Asuntos Regulatorios

Food contact status in Europe

Food Contact Regulation:

Materials used in food contact applications are regulated in Europe by the following regulations and directives:

Regulation 1935/2004/EC:

Materials intended for food contact applications

Directive 2002/72/EC (plus amendments):

Plastic Materials intended for food contact applications 2004/1/EC, 2004/19/EC, 2005/79/EC, 2007/19/EC, 2008/39/EC and Regulation (EC) No. 975/2009

Directive 82/711/EEC:

Migration Testing

Directive 85/572/EEC:

Simulants for Migration Testing

Commmission Regulation (EU) No 10/2011 Food Contact Regulation that will repeal Directives 2002/72/EC and its amendments as well as Directives 82/711/EEC and 85/572/EEC

Compositional Requirements:

The above mentioned European regulation and directives define the following compositional requirements:

• Authorized substances
• General requirements on substances
• Specific requirements on substances
• General restrictions on plastics materials and articles
• Specific migration limits
• Overall migration limit of < 10 mg of total constituents released per dm2 of food contact surface
• Overall migration limit of < 60 mg of total constituents released of 1 kg of food simulant (for applications used by infants and young children)

1. European Regulation:

1.1. Authorized substances:

The above mentioned materials are in chemical compliance with the requirements and specifications of Regulation (EC) 1935/2004 (declaration of conformity).

With respect to its monomer and additive composition, the products comply also with Commission Regulation (EU) No. 10/2011. All monomers and additives used in the above mentioned materials are listed in Annex 1.

1.2. Specific migration limits:

Please contact Product Stewardship Department for assistance, [email protected]

2. German Regulation:

The BfR (Bundesinstitut für Risikobewertung / Federal Institute for Risk Assessment) has published "Recommendations on the health assessment of plastics and other high polymers". The BfR Recommendations on Food Contact Materials are based on European law and its transposition into national law.

For natural and colored ABS materials, the following BfR recommendations apply:

Recommendation VI: “Styrene Copolymers and Graft Polymers, and Mixtures of Polystyrene with other Polymers”

Recommendation IX: “Colorants for Plastics and other Polymers used in Commodities”

With respect to its volatile components, additives and further constituents the above mentioned materials comply with these two BfR Recommendations.

In view of the vast number of colors and the wide variety of requirements you are requested to contact Product Stewardship Department, [email protected]

Food contact status in U.S.

• ELIX ABS M203FC
• ELIX ABS M205FC
• ELIX ABS M545TF
• ELIX ABS-CC grades

The above mentioned materials are in chemical compliance with the U.S. FDA 21 Code of Federal Regulations Section 181.32 (acrylonitrile copolymers and resins) for use in repeated-use food-contact applications, subject to the limitations of this regulation and any other applicable regulations.

In view of the vast number of colors and the wide variety of requirements you are requested to contact Product Stewardship Department, [email protected].