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1. Is there any mandatory terminology that needs to be displayed on a product sampling package of a non-food item?

2. My question is regarding paper baking cups, the items inserted into baking trays when baking cupcakes. Are they regulated under the California Proposition 65 regulations on lead content or FDA regulations, similar to food wrappers, since this is a food contact item. Can you offer any insight into which regulation should be followed for paper baking cups?

3. Is there a monograph in the European Pharmacopeia that covers colorants used in the manufacture of rigid plastic containers to contain pharmaceuticals?

4. In 16 CFR Part 500 it outlines the requirements for net quantity content labeling of product contained in a package. My question pertains to products that are contained in flexible tube type packages. For example, if the product labeling states the package contains 3 oz of product should the target fill level be 3 oz, or 3 oz plus an amount of product that the consumer cannot express from the tube? There is always some product that is contained in the tube head, or just below the head, that the consumer cannot get out of the tube. Does this small amount of product need to be accounted for? Is there any formal guidance available?

5. Regarding extractives compliance testing (end tests), when we change the manufacturer of a multilayer plastic container using the same materials and the same specifications, are extractives (end tests) required on the finished container made at the new manufacturer?

6.
I am the Package Design Manager for a consumer products company specializing in crafts products. I am looking for laws or regulations detailing what warning labels must be placed on the plastic bags in which our products are packaged.

Specifically I would like to know if these two warnings may be combined into one: "Choking Hazard-Small parts. Not for children under 3 years" and "WARNING: This bag is not a toy. Please dispose of properly. To avoid danger of suffocation, keep bag away from babies and children. Do not use bag in cribs, beds, carriages or playpens."

7. Are co-packers required to cook barbecue sauce at a certain temperature regulated by the FDA to ensure shelf life is certain? If so, what temperature is required? Also, what is the lowest temperature a barbecue sauce can cooked at and still maintain shelf life according to the FDA?

8. Do the FDA's food contact substance (FCS) regulations apply to a product that is sold separate of food and is not intended to be used with any particular food type or exclusively for food storage? An example is a food storage bag with a zip lock-type closure that would be marketed for food storage but may also have other applications.

9. Has FDA changed any of the existing Food Contact Notification requirements or procedures since the 2008 budget was passed by Congress? Will FCN be eliminated in the near future?

10. Must all packaging containing products for retail sale display a physical address and phone number along with the company name, or will just a website address suffice? This is pertaining in particular to a packaged gift item, no food products included.

11.
1. How does the "slack law" pertain to packaging in pouches?

2. What are the current laws or regulations that govern changes in package sizes in relationship to the price or weight?

12.
1. We have been told by a customer that PVC packaging will be banned in California. I can find no such reference provided that the packaging conforms with existing RoHS rules. Can you confirm for me laws in California, USA or the EU do not ban PVC packaging per se?

2. What is the ruling on using PVC bottles for a consumer product. I understand that some states such as California and Washington have banned the use of PVC. Can you tell me if this is true and what states have this regulation?

13. California Prop 65 NSRLs and MADLs are stated in terms of exposure levels (µg/day) but suppliers of raw materials (resins, inks, etc.) used in manufacturing plastic goods use concentration levels (ppm) when responding to inquiries concerning substances controlled by Prop 65. A telephone conversation and email exchange with a representative of the Cal EPA resulted in little more than confirmation of the above discrepancy. Thus, letters from raw material suppliers that refer to a ppm level cannot be translated into an equivalent µg/day that does or does not require a warning notice. Of course, any such translation would require certain assumptions concerning the sum of exposures of a theoretical subject person but California provides no equation or table for this purpose. Question: In light of the above, how can a manufacturer of finished plastic goods safely respond to requests from its customers for written assurances that the finished goods do not require a warning under Prop 65?

14. I have seen several e-mails regarding the packaging and labeling of skin care products but still have a more specific question. Is there a regulation on the extent to which packaging materials should be cleaned (i.e. sterilized or sanitized before use/packaging). I am planning on making and selling skin-care products at home and want to make sure there are no laws governing how packaging materials are cleaned and sanitized before use. Moreover, does the package with skin care contents need to be safety-sealed?

