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#1 Sankara narayanan

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Posted 28 January 2007 - 07:52 AM

;)

Is there any criterion in selecting a label for my product which is a food additive? If I am using a self sealing sticker, do I have to bother about the quality of gum used ? Can any one enlighten me?
A.Sankara Narayanan

#2 Charles.C

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Posted 28 January 2007 - 02:33 PM

Dear Sankara,

Very interesting question for the packaging gurus IMO.
I have no idea of the answer but would also like if I may to extend yr query to the printing ink on the label. is there a list of gums / inks anywhere which are considered safe to use. I daresay the absolute requirement for use of such relates to potential for direct / indirect food contact but are the available options listed anywhere. I usually got very evasive responses from suppliers of such items when faced with such questions.

Rgds / Charles.C


Kind Regards,

 

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#3 Simon

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Posted 28 January 2007 - 08:56 PM

Is there any criterion in selecting a label for my product which is a food additive? If I am using a self sealing sticker, do I have to bother about the quality of gum used ? Can any one enlighten me?


but would also like if I may to extend yr query to the printing ink on the label. is there a list of gums / inks anywhere which are considered safe to use. I daresay the absolute requirement for use of such relates to potential for direct / indirect food contact but are the available options listed anywhere.

In the EU/UK Regulation (EC) No 1935/2004 applies to Food Contact Packaging.

"Provisions also apply to materials and articles that can reasonably be expected to come into contact with foods or to transfer their constituents to food (such as printing inks and adhesive labels)."

Information on Food Contact Materials from the Food Standards Agency

Adhesives

Article on Food Packaging and Printing Inks
A bit of an old article but interestingly discusses the transfer of uncured / wet ink from non contact side of packaging to food contact side during nesting of packaging or winding on reel.

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#4 Simon

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Posted 29 January 2007 - 08:52 AM

Some more reading related to printing inks and food packaging.

The BCF Guide to Printing Inks for Use on Food Wrappers and Packages

There is some other useful documents on the CEPE website: http://www.cepe.org, especially:

"EuPIA Guideline on printing inks applied to the non-food contact surface of food packaging material and articles"

I cannot link directly to the document as the site uses frames. To find the publications relating to printing inks use the right left hand menu PUBLICATIONS > PRINTING INK (EUPIA) DOCUMENTS


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#5 Charles.C

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Posted 29 January 2007 - 09:14 AM

Dear Simon,

Maybe it's my computer but some of the links in 1st post giving trouble for me.-

link 1935.. OK, very interesting but didn't see any direct suggestion to lists other than list of relevant varieties at end - maybe I missed it in all the mass of gobbledegook
link 2 wouldn't open unless saved first, then none of the x-links worked
link4 similar problem (maybe 1998 too old to expect anyway) however link material looks on the ball

I will try again later

Rgds / Charles.C


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#6 Simon

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Posted 29 January 2007 - 09:24 AM

Charles, I tried all links and they are OK, one is a PDF. :dunno:

Probably the most important document you are looking for is the Exclusion List for Printing Inks and Related Products, which can be found on the CEPE website.

Regards,
Simon


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#7 cazyncymru

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Posted 29 January 2007 - 09:34 AM

Charles, I tried all links and they are OK, one is a PDF. :dunno:

Probably the most important document you are looking for is the Exclusion List for Printing Inks and Related Products, which can be found on the CEPE website.

Regards,
Simon



Good site Simon...very interesting reading!

#8 Sankara narayanan

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Posted 29 January 2007 - 10:36 AM

:thumbup:


Thanks Simon,

The links made interesting reading.
A.Sankara Narayanan

#9 Jenny

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Posted 29 January 2007 - 09:31 PM

Dear all:

Check this following site, ***BROKEN LINK REMOVED - INFO POSTED BELOW*** EU Industry Requirement ( the ink is NOT in the Negative List as per EU list as attached).

Regards,
Jenny



#10 okido

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Posted 30 January 2007 - 07:41 AM

G'day Jenny,

Are you sure to link is OK,
I got following error: Erreur inconnue -%PDF (404-0-63)

Regards, Okido



#11 Simon

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Posted 30 January 2007 - 08:56 AM

I get the same error. Can you fix or edit your post please Jenny.

Thanks,
Simon


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#12 Jenny

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Posted 30 January 2007 - 04:59 PM

Dear All:

I'm sorry for the link. I used to be able to open it but now I got error too. Following is the information which I saved it from that link.

Thanks,
Jenny

EU – Exclusion List for Printing Inks and Related Products

The following categories (selection criteria) and individual substances is excluded from raw materials for the manufacture of printing inks and related products supplied to printers:

Selection Criteria
a. Carcinogenic, mutagenic and toxic for reproduction substances and preparations classified and labelled as toxic (T) according to the Dangerous Substances Directive 67/548/EEC with risk phrases R45, R46, R49, R60, R61
b. Substances and preparations classified and labelled as very toxic (T+) or toxic (T) according to the Dangerous Substances Directive 67/548/EEC with risk phrases R23, R24, R25, R26, R27, R28, R39, R48.
c. Pigment colourants based on and compounds of antimony, arsenic, cadmium, chromium(VI), lead, mercury, selenium.

