Food Contact Regulatory Status Information

CERAFLOUR 913
Version 2.0

8/24/2015

1. Evaluation according to EC regulation

Ceraflour 913 is a micronized polypropylene wax.
1.1. The polypropylene wax base of this product is fully evaluated as SCF-list 0-4 and directly listed in
Annex I Table I of COMMISSION REGULATION (EU) No. 10/2011 of 14 January 2011 (PIM) on
plastic materials and articles intended to come into contact with food (as amended, superseding
Dir. 2002/72/EC - as amended by Dir. 2008/39/EC and Commission Regulation (EC) 975/2009).
The polypropylene wax wax is listed to be used as additive or polymer production aid in a.m. REG.
(EU) No. 10/2011 (PIM) (as amended).
1.2. The product is conform the compositional requirements of the German BfR-recommendation XIV
Plastic dispersions.
1.3. The product is conform the compositional requirements of the German BfR-recommendation
XXXVI Paper and Board.
1.4. Furthermore, the polypropylene wax is conform to the compositional requirements of the CEPE
Code of practice for food contact coatings, Edition 4, Version Feb. 2009.
1.5. The product is free of biocides.
1.6. BYK-Cera bv has a certified Quality Assurance System according to NEN-EN-ISO 9001:2008.
1.7. For impurities resulting from residual formulation aids and raw materials, Art. 3 of Framework
Regulation (EC) 1935/2004 apply (see general remarks).
In summary, the formulation of the product is conform to the compositional requirements for specific food
contact applications in the EU (including coatings, plastics, paper). 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.

1. Evaluation according to the Swiss Ordinance

The product is conform to the compositional requirements of the part for printing inks for packaging of
the Swiss Ordinance 817.023.21 (Version from 23 November 2005, last amended on 01 April 2013)
since all components are listed in Annex 6. (Part A, evaluated substances, no SML)

2. Evaluation according to Title 21 CFR (FDA) Regulations for indirect food additives
2.1. The polypropylene wax is listed in the following sections of the Title 21 CFR (FDA) Regulations for
indirect food additives:
Sec. 175.105 Adhesives
Sec. 175.300 Resinous and polymeric coatings
2.2. For other applications, the product may be used based on the no-migration-principle, i.e. if FDArecognized migration modelling or studies show no detectable migration (transfer of substance to
food) in a particular application.
This confirmation is limited to the use of our product in the above food contact applications and
does not apply to any use in drug, medical device, or cosmetic products or packaging. It is the
responsibility of the drug, medical device, or cosmetic manufacturer to establish that all materials used
as either components of medical devices or components of packaging materials for drugs, cosmetics or
medical devices comply with all regulatory and safety requirements.

3. Evaluation according to the Chinese Hygienic Standards for Food Packaging Materials
1/2

Food Contact Regulatory Status Information

CERAFLOUR 913
Version 2.0

8/24/2015

The product is conform to the compositional requirements of 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.

4. Heavy metals and Toys

The above mentioned product does not contain any heavy metal constituents. These elements are
not present in the product according to the recipe.
4.1 The product is therefore in line with the limits set by the EU Packaging Directive 2009/48/EC and
the amended European Toy Standard EN 71-3:2013-07.
4.2 Additional, the product 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 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 products.

5. Genetically Modified Organisms

In the production process for the above mentioned product we do not use any genetically modified
organisms (GMO). Furthermore, the 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
According to the recipe the above mentioned product does not contain any sulphur dioxide, sulphites or
latex. Furthermore, according to the recipe it 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 deterioration in
flavour, odour, colour or consistency of the food. In the US Federal Food, Drug and Cosmetic Act, resp.
21 CFR, 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 present 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 the legal requirements.
For more information about the food contact status of our products, please contact
Brief.BYK@altana.com or visit www.byk.com/foodcontact.
This document is valid without signature.
BYK-Cera bv

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

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 legislation. Since we have 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 safety department.

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

2/2