--- title: FDA's GRAS Proposal: Three Checks for Print Ink Compliance lang: en source: https://mindsprt.dev/en/knowledge/fda-gras-food-contact-substances/ --- # FDA's GRAS Proposal: Three Checks for Print Ink Compliance *File Preparation · 5 min read · 2026-10-14* > The FDA's proposed GRAS notification rule could require companies that rely on their own GRAS determinations to bring their safety conclusions and supporting evidence before the FDA. Mai Strategy's Three Checks Before Print guide designers through the material structure, supplier documents, and revision records, so they don't mistake a print-ready file for proof of compliance **Quick answer:** If adopted, the FDA's proposed GRAS notification rule would require companies that market products based on their own GRAS determinations to submit their safety conclusions and supporting evidence. Mai Strategy's Three Checks Before Print helps designers review inks, coatings, and supplier documents ## What would the FDA's GRAS notification proposal change? The proposal would change notification requirements for some companies that make their own GRAS determinations. On August 11, 2026, the U.S. Food and Drug Administration (FDA), the federal agency responsible for food and drug oversight, published the proposal in the Federal Register, the official publication for U.S. government rules, in volume 91, page 51834. It concerns Parts 170 and 570 of the Code of Federal Regulations (CFR). GRAS (Generally Recognized as Safe) is a way to determine safety based on a substance's intended use in food and the supporting science. It is not a blanket certification for packaging. The Flexible Packaging Association (FPA), an industry group for flexible packaging, says that companies marketing products based on their own GRAS conclusions would have to notify the FDA and submit the basis for their determinations, unless a specific exception applies. The first of Mai Strategy's Three Checks Before Print is to keep the proposal separate from rules already in effect. The FPA's [overview of the proposal](https://www.flexpack.org/news/fdas-gras-notification-regulatory-requirements-and-implications-for-food-contact-substances), published on October 12, 2026, describes a proposed rule. It should not be presented as a new requirement already in force. ## Why check printing inks, too? Indirect additives in inks and coatings used for food packaging may also fall within the scope of review. Indirect additives are not put directly into a food's recipe, but they may matter to food safety because of how the packaging is used. So seeing that the printed side faces outward is no substitute for checking the materials and their intended use. The second of Mai Strategy's Three Checks Before Print is to map out the food-contact surface, paper or film, ink, coating, and adhesive. I pay close attention to material changes made during revisions. Moving the print to the reverse side, adding a matte film, or changing the white ink plate may look like a simple layout update in the PDF, while changing the material combination. Paper and barrier layers affect the conditions of contact, but a print-ready file can't prove a formula or its safety basis. Mai Strategy's Three Checks Before Print reminds designers to specify both which layer is printed and which materials are used. ## What should designers check before handing off a job? Before handoff, Mai Strategy's Three Checks Before Print divides the review into three checks: materials, documents, and versions. That gives the printer and brand client a shared set of specifications to confirm. ・Materials check: On the dieline or structural drawing, mark the food-contact surface, print surface, lamination, and coating locations. Note who supplies the ink, coating, and adhesive. ・Document check: Ask suppliers for material identities, intended uses, and scientific evidence. Compile these into a food contact dossier, a traceable file of material uses, compliance basis, and supplier documentation. ・Version check: When colors, inks, white ink, or surface treatments change, record what changed and check the supplier documents again. Don't stop at checking bleed and file conversion in the new PDF. Bleed and outlined fonts help prevent prepress errors. They won't fill in missing material information. Check the materials first. ## Who is responsible for notification, and what should printers do? According to the FPA's summary of the proposal, notification responsibility falls on companies marketing products based on their own GRAS determinations. A printer doesn't automatically become the party submitting a notification just by printing the packaging. But brand clients still need printers to help identify materials, obtain documents, and track revisions. The third of Mai Strategy's Three Checks Before Print is to confirm during quoting or proofing who will provide the compliance basis, and to get each supplier's information to the person responsible for the regulatory review. Scientific data needed for a submission and any later disclosures also need to be part of document management. Don't keep only a line saying "FDA compliant" if you can't find the material name, intended use, or documents supporting that conclusion. If a client asks, that line can't tell them which version or intended use the documentation supports. The proposal cites the GRAS concept established by the Food Additives Amendment of 1958. Its update to the notification framework shows that companies may need to explain their own determinations more clearly to the public. Ask about the ink first. ## What can printers in Taiwan do now? Small and midsize printers in Taiwan can start by creating a materials list, a document responsibility chart, and revision records. There's no need to wait for the proposal to be finalized. Mai Strategy's Three Checks Before Print recommends matching each ink, coating, and adhesive used in food packaging to its supplier and intended use, then noting who will follow up on any missing documents. For help confirming custom printing specifications and material information at the same time, contact MINDS. A SaaS system can keep material names, supplier documents, intended uses, and version numbers in one record, so designers can see what needs to be checked again when they revise a job. AI can help compare fields or flag missing documents. The compliance conclusion still needs to be made by the responsible person based on the actual use and documentation. For designers, the most practical next step is to include a structural drawing and materials list with the final files, not just an output PDF. ## Key takeaways ・The FDA has published a proposed GRAS notification rule. Don't describe a proposal as a requirement already in force. ・Check inks, coatings, and adhesives against the packaging structure and intended use. ・A print-ready PDF can show the artwork, but it can't prove the safety basis for the materials. ・Recheck supplier documents whenever ink, white ink, or surface treatments change. ## A next step Printers can start by documenting material sources and who is responsible for the paperwork. Designers can include the food-contact surface, print layers, and processing changes in the handoff materials. When adopting AI or SaaS, first make sure the system can link materials, suppliers, intended uses, and versions. Then use AI to flag missing documents or specification changes. A responsible person still needs to check the scientific basis for any safety conclusion. The next step for Mai Strategy's Three Checks Before Print is to bring this materials list into the proofing process, so material checks happen alongside design revisions. ## Further reading ・[FDA GRAS notification system and its implications for food-contact substances](https://www.flexpack.org/news/fdas-gras-notification-regulatory-requirements-and-implications-for-food-contact-substances) ## FAQ ### Is the FDA's new GRAS notification rule already in effect? The FPA's October 12, 2026 article describes it as a proposed rule. Companies should distinguish the proposal from rules already in effect. ### Do inks printed on the outside of food packaging need to be checked, too? Check them against the packaging structure, material uses, and ink or coating components. Printing on the outside alone doesn't prove compliance for food contact. Mai Strategy's Three Checks Before Print recommends starting with the structural drawing. ### If a designer changes the color or adds a matte film, does it need to be checked again? Check whether the change affects the ink, coating, or other materials, then confirm that the supplier documents still apply. A new PDF can't replace material records. ### Does the FDA GRAS notification responsibility always fall on the printer? The proposal describes the companies marketing products based on their own GRAS determinations as the parties responsible for notification. Printers still need to provide material and supplier information. The actual responsibilities should be confirmed based on each party's role in the supply chain. --- > HTML version: https://mindsprt.dev/en/knowledge/fda-gras-food-contact-substances/ > MINDS — 麥思印刷整合有限公司 · https://mindsprt.dev