Substances List
Dye colorants
Auramine (Base Yellow 2 – CI 41000)
Chrysoidine (Basic Orange 2 – CI 11270)
Fuchsine (Basic Violet 14 – CI 42510)
Induline (Solvent Blue 7 – CI50400)
Cresylene Brown (Basic Brown 4 – CI 21010)
Other soluble azo dyes which can decompose in the body to bio-available carcinogenic aromatic amines of category 1 and 2 according to Directive 67/548/EEC.
Solvents
2-Methoxyehtanol
2-Ethoxyethanol
2-Methoxyethyl acetate
2-Ethoxyethyl acetate
Dichlorobenzene
Volatile chlorinated hydrocarbons, such as trichloroethylene, perchlorethylene and, ethylene chloride
Volatile fluorochlorinated hydrocarbons
2-Nitropropane
Metanol
Plasticisers
Chlorinated naphthalenes
Chlorinated paraffins
Monocresyl phosphate
Tricresyl phosphate
Monocresyl diphenyl phosphate
Various Compounds
Diaminostilbene and derivatives
2,4-Dimethyl-6-tertiary-butlphenol
4,4 tetramethyldiaminobenzophenone (Michler’s Ketone)
Hexachlorocyclohexane

In Addition, substances or preparations for which questions are addressed to the printing ink manufacturers
-which are not permitted according to Directive 76/769/EEC (relating to the restriction of the marketing and use of certain dangerous substances and preparations) and its amendments, such as:

Asbestos
Benzene
Pentachlorophenol and its salts
Polychlorinated biphenyls (PCB)
Polychlorinated terphenyls (PCT)
Vinyl chloride monomer

-which are not commercially available or not suitable for the formulation of printing inks and related materials such as:

Brominated flame retardants
Dioxines
Nitrosamines
Polybrominated bi- or terphenyls
Polychlorinated dibenzofuranes



#13 Sankara narayanan

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Posted 31 January 2007 - 09:25 AM

Thanks Jenny for the information.

Now another poser. We are not selling our product( a natural sweetener) to the end customer directly. So do we have to indicate the 'intended use' in the label? Any suggestions?


A Sankara narayanan


A.Sankara Narayanan

#14 Charles Chew

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Posted 31 January 2007 - 03:43 PM

Dear Sankaran
Certainly, you are part of your identified food chain passing pre-processed product(s) onto the next food chain for further processing.

Data on ingredients, storage instructions etc are essentials to meeting both Customer and Regulatory requirements

Regards
Charles Chew


Cheers,
Charles Chew
www.naturalmajor.com

#15 YongYM

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Posted 01 February 2007 - 08:12 AM

Hello Jenny & Charles:

Regarding the ink used, do you all remember the case of ITX (isopropylthioxanthone) around November 2005? This may be a new fear also.

Edited by YongYM, 01 February 2007 - 08:14 AM.


#16 Simon

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Posted 04 February 2007 - 07:49 PM

Hello Jenny & Charles:

Regarding the ink used, do you all remember the case of ITX (isopropylthioxanthone) around November 2005? This may be a new fear also.

Yes we do YongYM, for interest: ITX Discussions

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#17 Charles.C

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Posted 10 February 2007 - 03:00 PM

Dear All,

I just realised that I never saw a list of chemicals (partly my extending fault, sorry SN) for the original query as to safe "gums" in this thread. I've often watched people putting self-sticking labels on bags and wondered about it. (I did look through the interesting adhesives link but didn't see any actual "permitted" items specified ??)

Rgds / Charles.C


Edited by Charles.C, 10 February 2007 - 03:15 PM.

Kind Regards,

 

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#18 Simon

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Posted 13 February 2007 - 10:05 PM

I just realised that I never saw a list of chemicals (partly my extending fault, sorry SN) for the original query as to safe "gums" in this thread. I've often watched people putting self-sticking labels on bags and wondered about it. (I did look through the interesting adhesives link but didn't see any actual "permitted" items specified ??)

It's late here Charles and I've had a couple of glasses of Merlot. OK now I've covered my A** Is it because the list is a list of what cannot be used (an exclusion list rather than a permitted list). :dunno:

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#19 Charles.C

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Posted 14 February 2007 - 03:23 PM

Dear Simon,

Maybe I need the Merlot (whatever that is, sounds vaguely magical?).
I saw the list in the thread but this only seemed relevant to inks or have I misunderstood (again)? I assumed gums would be something else??

Rgds / Charles.C


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#20 Simon

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Posted 15 February 2007 - 10:21 PM

Maybe I need the Merlot (whatever that is, sounds vaguely magical?).

red wine.

I saw the list in the thread but this only seemed relevant to inks or have I misunderstood (again)? I assumed gums would be something else??

let me check...

