matrices that can be dissolvedin acidic media releasing ionic aluminum (Al) that has an
SML of 1mg/kg food. Based on testing, and in accordancewith EFSA guidance, we advise that plastic materials andarticles produced from above mentioned grades shouldbe verified for compliance to the aluminum SML.
It remains the responsibility of the end-user to ensure compliance of the finishedarticles with the above-mentioned Migration Limits

As a consequence, compliance is granted in the following
countries which do not have national laws on the use ofcolorants (in plastics) for materials and articles intended
to come into contact with food: Austria, Belgium,Bulgaria, Croatia, Cyprus, Czech Republic, Denmark,Estonia, Finland, France, Greece, Hungary, Ireland, Italy,Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal,Romania, Slovakia, Slovenia and Sweden.
Council of Europe: The above products, as supplied,comply with Resolution AP (89)1 “On the use of colorants
in plastic materials coming into contact with food”,
including the purity criteria outlined in section II, 2 in theappendix to the Resolution.

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Titanium Dioxide

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)in non-polar polymers (LDPE) and typically in the rangeorder of magnitude greater than similar testing results
obtained from studies performed in polar polymers thatswell in the 3% acetic acid food simulant for the sametime/temperature regime (e.g., polyacrylamide).

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 tofood simulant concentration was calculated using theprescribed plastic article surface area to food simulant
ratio of 6 dm2 to 1000 ml food simulant and the standard
assumption that migration comes from the first 0.25 mmof the surface of said article. For this calculation, amass fraction loading of 25% was used for the pigment
content. Testing was performed using conditions
considered as severe for complying to any time andtemperature specification (4 hours at 100 °C followed by
10 days at 60 °C) in 3% acetic acid. The results from thismethod are typically much higher versus tests performed
Table 1. Comparison of Al migration data for the method
above versus standard testing protocols
TiO2 pigment(no polymer)

25% TiO2 in
25% TiO2 in LDPE Polyacrylamide

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 food

Test item
Conditions

57 mg/kg food

25% TiO2 in
Polyacrylamide

3% Acetic acid
0,64 mg/kg foodEnd-Use Testing
Manufacturers using the above products for thefabrication of plastic materials and articles intended
to come into contact with food, must comply with thegeneral principles or regulatory requirement that thesematerials and articles should not, by reason of theircoloration, pose a risk to human health or bring about
either a deterioration in the organoleptic characteristics
or other unacceptable changes to the food which theycome into contact with. Colorants should be sufficiently
integrated within the plastic materials and articles so
as to preclude migration into foodstuffs under normal
conditions of use, as determined by an appropriate
migration test methods outlined in:• Annex III and V of regulation EC nº 10/2011; and/or• Annex 4 of DFI Swiss Ordinance 817.023.21
The present review only refers to food-contact applications.
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 for implantation in
the human body without prior written agreementof 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.

© 2024 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.

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