CERAFLOUR 1000

Food Contact Regulatory Status Information

08/13/2012

1.

Evaluation according to EC regulation

1.1.

Ceraflour 1000 is a biodegradable polymer based on renewable resources with wax-like properties.
The wax base is evaluated and classified and directly listed in Annex 1 table 1 of Commission
Regulation (EU) No. 10/2011 of 14 January 2011 (PIM) (as amended by Reg. EU 1282/2011) on
plastic materials and articles intended to come into contact with food (superseding Dir. 2002/72/EC
as amended by Dir. 2008/39/EC and Commission Regulation (EC) 975/2009.

1.2

Additionally the product can be used in compliance with national legislation for coatings, incl. BfRRecommendation XIV Plastics dispersions for coating commodities intended to come into contact
with Foods and Resins and Plastics and BfR-Recommendation XXXVI - Paper and board for food
contact.

1.3

Additionally the wax base of this product is in compliance with the CEPE Code of practice for food
contact coatings, Edition 4, Version, Feb. 2009.

1.4

The wax base of Ceraflour 1000 is listed in Annex 6 of the Swiss ordinance 817.023.21 in the part for
printing inks for packaging (version from 23 November 2005, as amended on 1 May 2011).
The wax base is on the A-list (evaluated).

1.5

For impurities resulting from residual formulation aids and raw materials, Art. 3 of Framework
Regulation (EC) 1935/2004 applies (see general remarks)

1.6

The product is free of biocides

1.7

BYK-Cera bv has a certified Quality Assurance System according to NEN-EN-ISO 9001:2008.

According to the a.m. status information the product can be used for food contact applications (incl.
plastics applications defined in REG. (EU) No. 10/2011 (superseding Dir. 2002/72/EC), however, final
legal compliance needs to be verified by the producer of the final article under consideration of the
final application and the conditions of use of the product. Furthermore, we recommend migration
testing to verify compliance.

2.

Evaluation according to 21 CFR

2.1

The active compound of this product is listed in following the Regulations for indirect food additives as
laid down in 21 CFR:
At this moment there is no FDA data available for the components Ceraflour 1000 consists of.
So we can say that Ceraflour 1000 is not in compliance with FDA.

3.

Evaluation according to Chinese Hygienic Standards for Food Packaging Material

3.1

The wax base of this product complies not with the National Standard of the Peoples Republic of
China, GB9685-2008 regarding Hygienic Standards for Uses of Additives in food containers and
packaging materials, Sept. 09, 2008 / second batch.

4.

Heavy metals and Toys

The wax base of Ceraflour 1000 does not contain any heavy metal constituents. These elements are
not present in product according to the recipe and is therefore in line with the limits set by the EU
Packaging Directive 94/62/EU and the European Toy Standard En 71-3 (December 1994). It is also
compliant with the requirements of the Coalition of Northeastern Governors (CONEG) model
legislation limiting heavy metals (January 1994 as well as the Consumer Product Safety improvement

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CERAFLOUR 1000

08/13/2012

Act of 2008 (H.R. 4040 Public Law No. 110-314, August 14, 2008) establishing consumer product
safety standards and other safety requirements for childrens product.
5.

GMO
In the production process for the above mentioned product we do not use any genetically modified
organisms (GMO). The above mentioned product is no GMO, constitutionally it does not contain any
GMO and has not been in contact with any GMO. Therefore the Regulations (EC) No 1829/2003 (as
amended) and No 1830/2003 (as amended) are not applicable.

6.

Allergens
This product does not contain any sulphur dioxide, sulphites or latex. Furthermore, according to the
recipe it does not does not contain any of the ingredients usually considered to be allergens according
to EC- Directive 2000/13/EC and amendments (such as 2003/89/EC, Appendix III a, 2006/142/EC,
2007/68/EC, (EC) No. 1332/2008) and according to the ALBA-list.

7.

General Remarks
General restrictions as laid down in the Framework Regulation (EC) 1935/2004 are applicable to all
materials and articles intended to come into contact with foodstuffs. The general requirement laid
down in the Framework Directive (Article 3) is that the materials/articles may not cause a deterioration
in flavor, odor, color, or consistency of the food. In the US Federal Food, Drug and Cosmetic Act, resp.
21CFR, the general provisions applicable to indirect food additives are laid down in 174.5. Since
residues of formulation aids (e.g. solvents), raw materials, and other non-intentionally added
substances (NIAS) may be in the product without our knowledge, the compliance with the general
requirement is the responsibility of the end user. This information is based on currently valid
regulations.
The regulations are subject to possible modifications in the future that might change the compliance
with legal requirements. For more information about the food contact status of our products, please
contact:
foodcontact.byk@altana.com or visit www.byk.com/foodcontact.

Mr. W.J. de Blok

Managing Director

BYK-Cera bv

Danzigweg 23
7418 EN Deventer
The Netherlands
www.byk.com

Mrs. Hettie Olthaar-Koier

Product Safety Regulatory Affairs

The information provided above is the result of our product assessment based on our best knowledge at the
time of issue and the present status of the legislation. Since we have no information about your products,
recipes, manufacturing processes or conditions of use of our additives, this statement represents a general
overview and cannot reflect specific applications. The final legal compliance needs to be verified by the
manufacturer of the finished product. If necessary, a new regulatory statement can be requested to our
department of product safety.

Hettie Olthaar
Tel +31 570 678 200
foodcontact.byk@altana.com
www.byk.com/foodcontact

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