Thanks so much for inviting me to be a part of this webinar. I'm sorry that I wasn't able to address all of the questions that were raised during the presentation, so I will attempt to address them here.
1. Is there enough with a guarantee letter from the ink and plastic supplier?
The answer here is, 'it depends.' Certainly, if you have a valid and appropriate assurance letter from your suppliers that addresses the food-contact status of all of the components, you can feel free to rely on that assurance. The key is to make sure that the assurance statement is appropriate to the jurisdiction of interest and that it reflects an understanding by the supplier of the regulatory scheme. For example, an assurance statement for a PET bottle that cites only to FDA's adhesive regulation (21 CFR 175.105) as a basis for using the PET bottle to package food should be a red flag, and should at least trigger a conversation with the supplier. Similarly, such an assurance statement would not be sufficient to ensure EU compliance. When relying on supplier assurance statements, it is important to understand the applicable regulatory scheme in sufficient detail so that you know when an assurance statement is satisfactory, and when you should be asking more questions about how the supplier has arrived at their compliance conclusion.
2. Do you think that the FDA will introduce regulations around ink products?
At this time, I am not aware of any activity at FDA related to the regulation of food-contact printing inks. For that reason, and because the current FDA regulatory scheme is aimed more at individual substance clearances (under the FCN system), rather than regulations covering categories of substances, I do not expect FDA to put forth a new regulatory scheme for printing inks - at least not in the foreseeable future.
3. Is the US behind the EU on printing ink safety?
I don't think that one jurisdiction is really ahead of the other in this area. In both the EU and U.S., the obligation for ensuring the safety of packaging materials that are not explicitly regulated is on the individual business operator. Just as there are no printing ink regulations at the Community level in the EU, there are no printing ink regulations in the U.S. In both jurisdictions, however, there is an expectation that business operators will ensure the compliance and safety of the finished material. Admittedly, some of the individual countries in Europe (e.g., Switzerland and Germany) have made efforts to regulate printing inks through printing ink ordinances, but these regulations will only be legally applicable in the specific countries in which they are enacted.
4. Do you think the risk to food is mainly from packaging materials or printing inks?
This is a tricky question, as it assumes that one or both categories of food-contact materials are somehow risky. I don't view either category as inherently risky. To the extent that a company is concerned about the potential for food contamination as a result of food-contact materials, this tends to be driven more by product stewardship than by the particular category of food-contact material. In other words, the risk of either a regulatory compliance problem, or an actual safety issue, is more likely to depend on whether the company conducting the regulatory and safety assessment understands the products and issues, and addresses them appropriately. This is true regardless of whether the material at issue is a package or printing ink.
I hope that this addresses the remaining questions, and that the presentation was otherwise helpful.