Do you know the differences between EC 1935/2004 and 2002/72/EC, and EU 10/2011?
• Do you understand what overall migration means?
• Are you aware that every belting product needs its own certifi cate for direct food contact?
If you are unsure about the answers, you can fi nd them all in this leafl et. It
covers the most important issues regarding regulations about food contact
materials in the European Union on processes where plastic materials are
used. The information is valid for all belt products in direct contact with
foodstuffs – whether fabric-based conveyor belts, plastic modular belts,
plastic chains, and round or timing belts.
Habasit knows the law
Habasit has always respected the laws on food conveyor and processing
belts, and keeps fully up-to-date with all current requirements. Regardless
of where a belt application takes place, we ensure that the EU regulations in
force for the product are met.
Legal harmonization
The directives and regulations in force within the European Union and its
member states can be demanding and are not always easy to understand.
To simplify matters, the EU started to harmonize legislation on food contact
materials several years ago. Currently, harmonized legislation only exists for
a few materials. Legislation on ceramics, plastics and regenerated cellulose
can be considered complete, while other areas are pending and further
developments are expected.
EU regulations and directives
The legal basis for the enactment of regulations is Article 288 of the Treaty on the
Functioning of the European Union. It says:
“A regulation shall have general application. It shall be binding in its entirety and directly
applicable in all Member States.” Therefore, after enacting a regulation it comes into force
immediately throughout the entire EU.
“A directive shall be binding, as to the result to be achieved, upon each Member State
to which it is addressed, but shall leave to the national authorities the choice of form and
methods.” This means that a directive needs to be implemented into national legislation
before it can come into effect in each member state, which is why sometimes reference is
made to national legislation.
Three main documents
For the food processing industry, when doing business in the European Union there are
three main documents to be considered:
• “Framework” Regulation EC 1935/2004
• Regulation EC 2023/2006 on good manufacturing practice
• Regulation (EU) No. 10/2011 - “Plastic implementation measure” PIM
“Framework” Regulation EC 1935/2004
One of the most important regulations is Regulation (EC) No 1935/2004, which applies
to all food contact materials (FCM). It contains defi nitions, restrictions and requirements,
including:
Regulation (EU) No. 10/2011 - “Plastic implementation measure” PIM
Regulation (EU) No. 10/2011, in force since May 1, 2011, is the replacement of Directive
2002/72/EC, commonly called the “Plastics Directive”.
This is a specifi c measure within Regulation (EC) No 1935/2004, which has immediate
legal force in all member states. There are various transitional provisions for this new
regulation, and migration testing and supporting documents are needed. However,
Declarations of Compliance based on the “old” rules according to Directive 2002/72/EC
remain valid until December 31, 2015. So for conveyor belt users, no change of behavior
is required immediately.
Both Directive 2002/72/EC as well as Regulation (EU) No. 10/2011 establish:
• A complete Positive List of monomers, additives and other starting substances that can
be used in food contact plastic production
• Requirements, e.g. Overall Migration Limit, Specifi c Migration, etc., that the fi nished
article must meet when tested with appropriate food simulants related to real use
conditions
The Overall Migration Limit (OML) is usually fi xed at 10 milligrams per square decimeter
of the article (or 60 mg/kg). The directive also defi nes the Specifi c Migration Limit (SML)
and the Maximum Quantity allowed (QM) for some specifi c substances.
Accordingly, all monomers and additives intended for use in the production of food
contact plastics must be listed in Regulation (EU) No. 10/2011 just as they were
previously in Directive 2002/72/EC. The fi nal food contact article must meet the OML and
any specifi cations that have been established for substances used as components of the
article.