PRI Plus
regulatory status on roll label constructions
Revision 01.011 | August 2025
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PRI Plus Roll Label Constructions are considered Articles as defined by the Federal Occupational Safety and Health Administration (OSHA).
According to OSHA’s Hazard Communication Standard [29 CFR 1910.1200 (c)]:
Article means a manufactured item other than a fluid or particle:
(i) which is formed to a specific shape or design during manufacture;
(ii) which has end use function(s) dependent in whole or in part upon its shape or design during end use; and
(iii) which under normal conditions of use does not release more than very small quantities, e.g., minute or trace amounts of a hazardous chemical and does not pose a physical hazard or health risk to employees. -
According to 29 CFR 1910.1200(b)(6)(v), the section 1910.1200- Hazard Communication does not apply to articles. Thus, PRI Plus Roll Label Constructions are exempt from the Safety Data Sheets (SDS) provisions.
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Twenty chemical substances have been designated by the EPA as a high priority for upcoming risk evaluations. Nineteen of these twenty substances are not used in the manufacture of PRI Plus Roll Label Constructions. Butadiene is used as a starting material for a rubber in some rubber-based adhesives. It is anticipated that after processing from the supplier, butadiene is present in negligible amounts.
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PRI Plus Roll Label Constructions meet the safety requirements for lead and phthalates in the Consumer Product Safety Improvement Act (CPSIA) of 2008 for children’s products. A General Conformity Certificate is not required.
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To the best of our knowledge and belief, based on tests conducted by us or our suppliers, the adhesive used in PRI Plus Roll Label Constructions is not considered a primary irritant to the skin or eyes, as defined in the Federal Hazardous Substances Act (16 CFR 1500.3(c)(4) and 16 CFR 1500.3 (c)(2)(i)).
PRI Plus also represents, to the best of our knowledge and belief, that the adhesive in the product is not toxic by oral ingestion per the standards set forth in the Federal Hazardous Substances Act (16 CFR 1500.3 (c)(2)(i).
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This product meets the standards set by the FDA to comply with Indirect Food Contact.
There are no Fluorinated Surfactant Agents (FSA) in any PRI Plus adhesive products.
The end-user is responsible for determining the applicability of the FDA requirements for the intended use(s) for full compliance with 21 CFR 175.105- Adhesives. This section requires the 4 PRI Plus Regulatory Status: Roll Label Constructions 01.011 adhesive is either separated from food by a functional barrier or used subject to the following limitations:● In dry food. The quantity of adhesive that contacts packaged dry food shall not exceed the limits of good manufacturing practice.
● In fatty and aqueous food., the quantity of adhesive that contacts packaged fatty and aqueous food shall not exceed the trace amount at seams and at the edge exposure between packaging laminates that may occur within the limits of good manufacturing practice.
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PRI Plus does not intentionally add any of the toxic chemicals listed pursuant to the California Safe Drinking Water and Toxic Enforcement Act of 1986 as known to cause cancer or reproductive toxicity (sometimes referred to as “California Proposition 65”). We further represent that, to the best of our knowledge and belief, the products do not contain levels of the listed chemicals in amounts and form that would pose a significant risk to any individual who might be exposed to the products under normal conditions of use.
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This is to advise you that PRI Plus does not add any persistent, bioaccumulate, toxic chemicals (PBTs), including Decabromodiphenyl ether (DecaBDE); Phenol, isopropylated phosphate (3:1) (PIP (3:1)); 2,4,6-Tris(tert-butyl)phenol (2,4,6-TTBP); Hexachlorobutadiene (HCBD); Pentachlorothiophenol (PCTP) in the Roll Label Constructions.
We can further advise you that our raw material suppliers have represented to us that they do not intentionally add any of these PBTs to the raw materials they supply to us for incorporation into the products.
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PRI Plus does not intentionally add to the product any of the following heavy metals or their compounds: cadmium, hexavalent chromium, lead, and mercury. And though we have not analyzed this product specifically for these substances, based on our knowledge of the raw materials and the manufacturing process, we expect that the sum of any trace quantities is below the legislation limit of 100 ppm.
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PRI Plus does not source raw materials from companies or persons located in the Xinjiang Uyghur Autonomous Region (XUAR) pursuant to the Uyghur Forced Labor Prevention Act of 2021.
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100% solids are used to coat PRI Plus Roll Label Constructions without the use of solvents. Any residual monomers are expected to be extensively removed during the coating and drying process. PRI Plus does not routinely test for VOC’s.
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PRI Plus hereby represents that we do not intentionally add any of the chemicals listed pursuant to the EU 2017/745, Annex I, Chapter II, Section 10.4.1 regulation for medical devices. We further represent that, to the best of our knowledge and belief, the products do not contain levels of the listed chemicals in amounts and form that would pose a significant risk to any individual who might be exposed to the products under normal conditions of use. Our products are considered to be “articles” as defined by ECHA, and as such, do not release or otherwise result in exposure to hazardous chemicals under the conditions of intended use.
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PRI Plus does not intentionally add any of the twelve initial POPs listed in Annexes A, B, or C, any of the nine new POPs added in May 2009, the one POP added in May 2011, the one POP added in April 2013, the three POPs adopted in May 2015, the three POPs added in May 2017, or the two POPs added in May 2019 to the product during our manufacturing process.
Further, we have inquired of our major raw material suppliers, and they have represented to us that they do not intentionally add any of the POPs mentioned previously to the raw materials they supply us for use in the manufacture of the products.
