Dear All,
I added this post since on looking through the net, it seemed to me the most frequently used option at this moment was the “FDA appoved system” so I thought some amplification might be useful. (I also added one para. regarding Eu [No.8] since it appeared helpful.)
I personally found much of the official website info. rather overwhelming so I extracted some chunks from various links and put them together for my/yr comparison. I left out the links to save space. Changes keep occurring in this area so I am quite happy to be corrected by current users if any of these extracts are obsolete/wrong. Also some of the details have significant legal implications so care / professional advice may be valuable.
(1) (FDA) – “Food Additive - A food additive is defined in Section 201(s) of the FD&C Act as any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use); if such substance is not GRAS or sanctioned prior to 19581 or otherwise excluded from the definition of food additives.
Indirect Food Additive - In general, these are food additives that come into contact with food as part of packaging, holding, or processing, but are not intended to be added directly to, become a component, or have a technical effect in or on the food. Indirect food additives mentioned in Title 21 of the U.S. Code of Federal Regulations (21CFR) used in food-contact articles, include adhesives and components of coatings (Part 175), paper and paperboard components (Part 176), polymers (Part 177), and adjuvants and production aids (Part 178). Currently, additional indirect food additives are authorized through the food contact notification program. In addition, indirect food additives may be authorized through 21 CFR 170.39.
Secondary Direct Food Additive - This term is in the title of 21 CFR 173, which was created during recodification of the food additive regulations in 1977. A secondary direct food additive has a technical effect in food during processing but not in the finished food (e.g., processing aid). Some secondary direct food additives also meet the definition of a food contact substance. For more on food contact substances, consult the Food Contact Substance Notification Program.
Prior Sanctioned Substance - A substance whose use in or on food is the subject of a letter issued by FDA or USDA offering no objection to a specific use. The prior sanction exists only for a specific use of a substance in food delineating level (s), conditions (s) and product (s) set forth by explicit approval by FDA or USDA prior to September 6, 1958. Some prior sanctioned substances are codified in 21 CFR Part 181.”
Food Contact Substance (FCS) - Section 409 of the FD&C Act defines an FCS as any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use of the substance is not intended to have any technical effect in such food. Additional information can be found on the Food Contact Substances Notification Program page.
(2) (Not FDA) - The FDA considers three different types of food additives: - (a) Direct food additives, Components added directly to the food, - (b) Secondary direct food additives - components that are added to the food due to food treatment like treating food with ionic resins, solvent extraction – © Indirect food additives - substances that may come into contact with food as part of packaging or processing equipment, but are not intended to be added directly to food
(3) “Direct additives are defined as ingredients that are included in the food and are thus consumed. Indirect additives are defined as materials that come in contact with food”
(4) “FDA 21 CFR 175.105
this number represents the FDA regulation governing materials acceptable for indirect food contact. Adhesives that meet this regulation have components in compliance and acceptable for labeling of food items when there is a functional barrier between the adhesive and the food. A functional barrier would be packaging for the food.
FDA 21 CFR 175.125
this number represents the FDA regulation governing materials acceptable for direct food contact. Adhesives that meet this regulation have components in compliance and acceptable for being applied directly to the food item. For example labels that need to be applied to fruits and vegetables that have edible skins need to be in compliance with this regulation.”
(5) “The term indirect additive has been applied to substances that are not intended to be ingredients in food but become components in food indirectly by how they are used. Usually this applies to food packaging materials or processing equipment in direct contact with food but may apply also to other substances used in a manner such that their presence of food is expected though not desired. The term has no special legal meaning although it has been a useful as a way of describing substances requiring safety evaluation and approval but not ingredient labeling.”
(6) – “Among the responsibilities of the U.S. Food and Drug Administration (FDA) is regulation of components of food contact materials, including packaging. Once known as indirect food additives, FDA now refers to these materials as food contact substances (FCS).”
(7) - Food Contact Regulations
“In the U.S., food packaging materials are regulated by the Food and Drug
Administration. Many substances used in packaging materials may reasonably
be expected to become components of food by migration of the packaging
components into the food. These types of additives are referred to as indirect
additives--substances that may have contact with food but are not directly added
to food. Regulations related to food additives are listed in 21 CFR 170 through
189. In January 2000, FDA promulgated new regulations that have added
another category, food contact substances. These materials are typically food
packaging materials. The older regulations continue to be effect, but new food
packaging materials will be known as food contact substances and will be
reviewed by FDA under the Food Contact Notification process.
Coatings and adhesives used in packaging are considered indirect food additives
– they are not directly added by the food processor to the food. Some package
adhesives may not come into direct contact with food and therefore are
considered to have indirect food contact – these substances would need to
comply with 21CFR 175.105. Any manufacturer of a substance can review the
composition of a product and claim compliance with a given regulation. [It
should be noted that in addition to the regulations listing compositions that
comply with the regulation, the regulations may require that the finished form of
the packaging pass specific regulation tests.] The Food Contact Notification
system differs in that it covers a specific material made by a specific
manufacturer for a specific use.”
And finally one more for EU (sorry if this getting boring but it looked useful background, also see the pdf in "added[3]" of prev.post which is definitely more up-to-date but requires some extended reading time) –
(8) – “Outside the US, other agencies have authority over food packaging. For example, in
Europe, the EU is currently in the process of harmonizing legislation on food contact
substances by adopting Directives that are designed to replace the existing
provisions of the Member States. Food contact materials used in the Member States
of the EU are governed by the so-called “Framework Directive” (Council Directive
89/109/EEC)(added later - oops!, haven't checked contents but I guess this has been superceded by Framework Regulation (EC) No 1935/2004 - available in "added (2)" link at end prev.post or Simon's earlier post) which provides the general safety criteria applicable to all food-contact materials:
Article 2 establishes the following general principles for all food-contact materials
• Food contact materials must be manufactured in accordance with good
manufacturing practices (GMPs);
• Food contact materials must not transfer their constituents to foodstuffs in
quantities that could endanger human health or bring about an unacceptable
change in the composition of the food or its organoleptic characteristics, i.e.,
they must not adulterate food.
The Framework Directive also calls upon the European Commission to adopt specific
Directives for the regulation of food-contact materials.
To date, only a few of these specific Directives have been adopted. The most
comprehensive of these specific Directives is the Directive 2002/72/EC, which
applies to plastics materials. This Directive provides:
• A complete positive list of monomers/starting substances
• An incomplete positive list of additives as it does not contain all the substances
which are currently accepted on one or more Member States, accordingly these
substances continue to be regulated by national laws pending a decision on
inclusion or not in the EU Directive. (Expected date of “completion: end of 2006).
• An overall migration limit (OML) that must be met for all plastics in contact with
food (10 mg/dm2) (added later - this value probably still valid but now also re-interpreted - see "added (2)" link at end prev.post, the difference relates to specific situation and is explained in pdf of "added (3)" link of previous post)
• Specific migration limits (SML) and quantitative limitations (QM) have also been
established for specific substances.
These regulations can be confusing. The discussion above is meant for general
use and awareness; specific end uses and applications are the responsibility of
the customer to ensure the adhesive or coating as it is applied and used is
complying with the proper regulations as they or their legal advisor interprets
them. It is important to have someone conversant with food law on staff, to seek
legal advice in writing, and use outside firms, consultants or agencies for
opinions.”
I noted that some websites give assistance if you know yr adhesive and wish to see its approval possibilities – eg
http://www.omnexus4a...tact/index.aspx
To illustrate the need for harmonisation can see this example of the mutiple international requirements for a coloring additive –
http://www.titanium....ood_Contact.PDF
Rgds / Charles.C