15. Is it legal for a company to sell a PET plastic product with the intent that consumers reuse it repeatedly over a course of years? It is my understanding that #1 plastics are only recommended for food contact for single use, and that further use runs the increased risk of leaching DEHP into the contents.

16. Is paper packaging coated or film laminated with Polypropylene recyclable?

17. We have a cellulite cream that is packaged as four small jars in a larger box. Do we need the ingredients on the jars themselves, or can we just have them listed on the back of the box that houses the jars? We are very tight for room on the labels and the ingredients are rather long. Thank you in advance!

18. I am writing from the Korean Small Business Corporation U.S. office, a government agency that promotes exports from small manufacturers in South Korea. A manufacturer of food packaging machines in Korea has an order from a U.S. company for one of its machines that uses some kind of fiberglass element in the sealing process. The question is if there might be FDA, USDA and/or EPA restrictions on importing a food packaging machine that has this kind of element. What is the process for importing the machine if these restrictions exist?

19. The FDA in November 2006 published a guidance document "Lead in Candy Likely to be Consumed by Small Children: Recommended Maximum Level and Enforcement Policy". This proposes that 0.1 ppm be the maximum level for candy and related food items. How does this correlate with the 100 ppm maximum level that CONEG (TPCH) model legislation states?

20. We are installing a automated powder filling machine for our protein drink. We are trying to set the tolerances. If the label says we have 450 grams of product, how much under and over can we be and still be within FDC or FDA regulations?

21. Are there any current requirements for tamper evident features on packages for oral solutions or for oral solids in clinical studies? Does the requirement differ if the study will be done at hospital/clinical study center or if the study will be done at home? The only document we can found concerning tamper evident is 21 CFR 211.132 but this is only valid for OTC products.

22. Does the label on the primary and secondary pack of a Class I or II device need to comply with the OTC regulation when the device is always recommended (not necessarily prescribed) to the user by a medical professional?

23. Is there a law governing the restriction of the use of the word 'Healing' on topically applied products designed to promote the healing of cuts, wounds, infections and to ward off bacterial infections? These products would be based on a formula of essential oils, vegetable oils, nut butters, lanolin and bees' wax - all natural products.

24. What are the EU and FDA rules pertaining to packaging food in UV coated board? Also, are there any advantages in using water-based coatings instead of UV-based coatings on board for use in food packaging?

25. Can you clarify the impact of REACH regulations on non-European manufacturers of packaging materials exported to the EU? We've invested some time in studying this but have yet to reach an understanding precisely what impact REACH will have on us in terms of documentation. I've also seen a BBC article claiming that packaging materials are exempt from REACH. At the same time numerous professional organizations are holding seminars to aid packaging manufacturers in dealing with the new legislation. Where does the truth lie?

26. If a product is manufactured using an FDA approved resin and FDA approved colorant does essentially mean that the resulting manufactured product is FDA approved ?

27. We make disposable plastic products that are used in contact with food. We comply to FDA CFR 110. Do our raw material suppliers of plastic resins and colorants have to comply with 21 CFR 110 or 21 CFR 174.5 or both?

28. What is the permissible limit of lead content in food packagings (like paperboard) having direct food contact?

29.
1. We make a candle in the US. The glass container comes from China. The wax, fragrance, oil, label and wick are made in the U.S. The glass is the only thing from China. Is it ok to pull the made in china sticker off the glass?

2. We manufacture a promotional piece with 3 components. One component of the product is supplied to us from China. Our product is then added to a another printed piece that is manufactured in the U.S. There is nothing involving food. Do we need print "Made in China" or any notification that a component was made in China?

30. Does labeling for a Prescription Medical Devices have to meet the regulations for OTC medical device labeling (21CFR801.61, 21CFR801.62, 21CFR801.15)? If not, what are the minimum requirements for labeling content and presentation (placement, font size) for Rx only devices?

