BYK®-011 3/16/2011

Food Contact Regulatory Status Information

1. Evaluation according to EC regulation

The product consists of two actve compounds, one dual use additive and two carriers (solvents)

1.1. The main active compound (WS1) is a polymer and manufactured using monomers which are 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 (superseding Dir. 2002/72/EC - as amended by Dir. 2008/39/EC and Commission Regulation (EC)
975/2009). Restrictions apply.

1.2. Active compound WS1 as such is not listed as a “polymeric additive” in a.m. REG. (EU) No. 10/2011
(PIM) (as amended), however WS1 fully complies with national legislation for food contact coatings, incl.
BfR-Recommendation XIV “Plastics Dispersions”.

1.3. The second active compound (WS2) is a defoamer and fully evaluated for food contact coatings and
EFSA/SCF classified as SCF List 3. The use of this active compound is subject to restriction, for use level
recommendations see summary below.

1.4. The Dual Use Additive is 2,6-Di-tert-butyl-p-kresol (BHT) and usage is subject to restrictions as a direct
food additive.

1.5. Additionally, the active compounds of this product comply with the CEPE “Code of practice for food
contact coatings”, Edition 4, Version, Feb. 2009.

1.6. The product contains two carriers (solvents) which are currently not regulated by food contact positive
lists as it is assumed that solvents evaporate off from the finished product so that only residues or traces
of no toxicological concern remain. Both solvents in this product have boiling points above 180°C and
evaporation needs to be moniotred by the manufacturer of the final product. (Art. 3 of Reg. (EC)
1935/2004 applies, see general remarks)

1.7. All substances of this product are 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 25 November 2009). The
product does contain substances on B-lists. (solvents). For B-List substances the 10 ppb-rule applies.

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

1.9. BYK-Chemie GmbH has a certified Quality Assurance System according to ISO 9001:2000 and is
therefore in compliance with the requirements of Commission Regulation (EC) 2023/2006
regarding“Good Manufacturing Practice” (GMP) in the food packaging supply chain.

In summary, the product complies with EU-Legislation for food contact coatings (not applications acc. to
a.m. REG. (EU) No. 10/2011 (PIM), however, restrictions apply and need to be monitored by the producer
of the final article. In order to meet the restrictions for active compound WS2, the maximum use level in
wet coating formulations is 0.2 % (solid content 40 %, film thickness 12µm). Furthermore, we recommend
migration testing to verify compliance.

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2. Evaluation according to 21 CFR

2.1. The active compounds WS1 and WS2 comply with the requirments of Title 21 CFR (FDA) for substances
used for coatings in contact with food stuffs (incl. Sec. 175.300 “Resinous and polymeric coatings),
restrictions apply. Based on the restrictions for WS2 we recommend the following use conditions:

• Max. Use level of 0.2 % in wet coating formulations

• For formulations with a solid content of 40 % and a final film thickness of 12 µm
• The use level can be adapted for deviating film thickness and solid content

2.2 Simerlar to point 1.6 and 1.8, Solvents are not regulated by Title 21 CFR (FDA) as evaporation is
assumed, Sec. 174.5 applies. Evaporations needs to be monitored by the manufacturer of the final
product.

3. Evaluation according to Chinese Hygienic Standards for Food Packaging Material

3.1. The active compounds of this product are not listed in the National Standard of the People’s 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 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 Act of 2008
(H.R. 4040 – Public Law No. 110-314, August 14, 2008) establishing consumer product safety standards
and other safety requirements for children’s 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. 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 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:
[email protected] or visit www.byk.com/foodcontact.

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BYK-Chemie GmbH

i.V. Dr. Holger Hein i.A. Gerald Albrecht

Head of Regulatory Affairs Regulatory Affairs Specialist

BYK-Chemie GmbH The information provided above is the result of our product assessment based on our best knowledge at the
P.O. Box 100245 time of issue and the present status of the legislation. Since we have no information about your products,
46462 Wesel recipes, manufacturing processes or conditions of use of our additives, this statement represents a general
Germany overview and cannot reflect specific applications. The final legal compliance needs to be verified by the
www.byk.com manufacturer of the finished product. If necessary, a new regulatory statement can be requested to our
department of product safety.
Gerald Albrecht
Tel +49 281 670-760
[email protected]
www.byk.com/foodcontact

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