Product Stewardship Information Sheet: CR350CL
Notice Regarding Medical Application Restrictions
US FOOD AND DRUG ADMINISTRATION (FDA)
The base resin in this product complies with 21 CFR 177.1520(c) 3.1a. In addition, all other
ingredients used in this product meet the requirements of their respective FDA regulations and
21 CFR 178.2010, subject to limitations on temperature or food type contacted.
It is the responsibility of the manufacturer to determine that the articles fabricated from the
product meet both the technical and regulatory requirements for use in their intended
CANADA HEALTH PROTECTION AND FOOD BRANCH (HPFB)
As of July 2, 2014, regulations administered by the Canadian Food Inspection Agency (CFIA) were amended to remove the registration requirement for packaging and other materials used in federally registered establishments. Thus, pre-market approval in Canada for food packaging materials is no longer mandatory, with a few exceptions (e.g., packaging for infant formula). There is no legal obligation to obtain “Letters of No Objection” from HPFB. As such, Phillips 66 no longer requests nor obtains such letters from HPFB.
As before, the responsibility for ensuring the safety of packaged food products resides with the food seller, who is prohibited under Canada’s Food and Drugs Act and Regulations from placing into the market food that is unsafe, unfit for consumption, adulterated, or unsanitary.
EUROPEAN UNION (EU) FOOD CONTACT
This product complies with applicable European Union (EU) food-contact legislation, including the EU regulation 10/2011, when used in food packaging applications, subject to the following conditions and limitations:
- All monomers and additives used in this product are included in the positive lists of the EU 10/2011.
- This product is manufactured in accordance with good manufacturing practices as outlined in 2023/2006/EC.
- At least one additive used in the product is subject to a specific migration limit (SML). Information on the applicable SML will be supplied upon request.
- This product contains Dual Use Additives as defined in (EC) 10/2011: Plastic materials and articles intended to come into contact with food as well as in (EC) 1333/2008: Food additives and/or (EC) 1334/2008: Flavoring and certain food ingredients with flavoring properties for use in and on foods.
It is the responsibility of the manufacturer of the finished food-contact article to verify compliance of the finished article with applicable EU legislation, including the SML noted above, as well as the overall migration limit. In addition, it is the responsibility of the manufacturer of the finished article to verify that their final article, made according to good manufacturing practices (GMPs), does not modify the organoleptic properties of the food. Provided that the above limitations are met in the finished article, the product complies with applicable EU law, including Article 3 of the European Framework Regulation 1935/2004/EC, and the EU regulation 10/2011.
DRUG MASTER FILE (DMF)
Components in this product are listed in DMF 19969.
US PHARMACOPEIA (USP)
- This product meets the requirements for USP 39 / NF 34 Supplement 2 <661.1>.
- Plastic Materials of Construction—PP Identification, Physicochemical Tests, Extractable metals
- Plastic Materials of Construction—Plastic Additives (Phenolic Antioxidants – Test B, and Nonphenolic Antioxidants, Amides and Stearates – Test A)
- This product meets the requirements for a USP Class VI plastic.
EUROPEAN PHARMACOPEIA (EP)
This product has been tested for EP 3.1.3. This product meets EP 7th edition specifications for the test conducted.
This product is not UL listed.
This product is not NSF listed.
Phthalates are not used in the manufacture of or the formulation of this product. However, we do not test this product for phthalates.
NOTICE REGARDING MEDICAL APPLICATION RESTRICTIONS
In no event shall a Phillips 66 Company COPYLENE® product be used in any connection with the following applications:
- US FDA Class III Medical Device, Health Canada Class IV Medical Device, or European Union Class III Medical Device.
- The manufacture of implanted medical or surgical devices.
- Life-sustaining medical applications.
No Phillips 66 Company COPYLENE® product should be used in any US FDA Class II Medical Devices or Health Canada Class II or Class III Medical Devices without prior written approval by Phillips 66 Company for each specific product or application.
This Product Stewardship Information sheet (“PSI”) is intended for informational purposes only. Phillips 66 Company makes no representations or warranties with respect to the accuracy or completeness of the information contained herein. This information in no way modifies, amends, enlarges or creates any specification or warranty, and ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE HEREBY EXCLUDED. The information contained herein relates only to the specific product and/or material designated and may not be valid for such product and/or material used in combination with any other product and/or material. Determination of the suitability and fitness of the specific product and/or material for any application is the sole responsibility of the purchaser. Phillips 66 Company shall not be responsible for any damage or injury resulting from abnormal use, from any failure to follow appropriate practices or from hazards inherent in the nature of the product and/or material, nor for toxicological effects or industrial hygiene associated with particular use of any product described herein. Purchaser must make its own determination that its use of the product is safe and lawful (except as provided in the certifications set forth herein). Information provided is of the date hereof and Phillips 66 Company assumes no responsibility to update, revise or amend this PSI or the information contained herein.