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#21 Charles.C

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Posted 16 February 2007 - 04:48 PM

Dear Simon,

Hmm. I suppose it's a case of red wine at night, Simon's delight. Always found the red a bit too potent myself but I have lasting memories of my single trip to Italy where small, cheap UHT type boxes of mild white wine were the standard liquid accompaniment in the company luncheon area. Wonderful! I reckon add this plus a bit of Spanish siesta plus the Scandinavian liberalities to the English culture and Nirvana is a bit nearer. :thumbup:

Rgds / Charles.C


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#22 Simon

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Posted 19 February 2007 - 08:59 PM

Hmm. I suppose it's a case of red wine at night, Simon's delight. Always found the red a bit too potent myself but I have lasting memories of my single trip to Italy where small, cheap UHT type boxes of mild white wine were the standard liquid accompaniment in the company luncheon area. Wonderful! I reckon add this plus a bit of Spanish siesta plus the Scandinavian liberalities to the English culture and Nirvana is a bit nearer. :thumbup:

Sounds like the perfect day to me Charles. ;)

On a slightly different note I remember auditing a packaging company in Bavaria about five years ago; at that time they had only just removed the beer vending machines from their site, workers could drink as many beers as they wanted during their shift and could actually drink them at the machine. It was written into Bavarian law. :lol:

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#23 Charles.C

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Posted 23 March 2007 - 11:50 AM

Dear All,

Thanks to my OT tendencies I think the original query never got a direct answer.

I bought some dishes the other day which had pretty (barcode + other detail) stickers on them. After removing them I could see there were various residues which I failed to scrub off. This reminded me of this thread both for the (hopefully) food compatible label printing inks which Simon’s earlier website link seems to well answer plus the remaining bits of adhesive. The following refers to adhesives. (I initially missed some useful pages in the FSA link given earlier by Simon (apologies! I blame the chianti) - see "added [3] below" )

The European Framework Regulation (EC) No. 1935/2004 (link in Simon's prev.post) defines the application problem nicely but does not seem to provide any specific operational data (for printing inks or adhesives).
I googled around for adhesives data and eventually found the item below which suggests that for adhesives there are 2 main approval options – “BfR” or (US) “FDA”

http://www.europe.fa...12572A7003676CD

(1) BfR (German website (see link at bottom) – Federal Institute for Risk Assessment [with English also]) presents a (seemingly up-to-date) nice summary of the EU harmonisation situation and notes that the primary EU link (Directive 2002/72/EC ) list is currently “incomplete”. It also contains this comment –
“According to this timetable, the European Commission will establish by 31 December 2007 at the latest the date on which the incomplete list of additives will become a positive list.”

Nonetheless the current EU list [see link in the BfR doc.] is already enormous.

(2) (US) FDA – The relevant section (s) seems to be this (see particularly 175.105 and 175.125) –

http://www.gpo.gov/n...1cfr175_00.html

The text is quite difficult to follow IMO and lists various situations / requirements of possible food label adhesive use, has a list of categories of permitted chemicals plus a more detailed list of specific chemicals / limitations.
I liked the idea of this comment but still not 100% sure what is covered by it –

“(b) To assure safe usage of adhesives, the label of the finished adhesive container shall bear the statement ``food-packaging adhesive''

I saw one example of a proposed patent for a new adhesive which contained the text –

“An adhesive is described. The adhesive is formulated from one or more organic components that have FDA approval.”

This is the kind of statement I think represents an absolute minimum (with the additional words “for direct food contact” or whatever). The next question is of course – what is in it, where listed approved and (but probably unavailable) - where validated) ?
It seemed to me that very little info. was given on composition of any promoted products, for the usual commercial reasons I guess.

Overall it seems to me that the situation for adhesives is less clear than for inks. Maybe I have missed something more directly usable, additions (or corrections) welcome.

Rgds / Charles.C

added - I forgot to include this example of a product which seemed to have some useful declared specifications although I'm unclear as to the significance of the "with minimum opportunity for exposure" addition.

http://multimedia.mm...s6665RaCOrrrrQ-

added (2) - apologies! - I omitted link for no.1 -

http://www.bfr.bund.de/cd/6128

in addition I think this up-to-date general link is also probably useful -

http://ec.europa.eu/...u_legisl_en.htm

(If anyone is interested, EU also maintains a website to handle the more technical aspects of these subjects at -

http://cpf.jrc.it/webpack/

added (3) as mentioned higher up, I missed several useful page links in FSA site, eg -

http://www.food.gov....rialsquestions/

This (and Simon's link) points to a page with a very useful pdf dwl (rev July 2006) which nicely amplifies and explains the EU regs -

http://www.food.gov....contactarticles


Edited by Charles.C, 25 March 2007 - 09:29 AM.

Kind Regards,

 

Charles.C


#24 Charles.C

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Posted 24 March 2007 - 11:23 AM

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


Edited by Charles.C, 26 March 2007 - 06:24 AM.

Kind Regards,

 

Charles.C


#25 Simon

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Posted 26 March 2007 - 08:11 PM

;)

Is there any criterion in selecting a label for my product which is a food additive? If I am using a self sealing sticker, do I have to bother about the quality of gum used ? Can any one enlighten me?

And just to finish off this thread of wonderful information - please remind me of the answer to Sankara's original question?

Simon

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