Finally, based on their review of applicable SDSs and certificates of compliance they have received from their suppliers, they do not believe the raw materials they use to manufacture the products they supply to us contain any of the POPs mentioned previously.
Based on the foregoing, and all information otherwise available to us, we further represent that we have no reason to believe that any of the POPs mentioned previously are present in the products in concentrations in excess of incidental amounts.
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Agency effective as of 11 August 2025 (the “SVHCs”) Under EU Regulation (EC) No. 1907/2006 Registration, Evaluation, Authorization and Restriction of Chemicals (“REACH”), and specifically, whether these products contain any of the Substances of Very High Concern identified by the European Chemicals- PRI Plus represents to you the following:
1. We do not intentionally add to the products any of the SVCHs;
2. We have inquired of our major raw material suppliers and, based on the representations they have made regarding the raw materials they supply to us for use in our manufacture of the products, we have no reason to believe that any of the SVHCs is present in excess of 0.1% w/w.
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The following statements are related to the European Union’s January 27, 2003, Directives governing the restriction of the use of certain Hazardous Substances in electrical and electronic equipment, as amended June 8, 2011 (2011/65/EU-RoHS2), and again in 2015 (2015/863/EURoHS3), and Waste Electrical and Electronic Equipment (2002/96/EC-WEEE) (collectively referred to as the “Directives”). We confirm that PRI Plus:
1. does not knowingly incorporate or use the Restricted Substances in the products;
2. does not knowingly purchase any stock or ingredients which are used in the products that contain the Restricted Substances; and
3. has received representations from our suppliers, based upon their review of raw material composition and applicable SDSs, that they do not intentionally or knowingly incorporate the Restricted Substances in the ingredients they provide to us that are incorporated in the products. Based on the above, we believe that the products meet the RoHS3 and WEEE compliance standards.
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In the development and manufacturing of our adhesive products, PRI Plus may incorporate a range of proprietary additives, which could include biocides, to enhance product performance and durability. Whether or not biocides are present in any given formulation, we ensure that all our products are fully compliant with the European Union Biocidal Products Regulation (EU BPR).
Due to the proprietary nature of our formulations, we do not disclose specific details regarding the presence or concentration of biocides. However, we assure our customers that all additives used in our products meet the highest standards of safety and environmental compliance.
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PRI Plus Roll Label Constructions use adhesives that are 100% free from animal sourced rubber and present no risk of exposure to Bovine Spongiform Encephalopathy / Transmissible Spongiform Encephalopathy (BSE / TSE).
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This is to advise you that PRI Plus does not add any of the Conflict Minerals [cassiterite, columbite-tantalite, gold, and wolframite (Public Law 111-203)] and their derivatives [tantalum, tin, and tungsten (77 Federal Register 56273 and 56285)] to the products during our manufacturing process. We also confirm that our suppliers have represented to us that they do not intentionally add any of these minerals to the raw materials they supply to us. PRI Plus and our suppliers do not routinely test for the presence of these minerals, however.
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This is to advise you that PRI Plus does not add the perfluorochemicals / fluorotelomers perfluorooctanoic acid (PFOA), Per- and polyfluoroalkyl substances (PFAS) and perfluorooctanesulfonic acid (PFOS) to our products during our manufacturing process. We further advise you that our raw material suppliers have represented to us that they do not intentionally add PFOA, PFAS or PFOS to the raw materials they supply to us for incorporation into our products.
While neither PRI Plus nor our suppliers routinely test for the presence of PFAS, PFOA or PFOS, we represent to you that PRI Plus has no other information in our possession that would give us reason to believe that the products contain PFAS, PFOA or PFOS in other than trace amounts.
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Our products do not intentionally contain nitrosamines, nor are they added during the manufacturing process. Nitrosamines are not tested for in our products. Our suppliers have represented to us that no amines or amides—substances that could potentially act as precursors to nitrosamine formation under certain conditions—are intentionally included in the raw materials used in our formulations.
While our materials meet FDA guidelines for indirect food contact, this does not guarantee the absence of all amine-based compounds. However, if such compounds are present, they are within the safety thresholds established for indirect food contact by the FDA.
Nitrosamine formation is dependent on external conditions, such as the presence of nitrites in certain environments, and it remains the responsibility of the end-user to ensure the suitability of our products for their specific applications.
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Some of PRI Plus Roll Label Constructions are formulated using natural rubber and/or natural and synthetic rubber latex. Some products are formulated using chlorinated compounds. For more information regarding these, please contact your customer support representative. PRI Plus Roll Label Constructions are not formulated with the following substances of interest: ● Aromatic amines ● Asbestos or Crystalline Silica ● Azo Dyes ● Benzophenone ● BHT and BHA ● Bisphenol A (BPA) ● Brominated Flame Retardants ● Cobalt ● Dimethyl Fumarate ● Dioxins ● Dysprosium ● Epoxy Derivatives ● Food Material of Food Allergens ● Formaldehyde ● Gadolinium ● Lutetium ● Mica ● Microplastics ● Ozone Depleting Substances ● Phthalate Plasticizers, including DEHP, DINP, DIDP, DnOP, DnHP, BBP, DBP, DIBP, DCHP ● Polychlorinated Biphenyls (PCBs) ● Samarium ● Scandium ● Short-Chained Chlorinated Paraffins (SCCP) ● Terbium ● Tri Nonyl Phenyl Phosphite (TNPP) ● Yttrium