31. When an animal food is manufactured for a company by another company in a different location, must this be disclaimed, as in "Manufactured for XYZ"?

32. What FDA regulations are applicable to sealers and finishes for countertops?

33. Is it acceptable to sell product with English only on the packaging in Ontario?

34. We make closures for the tooth paste industry. We have a DMF number in our USA plant but we want to supply the same product from our Mexican Plant. Do I need to register another DMF number?

35. Is it required to label a photo of our product as "serving suggestion" on the PDP? What are the rules governing this? Thank you

36. When repackaging OTC vitamins/supplements, does it have to be in a childproof container? Where can I find this information?

37. Is there a rule in labeling Personnal Care products with the words natural, organic, or/and biodegradable? Please direct me to links for these topics.

38. We are importing a number of products manufactured offshore for re-sale in the U.S. Some of them are quite small and irregular shaped and packing in plastic bags, making labeling difficult. Is a small stick on label with just "China", "Taiwan", "Korea", etc. sufficient to serve as manufacturing source of origin or does it have to be the full "Made in China", "Made in Taiwan", "Made in Korea", etc. and is there a reference source where we can find the relevent regulation details. Thank you.

39. Hi... I have a general question. What paths do we have to take to get FDA compliance for an inorganic additive that we intend to add to fibre packaging and plastic packaging, e.g. it would be an "indirect food additive." My understanding for plastic packaging is if it is not listed under 21 CFR we would have to go down the path of FCN/FAP unless it is classified as "exempted from evaluation." The way it is exempt from evaluation is if we can prove it does not migrate into food via the FCN migration techniques (chemistry section). Is the above approch correct for plastics? What about fibre/paper? Thanks in advance

40. Are there any detail requirments about the suffocation warning on polybag packing product to European market? Does evey poly bag need that? Or it depends on the opening size or other criteria?

41. What are the FDA regulations regarding shape of packaging used for retail primary containers of food? If the FDA doesn't regulate shape, then does another federal agency?

42. I'm trying to establish if there's any legislation governing the use of the word "new" on the label of a product going into the UK. I'm led to believe there might be a limited period after the launch of the new product that the term can be used on the packaging, thereafter it has to be removed. I'd appreciate your input.

43. What if any are the FDA specifications or regulations for containers that hold alcohol, mostly for plastic bottling?

44. What is the law regarding listing ingredients on hair products? Can they just be listed on the outside box or must they be placed on the jar as well? If the consumer discards the box, there is no reference to the ingredients in case of an emergency, such as accidental ingestion. Shouldn't the ingredients be listed on the final product itself? What if the product is imported? Thank You.

45. If a products package is clearly marked with "Made in China" is it necessary to also mark the product within the package? My question is concerning hardline products (not food) where the packaging mentioned is seen by the ultimate consumer at retail.

46. Regarding to the French food contact safety regulation, is the decree N°92-631 replaced by DGCCRF 2004-64? Are they having the same legal status?

47. Is there currently a ban on PVC packaging material in the European Community?

48. We manufacture several organic compounds that are blended with pigments to make colorants for use in food packaging. Are our products affected by the 'French Positive List'? Where can this list be found? Thank you

49. In our factory in Europe we work with a plastic additive that it is been approved by European Community but it is not still approved by FDA. What will happen if we have to export to USA or South America?

50. Please confirm whether we can use non DMF garde Packaging Materials for OTC products in US Market.

51. Which European directive is similar to U.S. FDA 21 CFR 175.105 INDIRECT FOOD ADDITIVES - adhesives?

52. We are food manufacturers. What is the current food packaging law in the UK, which we need to consider when we receive food packaging specifications from suppliers? For example, what if we receive a statement such as the following: ". . . this packaging meets the requirements of the European Union regulations . . ."

53. We are in the business of producing industrial grade nitrocellulose. This product is damped with alcohols like ethyl alcohol, n-Butanol, isopropyl alcohol, and plasticizers like dibutyl pthalate. I would like information about permissible limits of these chemicals in printing inks used in food packaging.

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